GMO Law Review Articles (Including Notes and Comments)

“The pursuit of food security faces an uncertain future. In the absence of a robust consumer rights framework, both farmers and consumers are heading into a future replete with unsafe and insecure food. Moreover, if the federal regulatory framework continues to rely on arcane federal laws, without incorporating modern research on biotechnology applications’ adverse impacts on environmental, ecological, and human health, the threats to food safety will worsen.” (Saby Ghoshray, “Food Safety and Security in the Monsanto Era: Peering through the Lens of a Rights Paradigm against an Onslaught of Corporate Domination,” Maine Law Review, Vol. 65, No. 2; 2013 – 34 pages)

GMO Law Review Articles (Including Notes and Comments)-Blog (v2)The Encroachment of Intellectual Property Protections on the Rights of Farmers,” by Justin T. Rogers, Drake Journal of Agricultural Law, Vol.15; 2010

This is a resource of law review articles, notes and comments related to GMOs. “Articles,” “Notes” and “Comments” are different types of publications in law journals. Law review journals can be a robust source of information and may be of interest to anyone who is interested in researching the complex subject of GMOs. The publications focus on law-related issues but they also incorporate many other subjects that relate to GMOs. This is a working post that will be updated periodically.


A resource of law review articles, notes and comments related to GMOs

This is a working post that will be updated periodically.

Last update: October 29, 2016

pdf icon A pdf version can be viewed & downloaded HERE.

 

Contents:

Introduction

Law articles, notes & comments in descending order by date of publication

Law articles, notes & comments that address patent and cross-contamination issues

Law articles, notes & comments that address US regulatory issues

Law articles, notes & comments that address ethical issues

Publications that are not published in Law Review Journals that discuss legal issues

Law Review Articles which are not specific to GMOs that may have some relevance

Noteworthy GMO related Lawsuits

Some common Latin phrases used in legal documents

Definition of law articles, notes & comments

Frequently used Acronyms


Introduction

 

Thank you for your interest in this important and complex topic. The subject of GMOs transcends science; the complexity of GMOs overlaps and encompasses many other fields of study and various disciplines, including law, ecology, human rights, ethics, indigenous rights, food sovereignty, sociology, socio-economics, and so much more.

We now live in an age when a handful of corporations more or less control the world’s food system: “With a handful of global seed companies monopolizing the market, we have handed our freedoms over to corporate boards. Right now, according to the ETC Group, six multinationals control 75% of all private-sector plant breeding research, 60% of the commercial seed market and 76% of global agrochemical sales.” (See: “Remembering the Seeds of Freedom,” by Alice Cunningham, Huffington Post; July 8, 2016)

At the root of this development are patent and intellectual property (IP) issues. It has been argued by legal scholars that patent laws are about inventions, and isolating or purifying biological materials do not constitute a legal justification for patentability. DNA is not patentable; essentially, the patents that are the basis for GMOs are granted to biotech corporations illegitimately according to the law. In other words, they are not legal patents. (For example, see: Luigi Palombi, Gene Cartels – Biotech Patents in the Age of Free Trade, Edward Elgar Publishing (November 30, 2010) and “Genetically Modified Plants Are Not ‘Inventions’ and are, therefore, not Patentable,” by Nathan A. Busch, Drake Journal of Agricultural Law, Vol. 10; 2005 – 96 pages). Nathan Busch argues that the “patent laws of the United States and Canada prohibit the issuance of a patent for most, if not all, genetically modified plants, plant cells, and transgenes contained in those cells as well as all other genetically modified organisms.”

(The legality of intellectual patent (IP) rights is only one troubling aspect of GMOs; for many, the very concept of patenting life (and seeds) is an abhorrent unethical action in and of itself.1 For example, the German group Testbiotech writes that, “Ethical boundaries need to take the integrity of the genome into consideration. Genes and living organisms must be excluded from patenting.” (See: “Biotechnology, genetic engineering and our responsibility for nature,” by Testbiotech)).

In 1980, the US Supreme Court decided that living organisms were patentable (Diamond v. Chakrabarty, 447 U.S. 303, 316 (1980)). The Supreme Court “held that living organisms with a requisite degree of creative human agency may be granted utility-patent protection.” (See: “Seeds of Dispute: Intellectual-Property Rights and Agricultural Biodiversity,” by Keith Aoki, Golden Gate University Environmental Law Journal, Vol. 3, Issue 1; 2009).

Despite this landmark Supreme Court hearing, very few Americans are aware of the ramifications of the decision from Diamond v. Chakrabarty. Over time, this led to the manifestation of GMOs as we know them today. Some of the main GM crops are soy, corn, cotton, canola (this is also known as rapeseed), sugar beets, and alfalfa (GM alfalfa is used for animal feed). Consequently, after thousands of patents have been issued in America decades following Diamond v. Chakrabarty, GMOs are so ubiquitous that they touch everyone’s life on a day to day basis whether they realize it or not. For example, taxpayers support the biotech industry in ways that are not well-known. Farm subsidies (supported by tax dollars) may be primarily directed at supporting commodity crop growers and the vast majority of commodity crops (such as corn and soy) are genetically engineered (over 85% to 95% respectively). Additionally, the U.S. Department of Agriculture is mandated to promote biotechnology in agriculture, using American taxpayers to fund research into GMOs. In fact, the Terminator Technology that was patented by Delta & Pine Land Co (seePatent US5723765 – Control of plant gene expression,” by Google Patents; March 3, 1998) was shared by the USDA who helped fund the research that produced the despised seeds that will never reproduce

“In March of 1998, the United States Department of Agriculture and Delta and Pine Land Company announced the joint development and patent of this new self-policing biotechnology. The patent, officially titled ‘Control of Plant Gene Expression,’ provided a tool for the agriculture industry to protect their investments. The terminator technology, which applies to all species of plants and seeds, works by programming the DNA within the plant to kill its own embryos, thus creating sterile seeds. When a farmer attempts to save the seeds produced by these genetically altered plants, the next generation of plants will not grow. This technology is highly controversial as it forces farmers using seeds that employ this technology to buy the seeds from a seed company every year. ‘[F]armers perceive this technology as interfering with [the] traditional and historical right to save and replant seed.’ However, large seed companies saw terminator technology as means to ‘enforce commercial control over seeds.’” [Citations omitted] (See: “The Encroachment of Intellectual Property Protections on the Rights of Farmers,” by Justin T. Rogers, Drake Journal of Agricultural Law, Vol.15; 2010 – 17 pages).

Terminator seeds are considered a severe threat to biodiversity, but the threat to biodiversity from GMOs is not limited to Terminator Technology. Even the Supreme Court considered this to a small degree in their 1980 decision. As one author (Meghan Marrinan Feliciano – who is cited below) pointed out, “In Chakrabarty, the Supreme Court acknowledged that ‘genetic research and related technological developments . . . may result in a loss of genetic diversity.’”

The statement from the Supreme Court cased only considered the loss of genetic biodiversity (Diamond v. Chakrabarty) as a possibility. Decades later, one has to wonder why they failed to have the foresight to understand the ultimate ecological threat that has been the result of their court decision. In 2007, Carmen Gonzalez wrote that:

“One of the primary concerns about GM crops is that they reinforce the monocultural production techniques introduced during the colonial era and reinforced by the Green Revolution and by structural adjustment … the displacement of indigenous crop varieties and biodiverse cultivation systems by monocultures increases vulnerability of crops to pests and disease, depletes the fertility of the soil, increases dependence on synthetic fertilizers and pesticides, increases the probability of catastrophic crop failure in the event of blight, and adversely affects human nutrition by reducing the variety of foods consumed. The cultivation of GM crops is thus inherently inconsistent with the biodiversity necessary to promote ecologically sustainable food production. [Citations omitted] (See: “Genetically Modified Organisms and Justice: The International Environmental Justice Implications of Biotechnology,” by Carmen G. Gonzalez, Georgetown International Environmental Law Review, Vol. 19; 2007 – 53 pages)

Keith Aoki also observed that one of the negative consequences of GMOs today is the relationship to their emergence and proliferation and the increase in the loss of biodiversity:

“While [intellectual-property rights] are not strictly correlated with conservation, the types of markets and companies producing commercial seeds and other agricultural inputs tend to promote monocultures that erode biodiversity in both the developed and developing world. Furthermore … the rise of genetically engineered crops in the last two decades further exacerbates both intellectual-property claims of companies owning patented seed and biodiversity, as metaphorical monoculture becomes realized with genetically engineered crops in fields where all the plants have the same genetic structure … mass-scale industrialized agriculture occurred in the U.S. in the early twentieth century as private companies began to produce seeds and other high-chemical crop inputs like fertilizer, pesticides, and herbicides. During this period, commercial agriculture underwent a fundamental change from a model in which farmers bred and adapted crops to local soil and growing conditions to a model where ‘one seed feeds the world,’ and local conditions were modified to suit a particular seed using chemical supplements. This was the so-called ‘Green Revolution,’ which, in the middle twentieth century, gave rise to high-yield industrial agriculture; environmental degradation and dramatic loss of plant genetic diversity followed … by the 1990s, all of these developments were beginning to intersect. By the end of the twentieth century, genetically engineered (GE) crops such as soybeans, cotton, canola, and corn were beginning to dominate certain agricultural niches in countries like the United States and Canada. This Article considers how the fragmented regulatory framework for genetically modified crops reinforces the increasingly broad intellectual-property rights in such crops, which in turn brings about further erosion of biodiversity.” [Citations omitted] (See: “Seeds of Dispute: Intellectual-Property Rights and Agricultural Biodiversity,” by Keith Aoki, Golden Gate University Environmental Law Journal, Vol. 3, Issue 1; 2009).

 

In the context of GMOs, intellectual property rights (which lead to the loss of biodiversity) pose a threat to food security on a global scale:

“The enforcement of intellectual property protections for seeds limits access to genetic resources that are necessary for plant breeders to develop new varieties of plants. A lack in genetic diversity of crops within a certain geographic area could result in the crops reacting similarly to drought or disease and, thus, resulting in a large-scale crop failure in the event of a far-reaching environmental disaster.” [Citations omitted] (See: “The Encroachment of Intellectual Property Protections on the Rights of Farmers,” by Justin T. Rogers, Drake Journal of Agricultural Law, Vol.15; 2010).

Six years after Keith Aoki’s publication above, Caitlin Kelly-Garrick wrote that:

“Studies show that the introduction of GMOs into the agricultural system actually increases the use of toxic chemicals and negatively impacts the biodiversity of nontarget organisms, including those listed as endangered or threatened to be endangered … In determining the presence of adverse effects on production and consumption, agencies rely on the scientific evidence set forth by the applicant. Once the GMO is approved for deregulation, the regulatory agency ceases oversight of the introduced GMO. This lack of oversight means there is no required review or measurement of the impact of the approved, i.e., deregulated, GMOs on biodiversity after deregulation … This substantial equivalence approach is fundamentally at odds with effective regulation of biodiversity threats: where GMOs are assumed to pose the same risks as other crops, an agency does not have to look at the indirect effects on biodiversity unique to GMOs; where oversight completely ceases with the deregulation of GMOs, an agency does not have to look at the cumulative environmental effects over time … The world is currently in the sixth mass extinction: we have already exceeded the number of extinctions that occurred in the previous five mass extinctions. Normally, a thirty percent decline in the number of species occurs once every ten million years, but over forty percent of all species evaluated by the International Union for Conservation of Nature (‘IUCN’) are currently threatened with extinction. This species decline is directly impacting agricultural outputs.” [Citations omitted] (See: “Using the Endangered Species Act to Preempt Constitutional Challenges to GMO Regulation,” by Caitlin Kelly-Garrick, Hastings Constitutional Law Quarterly, Vol. 43, Issue 1; 2015).

I absolutely agree with Meghan Marrinan Feliciano’s assessment of the patenting of life and join her in her plea to Congress:

“The author begs Congress to address the question of wise IP protection for plants before the world loses the genetic resources necessary to cope with future environmental stresses and unforeseen pests and diseases – before the time bomb in our farmers’ fields leads us to a rendezvous with extinction.” (See: “We Are What We Eat: Securing our Food Supply by Amending Intellectual Property Rights for Plant Genetic Resources,” by Meghan Marrinan Feliciano, University of St. Thomas Law Journal, Vol. 8, Issue 3; Spring – 2011).

Although intellectual property issues (and the questionable legality of granting patents which has led to GMOs) have played a major role in the development of genetically modified foods and the consequent threat to our biosphere, the overall proliferation has been based on systematic lies, fraud, propaganda and disinformation. The primary lie is that GMOs are needed to feed the world. GMOs are not needed to feed the world, now or in the future; this is the Great Lie of GMOs that its supporters rely on to spread this disaster on a global scale. (See: “GMOs are not necessary to feed the World,” – a working post on Ban GMOs Now).

After reading dozens and dozens of law review articles, notes and comments, it became clear that this propaganda has been so ingrained in the generalized belief system of society that very few authors question this lie at all. The vast majority of research in these publications seems to be, on the whole, accurate and thorough. Overall, it is an admirable accomplishment, and all of them deserve praise for the effort and time they have put into them. Yet it is troubling that in so many cases, propaganda and disinformation were mistaken as facts.

(Here is typical example – in this case, it was found in the comment section about a book on GMOs on Amazon: “It comes down to taking the huge risk of GMO run wild to feed an overpopulated world or letting the population starve.”  — Actually, it doesn’t; but this shows that the power of propaganda has nothing to do with facts).

Nonetheless, I feel that all of these publications are worth consideration for those interested in further reading and research.

It’s been my experience that the more people learn about GMOs, the more inclined they are to support a ban on GMOs. They are not needed, unwanted, and have many risks and have caused adverse events and unintended consequences.

We are now facing an extreme global crisis. We are said to be in the 6th Extinction period; some refer to this as the Anthropocene. Many analysts highlight climate change as the main contributor, but this is only a small part of the problem. A recent publication attributed exploitation and agriculture as the two leading contributors:

“Despite a ‘growing tendency for media reports about threats to biodiversity to focus on climate change,’ over-exploitation and agriculture are ‘by far the biggest drivers of biodiversity decline,’ the authors write in a comment published Wednesday in the journal Nature  … Thomas Brooks, a co-author of the report and head of [International Union for the Conservation of Nature] IUCN’s science and knowledge unit, told The New Yorker that while addressing climate change remains crucial, there are more immediate threats to the world’s imperiled species. ‘If we don’t address them, we’re going to lose most of our biodiversity, no matter what we do about climate change,’ he told the publication.” (See: “Climate Change is not the ‘Biggest Killer’ Of Biodiversity,” by Chris D’Angelo, Huffington Post; August 10, 2016)

“They found that 72 percent of species are imperiled by overexploitation (the harvesting of species from the wild at rates that cannot be compensated for by reproduction or regrowth), while 62 percent of species are imperiled by agricultural activity (the production of food, fodder, fiber and fuel crops; livestock farming; aquaculture; and the cultivation of trees). In comparison, 19 percent are considered threatened by climate change. There are 5,407 species threatened by agriculture alone, including cheetah, African wild dog and Asia’s hairy-nosed otter.” (See: “Guns, Nets, and Bulldozers: Three Quarters of the World’s Threatened Species are Imperiled from Agriculture, Land Conversion, Overharvesting,” by the Wildlife Conservation Society, Press release; August 10, 2016).

The global threat of GM agriculture is real and that threat should not be dismissed so that a handful of corporations can continue to have control over the world’s food system; such a system endangers us all.  It is growing and it must be stopped. GM agriculture promotes the type of monoculture, chemical requirements, and more that all contribute greatly to the loss of biodiversity which are ultimately a major threat to our world. We must change the way we grow our food on this planet, and we need to do it now. GMOs should be banned. GMOs need to be banned.  – Jeff Kirkpatrick

We are at a crossroads. There is no doubt that in the age of the ‘Anthropocene,’ biodiversity has already been severely impacted by human activities such as those in agriculture and land use. Gene flow from transgenic organisms and/or from organisms derived from synthetic gene technologies into the environment and native populations, is adding an extra level of risk to biodiversity. If we do not manage to stop the uncontrolled spread of genetically engineered organisms, all future generations will have to deal with new uncertainties, risks and long-term impacts created by current short-term economic interests and flaws in international and national regulation.”

See: “Escape of Genetically Engineered Organisms and Unintentional Transboundary Movements: Overview of Recent and Upcoming Cases and the new Risks from SynBio Organisms,” by Andreas Bauer-Panskus et al, Testbiotech; September, 2015


Law articles, notes & comments in descending order by date of publication

 

 

Transgenic Transboundary Pollution: Liability when Genetically Modified Pollen Crosses National Borders,” by Teal O. Miller, The University of the Pacific Law Review, Vol. 47; 2016 (23 pages)

Also listed with an excerpt under “Law articles, notes & comments that address patent and cross-contamination issues”

 

The Rise of the Mutants: Obtaining Regulatory Approval for the Release of Genetically Modified Mosquitoes,” by Joel F. Aldrich, Columbia Science & Technology Law Review, VOL. XVII; Spring 2016 (23 pages)

Excerpt: [Pages 294-295] The Coordinated Framework for the Regulation of Biotechnology, as promulgated by the Reagan Administration’s Office of Science and Technology Policy, provides a jurisdictional map for the regulation of biotechnology products by various government agencies. Some transgenic insects have previously been tested in the field, and these organisms have traditionally been regulated as a biotechnology product under the authority of the Animal and Plant Health Inspection Service (APHIS). In contrast, the aforementioned mosquito technology is presently pending approval as a “new animal drug” under the FDA. The FDA broadly defines a new animal drug as “any drug intended for use in animals other than man . . . [that] is not generally recognized as safe and effective for the use under the conditions prescribed, recommended, or suggested in the labeling of the drug.” This seemingly inconsistent regulation of genetically modified insects creates confusion among parties interested in the expansion of these technologies (as well as parties interested in the regulation of biotechnology in general) and calls to question the efficacy of the current regulatory regime.

[Page 310] Another potential solution would be to establish a central regulatory authority that conducts an initial assessment of genetically modified organisms seeking regulatory approval and redirects the products to the appropriate governmental agency. This approach has previously been proposed by others, as one commentator suggested that the United States establish a Supreme Office of Transgenic Oversight in response to the unregulated status of the GloFish®. Such an agency would be responsible for taking a first look at all transgenic products (or perhaps all products of genetic manipulation) and then channeling them to the appropriate agency. This office could also assume responsibility for the regulation of any awkward product categories that escape the jurisdiction of the current regulatory agencies. [Emphasis added, citations omitted]

One Turkey, Seven Drumsticks: A Look at Genetically Modified Food Labeling Laws in the United States and the European Union,” by Jessica A. Murray, Suffolk Transnational Law Review, Vol. 39 Issue 1; 2016 (24 pages)

This can also be found HERE

Moderator’s comment:  Some of the points in this article are moot since Congress voted for and then President Obama signed into law the GMO labeling bill in July 2016 (S. 764) which pre-empted the rights of states, such as Vermont, from enacting their own GMO labeling laws.

Excerpt: Along with effects on the environment, the ethical argument is also far-reaching to religious communities, and while considerations of GMOs often include hunger, poverty, ecological risks, and unforeseen consequences, the development of GMOs has also raised religious concerns. For example, within the Jewish religion, biotechnology raises various issues, especially in relation to the Jewish law kilayim, which prohibits mixing species. While the Catholic Church is in a state of uncertainty when interpreting scripture in relation to GMOs, there is emphasis on skepticism relating to humans’ producing unnatural lineages, which are presumed to be solely creations of God. The Catholic Church is generally opposed to humans’ encroaching upon the roles that are traditionally held as divine, such as creation and genetic modification of life. Similar discussions regarding the acceptability of GMOs take place in the Islamic religion and some scholars have suggested that foods derived from GE crops could become haram (non-halal) because there is a possibility they contain DNA from forbidden foods. Ultimately, across the board, religions are open to accepting technological changes like GE foods; however, individuals in those communities remain wary of the developments conflicting with their religious beliefs.

 

When They Don’t Want Your Corn: The Most Effective Tort Claims for Plaintiffs Harmed by Seed Companies Whose Genetically Engineered Seeds Produced More Problems than Profits,” by Sarah Holm, Hamline Law Review, Vol. 38  Issue 3; 2015 (54 pages)

Also listed with an excerpt under “Law articles, notes & comments that address patent and cross-contamination issues”

 

Farming in the Modern Era: Feeding the World with an Environmental Conscience,” by Kelsey Peterson, Seattle Journal of Environmental Law, Vol. 5, Issue 1; May 2015 (28 pages)

Fields of Change: Municipal GMO Regulation and the Federal Takings Clause,” by Kenneth F. Noga, Vermont Law Review, Vol. 39; 2014 (36 pages)

[Can also be downloaded HERE]

Excerpt: Municipal legislative efforts to deal with problems associated with GMOs have only just begun. The issue of how best to deal with the environmental, economic, and human health threats associated with these organisms is unlikely to dissipate in the foreseeable future, crystalizing the need for novel measures to deal with these issues. A flat ban on the planting of GMO crops appears to be a viable option in some circumstances under the constitutional takings standard, so long as the ban allows for subsequent uses of land and patents associated with the GMO. Where commercial products are concerned, a GMO ban is unlikely to rise to the level of a taking at a local level, but a federal ban may tip the balance of interests differently. Despite the ostensible lack of a viable takings claim, the prognosis for the availability of a GMO ban appears somewhat bleak, as industry and farmers alike combat what they see as a threat to both agriculture and their livelihood. Nevertheless, with the constitutional standard requiring just compensation potentially evadable, municipalities may gain confidence in dealing with local problems with local legislation.

 

Pirate Patents: Arguing for Improved Biopiracy Prevention and Protection of Indigenous Rights through a New Legislative Model,” by Katherine A. Kelter, Suffolk University Law Review, Vol. 47; 2014 (24 pages)

Also listed with an excerpt under “Law articles, notes & comments that address patent and cross-contamination issues”

Bowman v. Monsanto: Bowman, The Producer and the End User,” by Tabetha Marie Peavey, Berkeley Technology Law Journal, vol. 29, Issue 4; 2014 (29 pages)

Induced Nuisance: Holding Patent Owners Liable for GMO Cross-Contamination,” by Sabrina Wilson, Emory Law Journal Volume 64:169; 2014 (31 pages)

Also listed with an excerpt under “Law articles, notes & comments that address patent and cross-contamination issues”

 

Genetically Engineered Crops, It’s What’s for Dinner: Monsanto Co. v. Geertson Seed Farms,” by Noreen Guregian, Loyola of Los Angeles Law Review, vol. 44; Spring, 2014 (21 pages)

Also listed with an excerpt under “Law articles, notes & comments that address patent and cross-contamination issues”

 

Organic Farming, Drift, and the Law: Addressing the Legal Mechanisms Enabling Pesticide and GMO Drift in American Agriculture,” Zachariah Baker & Elizabeth Berg, Environmental and Natural Resources Law Center; 2014 (47 pages)

 Also listed under “Law articles, notes & comments that address patent and cross-contamination issues”

 

A Proposed Reconciliation of Stakeholder Interests in the GE Soybean Industry and Role of Earth Jurisprudence Principles,” by Kristen N. King Jaiven, Florida A&M University Law Review, Vol. 10, No. 1; 2014 (37 pages)

Excerpt: This type of innovation may be the answer to our growing population, but these technologies should not be implemented at the expense of other stakeholders in the industry or to the earth community itself. To provide adequate protection and meet maximum sustainability for all interested parties, it is essential that governing law controlling the soybean industry considers the soybean as a stakeholder. To begin this recognition, the interest of all stakeholders, including corporations, farmers, consumers, the earth community, and the soybean, must be balanced. Next, soybean interests should be recognizable and justiciable [able or required to be tried in a court of law]. Finally, the earth community must begin to shift away from an anthropocentric ethical perspective to an eco-centric perspective. Aldo Leopold explains that “a thing is right when it tends to preserve the integrity, stability, and beauty of the biotic community. It is wrong when it tends otherwise.” While we are not sure what a balanced soybean industry will look like, we can be assured that these steps will place us in the direction to ultimately meet the “right” result.

 

Rubber-Stamped Regulation: The Inadequate Oversight of Genetically Engineered Plants and Animals in the United States,” by Genna Reed, Sustainable Development Law & Policy, Volume 14, Issue 3; 2014 (12 pages)

Also listed with an excerpt under “Law articles, notes & comments that address US regulatory issues”

 

The Constitutionality of State-Mandated Labeling for Genetically Engineered Foods: A Definitive Defense,” by George A. Kimbrell & Aurora L. Paulsen, Vermont Law Review, Vol. 39:341; 2014 (70 pages)

Also listed with an excerpt under “Law articles, notes & comments that address US regulatory issues”

 

Playing Politics with Food: Comparing Labeling Regulations of Genetically Engineered Foods across the North Atlantic in the United States and European Union,” by Tiffany B. Wong, San Joaquin Agricultural Law Review, Vol. 23, 2013-2014 (42 pages)

Also listed with an excerpt under “Law articles, notes & comments that address US regulatory issues”

 

Does Regulation Chill Democratic Deliberation? The Case of GMOs,” by Alison Peck, Creighton Law Review, vol. 46; 2013 (56 pages)

This has to be viewed or downloaded from HERE

Also listed with an excerpt under “Law articles, notes & comments that address US regulatory issues”

 

The Wheat and the (GM) Tares: Lessons for Plant Patent Litigation from the Parables of Christ,” by Margo A. Bagley, University of St. Thomas Law Journal, Volume 10, Issue 3; Spring 2013 (32 pages)

Also listed with an excerpt under “Law articles, notes & comments that address patent and cross-contamination issues”

 

Is Anyone Regulating? The Curious State of GMO Governance in the United States,” by Rebecca Bratspies, Vermont Law Review, Vol. 37; 2013 (35 pages)

Also listed with an excerpt under “Law articles, notes & comments that address US regulatory issues”

 

Gone with the Wind: Why Even Utility Patents Cannot Fence in Self-Replicating Technologies,” by Jessica Lynd, American University Law Review, Vol. 62 Issue 3; 2013 (40 pages)

Also listed with an excerpt under “Law articles, notes & comments that address patent and cross-contamination issues”

 

Food Safety and Security in the Monsanto Era: Peering through the Lens of a Rights Paradigm against an Onslaught of Corporate Domination,” by Saby Ghoshray, Maine Law Review, Vol. 65, No. 2; 2013 (34 pages)

Excerpt: Inadequate regulation since the 1980s has allowed corporate interests to predominate the consumer food crop in the U.S. An abundance of GM crops began flooding the U.S. food chain without adequately analyzing the long-term effects of consumption of GM crops on human health and the natural environment … Moreover, if the federal regulatory framework continues to rely on arcane federal laws, without incorporating modern research on biotechnology applications’ adverse impacts on environmental, ecological, and human health, the threats to food safety will worsen.

… Beneath the glossy veneer of America’s food system, there is a silent yet stark reality. This reality manifests itself in many ways: through the documented stories of farmers’ plights under biotechnology corporation’s seed restrictions, in consumers’ inability to identify their genetically modified staples, through transgenic pollution and proliferation of superweeds. Prompted by this realization, this essay embarked on exploring some poignant questions: Is American food security at peril? Has America’s legendary food safety been hijacked by unbridled corporatization? Tracing two distinct legal pathways – the regulatory landscape and the intellectual property paradigm – this essay addresses food security and safety along the same thematic lines.

Commenting on the linkages between threats to the food system and the legal paradigms overseeing the system, I contend that, although the concepts are fundamentally distinct, they are also complementary, conveying similar concerns within a broader spectrum. They are also linked in terms of their corresponding supervisory legal frameworks, which leads to two observations. First, threats to food security arise from questionable patent prosecutions of farmers, which are facilitating a broader agenda of corporate hijacking of the intellectual property framework. Second, threats to food safety in the U.S. have been accentuated by lackluster implementation of biotechnology regulations, wherein regulatory authority is derived from arcane statutes and through a fragmented patchwork of federal agencies.

A future safe and secure food supply in the U.S. must be illuminated by two observations from the present. First, the current regulatory framework inadequately deals with the uncertain and complex nuances of biotechnology applications for food crops. Second, loopholes within the current intellectual property framework have allowed leading agriculture biotechnology companies to reshape centuries-old farming practices in the U.S. As an example, by using its leadership position in agricultural biotechnology, Monsanto has been able to both monopolize the market and force both farmers and consumers into making less than optimal choices.

Finally, this essay calls for a reexamination of the traditional discourse on food safety and security in the West. By shifting the conversation into a rights-based narrative, we must first identify the rights that must be part of the conversation. Second, we must place these rights within their identifiable loci. After all, without identifying appropriate rights and how they must evolve, we cannot develop a proper construction of such rights. It is high time to recognize the rights of farmers, consumers, and non-corporate citizens within the broader spectrum of fundamental rights. Only then will the inertia within both the regulatory and intellectual property paradigms be disturbed, and only then humans will be empowered to change course from an unbridled pursuit of eat, drink and be merry to a tempered pursuit that fosters life, celebration, and more importantly, food and water prosperity for all mankind. [Emphasis added, citations omitted]

 

More than Curiosity: The Constitutionality of State Labeling Requirements for Genetically Engineered Foods,” by Laura Murphy, Jillian Bernstein & Adam Fryska, Vermont Law Review, vol. 38; 2013 (78 pages)

 

Lack of Transparency in the Premarket Approval Process for AquAdvantage,” by Michael P. McEvilly, Duke Law & Technology Review, vol. 11, no. 2; 2013 (21 pages)

Also posted with an excerpt under “Law articles, notes & comments that address US regulatory issues”

 

Genetic engineering and seed banks: Impacts on global crop diversity,” by Dr. Sommer Jenkins, Macquarie Journal of International and Comparative Environmental Law, Volume 9 Issue 1; 2013 (11 pages)

 

Liability for Genetically Modified Food: Are GMOs a Tort Waiting to Happen?” by Debra M. Strauss, The SciTech Lawyer; Fall, 2012 (6 pages)

This publication can also be viewed and downloaded from HERE.

 

From Wall Street to Wheat Fields: Using the Business Method Patent’s ‘First Inventor Defense’ as a Model for Genetically Engineered Seed Protection,” by Christopher W. Dawson, The George Washington Law Review, Vol. 80 No. 4; June 2012 (35 pages)

Also posted with an excerpt under “Law articles, notes & comments that address patent and cross-contamination issues”

 

Genetically Modified Plants and Regulatory Loopholes and Weaknesses under the Plant Protection Act,” by Emily Montgomery, Vermont Law Review, Vol. 37; 2012 (30 pages)

Also posted with an excerpt under “Law articles, notes & comments that address US regulatory issues”

Food and Superfood: Organic Labeling and the Triumph of Gay Science over Dismal and Natural Science in Agricultural Policy,” by Jim Chen, Idaho Law Review, Vol. 48, Issue 2; 2012 (13 pages)

[This can be viewed or downloaded from HERE and it can also be downloaded from HERE]

Excerpt: If indeed the release of genetically modified organisms imperils the environment – whether through gene flow among related species, negative impact on non-target organisms, or the acceleration of herbicide or pesticide resistance – then consumer warnings represent a woefully inadequate regulatory response. At the very least, these concerns demand production-level controls. If the environmental threats are that substantial, the only proper remedy is parallel to the remedy that American food and drug law prescribes for any agent that adulterates food: an outright ban. As a tool for managing the risks that may arise from the use of genetically modified organisms, labeling effectively abdicates responsibility over serious questions of environmental protection and public health to the basest of instincts among uninformed consumers: ignorance, fear, and distrust. [Emphasis added]

 

Where’s the Beef? How Science Informs GMO Regulation and Litigation,” by Guy R. Knudsen, Idaho Law Review, vol. 48, Issue 2; 2012 (27 pages)

Excerpt: (Pages 233-234) Monsanto’s NewLeaf potato varieties remain fully approved in the U.S. and Canada, and as the company itself notes, potatoes are an important crop and the day may come when, depending on market demand and other factors, Monsanto will re-enter the GM potato business. If that day comes, the company is likely to avoid the strategic mistake of widely advertising the GM nature of its product. The reluctance of consumers to knowingly purchase and eat transgenic foods presents an ongoing challenge to the agricultural biotech industry, which has devoted considerable resources to defeating efforts to require labeling of GM food products. Controversy over GM food labeling has frequently been presented as an “expert-lay divide,” with the implicit assumption that scientifically unsophisticated consumers are incapable of making informed choices.

Opponents of labeling have attempted to portray the biotech industry’s anti-labeling stance as a consumer protection issue. For example, the American Enterprise Institute has published a widely publicized book, which claims that GM food labeling laws in other countries have “no scientific justification . . . [and] have succeeded in stigmatizing and limiting the availability and benefits of GM foods.” As so often happens in biotech versus anti-biotech skirmishes, the side that most convincingly allies itself with science acquires a potent public relations weapon.

The biotech industry and some governmental organizations, both national and international, routinely make the claim that a history of safely using GM foods can be upheld. However, the suggestion has been made that biotechnology companies would enhance the credibility of such claims if they routinely published results of their studies on the safety of GM foods in international peer-reviewed journals. As Jose Domingo remarked in a letter to the journal Science, “[t]he general population and the scientific community cannot be expected to take it on faith that the results of such studies are favorable. Informed decisions are made on the basis of experimental data, not faith.” Critics have noted that there is a paucity of long-term human or animal epidemiological studies to support claims of GMO safety due in part to the lack of labeling and traceability in GMO-producing countries. Indeed, the vast majority (ninety-seven percent by some estimates) of edible GM crops (soy, corn, oilseed rape, canola, excluding cotton) are grown in South and North America, where GMOs are not labeled. [Citations omitted]

 

Intellectual Property and Market Power in the Seed Industry: The Shifting Foundation of Our Food System,” by James Matson et al, University of Wisconsin Law School, Government and Legislative Clinic, September 1, 2012 (38 pages)

[This has to be downloaded from HERE]

Monsanto Co. v. Geertson Seed Farms: Limiting District Courts’ Equitable Discretion to Grant Permanent Injunctions for NEPA Violations,” by Nicole E. Grimm, Journal of Business & Technology Law, Vol. 7, Issue 1; 2012 (25 pages) [NOTE: The cover page has misspelled ‘Geertson’]

 

Reframing the Judicial Approach to Injunctive Relief for Environmental Plaintiffs in Monsanto Co. v. Geertson Seed Farms,” by Sarah Axtell, Ecology Law Quarterly, vol. 38, Issue 2; March 2011 (25 pages)

Excerpt: In Monsanto Co. v. Geertson Seed Farms, the Supreme Court reversed the Ninth Circuit’s permanent injunction against partial deregulation and planting of genetically engineered alfalfa. The Court held that a four-factor test applies when a plaintiff seeks a permanent injunction to remedy a National Environmental Policy Act violation. Even though the only remedy available to the plaintiffs was an injunction, the Court reasoned that it was overbroad because irreparable harm to the environment was not certain.

This Note argues that the Monsanto decision cuts away at the longstanding judicial approach of granting near automatic injunctions for environmental harms by requiring judges to instead follow a balancing test to determine whether an injunction should issue. Further, it discusses how the Monsanto decision fits into established trends of the conservative Supreme Court. Finally, this Note analyzes the implications of the four-factor balancing test, focusing on how it affects the availability of judicial remedies and the standards of judicial review.

[Page 339]: Monsanto presents a troubling development in environmental law. The Supreme Court uses a seemingly innocuous case to significantly reframe how courts approach environmental plaintiffs and requests for injunctive relief. The decision cuts away at the longstanding judicial approach of granting nearly automatic injunctions for violations of environmental law where environmental injury was presumed irreparable.

Monsanto replaces the prioritization of environmental injury with a balancing test. The four-part balancing test is not well suited to remedying environmental harms. Although it is the generic standard for injunctive relief across legal disciplines, environmental harm is different and deserves special attention. Environmental harms do not nicely map onto a balancing scale because the injury is often irreversible and physically and temporally distant. It is difficult for judges to properly value harms that develop in the future or may occur in different jurisdictions. Therefore, if irreparable harm is not presumed, judges may devalue complicated environmental effects in the face of urgent economic needs.

Although a balancing of factors in equity may eliminate some of the unnecessary litigation that arises under NEPA, the tradeoff is too severe. Environmental plaintiffs often seek injunctive relief as their only remedy, so reducing the frequency of injunctive relief reduces the frequency of environmental relief as a whole. Further, the balancing test makes it more difficult for environmental plaintiffs to obtain judicial review under the deferential abuse-of-discretion standard, which is particularly troubling since ideologically driven decisions will be more likely to stand. Environmental protection is too important to be put in such a precarious position. [Emphasis added]

 

We Are What We Eat: Securing our Food Supply by Amending Intellectual Property Rights for Plant Genetic Resources,” by Meghan Marrinan Feliciano, University of St. Thomas Law Journal, Vol. 8, Issue 3; Spring – 2011 (24 pages)

Excerpt: [Page 546]: Today, crop genetic diversity is at great risk, and its diminishing existence threatens the sustainability of the world’s food supply. The danger is real: between 1903 and 1983, more than 95% of U.S. tomato varieties were lost. If we want tomatoes, as well as other crops, to remain on the table, we must act to preserve the diverse genetic resources found in agriculture around the globe.

[Pages 550]: In a study conducted by the Rural Advancement Foundation International (RAFI), it was found that between the years 1903 and 1983, the United States lost nearly 93% of its lettuce varieties, over 96% of sweet corn, about 91% of field corn, more than 95% of tomato, and almost 98% of asparagus. During the last century, over 7,000 named varieties of apples were grown in the United States. Today, less than fifteen percent of these varieties survive, and two varieties alone account for more than 50 percent of the current apple market. Likewise, at the close of the twentieth century, 73 percent of all the lettuce grown in the United States was iceberg. This relatively bland variety is often the only choice consumers have. Meanwhile, we have lost hundreds of varieties of lettuce with flavors ranging from bitter to sweet and colors from dark purple to light green. As this diminishing diversity suggests, monocultures are spreading through farm fields around America: Six types of corn now occupy 71 percent of the acreage in the United States, while two types of peas occupy 96 percent of the national acreage. Of the over 5,000 varieties of potatoes found worldwide, only four are major commercial varieties. With this growing crop monoculture, genetic erosion threatens to cause the degradation of the ability of agriculture to meet global food demand.

[Moderator’s note: Mentioned below, Diamond v. Chakrabarty was decided in 1980 by the Supreme Court. The ruling authorized the patenting of a genetically-engineered living organism.]

In Chakrabarty, the Supreme Court acknowledged that “genetic research and related technological developments . . . may result in a loss of genetic diversity.”204 While recognizing that the eligibility of Chakrabarty’s bacteria for a patent “may determine whether research efforts are accelerated by the hope of reward or slowed by want of incentives,”205 the Court clarified its role of interpreting the statute and called on the legislature to analyze this “matter of high policy.”207 Congress has not responded since Chakrabarty or its progeny.

The time is ripe for Congress to heed the Court’s call. This Note urges Congress to contrast the principles behind the patent system to the present day tapestry of IP protection for plants. In light of the modern crisis surrounding PGRs [plant genetic resources], as well as agriculture’s unique historical development, the author asks Congress to re-articulate the contours of IP protection for plants, evaluating proposals in light of how well they (1) protect crop genetic diversity and (2) equitably recognize the contributions and innovations of various stakeholders. To begin the dialogue, the author suggests four possibilities. First, in order to increase access to germplasm for crop development, Congress could create a research exemption for plants covered by UPs. Second, no-replant policies could be prohibited. By creating a system in which farmers make equitable royalty payments to patent holders in exchange for the ability to save seeds year to year, Congress could protect the interests of both patent holders and farmers. Third, Congress could protect farmers who opt not to plant genetically modified seeds, including organic farmers, by passing a law which clearly holds patent holders accountable for the spread of their genetically modified crops. If a patented trait contaminates a farmer’s field, the farmer should receive compensation for the damage done to his or her enterprise, and not be held strictly liable for patent infringement … The author begs Congress to address the question of wise IP protection for plants before the world loses the genetic resources necessary to cope with future environmental stresses and unforeseen pests and diseases – before the time bomb in our farmers’ fields leads us to a rendezvous with extinction. [Emphasis added, most citations omitted, most internal quotation marks omitted]

Citations not omitted:

204 Diamond v. Chakrabarty, 447 U.S. 303, 316 (1980)

205 Id. at 317

207 Id. at 307

 

Patents, Genetically Modified Foods, and IP Overreaching,” by Elizabeth A. Rowe, Southern Methodist University Law Review, Vol. 64; 2011 (37 pages)

Also listed with an excerpt under “Law articles, notes & comments that address patent and cross-contamination issues”

 

Comment: Protecting the Farmers: Limiting Liability for Innocent Infringement of Plant Patents,” by Kathleen C. Rose, Wake Forest Journal of Business and Intellectual Property Law, Vol. 12, No. 1; 2011 (19 pages)

 

An analysis of the FDA Food Safety Modernization Act: Protection for consumers and boon for business,” by Debra M. Strauss, Food and Drug Law Journal, Vol. 66, No. 3; December 2010 (25 pages)  [Can also be viewed and downloaded HERE]

Also listed with an excerpt under “Law articles, notes & comments that address US regulatory issues”

 

The Encroachment of Intellectual Property Protections on the Rights of Farmers,” by Justin T. Rogers, Drake Journal of Agricultural Law, Vol.15; 2010 (17 pages)

 

We Reap What We Sow: The Legal Liability Risks of Genetically Modified Food,” by Debra M. Strauss, Journal of Legal Studies in Business, Vol. 16; January 1, 2010 (29 pages)

 

Geertson Seed Farms v. Johanns: Why Alfalfa is Not the Only Little Rascal for Bio-Agriculture Law,” by Allison M. Straka, Villanova Environmental Law Journal, Vol. 21, Issue 2; 2010 (25 pages)

Also listed with an excerpt under “Law articles, notes & comments that address patent and cross-contamination issues”

 

As Montville, Maine Goes, So Goes Wolcott, Vermont? A Primer on the Local Regulation of Genetically Modified Crops,” by Charles J. Bussell, Suffolk University Law Review, Vol. 43; 2010 (22 pages)

 

Integrating Social and Ethical Concerns into Regulatory Decision-Making for Emerging Technologies,” by Gary Marchant et al, Minnesota Journal of Law, Science & Technology, Vol. 11, Issue 1; 2010 (20 pages)

Also listed with an excerpt under “Law articles, notes & comments that address ethical issues”

 

Genetically Modified Plants Used for Food, Risk Assessment and Uncertainty Principles: Does the Transition from Ignorance to Indeterminacy Trigger the Need for Post-Market Surveillance?” by Katharine A. Van Tassel, Boston University Journal of Science and Technology Law, Vol. 15; July 7, 2009 (32 pages)

This can be viewed online and downloaded from HERE

Also listed with an excerpt under “Law articles, notes & comments that address US regulatory issues”

 

Food Labeling and the Consumer’s Right to Know: Give the People What They Want,” by David Alan Nauheim, Liberty University Law Review: Vol. 4: Issue 1, Article 3; 2009 (38 pages)

Also listed with an excerpt under “Law articles, notes & comments that address US regulatory issues”

 

The Application of TRIPS to GMOs: International Intellectual Property Rights and Biotechnology,” by Debra M. Strauss, Stanford Journal of International Law, Vol. 45, No. 2; December 2009 (34 pages)

 

Globalization and National Sovereignty: Controlling the International Food Supply in the Age of Biotechnology,” by Debra M. Strauss, Journal of Legal Studies in Business, Vol. 15; December 2009 (20 pages)

 

Crop Insurance in the Age of Biotechnology: Should Federal Crop Insurance Endorse Biotechnology?” by Steve Cooper, Connecticut Insurance Law Journal Vol. 15, Issue 2; 2009 (36 pages)

 

Comment on Intellectual Property, Concentration and the Limits of Antitrust in the Biotech Seed Industry,” by F Kieff, et al, George Washington University Law Faculty Publications; 2009 (18 pages)

 

Seeds of Dispute: Intellectual-Property Rights and Agricultural Biodiversity,” by Keith Aoki, Golden Gate University Environmental Law Journal, Vol. 3, Issue 1; 2009 (83 pages)

Also listed with an excerpt under “Law articles, notes & comments that address patent and cross-contamination issues”

 

Genetically Modified Organisms: Who Should Pay the Price for Pollen Drift Contamination?” by Stephanie E. Cox, Drake Journal of Agricultural Law, Vol. 13; September 2008 (18 pages)

 

The Case for Regulating Intragenic GMOs,” by A. Wendy Russell and Robert Sparrow, Journal of Agricultural and Environmental Ethics, Vol. 21, Issue 2; 2008 (29 pages)

Also listed with an excerpt under “Law articles, notes & comments that address ethical issues”

 

Distributive and Syncretic Motives in Intellectual Property Law (with Special Reference to Coercion, Agency, and Development),” by Keith Aoki, UC Davis Law Review, Vol. 40, Issue 3; March 2007 (85 pages)

Also listed with an excerpt under “Law articles, notes & comments that address patent and cross-contamination issues”

 

Transboundary Pollution: Harmonizing International and Domestic Law,” by Noah D. Hall, University of Michigan Journal of Law Reform, vol. 40, Issue 4; 2007 (68 pages)

Also listed with an excerpt under “Law articles, notes & comments that address patent and cross-contamination issues”

 

A Court’s Dilemma: When Patents Conflict with Public Health,” by Julie A. Burger & Justin Brunner, Virginia Journal of Law & Technology, Vol. 12, No. 7; 2007 (42 pages)

Also listed with an excerpt under “Law articles, notes & comments that address patent and cross-contamination issues”

 

Defying Nature: The Ethical Implications of Genetically Modified Plants,” by Debra M. Strauss, Journal of Food Law & Policy Vol. 3, No. 1; 2007 (37 pages)

Also listed with an excerpt under “Law articles, notes & comments that address ethical issues”

 

Genetically Modified Organisms and Justice: The International Environmental Justice Implications of Biotechnology,” by Carmen G. Gonzalez, Georgetown International Environmental Law Review (GIELR), Vol. 19; 2007 (53 pages)

This publication can be viewed and downloaded from HERE

 

Genetically Modified Organisms in Food: a Model of Labeling and Monitoring with Positive Implications for International Trade,” by Debra M. Strauss, The International Lawyer, Vol. 40, No. 1; Spring, 2006 (26 pages) [This document is of poor quality]

 

Biopiracy and Beyond: A Consideration of Socio-Cultural Conflicts with Global Patent Policies,” by Cynthia M. Ho, University of Michigan Journal of Law Reform, Vol. 39; June 8, 2006 (110 pages)

 

High Plains Drifting: Wind-Blown Seeds and the Intellectual Property Implications of the GMO Revolution,” by Stephanie M. Bernhardt, Northwestern Journal of Technology and Intellectual Property, Vol. 1, Issue 4; 2005 (14 pages)

 

Out of the Petri Dish and Back to the People: A Cultural Approach to GMO Policy,” by Cara V. Coburn, Wisconsin International Law Journal vol. 23, No. 2; 2005 (38 pages)

Excerpt: In 1996, 1.7 million hectares in the United States were planted with commercial GM crops; by 1999, that number had risen to 28.7 million hectares. Since 1996, companies have developed over 4,000 varieties of GM soybeans, hundreds of varieties of GM corn, and hundreds of varieties of GM wheat. The value of all GM crops grown in the world is estimated at US$44 billion, and the United States is the largest producer, with US$ 27.7 billion worth of GM crops. Given the prohibitively costly nature of biotech research and development, a few highly capitalized Northern multinationals have dominated agricultural GMO development. In 2000, this included Monsanto, Dow, DuPont, Bayer, and other chemical companies that had business deals with seed and breeding companies. With exclusive rights to products and few competitors, these corporations exerted increasing control over the market.

Furthermore, GMO corporations have manipulated those who purchase GMOs. It has been reported that Monsanto and Pioneer, another of the multinational seed companies, colluded in the early to mid-1990s to charge customers elevated prices for their GM seeds. In addition, under the “Roundup Ready Gene Agreement,” which Monsanto forced farmers to sign as a condition of purchasing the Roundup Ready soybean, farmers had to pay a $5 “technology fee” surcharge for each pound of seed they purchased. The farmers could neither save the seeds for their own use nor sell or supply them or materials derived from them to any other person or entity. If any part of the agreement was violated, the farmer had to pay 100 times the value of damages. Finally, for three years following signature of the agreement, Monsanto had the right to visit each farmer’s fields, regardless of the farmer’s presence or permission. Missing from the agreement was any liability clause that might hold Monsanto responsible in the event that the seeds failed or caused ecological damage. By marketing GMOs as something without which farms cannot survive and forcing farmers to enter into such “contracts,” savvy multinational corporations have reaped enormous profits at the cost of farmer autonomy, choice, and dignity.

Meanwhile, the U.S. government supports GMOs. U.S. federal agencies have spent, and continue to spend, millions of dollars on international GMO marketing. The U.S. Department of Agriculture (USDA) spends about US $60 million each year researching biotechnology, “educating” current and potential markets, conducting training programs, undertaking regulatory capacity building initiatives, and collaborating with researchers in LDCs. Another significant promoter of GMOs is the U.S. Agency for International Development (USAID), the foreign assistance branch of the U.S. State Department. USAID spends about US $7 million on cooperative research and development programs annually. Having dedicated millions of dollars to GMO development and marketing, the U.S. government has an interest in generating worldwide demand for GMOs. [Emphasis added, citations omitted]

 

The Innocent Bystander Problem in the Patenting of Higher Life Forms,” by Norman Siebrasse, McGill Law Journal, vol. 49; 2004 (44 pages)

 

Farmers’ Rights,” by John E. Haapala, Journal of Environmental Law and Litigation, Vol. 19, No. 2; 2004 (7 pages)

 

Patent Pools and Antitrust Concerns in Plant Biotechnology,” by John E. Haapala, Journal of Environmental Law and Litigation, Vol. 19; 2004 (20 pages)

 

Product vs. Process: Two Labeling Regimes for Genetically Engineered Foods and how they relate to Consumer Preference,” by Lauren Zeichner, Environs, Vol. 2; Spring 2004 (24 pages)

 

In re StarLink Corn: The Link between Genetically Damaged Crops and an Inadequate Regulatory Framework for Biotechnology,” by Linda Beebe, William & Mary Environmental Law and Policy Review, Vol. 28, Issue 2; 2004 (28 pages)

Also listed under “Law articles, notes & comments that address US regulatory issues”

 

Legal Issues Related to the Use and Ownership of Genetically Modified Organisms,” by Roger A. McEowen, Washburn Law Journal, Vol. 43; 2004 (50 pages)

Also listed with an excerpt under “Law articles, notes & comments that address US regulatory issues”

 

Traditional and Modern-Day Biopiracy: Redefining the Biopiracy Debate,” by David Conforto, Journal of Environmental Law and Litigation, Vol. 19, Issue 2; 2004 (40 pages)

Excerpt:  If history is any indicator, biodiversity and biotechnology cannot coexist. At odds in the traditional biopiracy debate are the developing global South, home to the large majority of the earth’s flora and fauna, and the global North, owner of the capital and technology necessary to develop this natural wealth.

 

Pollen Drift and Potential Causes of Action,” by Carie-Megan Flood, Journal of Corporation Law, vol. 28; 2003 (26 pages)

Also listed with an excerpt under “Law articles, notes & comments that address patent and cross-contamination issues”

 

J.E.M. Ag Supply, Inc. v. Pioneer Hi-Bred International, Inc. – Its Meaning and Significance for the Agricultural Community,” by Michael T. Roberts, Southern Illinois University Law Journal; 2003 (36 pages)

 

Patent First, Ask Questions Later: Morality and Biotechnology in Patent Law,” by Margo Bagley, William & Mary Law Review, vol. 45, Issue 2; 2003 (80 pages)

Also listed with an excerpt under “Law articles, notes & comments that address ethical issues”

 

The Illusion of Care: Regulation, Uncertainty, and Genetically Modified Food Crops,” by Rebecca Bratspies, New York University Environmental Law School Journal, Vol. 10; December 12, 2002 (59 pages)      [Can also be viewed and downloaded HERE]

Also listed with an excerpt under “Law articles, notes & comments that address US regulatory issues”

 

Biopiracy: The Appropriation of Indigenous Peoples’ Cultural Knowledge,” by Marcia Ellen DeGeer, New England Journal of International and Comparative Law, Vol. 9; 2002 (30 pages)

 

Seed Wars: Biotechnology, Intellectual Property and the Quest for High Yield Seeds,” by Lara E. Ewens, Boston College International and Comparative Law Review, vol. 23, issue 2; 2000 (27 pages)

Also posted with an excerpt under “Law articles, notes & comments that address patent and cross-contamination issues

 

Intellectual Property Rights and Biodiversity: The Industrialization of Natural Resources and Traditional Knowledge,” by Mark Ritchie, Kristin Dawkins and Mark Vallianatos, Journal of Civil Rights and Economic Development, vol. 11, issue 2; March 1996 (25 pages)

Also posted with an excerpt under “Law articles, notes & comments that address patent and cross-contamination issues”


Law articles, notes & comments that address patent and cross-contamination issues

 

Transgenic Transboundary Pollution: Liability when Genetically Modified Pollen Crosses National Borders,” by Teal O. Miller, The University of the Pacific Law Review, Vol. 47; 2016 (23 pages)

Excerpt: (Page 323) The spread of genetically modified plants is a global environmental issue. Keeping transgenes within a nation’s borders is impossible; they spread not only through trade of foodstuffs, but also through natural means like the dispersal of pollen by wind and insects. Because of this, nations leading GM crop development must be thorough in their assessments of the environmental impacts of those crops. Moreover, these nations need to ensure that their policies and use of GM crops do not harm their neighbors environmentally, culturally, politically, or economically. Transboundary pollution law principles are applicable to the spread of transgenes and it follows that each nation must ensure that no activities involving GM crops occurring within its borders negatively affect its neighbors.

As the leader in the development of new biotechnologies and transgenic crops, the United States holds the unique position of being the first to study and determine the risks of allowing a new transgenic crop to be planted. As of now, the United States has some of the world’s lowest standards for allowing new GM crops into the market. Because of international trade regulations, other countries that are more wary of transgenic crops have been required to lower their own standards and accept the import of GM products. This allows the United States to set the bar on how in-depth a new GM crop and its effects on the environment must be examined before being commercialized. However, if such a new product does have a deleterious effect on the environment of the United States or a neighbor, such as Mexico, then the principles put forth in Trail Smelter and its progeny provide a basis for liability. [Emphasis added, citations omitted]

 

When They Don’t Want Your Corn: The Most Effective Tort Claims for Plaintiffs Harmed by Seed Companies Whose Genetically Engineered Seeds Produced More Problems than Profits,” by Sarah Holm, Hamline Law Review, Vol. 38 Issue 3; 2015 (54 pages)

Excerpt: Moreover, the United States’ patchwork regulatory system rewards the seed companies’ “beg forgiveness later” approach by retroactively approving genetically engineered crops. This approach may make life easier for the regulatory bodies but it does not instill confidence in farmers and exporters. Unfortunately for the U.S. agricultural industry, there are no signs that the patchwork system that regulates genetic engineering will be reformed. Therefore, the likely occurrence of future cases like StarLink Corn, LibertyLink Rice, and Syngenta Corn is not a question of if, but one of when.

 

Pirate Patents: Arguing for Improved Biopiracy Prevention and Protection of Indigenous Rights through a New Legislative Model,” by Katherine A. Kelter, Suffolk University Law Review, Vol. 47; 2014 (24 pages)

Excerpt: The protection of indigenous biodiversity is at an international crossroad. Without the intervention of substantial national legislation, the agricultural crops and their associated traditional, indigenous knowledge face extinction at the hands of a richer, more legally savvy world. Extinction of biodiversity anywhere threatens agriculture everywhere. Current international legislation fails to accommodate the unique nature of indigenous crop development and the indigenous innovators have subsequently suffered from the gap.

From an American perspective, lacking strong national regulation over biodiverse resources exposes the United States to biopiracy from global competitors. By implementing the provisions of the model, the United States and its developed counterparts could more adequately protect its own indigenous resources and ensure their sustainable growth and development for generations to come. From an indigenous perspective, enhanced national legislation explicitly tailored toward indigenous concerns will protect their rights over developed biodiversity and its traditional knowledge, ensuring its continued existence into the future. [Citations omitted, emphasis added]

 

Genetically Engineered Crops, It’s What’s for Dinner: Monsanto Co. v. Geertson Seed Farms,” by Noreen Guregian, Loyola of Los Angeles Law Review, vol. 44; Spring, 2014 (21 pages)

Excerpt: On January 27, 2011, the U.S. Department of Agriculture (USDA) decided to fully deregulate Monsanto’s genetically engineered crops – a choice favored by large biotech companies. This step was taken after an extensive inquiry into the effects of RRA [Roundup Ready Alfalfa] deregulation, a draft EIS [Environmental Impact Statement] that listed preliminary conclusions, and a public comment period, which was met with such an overwhelming response that the APHIS decided to extend the public comment period. The USDA had the option to maintain “regulatory status” over RRA, an incredibly important crop for the livestock industry, or the option to limit the deregulation with bans on the planting of GE alfalfa seeds in seed growing regions to attempt to limit the contamination of alfalfa seed stock by foreign DNA from Monsanto’s crop. Instead, although receiving over 250,000 public comments, with the majority opposing deregulation, the agency decided to completely deregulate under extensive pressure from the biotech sector.  One positive result is the announcement that the USDA would establish a second germ plasm/seed center for alfalfa in the state of Idaho to try and maintain GE-free strains of alfalfa. Even so, full deregulation to the extent allowed by the USDA will have severe consequences on both the farming industry and the environment.

Monsanto [Monsanto Co. v. Geertson Seed Farms] has far broader implications beyond GE alfalfa. For one, it illustrates the growing trend of genetic modification in agriculture, the unanswered questions surrounding its environmental effects, and the insufficiency of APHIS’s decision-making under existing laws. Deregulation can lead to the contamination of pure strains of alfalfa, a complaint described by the owner of Geertson Seed Farms. It is critical to keep strains of alfalfa pure from crosspollination to ensure the health of those consuming organic products. If the distinction between pure and GE alfalfa is blurred, the farming industry, more specifically small, family-owned farms, will encounter great obstacles in distinguishing between GE and pure varieties of their crop.

… Furthermore, the American Academy of Environmental Medicine’s (the “Academy”) position on GE crops is that they “have not been properly tested and pose a serious health risk,” and that production of GE foods should be halted until long-term studies demonstrate their safety. According to the Academy, “[a]nimal studies indicate serious health risks associated with GE crops,” including reproductive problems, compromised immunity, accelerated aging, blood sugar imbalances, and harm to major organs. Many other local and national environmental, public health, and consumer protection organizations are also calling for these initiatives to be taken and for Monsanto’s destructive ways to be stopped.

Despite GE agriculture’s wide usage, GE products are regulated under APHIS, an agency that was “created at a time when [GE] products had not yet been conceived.” As a result, the current regulations governing GE agriculture do not properly handle the issues that GE crops pose … Furthermore, courts are not equipped to make decisions about the safety of GE products for two reasons. First, they lack the necessary scientific knowledge to make findings about the safety of these products. And second, there is insufficient research to provide to courts when making decisions about GE food safety … Given the significant increase in GE foods, legislatures must develop new laws specifically geared to the regulation of GE agriculture and the “division of regulatory authority over [GE] agriculture must shift from APHIS to an agency with the scientific knowledge, experience, and resources to properly assess the environmental effects of this technology.” [Internal quotation marks omitted, citations omitted, bold emphasis added]

 

Organic Farming, Drift, and the Law: Addressing the Legal Mechanisms Enabling Pesticide and GMO Drift in American Agriculture,” Zachariah Baker & Elizabeth Berg, Environmental and Natural Resources Law Center; 2014 (47 pages)

Excerpt: Our research indicates that the current legal framework leaves organic farmers without much protection from pesticide and GMO drift. Furthermore, the current framework leaves organic farmers without a meaningful way to redress harms caused by drift. Federal laws do not currently protect organic farmers from drift. In fact, those laws exacerbate the problem by failing to limit, and effectively encouraging, the use of pesticides and GMOs, ensuring that drift will be an inevitable consequence of the U.S. agriculture industry. State laws likewise do not provide sufficient protections for organic agriculture, and in some cases prevent drift from being addressed by preempting local efforts to limit pesticide and GMO use. Some local communities have passed bans on GMOs and restrictions on pesticide use that provide protections from drift, but those bans, if challenged, may be deemed invalid for conflicting with state or federal laws.

In order to protect organic agriculture, advocates should focus on policy initiatives at various levels of government to promote and protect the rights of organic farmers to be free from pesticide and GMO drift. At the federal level, more stringent regulations regarding pesticide approval and application would help to reduce the risk of pesticide drift. Likewise, policymakers should be encouraged to amend federal laws to discourage drift-producing agricultural practices and allow for more local control over pesticide and GMO use. Statutory amendments would be most effective if the law requires more meaningful environmental risk analysis that considers existing research and requires ongoing environmental monitoring. At the state level, existing right-to-farm laws should be amended to allow organic farmers to seek redress for drift contamination of their crops. Such an amendment should explicitly permit farmer-to-farmer lawsuits and establish generally accepted agricultural practices that prevent drift from occurring in the first place. [Emphasis added]

 

Bowman v. Monsanto: Bowman, The Producer and the End User,” by Tabetha Marie Peavey, Berkeley Technology Law Journal, vol. 29, Issue 4; 2014 (29 pages)

Excerpt: (Pages 485-486) Even accounting for Monsanto’s Technology Agreement, Monsanto’s rights to its soybeans would still be exhausted at the point of reaching Bowman. The Technology Agreement permits the suppliers, the Farmers, to sell to a grain elevator without condition, and, as a matter of public policy, Monsanto’s rights to sell and use the patented articles have been exhausted. The distinctions among the Exporter, the Food Processor, and Farmer X all lie in the patent rights they would claim are exhausted. The Exporter would claim exhaustion of Monsanto’s right to sell its patented article. Farmer X, who feeds her cattle, and the Food Processor, which makes grain-based food products, would claim exhaustion of Monsanto’s right to an ordinary use of the patented article. However, the distinction in Bowman’s case is that the ordinary use of planting these purchased seeds actually makes more seeds. This distinction is unique to self-replicating technologies, and here, Bowman’s normal use of the seed necessarily makes new infringing articles.

It is well established that “a second creation” of a patented item “call[s] the monopoly, conferred by the patent grant, into play for a second time.” The exhaustion doctrine never authorizes a purchaser to “make” new copies of the invention. However, consider what the result would be if Farmer X, instead of merely using soybeans purchased from the grain elevator to feed her cattle, now decided to plant a field of commodity soybeans and grow her own feed. And unlike Bowman, she did not select for the Roundup Ready® soybeans. As a pesticide-free farmer, how would Farmer X be able to identify and remove the infringing crops without causing substantial harm to her harvest? Further, is Farmer X actually using Monsanto’s technology if she is a pesticide-free farmer? By planting commodity soybeans indiscriminately and not selecting for Monsanto’s patented biotechnology, is Farmer X simply making use of the natural properties of seeds that are not actually patentable? The Court’s focus on Bowman’s active participation in selecting for Monsanto’s technology leaves ambiguous whether Farmer X’s use should be considered different from Bowman’s, or if Farmer X’s use, regardless of her passivity, would still entail making and thus infringing.

  1. MAKING AND USING SEEDS: A SELF-REPLICATING TECHNOLOGY

Consistently, courts have failed to acknowledge that the distinction between making and using is ill-suited for approaching the question of patent exhaustion as it applies to self-replicating technologies. The patent exhaustion doctrine typically implicates the rights of sale and use. But because it is unlikely a product will be purchased without the intent to use or resell the product, self-replicating technologies also implicate the patentee’s right to exclude others from making the patented article. As Professor Rinehart points out, for consumers the “distinction between a product and the intellectual property embodied within it creates an uneasy tension.” This tension is heightened when there is a possibility that certain uses are virtually inexhaustible regardless of the purchaser’s position on the chain of distribution or how the purchase was or was not structured.

It was not until relatively recently that making a patented article could be a necessary element of the ordinary and expected use of the patented article. This question first arose in the animal context, concerning the extent to which purchasers of transgenic organisms should be able to use their property. In 1989, the Transgenic Animal Patent Reform Act was reintroduced to exempt the reproduction of genetically modified farm animals from the definition of infringement, while a separate bill attempted to initiate a two-year moratorium on patent grants for genetically modified animals. These bills were motivated by a fear that individuals would not be able to fully utilize their property, the animal, if farmers were not allowed to “utilize the animals in any farming operation,” which included breeding and selling. Seeds, such as Monsanto’s Roundup Ready® soybean, present similar concerns and are particularly troubling not only because their only real purpose is to reproduce, but also because all the aspects of the patented biotechnology are passed to subsequent generations. [Emphasis added]

 

Induced Nuisance: Holding Patent Owners Liable for GMO Cross-Contamination,” by Sabrina Wilson, Emory Law Journal Volume 64:169; 2014 (31 pages)

Excerpt: The promiscuous nature of GMOs and the substantial harm from cross-contamination are now realities of modern farming. StarLink corn was first planted in 1998 and later found to have contaminated human food products in 2000. Since that time, numerous cases of mass GMO contamination have been litigated. In 2010, the Supreme Court held that organic and traditional alfalfa farmers had standing to challenge the deregulation of genetically modified alfalfa due to a “reasonable probability that their organic and conventional alfalfa crops [would] be infected with the engineered gene” if deregulated. Thus, the farming community and the courts have recognized that GMO cross-contamination is substantially certain and foreseeable. Monsanto itself recognizes the likelihood, as it employs its army of inspectors to police U.S. farms for patent “infringement.” However, Monsanto continues to enlist and direct countless farmers to engage in acts that have a substantial certainty of cross-contaminating surrounding farmland. As discussed in Part II.B of this Comment, Monsanto maintains an extremely high degree of control over farmers’ conduct via its TSA [Technology Service Agreement*].

Therefore, Monsanto (and other similarly situated GMO patent owners, producers, or both) should be held liable under a theory of induced nuisance for GMO cross-contamination. In meeting the elements for induced nuisance, Monsanto, through its TSA, induces its licensees to engage in acts that result in contaminating neighboring farmland. Monsanto also has the required knowledge that those acts are substantially certain to lead to cross-contamination. Finding liability under this theory not only affords the organic farmer direct access to the source of the harm, but is especially fitting since it is born from both the aggressive patent assertions and rigid contractual directives that Monsanto itself establishes with GMO farmers

Monsanto (and companies like it) introduced genetically modified self-replicating organisms to U.S. agriculture via the patent system. That introduction truly created an imbalance of equities in U.S. farming. GMOs are living, reproducing, patented organisms filled with wanderlust. Cross-contamination is practically inevitable as evidenced by the catastrophic contaminations experienced with GMOs such as StarLink corn and LibertyLink rice. However, Monsanto is able to capitalize on the contamination it genetically engineered by wielding patent infringement wherever its GMOs decide to procreate. Even more perverse is the fact that Monsanto’s GMOs have the ability to destroy competing markets. [Emphasis added, citations omitted]

[*pdf icon A copy of the Monsanto Technology Stewardship Agreement 2015 (2 pages) can be downloaded HERE.

 

The Wheat and the (GM) Tares: Lessons for Plant Patent Litigation from the Parables of Christ,” by Margo A. Bagley, University of St. Thomas Law Journal, Volume 10, Issue 3; Spring 2013 (32 pages)

Excerpt: However, using viruses or gene guns to insert genes from completely different species into food crops without fully understanding how these modifications will affect people, animals, the environment, or other plants and knowing there is no way to control their spread is problematic indeed.  As one scientist notes: “[t]oday’s products of genetic engineering are at a dinosaur technology level. We use foreign genes without knowing where they are located in the genome or what else in the whole chain from gene to protein will be changed.

While GM crops have produced benefits, it is not at all clear that the benefits outweigh the host of problems they have engendered, which humans are unlikely to be able to fully counteract. Despite the continued promise of GM crops, as in the parable we may have been better off if we had not tried to genetically modify the seed, but instead put more work into the soil. Would that have provided all the touted benefits of GM seed? Maybe not, but now certainly organic farmers and purchasers of organic products, and many others could easily say, like Hamlet, it would have been better “to bear those ills we have than fly to others that we know not of.” [Citations omitted, emphasis added]

 

Gone with the Wind: Why Even Utility Patents Cannot Fence in Self-Replicating Technologies,” by Jessica Lynd, American University Law Review, Vol. 62 Issue 3; 2013 (40 pages)

Excerpt: The utility requirement in § 101 of the Patent Act has historically consisted of three necessary types of utility: specific, substantial, and moral. Specific utility requires that the patented subject be capable of “provid[ing] a well-defined and particular benefit to the public.” In In re Fisher, for example, a patent was denied for “expressed sequence tags” relating to maize genes because there was nothing useful about the tags to the public; they were merely “hypothetical possibilities.” Thus, inventions must actually function as claimed and not simply be “theories” or “speculations.

Substantial utility requires the patented subject to have a “significant and presently available benefit to the public.” This entails being applicable in the “real world” and not just beneficial for further research. In Brenner v. Manson, the Supreme Court found that even though the chemical compound at issue was not detrimental, it still did not merit a patent because its uses were still being researched; thus, it lacked substantial utility.

Though greatly limited and rarely applied today, the doctrine of moral utility holds that usefulness cannot be injurious. Moral utility is based on Lowell v. Lewis, where Justice Story held:

[T]he law requires . . . that the invention should not be frivolous or injurious to the well-being, good policy, or sound morals of society. The word “useful,” therefore, is incorporated into the act in contradistinction to mischievous or immoral. For instance, a new invention to poison people, or to promote debauchery, or to facilitate private assassination, is not a patentable invention.

Justice Story’s moral utility test was later limited in Fuller v. Berger, which held that injuriousness prohibits patentability where it is the only use of the invention. Where a patent subject can be used for both injury and benefit, it is still patentable. The moral utility requirement has been used to deny patents for morally objectionable inventions such as gambling machines and deceptive inventions such as stockings with a fake seam. It has also been applied where there were “concerns about the morality of practicing the patent’s underlying subject matter” and “concerns regarding the morality of allowing anyone to limit the practice of the patent’s underlying subject matter.” In Diamond v. Chakrabarty, the Supreme Court approved a patent for a “genetically engineered bacterium . . . capable of breaking down multiple components of crude oil” even though the living thing “may spread pollution and disease, that it may result in a loss of genetic diversity, and that its practice may tend to depreciate the value of human life.” Although the Supreme Court rejected the application of moral utility as a basis for denying patents for living microorganisms, moral utility has been applied for denying patents for part-human organisms. The PTO [Patent and Trademark Office] has rejected an application for a chimeric embryo made from both a human and non-human and applied Lowell in doing so, referring to the partially human organisms as “immoral” and as “monsters.”

Despite the remnants of moral utility, “the USPTO [U.S. Patent and Trademark Office, or PTO] has issued patents to inventions that may arguably be illegal at least in certain jurisdictions.” The courts have justified this because “a patent is not the granting of a right to make, use or sell” the invention. Instead, a patent “grants only the right to exclude others from making, using or selling the patented device.” Thus, the object cannot become injurious without human intervention.

When applied, all three forms of utility assess the invention overall – regardless of whether it is at the time of granting the patent or during trial. If utility is missing, it completely invalidates the patent – as opposed to restricting the patent rights only under particular circumstances, such as when human intervention uses a patented technology in an injurious way. [Citations omitted]

 

 

Liability for Genetically Modified Food: Are GMOs a Tort Waiting to Happen?” by Debra M. Strauss, The SciTech Lawyer; Fall, 2012 (6 pages)

[Can also be viewed and downloaded from HERE]

Excerpt: Who will bear the risk of the significant potential harm from GMOs? While in the short run it is the consumers who are unknowingly ingesting these substances due to the scientific uncertainty that in the United States has given the government the regulatory leeway to allow these substances into the food supply without mandatory labeling and monitoring, ultimately it will be the farmers who plant the GM crops and the biotech companies who have developed and propagated their invention. From a risk assessment perspective, biotech companies should have cause for concern. So too should farmers, who must be made aware of and carefully consider these legal liability risks in making their decisions on whether to plant GM crops and whether, indeed, they will in the long run be as profitable as the biotech companies would lead them to believe. In leaving these decisions to the farmers and companies through regulatory inaction and a lack of statutory rigor, perhaps US policy makers have after all unwittingly set the stage for a tort waiting to happen.

 

From Wall Street to Wheat Fields: Using the Business Method Patent’s ‘First Inventor Defense’ as a Model for Genetically Engineered Seed Protection,” by Christopher W. Dawson, The George Washington Law Review, Vol. 80 No. 4; June 2012 (35 pages)

Excerpt: Small farms instill values in families and the surrounding community and are important for the responsible maintenance of the United States’ agricultural industry and food supply. Moreover, small farmers are an important factor in the continuing development of novel plant breeds, as each farmer’s prior seed saving techniques have materially contributed to the innovative seed lines available today. By requiring small farmers to conform to the rigors of patent law, courts may force more and more small farmers out of business, destroying a vital part of the United States’ economy and agricultural industry. By granting small farmers an equitable defense to patent infringement modeled after the first inventor defense provided for business method patents, Congress would strike the appropriate balance between incentives for inventors and equity for small farmers, encouraging eve-revolving innovation in the agricultural community. This statutory scheme will allow farmers such as Homan McFarling to continue to operate the family farm for generations to come.

 

Genetically Modified Plants and Regulatory Loopholes and Weaknesses under the Plant Protection Act,” by Emily Montgomery, Vermont Law Review, Vol. 37; 2012 (30 pages)

Excerpt: In particular, a mechanism for post-market monitoring of GM plants is the most important change that could be made with respect to GM plant regulation. This would allow regulators to watch for and address problems that might arise from a GM plant after it has been approved and put on the market. Many problems associated with GM plants, such as cascade effects like the superweed, are not readily apparent until after the plant has been deregulated and released into the environment. Thus, regulators need to have the ability to deal with unanticipated impacts. This change would strike a balance by still allowing GM plants onto the market despite uncertain later effects while also enabling APHIS to detect and address those impacts where necessary.

However, improvements within the existing system are only a short term fix, and an overhaul of United States biotechnology policy is warranted. Even with improvements to APHIS [a division of the USDA that ‘regulates’ GM crops] oversight under the PPA [Plant Protection Act], there would still be many inefficiencies and overlaps at play under the Coordinated Framework. In the meantime, while the nation waits for a cohesive regulatory policy for GMOs, improvements should be made to APHIS regulation of GM plants under the PPA to help address and minimize environmental risks. [Citations omitted, emphasis added]

 

Patents, Genetically Modified Foods, and IP Overreaching,” by Elizabeth A. Rowe, Southern Methodist University Law Review, Vol. 64; 2011 (37 pages)

Excerpt: There is currently a void in the scientific knowledge relating to the effects of genetically modified foods on human health and the environment. Patent law perpetuates that void by allowing patent holders to control and restrict independent research in the area. Accordingly, this Article analyzes how these research restrictions are contrary to the public interest and inconsistent with the underlying goals of patent law. The Article concludes that, on balance, the public interest in promoting independent research on the health and safety effects of foods should outweigh the patent holder’s interest in controlling the state of adverse information available about its product. It recommends that courts use a “patent overreach” doctrine to rein in these restrictions where public health and safety may be threatened. This would serve as a limiting principle to avoid undue expansion of a patent’s power to exclude.

The Article also calls for continuing discourse and consideration of the larger questions about reconciling patenting with public policy, and patenting with science and research. Congress and the courts must begin to pay attention to the role of patenting in limiting, rather than promoting, the progress of science, especially when public health and safety is implicated. [Emphasis added]

 

Comment: Protecting the Farmers: Limiting Liability for Innocent Infringement of Plant Patents,” by Kathleen C. Rose, Wake Forest Journal of Business and Intellectual Property Law, Vol. 12, No. 1; 2011 (19 pages)

Excerpt: Under current laws, farmers may attempt to find protection for patent violation under common law property doctrines including negligence, nuisance, and trespass. Although these doctrines are available, it is difficult to successfully raise one of these defenses. There are inherent difficulties farmers will face, such as an inability to identify patented crops or traits resulting in an inability to determine the presence of contamination of their own crop and any damage that has been caused…

The inadvertent movement of patented seeds onto the land of farmers who do not have a license to use the seeds is a problem that can no longer be ignored. Under current laws and regulations, a great deal of power and control lies with the patent holders of these seeds resulting in inequitable results for farmers who choose to abstain from using patented seeds. As patent infringement litigation moves forward, it will be essential to the livelihood of farmers to balance the interests of plant patent holders and the interests of farmers who innocently obtain patented seeds on their land. Through the creation of an innocent infringement provision within plant patent law, innocent farmers will have access to a statutory mechanism through which their liability may be limited while still acknowledging the rights of plant patent holders.

 

The Encroachment of Intellectual Property Protections on the Rights of Farmers,” by Justin T. Rogers, Drake Journal of Agricultural Law, Vol.15; 2010 (17 pages)

Excerpt: “Currently, large corporate seed companies are at war with farmers. Intellectual property laws, through acts of Congress and decisions by the United States Supreme Court, serve to reinforce those laws in order to further strengthen the grip of seed monopolies on the agricultural industry. This enforcement is done to the detriment of farmers. Seed patents, used as a tool to restrict access to genetic material, result in the destruction of genetic diversity and lead to crops that are less suitable for changes in environmental conditions. Gene-licensing agreements and terminator technology, used to protect corporate investments, force farmers to return to seed companies each year in order to purchase seed for unreasonable prices. Industrial agriculture, by taking advantage of the legal system, threatens farmers with lawsuits that force them out of traditional farming practices and subject them to the whim of corporate monopolies. By reinforcing intellectual property laws through congressional action and court decisions, the traditional rights of farmers are slowly drowning in an industry dominated by corporate greed.” [Emphasis added]

 

We Reap What We Sow: The Legal Liability Risks of Genetically Modified Food,” by Debra M. Strauss, Journal of Legal Studies in Business, Vol. 16; January 1, 2010 (29 pages)

Excerpt: Ultimately, the risks of harm to human health and the environment, as translated into these multifaceted layers of legal liability, may justify a moratorium or ban in the use of GMOs in food and commercial medical applications. Until then, individual farmers would be better able to make choices about whether to plant GM crops if they are made aware of their potential liability and given critical information such as the need for sufficient buffer zones and proper segregation methods – including the cost of leaving large tracts of their land fallow, testing their crops, and cleaning their equipment – in order to minimize their legal jeopardy. Through their own evaluation of costs and benefits, these farmers may decide that any involvement with GMOs is not worth engendering these hazards and expenses. Perhaps additional measures can be developed to protect non-GM farmers and empower them to segregate and protect their crops, such as developing a non-GM certification and requiring special handling before their products enter the domestic market or export channels.

Most importantly, biotech companies must be sent a clear message that they will be held financially accountable for the harm caused by their genetically engineered products – injuries and damages that are no longer merely theoretical. As landmark multimillion dollar cases such as the LibertyLink® rice litigation proceed through the courts, this message is reaching a crescendo. Perhaps statutory liability and a transformation in the regulatory regime will follow. Through this risk analysis, the industry might be persuaded that safety is good business to ensure that, in the long-run, they continue to reap what they sow. [Emphasis added]

 

Geertson Seed Farms v. Johanns: Why Alfalfa is Not the Only Little Rascal for Bio-Agriculture Law,” by Allison M. Straka, Villanova Environmental Law Journal, Vol. 21, Issue 2; 2010 (25 pages)

Excerpt: Despite the wide use of GM agriculture, these products are regulated under NEPA [National Environmental Policy Act], which was created at a time when GM products had not yet been conceived. As a result, the current regulation of GM agriculture “is a product of the historical accident of transgenic products being squeezed into statutory definitions not intended for them.’ Though courts expressed a willingness to enforce the regulatory standards set forth by NEPA in Vilsack and International Center, the continued issuance of injunctions on a case-by-case basis for each new GM product may become costly and inefficient as GM agriculture and its accompanying regulatory problems grow. Furthermore, courts lack the scientific expertise needed to make determinations about the safety of these products. Rather than relying on the courts to enforce NEPA and make the scientific determinations required of regulatory agencies, a new regulatory system must be designed to rectify the inadequacies of the current system. New laws specifically devoted to the regulation of GM agriculture must be developed, and the division of regulatory authority over GM agriculture must shift from APHIS to an agency with the scientific knowledge, experience and resources to properly assess the environmental effects of this technology. [Emphasis added]

 

Seeds of Dispute: Intellectual-Property Rights and Agricultural Biodiversity,” by Keith Aoki, Golden Gate University Environmental Law Journal, Vol. 3, Issue 1; 2009 (83 pages)

Excerpt: This Article is about the interrelationship between expanding intellectual-property rights and the conservation of biodiversity. While these rights are not strictly correlated with conservation, the types of markets and companies producing commercial seeds and other agricultural inputs tend to promote monocultures that erode biodiversity in both the developed and developing world. Furthermore, this Article argues that the rise of genetically engineered crops in the last two decades further exacerbates both intellectual-property claims of companies owning patented seed and biodiversity, as metaphorical monoculture becomes realized with genetically engineered crops in fields where all the plants have the same genetic structure.

This Article begins with a brief overview of crop genetic diversity up to the late nineteenth century and examines the importance of controlling plant genetic diversity since the age of colonialism

The Article then moves on to look at how mass-scale industrialized agriculture occurred in the United States in the early twentieth century as private companies began to produce seeds and other high-chemical crop inputs like fertilizer, pesticides, and herbicides. During this period, commercial agriculture underwent a fundamental change from a model in which farmers bred and adapted crops to local soil and growing conditions to a model where “one seed feeds the world,” and local conditions were modified to suit a particular seed using chemical supplements. This was the so-called “Green Revolution,” which, in the middle twentieth century, gave rise to high-yield industrial agriculture; environmental degradation and dramatic loss of plant genetic diversity followed.

By the 1970s, an international network of seed libraries was established by the Rockefeller Foundation, the United Nations’ Food and Agriculture Organization, and the United States to conserve the swiftly vanishing store of plant genetic diversity. The parties characterized such resources as the “common heritage of [hu]mankind” and allowed open access to plant breeders around the world.

This Article also traces the growth of intellectual-property protection during the twentieth century, beginning with the Plant Patent Act of 1930, which granted protection to asexually propagated plants such as clones, the Plant Variety Act of 1970, which granted protection for sexually reproduced crop plants, and the landmark 1980 U.S. Supreme Court case, Diamond v. Chakrabarty, which held that living organisms with a requisite degree of creative human agency may be granted utility-patent protection.

This Article additionally traces developments at the international level regarding intellectual-property protection for agricultural crop plants, culminating in the 2001 International Treaty for Plant Genetic Resources (ITPGR), which characterized plant genetic resources as a form of “sovereign property” and established a list of staple crops available from the international seed banks as a “limited commons.” Of course, the ITPGR co-exists with multilateral trade treaties such as the 1995 Trade Related Aspects of Intellectual Property (TRIPS), the World Trade Organization (WTO), and multilateral agreements aimed at conservation such as the 1992 Convention on Biodiversity (CBD).

Against this increasingly complicated backdrop of national and international agreements, major technological advances were occurring in the area of agricultural biotechnology such as genetic engineering. This Article looks at how, by the 1990s, all of these developments were beginning to intersect. By the end of the twentieth century, genetically engineered (GE) crops such as soybeans, cotton, canola, and corn were beginning to dominate certain agricultural niches in countries like the United States and Canada. This Article considers how the fragmented regulatory framework for genetically modified crops reinforces the increasingly broad intellectual-property rights in such crops, which in turn brings about further erosion of biodiversity.

Pages 144 – 147: Despite the publication of a document in 1986 entitled, “Coordinated Framework for Regulation of Biotechnology,” from the Office of Science and Technology Policy, the federal government’s response to the risks and questions posed by genetically engineered crops has been anything but coordinated.

The EPA has no role in approving the field-testing of genetically engineered crops other than those that are pesticide-protected, and therefore the EPA will have no regulatory role in the second generation of genetically engineered pharmaceutical and industrial compound crops. The Animal and Plant Health Inspection Services (APHIS) [a branch of the USDA] has been criticized by the National Research Council for conducting inadequate environmental assessments of genetically engineered crops and often relying on existing scientific literature rather than conducting its own tests and experimental data. The FDA and APHIS do not evaluate the environmental impact of pharmaceutical crops. There are no requirements that a company notify the FDA prior to the introduction of a new genetically engineered crop. Once APHIS grants permission to field-test a genetically engineered crop, APHIS has no further authority to monitor the plant or its progeny. APHIS regulations do not extend to the release of wind-borne genetically engineered plant pollen If the question of intellectual-property protection on both national and international levels is added to the fragmented regulatory regimes pertaining to genetically engineered crops, the issue becomes yet more complicated … Moreover, in North America, the presumption in favor of agrochemical companies seeking to commercialize such crops is reinforced by the granting of patents in plants, plant varieties, and genetic sequences within such plants, and has effects on biodiversity because intellectually-property protection depends on the uniformity and stability of such traits, giving rise to agricultural monocultures. [Bold emphasis added, citations omitted]

 

Genetically Modified Organisms: Who Should Pay the Price for Pollen Drift Contamination?” by Stephanie E. Cox, Drake Journal of Agricultural Law, Vol. 13; September 2008 (18 pages)

 

A Court’s Dilemma: When Patents Conflict with Public Health,” by Julie A. Burger & Justin Brunner, Virginia Journal of Law & Technology, Vol. 12, No. 7; 2007 (42 pages)

Excerpt: “This article examines the revitalization of the public interest factor in patent cases in which a permanent injunction is sought against an infringer, particularly with respect to the public health. Governments internationally, the executive branch, and the U.S. Congress have taken actions to protect citizens when rights held by patent holders conflict with the public health. But decisions by the Court of Appeals for the Federal Circuit limited the judiciary’s ability to protect the public health and made entry of an injunction in patent cases the norm. This categorical rule was overturned by the U.S. Supreme Court in eBay v. MercExchange, and the Court provided instruction that equitable considerations in patent cases should mirror those found in other cases. Based on this precedent, the judiciary has the duty and the authority to take the public health into consideration when determining whether an injunction should issue. The article concludes with several equitable considerations relating to the public interest that courts may use in making this determination.”

 

Distributive and Syncretic Motives in Intellectual Property Law (with Special Reference to Coercion, Agency, and Development),” by Keith Aoki, UC Davis Law Review, Vol. 40, Issue 3; March 2007 (85 pages)

Excerpt: (Pages 781-782) The “Green Revolution” and Loss of Crop Genetic Diversity. The third converging trend was the growing criticism of the so-called “Green Revolution.” Agro-chemical corporations prospered, trumpeting industrial agriculture systems with the idea that “one seed would feed the world.” Rather than adapting seeds to different locales, the idea was to adapt diverse locales via heavy inputs to one seed. Yet, the social and environmental costs of high-input industrial agriculture became increasingly obvious in the United States, Europe, and the developing world. Books such as Rachel Carson’s Silent Spring made widely known the environmental damage arising from intense and expensive use of fertilizers, herbicides, and insecticides. The increase of industrialized agriculture drove small subsistence farmers off their land and into urban areas, in turn increasing the pressure on cash-strapped governments for necessary social services. Meanwhile, critics of mass industrial agriculture who worried about the dangers of losing crop genetic diversity arising from widespread crop monocultures began organizing themselves. During the late 1970s, Canadian nongovernmental organization (“NGO”) Rural Advancement Foundation International [RAFI] and activist Pat Mooney took the lead in decrying crop monoculture practices and railing against the UPOV, the PVPA, and the PPA. [UPOV = The International Union for the Protection of New Varieties of Plants is an intergovernmental organization; PVPA = Plant Variety Protection Act of 1970; PPA = Plant Patent Act of 1930].

U.S. Utility Patents in Living Organisms. The fourth and final prelude to the Seed Wars was the 1980 Supreme Court decision Diamond v. Chakrabarty. Chakrabarty held that U.S. utility patents could be obtained on living organisms that had been altered by human beings. In other words, inventive human agency via genetic manipulation could transform a living organism into something that could be patented. The U.S. Patent and Trademark Office (“PTO”) began granting utility patents to plants in 1985 with Ex parte Hibberd, starting with a variety of maize with high tryptophan levels. Additionally, in 2001, in J.E.M. Ag Supply, Inc. v. Pioneer Hi-Bred International, Inc., the Supreme Court upheld the validity of utility patents in selectively bred plants. While the U.S. legal system seems to have reached the firm conclusion that plants and their components are patentable IP, that legal conclusion remains controversial on an international level, notwithstanding agreements such as TRIPS. [TRIPS = Trade-Related Aspects of Intellectual Property Rights signed in 1994]

(Pages 799-800) CONCLUSION: SYNCRETISM AND INTELLECTUAL PROPERTY

The Operation was a Success, but the Patient Died. The final example returned to the question of technology, IP, and structural subordination. Instead of social collectives (chattel slaves), or individuals or artistic subgroups (black blues musicians), the salient dimension is how one group of nations (the OECD countries) [OECD = Organization for Economic Co-operation and Development*] have locked another group of nations (the developing countries) into a structurally subordinate position via IP protection for seed germplasm used to grow staple crops. As with the blues [music], lack of IP protection may have given rise to unjust exploitation and appropriation of raw genetic materials. However, is the solution necessarily expanded IP rights for all? To put it another way, expanded IP rights on a global scale may be, in the area of crop genetic resources, a way of killing the goose that has laid golden eggs for 10,000 years. For the sake of the global food supply and crop genetic diversity, will the disappearance of common heritage treatment of PGRs [plant genetic resources] destroy the very resource that the move to sovereign property was meant to preserve? To what extent does IP law extinguish the communal, undeniably innovative, and syncretic activities and practices that farmers have engaged in for millennia? Is the trade-off between supposed IP gains from monetary incentives worth the loss of, or serious reduction in, access to plant genetic resources? All three examples ask how we legally construct the public domain. If we do not take into account the distributive effects of IP law and practices, the question is this: Do we control our institutions and inventions or do they, like Frankenstein’s monster, control us? [Bold emphasis added, citations omitted]

[*] The OECD “is an intergovernmental economic organization with 35 member countries, founded in 1961 to stimulate economic progress and world trade … The OECD has been criticized by several civil society groups and developing countries. The main criticism has been the narrowness of the OECD because of its limited membership to a select few rich nations.”  – Wikipedia

Transboundary Pollution: Harmonizing International and Domestic Law,” by Noah D. Hall, University of Michigan Journal of Law Reform, vol. 40, Issue 4; 2007 (68 pages)

Excerpt: Environmental law is burdened with the desperate goal of protecting our natural environment from the human economy, for ourselves, our future generations, and nature itself. International environmental law shares these burdens, with the additional challenge of providing a peaceful and lawful means for resolving international disputes. History has shown that people and nations will go to war over environmental and natural resource disputes, and global environmental pressures are only increasing. Yet solving these conflicts with international governance creates potential conflicts with state sovereignty, a recipe for disaster on its own. Harmonizing accepted international environmental law principles with respected and independent domestic legal mechanisms could create a system that prevents and peacefully resolves transboundary environmental disputes, without threatening state sovereignty.

 

The Problem of Social Cost in a Genetically Modified Age,” by Paul J. Heald and James C. Smith, Hastings Law Journal; 2006 (86 pages)

Excerpt: “In short, Monsanto is in the unique position of being able to take a problem that it created – the contamination of non-GMO plants by pollen drift from GMO plants – and use it to its advantage by prosecuting those by-standing farmers whose crops become contaminated.”

 

High Plains Drifting: Wind-Blown Seeds and the Intellectual Property Implications of the GMO Revolution,” by Stephanie M. Bernhardt, Northwestern Journal of Technology and Intellectual Property, Vol. 1, Issue 4; 2005 (14 pages)

Excerpt:  “But where a man willfully causes or allows the property of another to be intermixed with his own without the other’s knowledge or consent the whole belongs to the latter. . . .” It is true that intellectual property rights are not fully consistent with tangible property rights, but in the case of a farmer unintentionally acquiring a patented seed, intellectual property rights do not seem totally appropriate. The unique nature of a property that can contaminate the property of others and reproduce on its own was not considered by lawmakers when they drafted the Patent Act. Something must be done to protect innocent infringers from liability and coercion while encouraging innovation and reward. Unfortunately, former Monsanto employees hold high positions both in the Department of Agriculture as well as the Food and Drug Administration. These agencies seem unlikely to move in a direction to help farmers battle the aggressive tactics of companies like Monsanto. This situation is truly David versus Goliath, but this time, Goliath is holding all the stones.  [Emphasis added]

 

Patent Pools and Antitrust Concerns in Plant Biotechnology,” by John E. Haapala, Journal of Environmental Law and Litigation, Vol. 19; 2004 (20 pages)

 

The Innocent Bystander Problem in the Patenting of Higher Life Forms,” by Norman Siebrasse, McGill Law Journal, vol. 49; 2004 (44 pages)

 

J.E.M. Ag Supply, Inc. v. Pioneer Hi-Bred International, Inc. – Its Meaning and Significance for the Agricultural Community,” by Michael T. Roberts, Southern Illinois University Law Journal; 2003 (36 pages)

 

Pollen Drift and Potential Causes of Action,” by Carie-Megan Flood, Journal of Corporation Law, vol. 28; 2003 (26 pages)

Excerpt: Although this Note provides no clear cut and obvious choice as to which cause of action will be most successful, a plaintiff organic farmer could find a remedy for pollen drift under either trespass or strict liability for abnormally dangerous activities. The cases cited in this Note-trespass of airborne pollutants, trespassing bulls, and pesticide drift cases-provide analogous arguments that can be utilized in pollen drift cases. If a plaintiff organic farmer presents sufficient evidence to satisfy each of the elements of trespass or strict liability claim, then a court should find a defendant GM farmer or biotechnology company liable for the plaintiffs damages sustained from pollen drift and the resulting genetic contamination.

 

StarLink™ – A Case Study of Agricultural Biotechnology Regulation,” by Donald L. Uchtmann, Drake Journal of Agricultural Law, Vol. 7; 2002 (53 pages)

 

Seed Wars: Biotechnology, Intellectual Property and the Quest for High Yield Seeds,” by Lara E. Ewens, Boston College International and Comparative Law Review, vol. 23, issue 2; 2000 (27 pages)

Excerpt: Until international intellectual property law increases awareness of the importance of the public domain in preserving genetic diversity, protecting the global food supply, and safe-guarding genetic resources, intellectual property law will under-value and under-compensate the contributions and agricultural concerns of the developing countries that safeguard the vast majority of the world’s plant genetic resources … Intellectual property law in the international context continues to inadequately address the legitimate concerns of developing countries and indigenous communities about control of their natural and cultural resources. In the area of plant genetic resources, intellectual property has established a system that treats plant germplasm as a free good, and that same germplasm which is then inserted into plant varieties as a commodity deserving of property right protection. There are several consequences of this policy: the continuing dependence of developing countries on developed countries; the threat of increasing genetic uniformity among plants and crops and of decreasing global genetic diversity as corporations mass market uniform, high-yield seeds; and the consolidation of private ownership of seeds that form the basis of the global food supply. The debate is over how to weigh public and private rights and wealth. The solution thus far has been to tip the scale in favor of free trade and corporate capital. This policy has serious ramifications, as well as distributive inequities, that affect not only capital and resources, but also genetic diversity and the viability of the world’s plants. At the very least, the formulators of intellectual property law in the field of plant genetic resources must make renewed efforts to protect the public domain. In part, this means protecting the plant genetic diversity that is our common heritage by decreasing the strong intellectual property protections corporations have been granted. [Emphasis added]

 

Intellectual Property Rights and Biodiversity: The Industrialization of Natural Resources and Traditional Knowledge,” by Mark Ritchie, Kristin Dawkins and Mark Vallianatos, Journal of Civil Rights and Economic Development, vol. 11, issue 2; March 1996 (25 pages)

Excerpt: The FAO’s International Undertaking on Plant Genetic Resources and the Convention on Biological Diversity establish important principles regarding the protection of biodiversity while recognizing the vast commercial value of germplasm. The recent expansion of international trade agreements, however, establishing a global regime of intellectual property rights, creates incentives which may destroy biodiversity, while undercutting social and economic development opportunities as well as cultural diversity. Presently, countries are under pressure to change their IPR laws to conform with the TRIPs agreement of the GATT. Such rules will supersede national laws and allow privatization of the world’s knowledge and resources. The ability of companies to gain monopolies over formerly freely available community resources, including seeds, plants, and even micro-organisms, may have devastating effects on both human communities and the protection of biodiversity. [Emphasis added]


Law articles, notes & comments that address US regulatory issues

 

 

Rubber-Stamped Regulation: The Inadequate Oversight of Genetically Engineered Plants and Animals in the United States,” by Genna Reed, Sustainable Development Law & Policy, Volume 14, Issue 3; 2014 (12 pages)

Excerpt: The U.S. Department of Agriculture first approved genetically engineered crops in the United States in the 1990s, and since then the country has been the biggest global adopter of this technology. GE crops were supposed to improve yields, lower costs for farmers, and reduce agriculture’s environmental impact. Yet nearly twenty years after their introduction, genetically engineered crops have not provided the benefits promised by the companies that patented them.

Additionally, the patchwork of federal agencies that regulates genetically engineered crops and animals in the United States has failed to adequately oversee and monitor GE products. Three U.S. federal agencies FDA, the USDA, and the EPA – each have some responsibility over these products but have largely failed to create any overarching regulatory structure to protect public health and the environment. Lax enforcement, uncoordinated agency oversight, inadequate review of GE foods, a failure to track post-market problems, and a failure to require labeling of these foods have allowed unregulated and unstudied GE plants and animals to slip through the regulatory cracks.

… In effect, the biotechnology industry self-regulates when it comes to the safety of GE foods. For whole foods (intact foods such as a whole apple or potato), safety determinations are made by the producer, and no FDA premarket approval is necessary. However, the FDA classifies substances added to food like biotechnology traits as “generally recognized as safe” (“GRAS”) or as food additives. A company may voluntarily submit a GRAS notification and scientific documentation to the FDA, but it is not a requirement … Under the current U.S. regulatory system, the FDA has no effective way to track adverse health effects in people consuming GE foods. And because there is no labeling requirement for food containing GE ingredients, consumers do not know when they are eating these ingredients.

Conclusion: New technologies – like genetic engineering – create uncertainties and risk that should first be carefully evaluated before being rapidly pushed into the market. The existing regulatory framework for GE foods simply does not protect consumers, markets, and international trade relationships. The U.S. regulatory system; comprised of piecemeal oversight by the Department of Agriculture, the Environmental Protection Agency, and the Food and Drug Administration; has failed to protect the environment, the food system, or public health from the uncertainties and negative consequences of GE foods. It is time for a new approach to biotechnology in the U.S. food system.

 

The Constitutionality of State-Mandated Labeling for Genetically Engineered Foods: A Definitive Defense,” by George A. Kimbrell & Aurora L. Paulsen, Vermont Law Review, Vol. 39:341; 2014 (70 pages)

Excerpt: (Pages 343-344) Americans are increasingly aware of the risks and negative impacts of genetically engineered crops, correctly seeing through several decades of myths that were carefully constructed by agrochemical companies to promote their genetically engineered crops. On the human health side, the public is realizing that the FDA does not actually test the food safety of engineered foods; rather, it has confidential meetings with industry in which it merely reviews the industry’s own testing – and even that is voluntary. Americans are also realizing that no long-term or epidemiological studies in the United States have examined the safety of human consumption of genetically engineered foods, and that without labeling, there is no accountability or traceability to link such foods to proliferating public health problems.

On the environmental side, people are recognizing that genetically engineered crops are a key cog of inherently unsustainable industrial agriculture and cause significant adverse environmental impacts. Genetically engineered crops are essentially a pesticide-promoting technology: They are overwhelmingly engineered to be resistant to pesticides or produce pesticides, and consequently have dramatically increased overall pesticide output into our environment.

On the agricultural side, transgenic contamination of conventional crops from engineered crops has caused U.S. farmers billions of dollars in market losses. And the widespread adoption of crops engineered for pesticide resistance has proliferated an epidemic of resistant “superweeds” now covering more than 60 million acres of U.S. farmland.

Juxtaposed against these risks and impacts, the U.S. public is discovering that industry’s hype is false. Namely, despite billions of dollars in research and nearly two decades of commercialization, there are no crops that are engineered to increase crop yields, reduce world hunger, or mitigate global warming; instead, the agrochemical companies that engineer crops have largely succeeded in making these crops resistant to their own products – pesticides.

The bottom line is that, due to the risks and known adverse impacts of genetically engineered foods, Americans understandably think, at a minimum, that they deserve the right to choose whether to buy these foods. That is, American consumers believe they are entitled to the same right – the right to have labeling on genetically engineered foods – that Russian, Japanese, European, and Chinese consumers already enjoy.

 

Playing Politics with Food: Comparing Labeling Regulations of Genetically Engineered Foods across the North Atlantic in the United States and European Union,” by Tiffany B. Wong, San Joaquin Agricultural Law Review, Vol. 23, 2013-2014 (42 pages)

Excerpt: As newer applications of GE foods emerge, existing United States policies are not able to address growing consumer concerns and increasing trade issues about the adequacy of oversight for GE organisms. American consumers are finding it increasingly difficult to navigate supermarkets saturated with GE products. Currently, the science remains inconclusive regarding whether GE foods are “as safe as” conventionally produced foods. Some believe the increase in food allergies and food recalls is linked with the GE process. The FDA, however, holds that GE foods are no more likely to cause allergic reactions. The FDA therefore takes the position that GE products can be adequately regulated under the existing framework that oversees conventionally grown foods.

The EU, on the other hand, takes a more precautionary approach to the potential health consequences of GE foods and regulates both the biotechnology process and the final GE product. The more risk-based EU legislation requires accountability at every stage of production and ensures transparency of the final GE product. The EU’s policies extend to international exporters—and the United States is the EU’s largest trading partner. However, the dearth of cohesive legislation in the United States has led to increased agricultural trade imbalances as other GE-producing countries threaten to displace United States GE exports. The lack of mandatory federal regulations that distinguish GE foods from other foods has led to state initiatives to label GE products. Yet the piecemeal state initiatives do not address the actual issue, which is to ensure transparency in the GE food production system.

To overcome the regulatory challenge, the United States should enact uniform risk-based GE labeling legislation consistent with the EU’s precautionary principle given the inconclusive science and international trade concerns. An amended Federal GE Bill will turn out to be a step in the right direction for consumer safety concerns and American agricultural foods in the world market. Mandatory labeling legislation may mitigate consumer risk perceptions as it did for rBST milk. After litigating over rBST milk labeling and non-rBST milk was labeled, companies voluntarily stopped using the GE version of the hormone even though no studies showed negative health effects for humans. Labeling actually increased consumer confidence and trade.

Adopting a precautionary approach and enacting federal labeling laws for GE foods in the United States would reduce international trade obstacles and increase consumer confidence in the government. Uniform labeling laws would streamline the approval process for GE crop exports. The ideal regulation would be modeled on an approach that ensures consumers receive information and increases the confidence of international trading partners in the American food production and regulatory system. Legislation that requires labeling would be more proactive and effective than a laissez-faire approach. It would minimize harm to international trade while also responding to consumer concerns. Federal law should preempt state laws and prevent patchwork legislation that would not serve state, federal, or consumer interests. In sum, a mandatory federal labeling law in the United States is a reasonable public policy for consumers on both sides of the Atlantic. [Emphasis added, citations omitted]

 

Is Anyone Regulating? The Curious State of GMO Governance in the United States,” by Rebecca Bratspies, Vermont Law Review, Vol. 37; 2013 (35 pages)

Excerpt: The United States regulatory system for genetically engineered crops is riddled with major gaps and omissions. Omitted from the regulatory inquiry are systemic environmental issues including the possibility of gene transfer to non-genetically engineered plants through cross-pollination; the cumulative effects of multiple genetically engineered crops on the evolution of pest resistance; and the probability of increased herbicide use. The neglected environmental, social, and economic issues have contributed to a profound lack of regulatory transparency in the regulation of genetically engineered crops, and the resulting erosion of trust in government more generally. Nothing shatters public confidence in a regulatory system more than the sense that obvious public interests and concerns are not being addressed. The time is ripe to improve the regulation of agricultural biotechnology. It is past time to consider whether we can establish a rigorous regulatory process that independently reviews and approves products that are safe for consumers and the environment. Such a system is essential if consumers are to have confidence in biotechnology going forward.

 

Lack of Transparency in the Premarket Approval Process for AquAdvantage,” by Michael P. McEvilly, Duke Law & Technology Review, vol. 11, no. 2; 2013 (21 pages)

ExcerptA trade secret is “a process or device for continuous use in the operation of . . . business” and “may consist of any formula, pattern, device or compilation of information which is used in one’s business, and which gives him an opportunity to obtain an advantage over competitors who do not know or use it.” Generally speaking, a trade secret is known only to one or a few people, and is kept secret from the general public. Disclosure of a trade secret may result in an abandonment of the essential element of secrecy. A number of federal and state cases bear on the issue of whether, and under what circumstances, the disclosure of a trade secret results in an abandonment of secrecy.

Courts have held that a general public disclosure of a trade secret by a party asserting a protectable interest, as in a patent application or a published material, results in abandonment of the element of secrecy and destruction of trade secret status. When, as in the case of AquAdvantage Salmon, the FDA discloses the mechanisms by which a company creates a transgenic animal, trade secret property rights contained in the disclosure are extinguished. This “abandonment” undermines the need for secrecy throughout the premarket approval process.

The Supreme Court considered whether trade secret property right protection should continue after public disclosure of data in Ruckelshaus v. Monsanto Co., which concerned a statutory scheme somewhat similar to the FDCA statutory scheme described above. Provisions of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) “authorize the [EPA] to use data submitted by an applicant for registration of a pesticide [product] in evaluating the application of a subsequent applicant, and to disclose publicly some of the submitted data.” Section 10 of FIFRA authorizes public disclosure of all health, safety, and environmental data, even though it may result in disclosure of trade secrets. Monsanto, an inventor, producer, and seller of pesticides, brought suit, alleging, inter alia, that the data-disclosure provisions of FIFRA effected a “taking” of property without just compensation.

In 1978, FIFRA was amended, revising its existing data-consideration and data-disclosure provisions. Congress added a new subsection, 7 U.S.C. § 136h(d), “that provides for disclosure of all health, safety, and environmental data to qualified requesters,” except disclosure of information that would reveal “manufacturing or quality control processes” or certain details about inert ingredients “unless the Administrator has first determined that the disclosure is necessary to protect against an unreasonable risk of injury to health or the environment.” The District Court found that much of the health, safety, and environmental data Monsanto sought to protect “contain[ned] or relate[d] to trade secrets.”

The Supreme Court recognized that the extent of the property right in a trade secret “is defined by the extent to which the owner of the secret protects his interest from disclosure to others.” Additionally, the Court found that information that is “public knowledge or that is generally known in an industry cannot be a trade secret.” Because Monsanto was on notice of the ways in which the EPA was statutorily authorized to use and disclose data received from applicants for product registration, Monsanto “could not have had a reasonable, investment-backed expectation that EPA would keep the data [submitted after the 1978 FIFRA amendments] confidential beyond the limits prescribed in the amended statute itself.” Any applicant knew that information relating to the formula of products could be revealed by the EPA to any federal agency and to the public at a public hearing when necessary to carry out their duties under FIFRA. The statute also provided Monsanto notice that “much of the health, safety, and efficacy data provided by it could be disclosed to the general public at any time.”  Thus, any voluntary submission of data in exchange for the economic advantages concomitant with product registration could not be a taking.

Like the applicants under FIFRA, new animal drug applicants under FDCA are on notice that the FDA may disclose a summary of safety and effectiveness data as appropriate for public consideration at advisory committee meetings. Applicants are also aware that the FDA intends to hold public advisory meetings for all applications for genetically engineered animals intended for human consumption. Any trade secrets disclosed to the public through such meetings, such as those found in the AquAdvantage Salmon meeting materials, are likely extinguished.

All of this is not to suggest that no trade secret protection should exist for NADAs prior to the announcement of a public meeting. Biotechnology companies should be able to retain their competitive advantage during the period between the submission of an application and the VMAC meeting. It is less clear, however, why safety and effectiveness data should not be fully disclosed during the comment period prior to and after the advisory committee meetings. If the purpose of the lack of transparency is to protect trade secrets, and many, if not most of those secrets, will be extinguished through disclosure, maintaining such a high degree of secrecy outlives its purpose. As such, the FDA should more seriously consider keeping the public apprised of the status of active applications after this time, even if it means a second summary of safety findings prior to final approval.

Conclusion: (Page 433) Most complaints surrounding AquAdvantage Salmon have concentrated on concerns both regarding the risk posed to other fish and the environment should they escape, as well as differences between genetically engineered salmon and farm-raised salmon that could pose a risk to consumers. To increase public trust, more should be done to keep consumers apprised of the status of NADAs during premarket approval. Additionally, more needs to be done to ensure the validity of the data used to determine whether the genetically engineered animals are safe for human consumption. By focusing on improving the transparency of the process, the public will have a better understanding of which deficiencies in data are real and which are not. Such an understanding would enhance public confidence in the safety of genetically engineered food as worldwide demand for protein sources continues to increase. [Emphasis added, citations omitted]

 

Does Regulation Chill Democratic Deliberation? The Case of GMOs,” by Alison Peck, Creighton Law Review, vol. 46; 2013 (56 pages)

This has to be viewed or downloaded from HERE

Excerpt: Breakthroughs in science and technology pose a challenge to the U.S. legal system: either regulate under pre-existing laws using a business-as-usual approach, or pass new laws to deal with new relationships and conflicts created by these breakthroughs … To examine this type of legislation/regulation decision, this Article focuses on an older example: the creation of the regulatory structure for genetically modified organisms (“GMOs”) in the 1980s and 1990s. The evidence explored in this case study suggests that deliberative asymmetries between the political branches, not public consensus behind a regulatory solution, led to both the creation and the persistence of a regulatory framework for GMOs under existing laws. The Article raises questions for contemporary regulation/legislation debates and lays a foundation for discussion of potential legal reforms.

(Pages 153-155) – For a quarter-century, the 1986 Coordinated Framework has guided the creation of a regulatory framework for legal controls on biotechnology that continues today. These regulations, based on authority under statutes written before the technology was imagined, were implemented at the same time as a brief early period of congressional interest in the topic. This congressional interest has not been approached since. The executive branch interpreted the scope of its regulatory authority and argued against Congress creating new oversight legislation. Federal agencies elaborated policies through policy statements and guidance documents that determined what information the public would receive about the new technology. In some cases, these policy statements were not subject to notice and comment but were still granted deference by courts. While a vocal group of citizens has challenged biotech regulatory policy since the late 1990s, those challenges have not translated into legislative change to the federal agencies’ statutory authority, substantial reinterpretation of that authority by the agencies themselves, or strong familiarity with biotechnology by the average American… the history of biotechnology development and public awareness of that technology raises doubts as to whether the public has had an opportunity to engage in meaningful democratic deliberation about biotech controls. As of 2006, most Americans had never had a conversation about biotechnology. Congressional leaders abandoned the effort by 1990 because of the existence, by that time, of the 1986 Coordinated Framework. Even as studies have begun to document serious harms to the environment and potential harms to human health related to the widespread planting of herbicide- resistant biotech crops, Congress has taken little action to review the regulatory structure, and the chief proponent of such oversight in the House was defeated in the 2012 primaries. Surveys do not support an inference that the public is simply content to defer to regulators on controls of new technology…

The creation of the GMO regulatory structure is water under the bridge. Substantial changes in the legislative authority of federal agencies to regulate GMOs will depend on further grassroots activism, strong new proponents in Congress, and, in all likelihood, growing evidence of environmental and human health harms. Unfortunately, it may also require a crisis of even greater magnitude than the widespread crop losses attributable in recent years to glyphosate-resistant weeds. As early as 1987, then-Senator Al Gore lamented,

In Congress, each proposal designed to bring regulatory order to biotechnology has met vigorous opposition from the industry and the Administration. Without a crisis to focus attention on biotechnology, it is difficult to argue for making regulatory reform in this area a priority, especially when compared to the needs to reform other major environmental laws such as Superfund and the Clean Air Act.

… If the GMO case study raises concerns about executive action that precedes, and possibly preempts, public deliberation about newly emerging science or technology, those concerns should apply all such agency action, regardless of the ideological appeal of the short-term goal such action serves. If the result seems to be an unsatisfying compromise of urgent protections to facilitate long-term engagement, then perhaps new mechanisms for balancing legislative power and agency authority in the short term should be explored. [Emphasis added, citations omitted]

 

Genetically Modified Plants and Regulatory Loopholes and Weaknesses under the Plant Protection Act,” by Emily Montgomery, Vermont Law Review, Vol. 37; 2012 (30 pages)

Excerpt: In particular, a mechanism for post-market monitoring of GM plants is the most important change that could be made with respect to GM plant regulation. This would allow regulators to watch for and address problems that might arise from a GM plant after it has been approved and put on the market. Many problems associated with GM plants, such as cascade effects like the superweed, are not readily apparent until after the plant has been deregulated and released into the environment. Thus, regulators need to have the ability to deal with unanticipated impacts. This change would strike a balance by still allowing GM plants onto the market despite uncertain later effects while also enabling APHIS to detect and address those impacts where necessary.

However, improvements within the existing system are only a short term fix, and an overhaul of United States biotechnology policy is warranted. Even with improvements to APHIS [a division of the USDA that ‘regulates’ GM crops] oversight under the PPA [Plant Protection Act], there would still be many inefficiencies and overlaps at play under the Coordinated Framework. In the meantime, while the nation waits for a cohesive regulatory policy for GMOs, improvements should be made to APHIS regulation of GM plants under the PPA to help address and minimize environmental risks. [Citations omitted, emphasis added]

 

An analysis of the FDA Food Safety Modernization Act: Protection for consumers and boon for business,” by Debra M. Strauss, Food and Drug Law Journal, Vol. 66, No. 3; December 2010 (25 pages)

[Can also be viewed and downloaded HERE]

Excerpt: In the area of genetically modified food, although supporters of this technology from agricultural states have previously prevailed, the new focus on safety issues may turn the tide to scrutinize the adequacy of a U.S. regulatory framework that predates the advent of agricultural biotechnology. Ongoing issues associated with the widespread use of GM crops include concerns about increased herbicide resistant weeds as well as the cross-contamination of other traditional and organically grown crops. In addition, while FDA appears poised to approve genetically engineered (GE) salmon as the first GE food animal to be approved for human consumption, the Senate has reintroduced a bill to ban GE salmon and a bill to require labeling if GE fish are approved. [NOTE – the FDA has already approved the fish and is regulating it “as a drug”] Citing the lack of consideration of the potential health and safety issues, a group of senators supported by environmental groups such as Food & Water Watch has urged FDA to shift the approval process to FDA’s Center for Food Safety and Applied Nutrition to study the potential consequences to human health. … Meanwhile the debate in Congress on other bills involving GM food continues. U.S. food law has not changed substantially in 70 years. Hopefully now that the importance of food safety is being widely recognized at last, other areas of U.S. food policy will be reexamined, particularly genetically modified foods and the use of milk and meat from cloned animals and their progeny. With the new focus on “prioritizing prevention,” this would be an appropriate time to make meaningful change in the area of biotechnology and food safety standards.

 

Food Labeling and the Consumer’s Right to Know: Give the People What They Want,” by David Alan Nauheim, Liberty University Law Review: Vol. 4: Issue 1, Article 3; 2009 (38 pages)

Excerpt: Under the current FDA policy, a fact is only considered material in two contexts: when it relates to an increased risk to consumer safety; or when it relates to a ‘material consequence,’ such as a change in a food’s organoleptic [An organoleptic difference is one capable of being detected by a human sense organ], nutritional, or functional properties ‘that would not be noticeable at the point of purchase but could be apparent when consumed or cooked.’ Of course, whether there is an increased risk to consumer safety is determined by the regulator, and that decision will receive deference from a reviewing court because the reasoning behind labeling decisions are ‘characterized by scientific and technological uncertainty.’

However, the FDA has not always held that materiality is a condition precedent to considering consumer interest. As discussed supra Part II.B.2, the FDA has previously mandated labeling, based solely on consumer interest. In its 1986 decision to mandate labeling for all irradiated food, the FDA stated, ‘Whether information is material under section 201(n) of the act depends not on the abstract worth of the information but on whether consumers view such information as important and whether the omission of label information may mislead a consumer.’ [Italics in original] The FDA reasoned that the ‘FDA has historically required the disclosure of a food processing agent whenever it is material to the processing of foods.’ It reasoned that if flour must be labeled as ‘bleached’ when bleaching agents are used in processing, or as ‘bromated’ when potassium bromate is used in the processing, then irradiated food should be labeled as irradiated, if irradiation is used in processing.

The FDA also gave other examples where it has mandated labeling, not because of the abstract worth of the information, i.e., safety concerns or organoleptic changes, but rather based solely on whether consumers view such information as important and whether the omission of label information may mislead a consumer. The FDA noted that it had required labeling where a food is enriched or fortified, where orange juice is made from a previously concentrated ingredient, or where orange juice has been pasteurized. The FDA further noted that manufacturers of [p]otato chips made from dehydrated potatoes, onion rings made from minced onions, and fish sticks made from minced fish are all required to disclose these material differences in processing.

The FDA has also proposed mandating labeling due to religious and cultural concerns. Consumers asked the FDA, for religious and cultural reasons, to require that labels state whether a protein hydrolysate is derived from animals or plants. The FDA recognized that, for religious or cultural reasons, some consumers wish to avoid foods or food ingredients that are of animal origin because their dietary convictions prohibit or discourage the consumption of such foods. The FDA, therefore, proposed a rule that would mandate labeling, concluding, ‘[T]he food source of a protein hydrolysate is information of material importance for a person who desires to avoid certain foods for religious or cultural reasons.’ [Italics in original] The FDA later backtracked on this proposed rule.

If the FDA requires labeling in all of these situations, then it would seem perfectly consistent for the FDA to require labeling of GMOs, or of milk from cows that have been treated with rBGH. Thus, while the FDA currently claims that it does not have authority under the FDCA to mandate labeling based solely on consumer interest, this seems a dubious claim. [Citations omitted, bold emphasis added]

 

Genetically Modified Plants Used for Food, Risk Assessment and Uncertainty Principles: Does the Transition from Ignorance to Indeterminacy Trigger the Need for Post-Market Surveillance?” by Katharine A. Van Tassel, Boston University Journal of Science and Technology Law, Vol. 15; July 7, 2009 (32 pages)

This can be viewed online and downloaded from HERE

Excerpt: The FDA’s regulatory presumption of bioequivalence is based on the now dated Central Dogma of molecular biology … Instead of viewing DNA as just a string of biological code, scientists have a new understanding that DNA is a highly complex operating system where a gene which expresses itself one way in a donor organism may not express itself the same way when dropped into an entirely different organism with its own complex operating system … And changing how even one gene works can have a ‘butterfly effect’ on the entire organism. Critically, epigenetics and epigenetic inheritance explain that these unintended consequences can be passed on to future generations and may not manifest themselves until triggered by external environmental factors … The bottom line is that the scientific acceptance of the existence of the networked gene establishes that the FDA’s presumption that GM plant food is bioequivalent to traditional plant food is no longer scientifically supportable and that a new system for GM plant food regulation is required

These studies all add up to a rapidly emerging picture of an exceptionally dynamic system where a gene which expresses itself one way in a donee organism to produce a particular protein, in a particular amount, in response to a particular stimulus, may not express itself the same way when dropped into an entirely different organism with its own complex operating system, as was the case with the GM peas. This new operating system may cause the transferred gene to change the phenotype of the donee organism in a way that is undetectable by the FDA as the products of gene expression by the donee gene are not tested as expressed in the donee organism …

The new understanding of the networked gene has shifted the general nature of uncertainty over the public health risks of GM food from ignorance to indeterminacy. In other words, from not knowing what we don’t know, to knowing what we don’t know. When the FDA first made its choice over how to regulate GM plant foods much less was known regarding gene function. Scientists simply ‘did not know what they did not know’ about the risks to public health of GM food. Thus, with regard to uncertainty, the scientific decisions and FDA regulatory choices based on those scientific decisions, were made in an environment of ignorance. Acting in ignorance, scientists at the FDA chose to regulate based on a false assumption of bioequivalence … Now, scientists have a much better grasp of what they don’t know and are operating in the realm of indeterminacy with regard to the health risks associated with GM food. They are aware that the assumption of bioequivalence is no longer scientifically supportable. Now, scientists must determine whether the network effects of gene transfers create unintended harmful effects. Thus, scientists are aware of the risks that they must rule out through the systematic study of each transplanted gene as it functions in the new organism and as that new organism responds to environmental triggers.

A large proportion of the U.S. consumers’ diet is GM food, reflecting a heavy exposure to novel substances. Now that the nature of the uncertainty the FDA is dealing with is indeterminacy, not ignorance, GM ingredient labeling and post-market surveillance should be required in order to provide for both the transparency and accountability necessary to protect public health. [Citations omitted, emphasis added]

 

In re StarLink Corn: The Link between Genetically Damaged Crops and an Inadequate Regulatory Framework for Biotechnology,” by Linda Beebe, William & Mary Environmental Law and Policy Review, Vol. 28, Issue 2; 2004 (28 pages)

Excerpt: (Pages 537-538) The federal government should pass a comprehensive regulatory scheme regarding genetically modified organisms that includes a liability scheme. The StarLink Corn case demonstrates that the “patchwork” regulatory system in place, coupled with state common law creates a situation in which valid claims are preempted and liability is unclear.

It would certainly behoove the United States to adopt comprehensive regulatory and liability schemes for GMOs. There are numerous reasons for this. First, the United States is by far the world leader in GMO production. The United States, however, lags behind when it comes to taking responsibility and regulating biotechnology. It is time that the largest GMO producing country adopts a clear and comprehensive regulatory scheme pertaining to these very real issues.*

[*] Note that this was published in 2004- Moderator

Second, in the past, the United States government’s desire was to encourage the biotechnology industry with their previous laissez-faire regulatory scheme. The United States, however, is now the established world leader and, considering most of the world’s GMO skeptical attitude, it is unlikely that this dominance will fade. The only way this dominance will fade is if the rest of the world blatantly refuses to accept American agricultural products-this has already occurred. In order to increase the confidence of American trading partners, therefore, it is essential that Congress enact specific measures regulating GMOs and enabling any parties injured by GMOs to recover, both adequately and readily. At this point, considering the international debate on the subject, it is the only way to encourage the burgeoning biotechnology industry.

The third reason the United States should look to the rest of the world is to increase consumer confidence. Although the American public is clearly not as opposed to genetic modification as are their European counterparts, there is growing concern about the possible consequences of genetically modified food. It is difficult to believe educating the public about the “patchwork” method in which the United States regulates GMOs would do anything to decrease this concern. The only way to increase consumer confidence is to adopt reforms, thus forcing real risk assessment, instead of following vague concepts such as “substantial equivalence” and “Generally Recognized as Safe.” [Emphasis added, citations omitted]

 

Legal Issues Related to the Use and Ownership of Genetically Modified Organisms,” by Roger A. McEowen, Washburn Law Journal, Vol. 43; 2004 (50 pages)

Excerpt:  (Pages 657-658)

1995 Antitrust Guidelines for the Licensing of Intellectual Property

Intellectual property licensing practices are the subject of extensive guidelines that were issued jointly by the Antitrust Division of the U.S. Department of Justice and the Federal Trade Commission. The guidelines were finalized in 1995. The issuance of the guidelines and several recent government antitrust investigations and enforcement actions (particularly those involving Microsoft and Intel) suggest that the antitrust enforcement agencies are paying particular attention to issues of technology and innovation, and the intersection of antitrust law and intellectual property. The intersection of antitrust law and intellectual property appears to be a major agenda item for the Antitrust Division of the Department of Justice. Thus, it may be appropriate to expect greater attention and activity from the antitrust community on issues of intellectual property law and policy.

Under section 1.0 of the guidelines, “the intellectual property laws and the antitrust laws share the common purpose of promoting innovation and enhancing consumer welfare.” [279]. Antitrust law has long focused on targeting practices that tend to block or discourage innovation, while simultaneously recognizing and accommodating the critical role of the intellectual property laws in promoting the development of new technologies. Perhaps the most difficult issue with respect to antitrust law’s application to intellectual property arises when the focus of antitrust law on avoiding the abuse of monopoly power and unreasonable restraints of trade appears to conflict with the purported freedom of an intellectual property owner to use (or not use) its property as it sees fit. This appears to be the critical legal issue involved in determining whether a contract restriction limiting the use of parent seed would be enforceable or unenforceable under antitrust law. Patent licensing issues are the subject of the 1995 guidelines, and the guidelines identify specific licensing practices that are likely to raise antitrust issues and trigger enforcement actions.

[279] U.S. Dep’t of Justice, Federal Trade Commission, Antitrust Guidelines For The Licensing Of Intellectual Property § 4.1.1 (1995), reprinted in 4 Trade Reg. Rep. (CCH) [Emphasis added, most citations omitted]

 

The Illusion of Care: Regulation, Uncertainty, and Genetically Modified Food Crops,” by Rebecca Bratspies, New York University Environmental Law School Journal, Vol. 10; December 12, 2002 (59 pages)

[Can also be viewed and downloaded HERE]

Excerpt:  The Bt case study underscores the dangers of ad hoc decision making. Although EPA identified maintaining insect susceptibility to Bt as a “public good,” the agency permitted wide-scale marketing and planting of gm crops before it had a resistance management plan in place. At each stage in the regulatory process, EPA adopted the least precautionary assumptions for every point of scientific uncertainty. As a result, the regulatory controls on gm crops begin from an untenable basis. In order for the existing regulatory scheme to be effective, every step of the process must work perfectly, and every unknown variable must express itself in the least harmful way possible. No safety margins exist. No margin of error protects against inaccuracy in risk projections concerning frequency of resistance alleles, degree of expression of resistance, mating behaviors of various pests, or the farming behaviors of various growersIn effect, the current non-precautionary defaults amount to a subsidy from the public, growers and the environment to Bt crop registrants. Precautionary defaults would place the burden of factual uncertainty on those who benefit from selling Bt crops. By forcing registrants to internalize the costs, these defaults ensure that the market price for Bt crops will more accurately reflect their true cost … Only through precautionary regulation can the United States ensure that exploitation of these crops happens in a responsible and orderly fashion. Such regulation is not now in place, and what little regulation exists is ineffective … As the largest producer of gm crops, the United States must take the lead in developing responsible and precautionary regulatory controls. Not only are the environmental risks too great to permit any other course, but the consequences of public doubt and distrust are also too significant and too corrosive of the faith in regulatory credibility necessary for a viable administrative system. [Emphasis added, citations omitted]

 

StarLink™ – A Case Study of Agricultural Biotechnology Regulation,” by Donald L. Uchtmann, Drake Journal of Agricultural Law, Vol. 7; 2002 (53 pages)


Law articles, notes & comments that address ethical issues

 

Integrating Social and Ethical Concerns into Regulatory Decision-Making for Emerging Technologies,” by Gary Marchant et al, Minnesota Journal of Law, Science & Technology, Vol. 11, Issue 1; 2010 (20 pages)

Excerpt: Given that many of the public concerns about such technologies are ethical or social in nature, it seems inappropriate from both a normative and instrumental perspective for regulatory agencies to continue to disregard such concerns because they are outside of their stated regulatory missions.

The straightforward normative argument for regulatory agency consideration of social concerns is that in a democratic society, citizens should have the right to comment on whatever issues concern them regarding government decisions. Moral and social concerns are often deeply-felt and strongly-held by many members of society, and in their perception such issues cannot be divorced from the scientific, economic, and other policy issues that regulatory agencies do consider. Thus, in a democracy, citizens should have the right to raise moral and social concerns about a proposed government action, and to have those concerns considered and addressed by government decision-makers. [Emphasis added, citations omitted]

 

The Case for Regulating Intragenic GMOs,” by A. Wendy Russell and Robert Sparrow, Journal of Agricultural and Environmental Ethics, Vol. 21, Issue 2; 2008 (29 pages)

Excerpt: ABSTRACT. This paper discusses the ethical and regulatory issues raised by ‘‘intragenics’’ – organisms that have been genetically modified using gene technologies, but that do not contain DNA from another species. Considering the rapid development of knowledge about gene regulation and genomics, we anticipate rapid advances in intragenic methods. Of regulatory systems developed to govern genetically modified organisms (GMOs) in North America, Europe, Australia, and New Zealand, the Australian system stands out in explicitly excluding intragenics from regulation. European systems are also under pressure to exclude intragenics from regulation. We evaluate recent arguments that intragenics are safer and more morally acceptable than transgenic organisms, and more acceptable to the public, which might be thought to justify a lower standard of regulation. We argue that the exemption of intragenics from regulation is not justified, and that there may be significant environmental risks associated with them. We conclude that intragenics should be subject to the same standard of regulation as other GMOs. [Emphasis added]

 

Defying Nature: The Ethical Implications of Genetically Modified Plants,” by Debra M. Strauss, Journal of Food Law & Policy Vol. 3, No. 1; 2007 (37 pages)

Excerpt: Genetic modification of plants and the failure of the U.S. government to treat these crops and food products as different from other foods raise critical ethical issues for consumers. The nondisclosure of the fact that their food was developed using bioengineering techniques removes the right of informed choice. This fails the assessment from any ethical perspective, particularly a Kantian model. U.S. citizens have been deprived of their autonomy and freedom of choice, just as the farmers have been deprived of their independent livelihoods and the plants have been deprived of their essence. Individuals have the fundamental right to know what they are buying and eating, as well as the responsibility towards others and the natural world

The government has a responsibility to protect its citizens, particularly in such a critical area as the safety of the food supply. As a matter of ethics, the risks must not be placed on the unsuspecting public rather than on the companies who have created these genetic modifications. To do so would also betray consumers’ trust in their government to ensure their health and well-being as fiduciaries acting on their behalf. The Food and Drug Administration (FDA) has recognized this mandate in its regulatory approach to other areas of the food supply.

ConclusionFrom an ethical perspective, the problem is not that this technology exists, but how that technology is being used. This article has raised for discussion some important issues to consider as to ethical dimensions of the technology and how it is being utilized. Is it being applied towards the greater good? Are genetically modified (GM) plants being cultivated to produce food for the masses, or to create profits for a company whose seeds have been genetically modified to require purchase every year and not regenerate as farmers have done for centuries in order to make their living? Are GM plants being used to help the environment, or is there a greater potential for harm to human health and the environment? And do the current regulations or lack thereof violate our responsibilities to others by not allowing them a choice as to whether they knowingly and willingly assume the risks of ingesting these GM substances?

If anything, this new technology should be used to assist less developed nations, rather than to further the disparities in natural resources and technical expertise between the United States and economically developing countries. Accordingly, research should be directed towards eliminating world hunger and lowering the barriers to food distribution. While the development of Golden Rice is certainly preferable as an ethical matter to Roundup Ready® crops, note that this justification for bioengineered food has been revealed to be flawed, as an oversimplification of the problems of world hunger, vitamin deficiencies, and more complex social issues. Biotechnology should not be used to divert important resources from researching and applying more sustainable solutions for world food security…

The ethical implications are clear, followed by the expectation that the legal system will fill in the ethical gap as it has done in so many other areas and, at the very least, require labeling, pre-market approval, and monitoring of Genetically Modified Organisms (GMOs) in food products and ingredients. EU law takes into account ethical issues. It is morally imperative for U.S. law to do so as well. The government must fulfill its responsibility to protect its citizens, respond to their concerns, and not betray their trust by forcing them to bear the risk of GMOs without informed consent. As one scholar has queried, “[w]ill we be able to make ethical choices about what is humanly desirable, or will society become progressively more enslaved to the ‘free-market’ dictum that whatever can be done will be done?”

Some opponents of genetically modified foods have labeled them “Frankenfoods.” The origins of this analogy, as a reaction to the proliferation of untested technology with consequences that are as yet unknown, cannot easily be dismissed. Perhaps policymakers should heed the advice of that classic moral: “Learn from me, if not by my precepts, at least by my example, how dangerous is the acquirement of knowledge, and how much happier that man is who believes his native town to be the world, than he who aspires to become greater than his nature will allow.” Fundamentally, genetically modified plants substitute human wisdom for the wisdom of nature. Our society has yet to address the ultimate issue, particularly with regard to Terminator seeds – should mankind be usurping the basic functions of life? [Emphasis added, citations omitted]

 

Patent First, Ask Questions Later: Morality and Biotechnology in Patent Law,” by Margo Bagley, William & Mary Law Review, vol. 45, Issue 2; 2003 (80 pages)

Excerpt: This Article explores the U.S. “patent first, ask questions later” approach to determining what subject matter should receive patent protection. Under this approach, the U.S. Patent and Trademark Office (USPTO or the Agency) issues patents on “anything under the sun made by man,” and to the extent a patent’s subject matter is sufficiently controversial, Congress acts retrospectively in assessing whether patents should issue on such inventions. This practice has important ramifications for morally controversial biotechnology patents specifically, and for American society generally.

For many years a judicially created “moral utility” doctrine served as a type of gatekeeper of patent subject matter eligibility. The doctrine allowed both the USPTO and courts to deny patents on morally controversial subject matter under the fiction that such inventions were not “useful.”

The gate, however, is currently untended. A combination of the demise of the moral utility doctrine, along with expansive judicial interpretations of the scope of patent-eligible subject matter, has resulted in virtually no basis on which the USPTO or courts can deny patent protection to morally controversial, but otherwise patentable, subject matter. This is so despite position statements by the Agency to the contrary.

Biotechnology is an area in which many morally controversial inventions are generated. Congress has been in react-mode following the issuance of a stream of morally controversial biotech patents, including patents on transgenic animals, surgical methods, and methods of cloning humans. With no statutory limits on patent eligibility, and with myriad concerns complicating congressional action following a patent’s issuance, it is not Congress, the representative of the people, determining patent eligibility. Instead, it is patent applicants, scientific inventors, who are deciding matters of high public policy through the contents of the applications they file with the USPTO.

This Article explores how the United States has come to be in this position, exposes latent problems with the “patent first” approach, and considers the benefits and disadvantages of the “ask questions first, patent later” approaches employed by some other countries. The Article concludes that granting patents on morally controversial biotech subject matter and then asking whether such inventions should be patentable is bad policy for the United States and its patent system, and posits workable, proactive ways for Congress to successfully guard the patent-eligibility gate.


Publications that are not published in Law Review Journals that discuss legal issues

 

How the GE Food Venture Has Been Chronically Dependent on Deception,” by Steven Druker, Independent Science News; August 21, 2016

This was also published HERE

Excerpt: Although it purports to be based on solid science and the open flow of information on which science depends, the massive venture to reconfigure the genetic core of the world’s food supply has substantially relied on the propagation of falsehoods. Its advancement and very survival have been crucially and chronically dependent on the misrepresentation of reality – to the extent that more than thirty years after the creation of the first genetically engineered plant, the vast majority of people the world-over (including most government officials, journalists, and even scientists) continue to be misled about the important facts.

Moreover, contrary to what people would expect, the biotechnology industry has not been the main source of the deceptions.

Instead, the chief misrepresentations have been issued by respected government agencies and eminent scientists and scientific institutions…

So if the world’s oldest and most respected scientific institution cannot argue for the safety of GE foods without systematically distorting the facts, it indicates that such distortion is essential to the argument. Moreover, when the multitude of distortions and deceptions that have been issued on behalf of these products over the last thirty-five years are compiled and irrefutably documented (as in my book), the conclusion that the GE food venture could not have survived without them becomes virtually inescapable.

And another conclusion is equally obvious. The incontestable fact that the evidence has been methodically misrepresented is in itself compelling evidence of how strongly the aggregate evidence raises reasonable doubts about the safety of these foods – because if it was as favorable as the proponents claim, there would have been no need to distort it.

 

Essential Features of Responsible Governance of Agricultural Biotechnology,” by Sarah Hartley, Frøydis Gillund, Lilian van Hove & Fern Wickson, PLoS Biology, vol. 14, No. 5; May 4, 2016 (7 pages)

Excerpt: Agricultural biotechnology continues to generate significant controversy. Much of this controversy goes beyond questions about human and environmental safety to include concerns regarding intellectual property and monopoly ownership rights, consolidating corporate control over seed markets and the food chain, consumers’ and farmers’ right to know and choose, and challenges concerning the coexistence of different agricultural production systems. Existing regulatory frameworks struggle to address this wide range of concerns, as they largely rely on scientific risk assessment of human and environmental health only…

(Pages 2-3) Responsible governance of agricultural biotechnologies first and foremost requires honesty and humility about several factors embroiled in the controversy. These factors include: the scope and quality of the available scientific knowledge, the underlying motivations for a technology’s use and development, the realisability of claimed benefits, the range of concerns at stake (e.g., including those beyond physical risks), the information available in application dossiers, and potential conflicts of interests in assessment and decision making.

The lack of candor in current risk regulatory frameworks is a foundation for public concern. Public stakeholders are not necessarily risk averse in the face of uncertainty. However, experience of past technological safety failures has sensitized people to the limits of scientific knowledge and made them skeptical of those advocating complete knowledge and an ability to predict and control technological risks in complex socioecological systems. A lack of truthfulness concerning the limits of scientific knowledge, motivations, expected benefits, and the basis of conflict can lead to significant misunderstandings and mistrust between scientists, policy makers, and the public. Certainty and predictability are typically considered to be a measurement of competence; however, candidly recognizing and truthfully representing scientific uncertainties and the full range of concerns at stake does not reflect a lack of competence. Rather, such candor allows debate to move beyond the unhelpful illusion of technological control and open up for a broader and more inclusive discussion about the role of technology in addressing socioecological challenges. [Emphasis added, citations omitted]

 

Should McDonald’s and Monsanto Have the Same Rights as People? A Debate on Corporate Personhood,” by Amy Goodman and Juan González, Democracy Now! Truthout; March 16, 2015   [This is an interesting article about corporate personhood and how Monsanto has tried to take advantage of the Supreme Court ruling in order to fight GMO labels]

 

Why The FDA’s Policy on Genetically Engineered Foods is Unscientific, Irresponsible, and Illegal,” by Steven M. Druker, Alliance for Bio-Integrity;  2015 (5 pages)

 

Seed Privatization and the Path toward Equitable Exchange,” by Kristina Hubbard, Director of Advocacy, Organic Seed Alliance; 2014 (11 pages)

This is an excerpt from: “Proceedings of the 2014 Summit on Seeds and Breeds for 21st Century Agriculture,” edited by Bill Tracy and Michael Sligh, Rural Advancement Foundation International, (RAFI); March 2014 (289 pages)

Excerpt: In fact, Congress long argued that sexually reproducing plants should not be awarded utility patents under the U.S. Patent Act – “patents for invention” – for fear of curtailing innovation, threatening the free exchange of genetic resources, and increasing market concentration. A 1966 congressional committee report states that while its members “acknowledge the valuable contribution of plant and seed breeders, it does not consider the patent system the proper vehicle for the protection of such subject matter” (Report of the President’s Commission, 1966).*

[*Moderator’s note: I found this, which may be the report she refers to: “To Promote the Progress of Useful Arts in an Age of Exploding Technology – Report of the President’s Commission on the Patent System,” by the Committee on the Judiciary, Subcommittee on Patents, Trademarks and Copyrights; February 2, 1967 (76 pages)]

But the seed trade and plant breeders were eventually successful in convincing Congress that more protection was warranted. This came in the form of a “patent-like” protection under the Plant Variety Protection Act (PVPA) of 1970. The law represented a compromise: Breeders had the exclusive right to propagate and market varieties for 20 years, but the law provided important exemptions. First, other plant breeders can use varieties protected by a PVP certificate for research, including plant breeding. Second, farmers can save seed from protected varieties to replant on their own farm. (Prior to 1994, this exemption also allowed farmers to sell saved seed.)

Although PVP protections are still widely used today, Congress’ concerns regarding IP and plants have been realized, but not because of the PVPA. In 1980, the U.S. Supreme Court upheld the first patent on a living organism in Diamond v. Chakrabarty. The PTO had originally refused to award this patent, which involved a GE bacterium, before Chakrabarty appealed. In 1985, in Ex parte Hibberd, the Board of Patent Appeals and Interferences effectively extended the Chakrabarty decision by allowing a broad utility patent on plant matter (Hibberd, 1985) [Ex parte Hibberd, 227 U.S.P.Q. 443 (Bd. Pat. App. 1985)].

A 2001 Supreme Court decision later affirmed in J.E.M. Ag Supply vs. Pioneer Hi-Bred International that the scope of the Patent Act was not limited by the Plant Patent Act or the PVPA. Although utility patents awarded for seed and plants increased after the earlier 1980 and 1985 decisions, this Supreme Court ruling eliminated remaining uncertainties around utility patents on plants, opening the floodgates to further privatize our plant genetic heritage…

Economists have established that an industry loses its competitive character when the concentration ratio of the top four firms reaches 40 percent or higher. In seed, we’ve clearly exceeded that benchmark. Three firms (Monsanto, DuPont, and Syngenta) collectively control more than half of the global seed market, up from a 22% share in 1996. By crop type it’s even more telling, where four major biotechnology and chemical firms command 86% of the retail market for corn. The top two firms (Monsanto and DuPont) account for 66% of this market and 62% of the soybean retail market (Matson et al., 2012)

 

The Case for No GMO Patents,” by Tony Pereira, Truthout; June 14, 2013

Excerpt: Anything is fair game here; the possible combinations are exponentially high, infinite. GMO patents that have been granted for genetically modified (GM) corn, canola, cotton, sugar beets and soy have their roots in a first case for a patent application filed with the US Patent Office by General Electric (GE), which developed a bacterium capable of breaking down crude oil, to be used in treating oil spills. GE listed one of its genetic engineers, Chakrabarty, as the inventor.

The application was rejected by the patent examiner, Sidney Diamond, because under patent law it was generally understood that living things were not patentable subject matter under Section 101 of Title 35 U.S.C.

GE appealed to The Board of Patent Appeals and Interferences, which agreed with the original decision. On a subsequent appeal, the US Court of Customs and Patent Appeals overturned the case in GE’s and Chakrabarty’s favor, writing that “the fact that micro-organisms are alive is without legal significance for purposes of the patent law,” thus blatantly disregarding Title 35. Sidney A. Diamond, commissioner of Patents and Trademarks, appealed to the Supreme Court of the United States (SCOTUS) in the Chakrabarty v. Diamond case, which was argued on March 17, 1980. A narrow 5-4 decision was issued on June 16, 1980. The patent was granted by the USPTO on March 31, 1981.

SCOTUS thereby handed corporations the right to patent life, bacteria, seeds, plants, and animals in a misguided decision, which again ignored Title 35’s exclusion of all patents on life and living organisms. While the manipulation process was new, all of the original existing DNA and all receiving DNA from whatever provenance are not…

On June 13, 2013, the SCOTUS light bulbs suddenly went on, and on a unanimous vote (9-0), the court rejected a patent application for two cancer genes isolated by Myriad Genetics, Inc. In the court’s opinion written by Justice Clarence Thomas, Title 35 was repeatedly invoked as “…we hold that a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated…” This is, finally, the right decision.

GMOs are just the reverse of this case, i.e., DNA is combined instead of being isolated, thus logically also not patentable just because two or more DNA segments have been mixed together.

The doors are now open to reverse all previous 30 years of wrongdoings and false GMO patents and end the absurdity that everything in life, the food that we eat, plants, microbes, viruses, fish and animals can ultimately be patented and owned by someone else. GMO patent insanity has already led to crimes against humanity, and crimes against the planet.

 

Terminator seeds, the right to food, corporate responsibility, business and human rights,” by Sinéad Corcoran, Sinead C bits and bobs (Blog); August 9, 2012

Excerpt:  “As a threat to local crops but also entire seed systems, V-GURTs [Terminator seeds] are a substantial threat to global plant genetic diversity and ultimately a threat to global food security. Potentially it could so be concluded that it is the obligation of ALL state parties to prevent the progress of V-GURT technologies in the interest of the right to food of the entire global population.”

 

Farmers’ Guide to GMOs – Second Edition,” by the Farmers’ Legal Action Group, Inc.; February 2009 (116 pages)

 

If Your Farm Is Organic, Must It Be GMO-Free? Organic Farmers, Genetically Modified Organisms, and the Law,” by Jill E. Krueger, Farmers’ Legal Action Group, Inc.; September 2007 (40 pages)

 

From Asilomar to Industrial Biotechnology: Risks, Reductionism and Regulation,” by Sheldon Krimsky, Science as Culture Vol. 14, No. 4; December 2005 (16 pages)

Excerpt: (Pages 309-310) The international meeting held in February 1975 at the Asilomar Conference Center in Pacific Grove, California, set in motion the first scientific evaluation of genetically modified organisms. It left a legacy that remains influential decades later when the world is faced with the prospect of a cornucopia of new products derived from gene-splicing technology…

In this paper, I focus on the cultural, political and epistemological components of risk analysis for GMOs and their impact on the regulation of the biotechnology industry.

I argue that, beginning in 1980 with the election of Ronald Reagan, a changing political climate took hold in the United States, which gave rise to a neo-conservative government along with its cultural and economic manifestations. This helped to fuel and reinforce an epistemology of scientific reductionism. In short, this neo-conservative political ideology supported the breakdown of traditional sector boundaries between universities and industry, which led to the adaptation of science toward private rather than public agendas.

(Pages 318-319) Beginning in the 1980s, the US regulatory response to biotechnology moved toward guidelines, which documents a departure from the command control regulations of the 1970s. This was a response to a pro-market, anti-regulatory shift in the political culture of government. As part of this shift, a new ideology of ‘junk science’ created a false dichotomy between ‘good science’ and ‘bad science’ to derail any attempts to use the weight of circumstantial evidence and precautionary approaches to regulate biotechnology. No new laws were passed in the United States for genetically modified organisms. Instead, laws passed to regulate chemicals were stretched to apply to GMOs

The FDA is largely a toxicology-driven agency, one highly receptive to reductionist genomics through being comfortable with the reductionism of biochemistry. During the 1980s, FDA officials vigorously supported a product-based approach. When OSTP’s Coordinated Framework for Regulation of Biotechnology was released in 1986, federal regulatory agencies interpreted the framework for their own regulations. The FDA had a choice of whether or not to consider foreign genes added to plants by genetic engineering techniques as food additives. Such a decision would require mandatory testing under the US Food, Drug and Cosmetic Act. In its 1992 policy of GM foods, the FDA instead chose to exempt foreign genes from being classified as food additives and designated them GRAS, a regulatory term meaning ‘generally regarded as safe’.

The US agro-biotechnology companies were also given a guidance document that gave them options for how to deal with GM products. GM food producers were asked to contact the FDA if they believed their GM food product was likely to introduce allergens or raise its microtoxin levels. Companies were not required to notify the agency before they introduced a genetically modified food product into the marketplace. The FDA left to the producers the responsibility for pre-market testing and providing the agency with any information supporting the conclusion that the GM product was as safe as its conventional counterpart.

(Pages 320-324) Another sector where reductionist genomics and the market system met was in the courts. The United States has exercised its hegemony in the science and development of biotechnology to create a new set of global rules on patents, and product safety. Nations like Canada, Germany and India that opposed US patent provisions were placed under economic pressure to conform to US intellectual property standards. A legal decision reduced all intellectual property to a single idea—bringing discovery, invention, the living and inert, organism, cell and gene under a uniform patent system based on the notion that for the US patent law ‘all is chemical’. Monopoly control over a modified seed was reduced to a patented foreign gene introduced into the plant genome.

In June 1980, a US Supreme Court decision (Diamond vs. Chakrabarty 1980) on a contested patent claim afforded the nascent biotechnology industry and academic research institutes involved in gene sequencing new opportunities for acquiring wealth from genetically modified organisms and research-derived intellectual property. By overturning the US Patent and Trademark Offices’ denial of a patent for a microorganism, sui genesis, in a five– four vote, the US Supreme Court cleared the way for the use of the patent system for all varieties of living organisms and their parts, including animals, cells, human genes and even sub-genomic segments (expressed sequence tags)…

By extending the radius of intellectual property ownership to organisms in-and-of-themselves, and by its liberal interpretation of patentable entities, the US Supreme Court gave the patent office its rationale for extending patent rights over genes, sub-genomic elements, animals and cell lines independent of the process in which they are used. In this way, an organism modified by a single genetic change can be claimed as intellectual property…

In sum, the US policy style of regulating the risks of, and developing biotechnology, has embraced reductionism, an initial scientistic legacy of Asilomar that became expanded economically, legally and geo-politically. [Emphasis added, citations omitted]

 

Transgenic Fish: Is a New Policy Framework Necessary for a New Technology?” by Nathaniel Logar & Leslie K. Pollock, Environmental Science & Policy, vol. 8, issue 1; 2005 (11 pages) Also found HERE

Excerpt: (Page 8) We will now turn to the challenge of meeting our fourth criterion: incorporating public participation into the process before approval of a transgenic fish species, and increasing the overall transparency of the process. Including this criterion will correct the non-participatory nature of the FDA’s current approval process. To review, we have shown that the exclusion of public participation results in: (1) the public’s inability to access information concerning specific transgenic animals under consideration, (2) the FDA’s lack of data on social values, norms and preferences when making the approval decision and (3) lost opportunity for the public to comment on environmental impacts. In order to make the process more democratic, the new regulatory framework – in whatever form it ultimately takes – should include specific provisions to incorporate public participation. Including such participation in the process will remedy the identified problems in the following ways. First, providing access to information regarding an application eliminates the need for interest groups to rely on speculation when formulating their positions in relation to transgenic animals. Making this information public also opens up the opportunity for the public to seek it out in order to find accurate information.

Second, creation of a public process is more likely to inspire confidence and an increased sense of fairness among constituents compared to the current closed-door method. From a focus group-based study on natural resource decision making, researchers found that notification of citizens by the regulatory agencies, along with providing citizen participation in decisions, had a significant impact on the public acceptance of the outcome (Smith and McDonough, 2000). The designers of the study found that secretive processes lead to less acceptance of decisions by the public. Furthermore, at times the focus groups felt that agencies allowed comments but failed to heed them. The findings of the study reinforced those posited by Lind and Tyler (1988), who found that a person’s sense of fairness of a particular process can depend on whether that person’s comments or questions are ignored or acknowledged. Thus, increased participation could improve the image of the FDA by providing more legitimacy and increased status (Berry et al., 1993), feelings which would transfer to its decisions

 

Issues in the Regulation of Genetically Engineered Plants and Animals,” by the Pew Initiative on Food and Biotechnology; April 2004 (178 pages)

Excerpt: When the federal agencies first proposed the Coordinated Framework nearly 20 years ago, they acknowledged the need to periodically reassess the regulatory system to ensure that it is keeping pace with the rapid development of the technology (OSTP 1984). The impending introduction of the next generation of agricultural biotechnology products has led to a renewed interest in examining the adequacy of the current regulatory system for such future products…

The use of existing, general laws to regulate biotechnology raises two issues. First, while agencies have issued regulations and guidances based on their interpretations of their authority to cover biotechnology products developed thus far, some of those interpretations may be legally questionable. Second, agencies have not yet provided guidance on how they will regulate some new, forthcoming products of biotechnology under existing laws. Biotechnology can be used to create new products that do not fit neatly within existing product definitions, which rely on old laws that clearly never anticipated modern genetic engineering techniques. Fitting some of the new products into existing legal frameworks may prove to be legally challenging.

An additional issue is that the agencies have yet to clearly indicate how (or whether) they will regulate some future biotechnology products. In a number of cases, a product might fall under more than one product category, and therefore under more than one law…

The regulatory system needs to be improved in order to catch up with the technology, and a failure to do so could not only pose human health and environmental risks, but undermine public trust in the regulatory system and jeopardize market acceptance of agricultural biotechnology. The gaps and inadequacies in the current system are becoming increasingly apparent with the development of new biotechnology products that do not fit into the system

The current system, which has already been stretched to cover current crops, is not likely to be adequate for dealing with the next generation of agricultural biotechnology products. Current legal authorities are not sufficient to cover certain new kinds of products and do not give agencies adequate tools to assess risk and prevent harm or to detect and respond to harm should it occur. The lack of an affirmative pre-market food safety approval process for most GE foods is an example of inadequate legal authority … Review that relies upon voluntary compliance is inadequate to protect public health and the environment from those who might challenge the system … Credibility is also challenged when a regulatory system depends on voluntary compliance by the industry. [Emphasis added, citations omitted]

 

Farmer’s Guide to GMOs,” by David R. Moeller and Michael Sligh, Farmers’ Legal Action Group, Inc., November 2004 (53 pages)

 

Holes in the Biotech Safety Net – FDA Policy Does Not Assure the Safety of Genetically Engineered Foods,” by Doug Gurian-Sherman, Ph.D., Center for Science in the Public Interest; January 8, 2003 (30 pages)

Excerpt: To determine the adequacy of FDA’s current voluntary consultation process, we performed a detailed examination of more than a fourth of the data summaries (14 of 53) that FDA has reviewed. Our evaluation found that the biotechnology companies provide inadequate data to ensure their products are safe. In addition, it was clear from our review that FDA performs a less-than-thorough safety analysis. In particular, we found:

When FDA requested additional information to conduct a complete and thorough safety assessment, 50 percent (3 out of 6) of the time the GE-food developer did not comply with that request. In those cases, FDA had little choice but to complete its evaluation without the desired information.

In three submissions, the data summaries contained obvious errors that were not identified by FDA during its review process.

The submissions did not evaluate some potentially deleterious compounds, such as scientifically recognized toxicants in tomatoes or anti-nutrients in corn. In addition, allergenicity testing was not always performed using the best tests available.

The data summaries reviewed by FDA often lacked sufficient detail, such as necessary statistical analyses needed for an adequate safety evaluation.

FDA did not receive adequate data that the transgene and transgenic proteins were unaltered in the GE plant. Safety tests, such as for allergenicity, used forms of the protein that may differ from the GE protein found in the transgenic plant.

FDA did not generate its own safety assessment, but merely summarized for the public the developer’s food-safety analysis.

Based on those findings, it is clear that FDA’s current voluntary notification process (even if made mandatory) is not up to the task of ensuring the safety of future GE crops.

 


Law Review Articles which are not specific to GMOs that may have some relevance

 

Patenting Nature: A Problem of History,” by Christopher Beauchamp, Stanford Technology Law Review, Vol. 16, No. 2; Winter 2013 (56 pages)

[Moderator’s comment: GMOs, Genetically modified food, Monsanto – none of these are mentioned at all. Nonetheless, it has some historical documentation on some patent related issues and decisions]

 

At the Tipping Point: Defining an Earth Jurisprudence for Social and Ecological Justice,” by Judith E. Koons, Loyola Law Review [of New Orleans], Vol. 58, No. 2; October 2012 (42 pages)

Excerpt: Pages 354-355: If governments fail to implement emission reduction initiatives, the surface temperature of Earth is likely to increase 5.2 degrees Celsius (9 degrees Fahrenheit) by the end of the century. Warming of five degrees Celsius will produce significant extinctions of plant and animal species, massive crop declines, and a rise in sea levels that will threaten coastal cities around the world, “including London, Shanghai, New York, Tokyo and Hong Kong.”

Second, the consortium of scientists also found that the ongoing anthropogenic interference with the nitrogen cycle is “profound.” Human activities are converting nitrogen from the atmosphere into reactive forms that accumulate in the land and biosphere, pollute the waterways and coastal zones, and add to the pollution in the atmosphere. In the past fifty years, the influx of reactive nitrogen into terrestrial ecosystems has doubled. Eutrophication caused by the human-induced increase in the flow of nitrogen and phosphorous has created 150 dead zones in the world’s oceans, ranging up to 45,000 square miles. Amplified nitrogen and phosphorous act as “slow driver[s] influencing anthropogenic climate change at the planetary level.”

The conversion of nitrogen into reactive forms takes place through industrial and agricultural activities, as well as through fossil fuel combustion. Most reactive nitrogen is traced to the expanded use of fertilizer in modern agriculture. The chemical intensity of agribusiness is contaminating soil, water, and air, with disruptive effects on habitats that in turn spurs the extinction of species. Human interference with the nitrogen cycle has resulted in crossing this biophysical boundary at the planetary level.

Third, the current phenomenon of species extinction is the sixth major event of extinction in the history of Earth but the first to be triggered by human activities. Scientists estimate that the upper end of the natural rate of mammalian extinction was, for each millennium, one species becoming extinct for every one thousand species of mammals. Human activities have increased the extinction rate by 100 to 1,000 times the background rate. An estimated 25% of species in taxonomic groups that have been studied are threatened with extinction. In the “Red List of Threatened Species,” the International Union for the Conservation of Nature and Natural Resources has identified 19,817 species of plants and animals as threatened species. The planetary effect of biodiversity loss of this scale is unimaginable. Biodiversity of species is directly related to functioning of ecosystems, preventing ecosystems from tipping into disturbed states. The current and projected rate of threatened loss of species takes humanity “deep into a danger zone,” affecting biodiversity throughout the planet.

Pages 356-357: While the foregoing biophysical boundaries have already been crossed, human activities are nearing three other planetary boundaries—freshwater use, land-system change, and ocean acidification. In addition, interactions between and among the different boundaries may result in destabilizing other boundaries to have wider planetary effects. For example, the changes in land use in the Amazon rainforest, when coupled with climate change, could create a “tipping point where the Amazon forest is replaced by savanna-like vegetation by the end of the 21st century.” The feedback loop could have planetary consequences, affecting surface temperatures across the globe, including remote regions such as Tibet. A climate change in Tibet, with 15,000 glaciers in the Himalaya-Hindu Kush region, would also affect water resources for 750 million people in Asia. Thus, the ripple effects of encroaching on one geophysical boundary are far-reaching.

Earth is at the tipping point in several significant areas. Corporate-dominated economic activity has driven the planet to this place of potentially cascading catastrophe. The next section addresses the role that systems of law and governance play in the causes and outcomes of Earth at the tipping point. [Emphasis added, citations omitted]

 

Controlling the Intellectual Property Grab: Protect Innovation, Not Innovators,” by Harry First, Rutgers Law Journal, vol. 38; 2007 (34 pages)

Excerpt: The existence of competition in all sorts of patented and copyrighted goods can, in a legal sense, be traced back to Adams v. Burke. Thanks to the first sale doctrine, copyright and patent holders’ post-sale efforts to impose “label licenses” restricting resale prices, or requiring tying, with regard to a variety of goods – books, phonographs, records, and pharmaceutical drugs – were all rebuffed on the ground that the license terms were “not within the monopoly conferred” under either the patent or copyright acts. In all these cases the Court was sensitive to the importance of price competition among those who purchased patented or copyrighted goods for subsequent resale, and also sensitive to the adverse effect that such restrictions might have on downstream consumers. The restrictions were, in the Court’s words, “obnoxious to the public interest.”


Noteworthy GMO related Lawsuits

Diamond v. Chakrabarty , 447 U.S. 303, 316 (1980)

This Supreme Court decision “held that living organisms with a requisite degree of creative human agency may be granted utility-patent protection … In 1980, the U.S. Supreme Court issued its landmark Diamond v. Chakrabarty decision recognizing the patentability of living organisms. In Chakrabarty, the Court ruled that a bacterium invented by a scientist working for General Electric that broke down crude oil was patentable subject matter because (1) it was a product of creative human agency containing characteristics ‘markedly different’ from those found in nature, and (2) it possessed potential for significant utility. In spite of the holding in Chakrabarty, whether living organisms more complex than a bacterium, such as sexually reproduced plants selectively bred by plant breeders, were patentable subject matter under the general U.S. patent statute remained unclear.” [Citations omitted] (See: “Seeds of Dispute: Intellectual-Property Rights and Agricultural Biodiversity,” by Keith Aoki, Golden Gate University Environmental Law Journal, Vol. 3, Issue 1; 2009 – 83 pages)

“Chakrabarty, a scientist, sought patent protection related to his discovery of a method for developing a bacterium that could break down multiple components of crude oil. His claims ranged from the process of developing the bacterium to the bacterium itself and an inoculum in which the bacterium was stored with a carrier material. While the examiner found that a patent was appropriate for the process and the inoculum, Chakrabarty was denied a patent for the bacterium itself on the grounds that it did not meet the subject matter requirements for a patent. Under 35 U.S.C. Section 101 and the 1930 Plant Patent Act, according to the patent examiner, a living organism may not be patented. Various appellate review panels reached clashing decisions on the matter before the Acting Commissioner of Patents and Trademarks sought certiorari review from the Supreme Court.” (See: “Diamond v. Chakrabarty, 447 U.S. 303 (1980) –Annotation,” by Justia U.S. Supreme Court Center).

“A person who eats cornflakes at breakfast, puts on a cotton shirt, or takes a vitamin C supplement to ward off a cold almost certainly benefits from the US Supreme Court’s 1980 decision in Diamond v. Chakrabarty. It has been [over] 25 years since this landmark decision, in which the Supreme Court held that a live, man-made microorganism is patentable subject matter under Section 101 of the US Patent Act.

“Chakrabarty is not well known outside the intellectual property community – the average person probably has never even heard the name. Yet Chakrabarty has affected the lives of virtually everyone in the United States, having contributed to a revolution in biotechnology that has resulted in the issuance of thousands of patents, the formation of hundreds of new companies, and the development of thousands of bioengineered plants and food products.

“In Chakrabarty, the US Patent and Trademark Office (PTO) rejected claims to a genetically engineered bacterium on the ground that living organisms are not patentable. The Supreme Court disagreed, deciding by a five-to-four majority that a patent may be obtained on ‘anything under the sun that is made by man.’

“… Chakrabarty began with a patent application filed in 1972 by microbiologist Ananda Chakrabarty on an invention for treating oil spills … Chakrabarty’s 1972 patent application contained three groups of claims directed to: (1) The method of producing the bacterium (2) An inoculum composed of a carrier material and the bacterium (3) The genetically engineered bacterium itself.

“The patent examiner allowed the first two groups but rejected the claims directed to the bacterium as unpatentable under 35 U.S.C. § 101. On appeal at the PTO, the Board of Patent Appeals and Interferences affirmed the examiner’s rejection. The Court of Customs and Patent Appeals reversed the Board’s decision, however, ruling that living organisms are patentable subject matter. The PTO then filed a petition for writ of certiorari to the Supreme Court.

“The question before the Court was whether the claimed microorganism constituted a ‘manufacture’ or ‘composition of matter’ within the meaning of the US Patent Act. Reviewing the broad congressional mandate regarding patentable subject matter, the Supreme Court concluded that it did and asserted the principle for which Chakrabarty is best known: that ‘anything under the sun that is made by man’ is eligible for patenting.” [Citations omitted] (See: “Diamond v. Chakrabarty: A Retrospective on 25 Years of Biotech Patents,” by Douglas Robinson and Nina Medlock, Intellectual Property & Technology Law Journal, Vol.17, No. 10; October 2005 – 4 pages)

 

Also see: “Diamond v. Chakrabarty: Oil Eaters: Alive and Patentable,” by Dennis J. Walsh, Pepperdine Law Review, vol. 8 Issue 3; April 1981 (37 pages)

Moderator’s Comments:

This is an informative article, but the author shows his bias in the abstract:

“The author makes an exhaustive survey of the areas of confusion surrounding interpretation of the patent statutes and analyzes the Chakrabarty decision from the perspective of resolving these areas of confusion. The author ultimately agrees with the decision, but notes that although the confusion in this area is abated, the controversy still remains.”

Interestingly, at the conclusion, he states:

“Some will be pessimistic about this decision, emphasizing that the dangers outweigh the promises. In contrast, optimists will agree with Shakespeare that ‘we know what we are, but know not what we may be.’ This could become the epitaph of the modern world if present biological achievements become future scientific, legal, and political problems. However, instead of viewing the possible consequences of the Chakrabarty decision from a biased perspective, one should be mindful that science promises truth, not peace of mind. Thus, opinions, whether scientific, legal, or commercial, should be reserved until the truth has, in fact, been ascertained.” [Bold emphasis added]

This case has led to “scientific, legal and political problems” (not to mention more, such as ethical and environmental problems). These problems are on a global scale. The author also concluded:

“Policy decisions concerning patent laws in new fields of technology are not the province of the courts, but, rather, of Congress. This case, however, required an interpretation of an existing but ambiguous policy. The Chakrabarty Court was performing a valid judicial function in deciding that living organisms were patentable. The decision was congruent with the constitutional mandate to promote the arts and sciences and if Congress is so fearful of organisms produced by genetic engineering, then section 101 should be amended to exclude such organisms.”

If it will take an amendment to any law to exclude living organisms from being patentable, then that is the goal that should be taken by this generation for future generations. – Jeff Kirkpatrick


Foundation on Economic Trends v. Heckler, D.C. District Court (May 16, 1984); affirmed by the D.C. Circuit Court of Appeals (756 F.2d 143 – February 27, 1985).

In this case, “the D.C. Circuit Court of Appeals discussed the significance of environmental releases of transgenic organisms when determining the adequacy of an EA for the deliberate field release of a genetically engineered bacterium. The court affirmed an injunction to prevent the release of the ice-minus bacteria, even though the engineered bacteria occur in nature. The court stated that ‘the environmental consequences of dispersion of genetically engineered organisms are far from clear,’ and that these unknown consequences therefore constituted a significant environmental concern requiring a detailed analysis in an EA [Environmental Assessment]” (See: “You Can’t Put the Toothpaste Back into the Tube: The Adequacy of Federal Regulatory Oversight to Prevent Potential Environmental Damage Resulting from the Open-Field Testing of Transgenic Crops,” by David Paulson, Environmental Law Program at the William S. Richardson School of Law; 2005 – 34 pages).

 

Also see: “Foundation on Economic Trends v. Heckler: Genetic Engineering and NEPA’s EIS Requirement,” by Elizabeth Pizzulli, Pace Environmental Law Review, vol. 2, Issue 1; 1984 (29 pages)

 

This case is important because at around the time the genetically engineered bacteria were released [Ice-Minus] – which was followed by this lawsuit – President Reagan had stated there would be no new regulations for biotechnology. The lawsuit prompted Reagan to respond, and eventually the Coordinated Framework was created – which still oversees GMOs to this day – even though it was created long before any GMOs as we know them today were conceived:

“This social history of science policy development emphasizes the impact on the agricultural community of federal policies regarding release of recombinant DNA (rDNA) organisms into the environment. The history also demonstrates that the U.S. Coordinated Framework for Biotechnology Regulation (1986) is based principally in political criteria, not solidly based in science as its proponents claimed. The power struggle among policy negotiators with incompatible belief systems resulted in a political correction of biotechnology. I also demonstrate that episodes in the rDNA controversy occur in repetitive and periodic patterns. During the 1980s, the first rDNA microbial pesticide, Ice-Minus, struggled through a policy gauntlet of federal agency approval processes, a Congressional hearing, and many legal actions before it was finally released into the environment. At the height of the controversy (1984-1986), the Reagan Administration would admit no new laws or regulations to slow the development of technologies or hinder American international competitiveness … the Reagan Administration was forced to respond to the domestic turmoil in biotechnology oversight with a concerted effort to satisfy demands for environmental and consumer protection without hamstringing the industry. The result was a document called the Coordinated Framework for Regulation of Biotechnology, the details of which will be discussed later in this chapter. The development of this product-oriented framework for oversight, which required the cooperation of several federal agencies with differing opinions on how it should be done, was coordinated by the Office of Science and Technology Policy (OSTP) in the Executive Office of the President.” (See: “Politically Corrected Science – The Early Negotiation of U.S. Agricultural Biotechnology Policy,” by Mary Ellen Jones, a Doctoral Dissertation in Science and Technology Studies at Virginia Polytechnic Institute; 1999 – 404 pages).


 

J.E.M. Ag Supply, Inc. v. Pioneer Hi-Bred International, Inc. 534 U.S. 124 (2001)

In the previously mentioned case from 1980 (Diamond v. Chakrabarty, 447 U.S. 303, 316): “In 1980, the U.S. Supreme Court issued its landmark Diamond v. Chakrabarty decision, recognizing the patentability of living organisms.” Keith Aoki explained the history and evolution that led to J.E.M. Ag Supply, Inc. v. Pioneer Hi-Bred International, Inc.:

“In spite of the holding in Chakrabarty, whether living organisms more complex than a bacterium, such as sexually reproduced plants selectively bred by plant breeders, were patentable subject matter under the general U.S. patent statute remained unclear. However, five years after the Chakrabarty decision, the issue of the patentability of sexually reproducible plants was addressed in Ex parte Hibberd. In Hibberd, a PTO [US Patent and Trademark Office] examiner had rejected a patent application for a maize plant containing high levels of the amino acid tryptophan, on the grounds that the enactment of the PVPA in 1970 [Plant Variety Protection Act of 1970] precluded granting of general utility patents for plant matter. On review of the patent examiner’s rejection of the maize patent application, the U.S. Board of Patent Appeals and Interferences rejected the examiner’s assertions, noting that the patent statute did not expressly exclude any plant from being proper subject matter for a utility patent.

“The legitimacy of the 1985 administrative adjudication by the U.S. Board of Patent Appeals and Interferences in Hibberd was challenged in the 2001 U.S. Supreme Court case of J.E.M. Ag Supply, Inc. v. Pioneer Hi-Bred International, Inc. The defendant, J.E.M.,* argued that in light of the PPA [Plant Protection Act of 1930] and the PVPA, the Board of Patent Appeals and Interferences in 1985 incorrectly extended the scope of utility patents because the extension was accomplished without congressional approval. Justice Thomas, writing for the majority of the Court, upheld the validity of the Pioneer Hi-Bred patents at issue in the case, adding that J.E.M.’s unauthorized resale of patented hybrid corn seeds infringed Pioneer Hi-Bred’s patents. Justice Thomas declared that since the PPA and the PVPA did not explicitly state that general utility patents cannot be issued for germplasm, the PTO was therefore free to extend utility-patent protection to asexually and sexually reproduced germplasm.” [Citations omitted] (See: “Seeds of Dispute: Intellectual-Property Rights and Agricultural Biodiversity,” by Keith Aoki, Golden Gate University Environmental Law Journal, Vol. 3, Issue 1; 2009 – 83 pages)

[*Note: J.E.M. is also referred to ‘as doing as’ – or DBA – “Farmer’s Advantage”]

“Pioneer Hi-Bred International, Inc. holds 17 utility patents issued under 35 USC section 101 that cover the manufacture, use, sale, and offer for sale of its hybrid corn seed products. Pioneer sells its patented hybrid seeds under a limited label license that allows only the production of grain and/or forage. J. E. M. Ag Supply, Inc., doing business as Farm Advantage, Inc., bought patented seeds from Pioneer in bags bearing the license agreement and then resold the bags. Subsequently, Pioneer filed a patent infringement suit. In response, Farm Advantage filed a patent invalidity counterclaim, arguing that sexually reproducing plants, such as Pioneer’s corn plants, are not patentable subject matter within section 101. Farm Advantage maintained that the Plant Patent Act of 1930 (PPA) and the Plant Variety Protection Act (PVPA) set forth the exclusive statutory means for protecting plant life. The District Court granted “Pioneer summary judgment. The court held that section 101 clearly covers plant life and that in enacting the PPA and the PVPA, Congress neither expressly nor implicitly removed plants from section 101’s subject matter. The Court of Appeals affirmed.

Question: May utility patents be issued for plants under 35 USC section 101? Yes. In a 6-2 opinion delivered by Justice Clarence Thomas, the Court held that utility patents may be issued for plants. The Court reasoned that the PPA and the PVPA were not the exclusive means of obtaining a federal statutory right to exclude others from reproducing, selling, or using plants or plant varieties, as nothing in the controlling PPA and PVPA’s texts indicated that the PPA’s protection for asexually-reproduced plants was intended to be exclusive. “Denying patent protection under section 101 simply because such coverage was thought technologically infeasible in 1930, however, would be inconsistent with the forward-looking perspective of the utility patent statute,” wrote Justice Thomas. Joined by Justice John Paul Stevens, Justice Stephen G. Breyer dissented. Justice Sandra Day O’Connor took no part in the consideration or decision of the case.” (See: “J.E.M. Ag Supply, Inc. v. Pioneer Hi-Bred International, Inc.,” by Oyez, Chicago-Kent College of Law at Illinois Tech, n.d. Sep 4, 2016)

Also see: “Opinion of the Court: J.E.M. AG Supply, Inc., dba Farm Advantage, Inc., et al., Petitioners v. Pioneer Hi-Bred International, Inc., Syllabus,” December 10, 2001 (33 pages)

Also see: “J.E.M. Ag Supply, Inc. v. Pioneer Hi-Bred International, Inc. – Its Meaning and Significance for the Agricultural Community,” by Michael T. Roberts, Southern Illinois University Law Journal; 2003 (38 pages)


 

Center for Food Safety v. Hawai’i Department of Agriculture, Civ. No. 03-1-1509 (Hawai’i Circuit Court filed July 23, 2003)

Center for Food Safety v. Department of Agriculture., CV03-00621 (filed Nov. 12, 2003)

“Attorneys with Earthjustice and the Center for Food Safety filed suit in federal district court in Honolulu today asking the court to order the U.S. Department of Agriculture (USDA) to assess the environmental and public health risks of, and better regulate, the open-air testing of biopharmaceutical test crops in Hawai’i and throughout the United States … USDA has authorized corporations such as Monsanto, DuPont, ProdiGene, and Dow to conduct hundreds of field tests of biopharm crops genetically engineered to produce pharmaceuticals, industrial chemicals, and other medical and industrial products, including a blood clotting agent, a blood thinner, various blood proteins, experimental animal vaccines, industrial enzymes, antibodies, and a potent abortion-inducing compound once considered for use as an AIDS drug. Well over 4,000 field tests of genetically engineered crops have been conducted in Hawai’i, more than anywhere else in the world, including more than two dozen tests of biopharm crops … ‘The shroud of secrecy surrounding biopharming is unacceptable,’ said Paul Achitoff of Earthjustice. ‘Members of the public have the right to know about these potentially harmful substances being grown in their backyards.’ Biopharm testing in Hawai’i carries risks above and beyond those of testing elsewhere. Hawai’i has over 300 endangered species — more than a third of all U.S. endangered species and more per square mile than anywhere else on earth — and about 97 percent of all native species in Hawai’i are found nowhere else. Open-air biopharm field trials risk catastrophic impacts to these species.” (See: “Lawsuit Challenges Open-Air Testing of Genetically Engineered ‘Biopharm Crops’ (Press Release),” by Earthjustice; November 12, 2003)

Also see: “You Can’t Put the Toothpaste Back into the Tube: The Adequacy of Federal Regulatory Oversight to Prevent Potential Environmental Damage Resulting from the Open-Field Testing of Transgenic Crops,” by David Paulson, Environmental Law Program at the William S. Richardson School of Law; 2005 (34 pages)


 

Center For Food Safety et el., Plaintiffs, v. Ann Veneman, Secretary, USDA, et al., Defendants, and The Biotechnology Industry Organization, Intervenor, No. CV.03-00621 DAE BMK; United States District Court, D. Hawai’i, March 29, 2005.

“The gravamen [the essence or most serious part of a complaint or accusation] of Plaintiffs’ Amended Complaint, filed on February 10, 2004, involves Defendants’ alleged failure to comply with several federal statutes, including Section 7(a)(2) of the Endangered Species Act (‘ESA’), 16 U.S.C. § 1536(a)(2), and the National Environmental Policy Act (‘NEPA’), 42 U.S.C. § 4321 et seq. when it issued eight permits of the U.S. Department of Agriculture’s Animal and Plant Health Inspection Service (‘APHIS’). Specifically, Plaintiffs allege that Defendants permitted open-air field tests of experimental, genetically engineered, pharmaceutical-producing plant varieties (‘GEPPVs’) of crops such as corn. These plant varieties are engineered to produce biologically active drugs, hormones, vaccines and industrial chemicals.

“Plaintiffs assert that Hawaii has become a preferred site for field testing genetically engineered crops at thousands of plot locations throughout the islands. Plaintiffs’ first through fifth claims involve Defendants’ alleged failure to comply with NEPA in the promulgation of the field tests at issue in the instant case. Plaintiffs maintain that Defendants never prepared an Environmental Impact Statement (‘EIS’) or environmental assessment (‘EA’) as they claim was required by NEPA before approving the permits at issue. Plaintiffs allege violations of ESA, 16 U.S.C. § 1533 et seq. in their sixth through tenth claims in part for Defendants’ failure to consult with the United States Fish and Wildlife Service (‘FWS’) prior to issuing the permits.

“Plaintiffs next assert in their eleventh claim for relief that Defendants violated the Plant Protection Act (‘PPA’), 7 U.S.C. § 7711 et seq., and the Administrative Procedure Act (‘APA’), 5 U.S.C. 551 et seq., by arbitrarily and capriciously denying their request to promulgate regulations under the PPA to both prohibit the challenged field tests generally and also prohibit the use of food crops affected by the tests. Plaintiffs seek declaratory and injunctive relief to compensate Plaintiffs for the risks Defendants’ actions pose to public health, the environment, and the economy.” [Citations omitted] (See: “Center for Food Safety v. Veneman, 364 F. Supp. 2d 1202 – Dist. Court, D. Hawaii 2005,” by Google Scholar)


 

Center for Food Safety v. Johanns, 451 F. Supp. 2d 1165 – Dist. Court, D. Hawaii 2006

“From 2001 to 2003, four companies-ProdiGene, Monsanto, Hawaii Agriculture Research Center (HARC), and Garst Seed—planted corn and sugarcane that had been genetically modified to produce experimental pharmaceutical products. The companies modified the genetic structure of the corn or sugarcane so that, when harvested, the plants would contain hormones, vaccines, or proteins that could be used to treat human illnesses. For example, one company engineered corn to produce experimental vaccines for the Human Immunodeficiency Virus and the Hepatitis B virus, while another company engineered corn and sugarcane to produce cancer-fighting agents. These techniques are still experimental, and from 2001 to 2003 these four companies conducted limited field tests of these genetically engineered pharmaceutical-producing plant varieties (‘GEPPVs’) on Kauai, Maui, Molokai, and Oahu.” [Google Scholar]


 

Geertson Farms Inc., et al., Plaintiffs, v. Mike Johanns, et al., Defendants, Preliminary Injunction Order, Case 3:06-cv-01075-CRB; March 12, 2007 (5 pages)

Geertson Farms Inc., et al., Plaintiffs, v. Mike Johanns, et al., Defendants, Memorandum & Order, No. C 06-01075 CRB; Feb. 13, 2007 (20 pages)

Geertson Farms Inc., et al., Plaintiffs, v. Mike Johanns et al., & Monsanto  Co. et al., Defendants, Memorandum & Order RE: Permanent Injunction, No. C 06-01075 CRB; May 3, 2007 (15 pages)

 

Center for Food Safety et al, Plaintiffs, vs. Charles Connor USDA & Cindy Smith APHIS, Defendants, Complaint for Declaratory & Injunctive Relief; Jan. 2008 (17 pages) [Challenge to deregulate Monsanto’s GM sugar beet]


 

Quanta Computer, Inc. et al. Petitioner, v. LG Electronics, Inc., Respondent, 553 U.S 617, 128 Supreme Court, 2109 (2008)

See: Quanta Computer, Inc. v. LG Electronics, Inc., 128 S. Ct. 2109 – Supreme Court 2008 (No. 06-937) – By Google Scholar

“LG Electronics owned patents for a group of products, including microprocessor chips used in personal computers. It licensed the patents to Intel, but in a well-publicized separate agreement excluded from the license any Intel customer that integrated the chip with non-Intel components. One purchaser disregarded the agreement and used the chips in computers made for Dell, Hewlett-Packard and Gateway. LG Electronics sued those who passed the chips down the line of commerce to companies that had not purchased licenses.” [Citations omitted] (See: “Quanta Computer, Inc., et al. v. LG Electronics, Inc.,” by Oyez, Chicago-Kent College of Law at Illinois Tech, n.d. Sep 4, 2016)

This case was fundamentally about patent exhaustion. In part, the question that was raised was after a product is sold, then sold again, at what point has the patent been exhausted due to the re-sale of an object. This is relevant because GMO seeds are self-replicating technologies and as future Supreme Court cases decided in the years after Quanta, their patent does not expire after the initial purchase. Therefore, growing from one season to the next using the seeds from the first season’s harvest would be a considered a violation since the patent was not exhausted; this also applies in other cases where farmers buy patented seeds from a previous harvest and plant them, whether they are aware that they are patented or not. This case drew a huge amount of attention from the biotech industry before the decision by the Supreme Court because of the implications of patent exhaustion and how that might affect self-replicating patents (genetically modified seeds, in this context).

“The case specifically concerned application of the ‘patent exhaustion’ doctrine as a defense to patent infringement. At issue were: (1) whether the sale of a product can exhaust the patent holder’s rights in a patented method; (2) whether the sale of a product that substantially embodies but does not contain all of the elements of a patented system or method can exhaust the patent holder’s rights in that system or method; and (3) whether the sales at issue triggered exhaustion despite an attempt by the patentee to condition the sales (i.e., whether the sales were authorized) … the Court found the sales at issue triggered exhaustion despite the patentee’s attempt to limit downstream use of the products.” (See: “Quanta Computer v. LG Electronics: The U.S. Supreme Court Breathes New Life into the Patent Exhaustion Defense,” by Jones Day; June 2008

“Initially, the Quanta decision, which involved licensing and sale of patented electronic component parts, would seem to have little to do with seeds. But the Court’s finding in this case does indeed have implications not just for seed patent owners, but for any patent owner whose licensing strategies involve multiple downstream users … In view of Quanta, seed companies may want to take a fresh look at their existing licensing strategies for protecting proprietary seeds … Seeds are unique. Unlike the component parts in Quanta, seeds can self-replicate, i.e., they can be used to create new seeds that embody the entire potential of a patented invention. This fact in itself, some have argued, makes seeds very different from microchips.” [Citations omitted] (See: “Implications of Quanta Computer, Inc. v. LG Electronics for Agribusiness Companies,” by the Law Firm of Faegre Baker Daniels; September 22, 2009)

 

Also see: “The Doctrine of Patent Exhaustion: The Impact of Quanta Computer, Inc. v. LG Elecs., Inc.,” by Yuichi Watanabe, Virginia Journal of Law & Technology, Vol.14, No. 273; Winter 2009 (24 pages)

Excerpt: The Supreme Court in Quanta did not specifically address the biotechnology industry, but the Biotechnology Industry Organization (BIO) and the American Seed Trade Association (ASTA) each submitted an amicus brief (in support of neither party) and advised the Court about the potential consequences of its decision on the biotechnology industry. Concerned that a broad interpretation of patent exhaustion may defeat license restrictions on their technology, both BIO and ASTA urged the Court to reach a decision that would preserve the patentee’s rights in subsequent generations of self-replicating products…

Because biotechnology inventions have the capacity to self-replicate in the hands of a downstream purchaser, BIO and ASTA argued that a sale of a patented, self-replicating product should not trigger patent exhaustion with respect to the patentee’s exclusive right to “make” the patented product. Hence, according to BIO and ASTA where a patentee licenses its patents and the licensee sells the patented products to a downstream purchaser, the patent exhaustion doctrine gives the purchaser only the rights to “use” the purchased products, not the right to make copies. Put another way, where exhaustion applies, the patentee’s patent rights are only relinquished with respect to the particular products sold and not to reproduced copies.122

In sum, prohibiting purchasers from exploiting a product’s self-replicating character and making unauthorized copies is one of the primary concerns for the biotechnology industry. It is common practice in the biotechnology industry to restrict licensees and eligible purchasers from further making or copying the products … the biotechnology industry claims that the authority to use a purchased product does not confer the right to freely reproduce new products by exploiting the original product’s self-replicating nature. However, with regard to at least some self-replicating products, such as transgenic seeds, the reasonable “use” of the seeds may entail planting the purchased batch of seeds, which causes the seeds to “make” or produce second-generation seeds. Put another way, the “making” of the seeds is inherent in or part of the “use” process. At least in this respect, the distinction between the exclusionary rights to “make” and “use” the invention on which the biotechnology industry relies is obscure. [Citations omitted, bold emphasis added]

Moderator’s comments: As mentioned, the Biotechnology Industry Organization (BIO) ADVISED the Supreme Court in how to decide this case (as amicus curiae) BIO is a rabidly pro-GMO group whose members include Monsanto, Bayer, DuPont, and Syngenta and other biotech corporations. BIO appears on an extensive list of “Myth Makers” created by GMWatch. They are a powerful lobbying group and have a reputation for spreading disinformation about GMOs.

According to Powerbase, which is connected to GMWatch, “The association has four major lobbying priorities: blocking government price controls of biotech drugs; promoting genetically modified foods; streamlining the regulatory process for biotech products; and supporting tax incentives for the industry. Threats of bioterrorism have also propelled the industry – and its trade association – onto the homeland security front.” (See: “Biotechnology Industry Organization,” by Powerbase)

Out of curiosity, I decided to read the Brief that BIO had submitted to the Supreme Court which would advise them how to vote in the Quanta case. It’s worth stressing that Justice Clarence Thomas framed the main issues of this case, and then wrote the opinion as well. As a former attorney for Monsanto, he is ethically obligated to recuse himself (or not participate in) cases in which he may have a conflict of interest. It could be argued that Quanta did not present such a conflict since it was about computer patents, but that argument is weak considering how deeply and directly involved the biotech industry was involved in this court case. Here are some excerpts from the Brief submitted by BIO to … Clarence Thomas:

Brief of the Biotechnology Industry Organization as Amicus Curiae in Support of Neither Party, Quanta Computer, Inc. v. LG Electronics, Inc. 553 U.S. 617 (2008) (No. 06-937);  [Filed November 13, 2007 (44 pages).]

Excerpt: (starting on page 12) Preserving the rule that patent exhaustion law does not extend to the making of patented products is of critical importance to the biotechnology industry. When DNA, cell lines, gene sequences, and crop seeds are licensed or sold, they have the capacity to self-replicate in the hands of the licensee or purchaser. With respect to seeds, while the patent exhaustion doctrine may give the purchaser full rights to use the seeds actually purchased, the patentee’s rights are not exhausted with respect to the second-, third-, fourth-, or nth-generation of seeds that might be made by the purchaser. Where exhaustion applies, the patent monopoly is relinquished only with respect to the article sold and not with respect to copies of it that the purchaser might make…

The fact that a patented technology can replicate itself does not give a purchaser the right to use replicated copies of the technology, and without the actual sale of the second generation, there can be no patent exhaustion

Because the potential for replication inheres in these unique products, the patentee cannot sell the product for its ordinary use – medical testing and research or production of a crop – without simultaneously arming the purchaser with the ability to take over independent production of the cells or seeds – a privilege for which the purchaser did not pay and to which purchasers are not entitled. Accordingly, this Court’s decision should leave undisturbed the longstanding rule that patent exhaustion does not preclude restrictions on the making or re-creation of a patented product

Furthermore, the imposition of reasonable restrictions on purchases is a practical, unavoidable, and genuine necessity for the biotechnology industry

(Page 34) For the foregoing reasons, the Court’s decision should preserve the right of patentees to impose restrictions that prevent the unauthorized making of the patented product, that regulate purchases and sales by licensees, or that restrict a buyer’s use of a product only as reasonably necessary to enforce the patentee’s reserved rights in the patented product’s replication or use in alternative fields, while reserving the reasonable and expected use of the product for the purchaser. [Emphasis added, citations omitted, internal quotation marks omitted]

Moderator’s comment: Many people are somewhat familiar with the Monsanto Protection Act of 2013 which basically allowed a GM crop to continue to be planted and grown even if a court ordered it should be halted pending a certain action (such as conducting an Environmental Impact Statement).

According to SourceWatch, there was a law firm/lobbying firm that was hired by Monsanto during the Monsanto Protection Act period. That lobbying group lobbied members of Congress on behalf of Monsanto during that time:

“In the second and third quarters of 2012, Monsanto paid $50,000 per quarter ($100,000 total) to the lobby firm Akin Gump Strauss Hauer & Feld for lobbying the U.S. House of Representatives and the U.S. Senate on ‘Issues relating to international trade agreements; introduction of client’s international activities; issues relating to funding of the U.S.-Brazil Framework on cotton; issues relating to Farmer Assurance Provision in Agriculture appropriations bill (H.R. 5973).” [Note that H.R. 5973 was an earlier version of the Monsanto Protection Act. Although that proposal failed to pass, the same provision passed in a bill called H. R. 933 shortly after that]. (See: “Monsanto Protection Act” by SourceWatch; also seeBiotech Riders in the 2012 Farm Bill,” by SourceWatch; also seeBiotechnology Industry Organization,” by Powerbase).

The name of that firm is listed as: “Akin, Gump, Strauss, Hauer & Feld.” It’s interesting to note – and very disturbing as well – that one of the signatories on the BIO amicus curiae is none other than: “Akin, Gump, Strauss, Hauer, & Feld, LLP.”

In sum, a certain firm has not only influenced members of Congress regarding GMOs (i.e., the Monsanto Protection Act), but they have also clearly tried (and succeeded) to influence Monsanto’s former employee on the Supreme Court – Clarence Thomas – in a case that would have far reaching benefits for the biotech industry.

By any ethical standard, all of this reeks of corruption and conflicts of interest, and begs the question, “Who is in charge of the United States government? Who do the politicians represent?” Clearly, in the context of GMOs, the politicians in Washington have a long and consistent history of ignoring the will of the American people and are only interested in fulfilling the will of the biotech industry at the expense of risking the health of the population of America and enabling an absolute destruction of our biosphere in the process.

For more on the Quanta case, see the following publications:

Quanta Computers, Inc. v. LG Electronics, Inc. – Supreme Court Reinvigorates Patent Exhaustion,” by Andrew Ungberg, JOLT Digest, Harvard Journal of Law and Technology, June 13, 2008

Excerpt: The Supreme Court reversed the Federal Circuit, which had held that patent holders could seek infringement damages from subsequent purchasers further “downstream” provided that the initial transfer had imposed some type of restriction on the initial purchaser … Justice Thomas delivered the unanimous decision, holding that the 155-year-old doctrine of patent exhaustion limits the patentee’s power to dictate the terms of use through the first level of sales only. [Emphasis added]

 

Syllabus: Quanta Computer, Inc. v. LG Electronics, Inc. 553 U.S. 617 (2008),” by Justia U.S. Supreme Court Center

Quanta Computer, Inc. v. LG Electronics, Inc. 553 U.S. 617 (2008),” by Justia U.S. Supreme Court Center [Opinion by Clarence Thomas]

Opinion of the Court: Quanta Computer, Inc., et al., Petitioners v. LG Electronics, Inc. 553 U.S. 617,” U. S. Supreme Court, No. 06–937; June 9, 2008 (19 pages)

[Justice Thomas delivered the opinion of the Court, on Writ of Certiorari to the United States Court of Appeals for the Federal Circuit]

Also see: “Slip Opinion of the Court: Quanta Computer, Inc., et al., Petitioners v. LG Electronics, Inc. 553 U.S. 617,” U. S. Supreme Court, No. 06–937; June 9, 2008 (22 pages)

“NOTE: Where it is feasible, a syllabus (headnote) will be released, as is being done in connection with this case, at the time the opinion is issued. The syllabus constitutes no part of the opinion of the Court but has been prepared by the Reporter of Decisions for the convenience of the reader.”

A slip opinion “is an official stage in the life of a U.S. Supreme Court opinion. When the Court announces a decision, it immediately releases a bench opinion. A few days later, the Court prints the slip opinion, which might include corrections not found in the bench opinion. This allows for wide dissemination and review of the opinion. Once enough opinions have been released to complete a volume, a few months have passed, and any necessary corrections have been made, the Court compiles the slip opinions into numbered printed paperback volumes of the U.S. Report. One year later, the paperback volumes are reprinted as hardcover bound volumes. Decisions contained in the bound U.S. Report are official legal precedent and cannot be changed.” (See: “Slip Opinion,” by the American Bar Association)


Center for Food Safety v. Vilsack, 753 F. Supp. 2d 1051 – Dist. Court, ND California 2010 (Amended Order Regarding the Remedies on Plaintiffs’ Motion for Preliminary Injunction)

“Plaintiffs filed this action challenging the decision by the United States Department of Agriculture (‘USDA’) and its Animal and Plant Health Inspection Service (‘APHIS’) (collectively, ‘Defendants’) to issue permits to four seed companies to plant stecklings of genetically engineered sugar beets. Plaintiffs contend that APHIS’s decision to issue these permits without conducting any environmental review violates the National Environmental Policy Act, 42 U.S.C. §§ 4321-4335 (‘NEPA’), the Plant Protection Act (‘PPA’), the 2008 Farm Bill, and the Administrative Procedure Act, 5 U.S.C. § 706(2)(A) (‘APA’).

“Monsanto Company (‘Monsanto’) owns intellectual property rights in the technology used to produce Roundup Ready sugar beets. Betaseed, Inc. (‘Betaseed’) is a supplier of sugar beet seed. Betaseed’s parent company, KWS SAAT AG (‘KSW’), pursuant to a licensing agreement with Monsanto, inserted the gene for glyphosate tolerance into sugar beets to produce a type of Roundup Ready sugar beets known as Event H7-1.

“KSW and Monsanto submitted a petition to the USDA seeking to deregulate Event H7-1, which the USDA granted on March 4, 2005. However, on August 13, 2010, in a prior case, Center for Food Safety v. Vilsack, Case No. 08-00484 (‘Sugar Beets I’), this Court vacated Defendants’ deregulation decision based on APHIS’s failure to prepare an Environmental Impact Statement (‘EIS’).

“The Court shall address additional facts as necessary to its analysis in the remainder of this Order.” (See: “Center for Food Safety v. Vilsack, 753 F. Supp. 2d 1051 – Dist. Court, ND California 2010,” by Google Scholar)


 

Vernon Hugh Bowman, Petitioner v. Monsanto Company et al., Respondents, 133 S. Ct. 1761, 185 L. Ed. 2d 931, 106 U.S.P.Q.2d 1593, 81 U.S.L.W. 4295 (2013), Court Opinion [12 pages]

[This links to the “Opinion of the Court” which was decided on May 23, 2013. The opinion of the Court was delivered by Justice Kagan who was appointed by President Obama]

This case concerned the concept of “patent exhaustion.” A previous case in 2008 also dealt with patent exhaustion, but it was not related to GMOs at all (“Quanta Computer, Inc. v. LG Electronics, Inc. 553 U.S. 617 (2008),” by Justia U.S. Supreme Court Center).

Essentially, this case was about patent exhaustion. After a product is sold, and then sold again, the patent was traditionally considered exhausted. This is relevant because GMO seeds are self-replicating technologies and their patent does not expire after the initial purchase. Therefore, growing from one season to the next using the seeds from the first season’s harvest would be a considered a violation since the patent was not exhausted; this was also applies in other cases where farmers buy patented seeds from a previous harvest and plant them, whether they are aware that they are patented or not.

 

Also See: Brief for Amici Curiae Center for Food Safety and Save Our Seeds, In Support of Petitioner, Vernon Hugh Bowman, Petitioner v. Monsanto Company et al., Respondents, 569 U. S. ____ (2013) (No. 11-796) [58 pages; filed December 10, 2012, case decided on May 13, 2013]

[Center for Food Safety and Save Our Seeds filed with the Supreme Court as “friends of the court” or “amici curiae” (the plural form of “amicus curiae”) to support and advise the Bowman legal team as interested parties, but without a formal role as litigants. This document is actually quite informative. Consider these two subjects listed in the contents: “Farming Is Not Genetic Engineering” and “Considering Farming ‘Making’ Allows the Absurd Result that Contaminated Farmers Are Also Infringers”].

 

Also see: “Bowman v. Monsanto: Bowman, The Producer and the End User,” by Tabetha Marie Peavey, Berkeley Technology Law Journal, vol. 29, Issue 4; 2014 (29 pages)


Some common Latin phrases used in legal documents

amicus curiae”: One (as a professional person or organization) that is not a party to a particular litigation but that is permitted by the court to advise it in respect to some matter of law that directly affects the case in question – Merriam Webster

Also, “amici curiae” plural form; more than one party will act as advisors

Also, “amicus curiae”: Literally, friend of the court. A person with strong interest in or views on the subject matter of an action, but not a party to the action, may petition the court for permission to file a brief, ostensibly on behalf of a party but actually to suggest a rationale consistent with its own views. Such amicus curiae briefs are commonly filed in appeals concerning matters of a broad public interest; e.g., civil rights cases. They may be filed by private persons or the government. In appeals to the U.S. courts of appeals, an amicus brief may be filed only if accompanied by written consent of all parties, or by leave of court granted on motion or at the request of the court, except that consent or leave shall not be required when the brief is presented by the United States or an officer or agency thereof. An amicus curiae educates the court on points of law that are in doubt, gathers or organizes information, or raises awareness about some aspect of the case that the court might otherwise miss. The person is usually, but not necessarily, an attorney, and is usually not paid for her or his expertise. An amicus curiae must not be a party to the case, nor an attorney in the case, but must have some knowledge or perspective that makes her or his views valuable to the court. – Legal Dictionary

Also, “amici curiae” plural form; more than one party will act as advisors

But cf.”: Authority supports the contrary of the position with which the citation is associated by analogy. – Legal Information Institute

cf.”: An abbreviation for the Latin word confer, meaning “compare.” The use of this abbreviation indicates that another section of a particular work or another case or volume contains contrasting, comparable, or explanatory opinions and text. – West’s Encyclopedia of American Law, 2nd Edition

See also, “But cf.”: Authority supports the contrary of the position with which the citation is associated by analogy. – Legal Information Institute

en banc”: French for “in the bench,” it signifies a decision by the full court of all the appeals judges in jurisdictions where there is more than one three- or four-judge panel. The larger number sit in judgment when the court feels there is a particularly significant issue at stake or when requested by one or both parties to the case and agreed to by the court. – Law [.com]

Also, “en banc”: A court sitting “en banc” or a decision released “en banc” means that the court, usually a court of appeals, has heard the case and reached a decision that includes every judge who currently sits on that court (except those who have been recused or are unable to participate due to illness or similar circumstances).  The phrase “en banc” is French, and it means “on the bench” – referring to the place judges usually sit while hearing cases. Some courts, like the United States Supreme Court and the supreme courts in most U.S. states, always hear decisions en banc.  Other courts, like the U.S. Courts of Appeals and many state courts of appeals, usually have cases assigned to a “panel” of three or more judges.  Panels contain fewer judges than the court as a whole.  The panel judges hear the appeal and give a decision, which is usually explained in a written opinion. Different courts choose which judges sit on the panel in different ways, but many courts assign panel members randomly. After the panel has heard the appeal and issued its opinion, either party to the appeal – the petitioner who brought the appeal or the respondent who responds to the petitioner’s arguments – may choose to request another hearing “en banc” in most appeals courts.  This request asks the court to hear the case again, this time with all of the court’s judges listening to the case.  In some courts, the request for a rehearing en banc must be made before one of the parties can take the case to the state’s supreme court; in others, the party can choose whether to request a rehearing en banc or to appeal the case directly to a higher court. [Bold emphasis in original] (For more, see: “What does ‘en banc’ mean?What does ‘en banc’ mean?” by Rottenstein Law Group LLP)

ex parte”: Latin meaning “for one party,” referring to motions, hearings or orders granted on the request of and for the benefit of one party only. This is an exception to the basic rule of court procedure that both parties must be present at any argument before a judge, and to the otherwise strict rule that an attorney may not notify a judge without previously notifying the opposition. Ex parte matters are usually temporary orders (like a restraining order or temporary custody) pending a formal hearing or an emergency request for a continuance. Most jurisdictions require at least a diligent attempt to contact the other party’s lawyer of the time and place of any ex parte hearing. – Law [com]

Also, “ex parte”: One side only; An ex parte judicial proceeding is conducted for the benefit of only one party. Ex parte may also describe contact with a person represented by an attorney, outside the presence of the attorney. The term ex parte is used in a case name to signify that the suit was brought by the person whose name follows the term. In a case name, ex parte signifies that the suit was initiated by the person whose name follows the term. For example, Ex parte Williams means that the case was brought on Williams’s request alone. Many jurisdictions have abandoned ex parte in case names, preferring English over Latin terms (e.g., Application of Williams or Petition of Williams). In some jurisdictions, ex parte has been replaced by in re, which means “in the matter of” (e.g., In re Williams). However, most jurisdictions reserve the term in re for proceedings concerning property. – West’s Encyclopedia of American Law, 2nd Edition

inter alia”: Inter alia is a Latin term that means “among other things.” It is used to indicate that something is one out of a number of possibilities. For example, “he filed suit against respondents in state court, alleging, inter alia, a breach of contract.” – US Legal

Also, “inter alia”: Latin for “among other things.” This phrase is often found in legal pleadings and writings to specify one example out of many possibilities. Example: “The judge said, inter alia, that the time to file the action had passed.” – Law [.com]

in Re”: In the matter of. Concerning or regarding; the usual style for the name of a judicial proceeding having some item of property at the center of the dispute rather than adverse parties. – West’s Encyclopedia of American Law, 2nd Edition

Also, “in Re”: In re is a Latin phrase meaning “in the matter of.” When in re appears in the title of a court case, it means that the judicial proceeding may not have formally designated adverse parties or is otherwise uncontested. The use of in re refers to the object or person that is the primary subject of the case. – US Legal [.com]

sui generis”: Latin for of its own kind, and used to describe a form of legal protection that exists outside typical legal protections — that is, something that is unique or different. In intellectual property law, for example, ship hull designs have achieved a unique category of protection and are “sui generis” within copyright law. – Legal Information Institute (Cornell Univ. Law School)

Also, “sui generis”: Of its own kind or class; i.e., the only one of its own kind; peculiar. – The Law Dictionary (Black’s Law Dictionary)

 


Definition of law articles, notes and comments

“The basic difference between a case note, a comment, and an article is the breadth of the subject matter covered. A case note should analyze a single case. In contrast, a comment addresses an area of the law, focusing on specific issues, cases, and legislation. An article is broader still and, unlike a case note or comment, is a non-student legal essay written either by a noted legal authority or a person with expertise in a certain area.” (See: “Writing a Case Note,” by the Montana Law Review, University of Montana – 2 pages).

“A Note is a student-authored piece of academic writing which discusses and analyzes an original legal issue or problem in some depth. A Comment is a student-authored piece of academic writing that is centered around an analysis or critique of a recent case, piece of legislation, law journal article, or law-related book. Comments are also significantly shorter than Notes.” (See: “Note Submissions,” by the Stanford Law Review).


Frequently used Acronyms

 

APHIS = Animal and Plant Health Inspection Service

APHIS is a division of the USDA that oversees GMOs which determines which GM crops require regulation; it is responsible for overseeing GMO field tests and determining whether or not a GM plant is a “plant pest.” APHIS primarily derives its authority under the Plant Protection Act of 2000 (“PPA”) which also gives authority to the USDA to prohibit or restrict the movement and environmental introduction of plants, plant pests, and noxious weeds.

Bt = Bacillus thuringiensis is soil-dwelling bacterium, commonly used as a biological pesticide; Cry proteins (such as Cry 1Ab) which are taken from Bt are inserted into the DNA of certain insect resistant GMOs, such as corn.

CBD = Convention on Biological Diversity

CBI = Confidential Business Information

CGIAR = Consulting Group on International Agricultural Research (See also IBPGR & ITPGR)

“By the 1970s, the Rockefeller Foundation collaborated with the U.S. government to create agricultural programs and International Agricultural Research Centers to ‘improve’ crops in different regions of the world, which included collecting and cataloging germplasm samples with the express goal of preserving ex situ the rapidly disappearing store of crop genetic diversity. The Rockefeller and Ford Foundations, along with the United States and the World Bank, created the Consultative Group on International Agricultural Research (CGIAR) to coordinate the global network of International Agricultural Research Centers (IARCs).

“Ironically, it was the Rockefeller Foundation and the United States that had promoted a unilinear model of agricultural high-yielding crop development in the post-war era that put crop genetic diversity in jeopardy in the first place. The FAO organized two conferences, in 1961 and 1967. Those present for the FAO conferences decided to undertake a coordinated global germplasm collection and conservation program. These pieces of legislation and public-private collaborations indicated that private breeders increasingly dominated plant breeding in North America and Europe and were eager to introduce their varieties into Latin America and Asia.

“The IARCs provided a framework for the transformation of agriculture in the developing world. The IARCs introduced new varieties that were double-edged. They were higher-yielding, but they were also high-input because of the necessity of high use of fertilizers, herbicides, and water. Cary Fowler writes that these new varieties ‘spread over Latin America and Asia with astonishing speed. In the process ancient centers of crop genetic diversity nearly disappeared. . . .In the twinkling of the evolutionary eye, the effects of thousands of years of crop evolution were wiped out … Over 100 million acres of new uniform rices and wheats were soon being gown where tens of thousands of farmer varieties had once been found.’ Thus, farmer varieties were being avidly collected and stored ex situ in places like the NSSL, while at the same time a legal regime was being constructed that would treat uniform varieties bred for industrial agriculture as intellectual property.” [Citations omitted] (See: “Seeds of Dispute: Intellectual-Property Rights and Agricultural Biodiversity,” by Keith Aoki, Golden Gate University Environmental Law Journal, Vol. 3, Issue 1; 2009 – 83 pages)

CVM = Center for Veterinary Medicine; a division of the FDA:

“Responsible for regulating the manufacture and distribution of food additives and animal drugs, has promulgated various rules governing the use of antibiotics in aquaculture. Before an antibiotic may be used on a fish farm, the manufacturer must first submit an Investigational New Animal Drug Application (INADA) in order to receive permission to do a pre-market study with the drug, and then submit a New Animal Drug Application (NADA) illustrating that the drug is safe and effective.” (See: “A Day on the Fish Farm: FDA and the Regulation of Aquaculture,” by Graham M. Wilson, Virginia Environmental Law Journal, vol. 23; 2004 (46 pages)

EA = Environmental Assessment

ESA = Endangered Species Act

EIS = Environmental Impact Statement

EPA = Environmental Protection Agency

The EPA has authority of pesticidal substances and chemical substances produced by transgenic crops under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Toxic Substances Control Act (TSCA)

ESA = Endangered Species Act

FAO = Food and Agriculture Organization of the United Nations (UN)

FDA = Food and Drug Administration; the FDA regulates GMOs based primarily on the Federal Food, Drug, and Cosmetic Act

FIFRA = Federal Insecticide, Fungicide, and Rodenticide Act.

The EPA has authority under FIFRA to regulate GMOs if they are registered as pesticides, such as certain GM corn brands which are classified as insect resistant because they contain Cry proteins from Bt toxin. The EPA also regulates the pesticides used on GM crops.

FOIA = Freedom of Information Act

FONSI = Finding of No Significant Impact [typically referred to in association with Environmental Assessment or Environmental Impact Statement]

FWS = United States Fish and Wildlife Service (or USFWS)

GAO = (Congressional) General Accounting Office

GEPPVs = Genetically Engineered Pharmaceutical-Producing Plant Varieties

GRAIN = Genetic Resources Action International (NGO)

GRAS = Generally Recognized As Safe

The FDA considers nearly all GM foods GRAS by default even though there is no scientific justification for doing so. There are a few exceptions, but overall, this policy decision means that GMOs do not have to undergo any kind of long-term safety studies prior to entering the market. Furthermore, the FDA leaves it up to the biotech corporation to determine if their new GMO is GRAS

GURT = Genetic Use Restriction Technology: (See also VGURT and T-GURT)

Generally speaking, GURTs, T-GURTs and V-GURTS are seeds that are sterile; they are more commonly known as “Terminator seeds.” Since they are genetically engineered to not be able to reproduce, farmers would be forced to buy seeds year after year. They are highly controversial and are the epitome of what agricultural biotechnology is really about: total control of the food supply. There are concerns that cross-contamination might occur and non-GMO crops and wild relatives could ultimately be destroyed, unable to reproduce.

A company called Delta Pine & Land partnered with the USDA in 1998 to develop terminator technology. The USDA also supported Purdue Research Foundation (1999) in their goal of developing terminator seeds. Monsanto tried unsuccessfully to buy Delta Pine & Land in 1999 but succeeded in 2006.

“Genetic Use Restriction Technology is a broad term that refers to genetic engineering technologies that use a number of interactive or interdependent genes in combination with an environmental or chemical inducer (such as heat-shock or ethanol) to switch on or off the expression of a plant’s genetic traits. In the case of varietal GURTs, or V-GURTs, the reproductive viability of the entire plant is under the control of the company/institution that sells the seed. T-GURTs, or trait-specific GURTs, are designed to restrict the use of particular transgenes (or events), such as those for herbicide tolerance, insect resistance, and other traits. In the ‘official’ language of the United Nations, the term GURT is used to refer to Terminator.” (See: “Terminator: The Sequel,” by the ETC Group, May/June 2007 – 28 pages).

HT = herbicide tolerant varieties of GMO brands, such as Monsanto’s Roundup Ready crops

IARC = International Agency for Research on Cancer

IARC = International Agricultural Research Centers (see CGIAR)

IBPGR = International Board for Plant Genetic Resources (See also CGIAR)

“In 1974, the CGIAR formed the International Board for Plant Genetic Resources (IBPGR), whose scientific experts would serve as a spur to plant genetic resource conservation activities … The legal treatment of these stored PGRs was somewhat ambiguous prior to the 1990s but, as discussed later, became clearer later in that decade. At the least, prior to the 1980s, PGRs would have been treated as belonging to the ‘common heritage of humankind’ and thus would have been subject to a principle of ‘open access’ with a norm of reciprocity … The IBPGR had the power to designate officially which crops were endangered as well as the order in which germplasm from such crops would be collected and preserved … during the mid-1980s, the legal characterization of PGRs underwent significant transformation. This shift may be seen in the way that the 1992 Convention on Biological Diversity (CBD) re-characterized PGRs as being the ‘sovereign national property’ of the country in which they are located.” [Citations omitted] (See: “Seeds of Dispute: Intellectual-Property Rights and Agricultural Biodiversity,” by Keith Aoki, Golden Gate University Environmental Law Journal, Vol. 3, Issue 1; 2009 – 83 pages)

INADA = Investigational New Animal Drug Application

In this context, it may refer to the use of a new antibiotic in a fish farm, or GM salmon farm; this is a prerequisite to receiving permission to do a pre-market study with the drug from the FDA’s Center for Veterinary Medicine (CVM). Also see: CVM = Center for Veterinary Medicine

IP = Intellectual property (often mentioned in the context of patenting seeds)

IR = insect resistant varieties of GMO brands

IRRC = International Rice Research Center (See also CGIAR)

“[A] collaboration between the Rockefeller Foundation, the United States, and the U.N.’s Food and Agriculture Organization created the Consultative Group on International Agricultural Resources (CGIAR), which is the parent institution of an international network of agricultural research centers (IARCs). For example, the International Maize and Wheat Center in Mexico focuses on collection, storage and breeding of barley, maize, wheat, and triticale. The International Rice Research Center focuses its work on varieties of rice.” [Citations omitted] (See: “Seeds of Dispute: Intellectual-Property Rights and Agricultural Biodiversity,” by Keith Aoki, Golden Gate University Environmental Law Journal, Vol. 3, Issue 1; 2009 – 83 pages)

ITPGR = International Treaty for Plant Genetic Resources (See also CGIAR)

“November 2001, 116 member nations (including the United States) signed a new multilateral agreement, the International Treaty for Plant Genetic Resources. The ITPGR reaffirmed a commitment to farmers’ rights as protecting traditional knowledge relevant to PGRs, recognized a right to equitable benefit sharing, and also recognized the right of farmers to participate in decisionmaking at national levels on matters related to conservation and use of PGR. However, the ITPGR allowed the most important issue with regard to farmers’ rights – the right to use, exchange, and sell farm-saved seeds of traditional as well as improved varieties – to remain within the sole discretion of national governments. The ITPGR sought to advance farmers’ rights by information exchange, facilitating technology transfer and capacity building, and sharing the benefits (monetary and non-monetary) of the commercialization of PGRs.

“The ITPGR addresses intellectual-property rights in PGRs by proposing the creation of a multilateral system (MLS). Under the MLS, a recipient of germplasm received through the MLS (i.e., from one of the international seed banks) ‘shall not claim any intellectual property or other rights’ that limit access to PGR ‘in the form received from the Multilateral System.’ This means that seed germplasm in the original form received from a seedbank cannot be protected by intellectual-property rights; however, any individual genes, advanced lines, cells, particular DNA sequences, and compounds derived from such germplasm may be protected. The ‘in the form received’ language is in tension with and works to undermine the farmers’-rights provisions of the ITPGR. The ITPGR does not recognize any rights in individual farmers/breeders who develop new plant varieties through systemic practices. In comparison, however, institutional public and private plant breeders continue to enjoy protection under patent or plant-variety protection regimes. Furthermore, while the ITPGR is more comprehensive in its treatment of farmers’ rights, it does little to effectively implement or vindicate those rights.” [Citations omitted] (See: “Seeds of Dispute: Intellectual-Property Rights and Agricultural Biodiversity,” by Keith Aoki, Golden Gate University Environmental Law Journal, Vol. 3, Issue 1; 2009 – 83 pages)

MLS = multilateral system (see: ITPGR = International Treaty for Plant Genetic Resources)

NAD = New Animal Drug

NADA = New Animal Drug Application; (Also see: CVM & INADA).

After a drug (in this context it may be an antibiotic on a GM salmon farm) has been permitted to do a premarket study by the FDA’s Center for Veterinary Medicine (CVM), the biotech firm would submit a NADA to show that (as per the biotech’s own assertions) the drug is “safe” and effective.

NAS = National Academy of Sciences – see also NRC

NSSL = National Seed Storage Laboratory

NEPA = National Environmental Policy Act

NIH = National Institute of Health

NGO = Non-governmental Organization; a non-profit, voluntary citizens’ group which is organized on a local, national or international level

NMFS = National Marine Fisheries Service

NOSB = National Organic Standards Board (A division of the USDA)

NRC = National Research Council

The “research arm of the National Academy of Sciences (NAS); they are often mistakenly referred to as an “independent science” group. However, since their funding comes from the US Government which is completely biased in favor of GMOs, and since they also receive private donations from biotech companies like Monsanto, they are not “independent” at all and quite biased. (See: “Under the Influence: The National Research Council and GMOs,” by Food & Water Watch; May 2016 – 12 pages)

OCDE = Organization for Economic Co-operation and Development

(This is the French name for the OECD; Organisation de coopération et de développement économiques)

OECD = Organization for Economic Co-operation and Development

The OECD “is an intergovernmental economic organization with 35 member countries, founded in 1961 to stimulate economic progress and world trade … The OECD has been criticized by several civil society groups and developing countries. The main criticism has been the narrowness of the OECD because of its limited membership to a select few rich nations.”  – Wikipedia

(French: Organisation de coopération et de développement économiques, OCDE)

OPTS = EPA’s Office of Pesticides and Toxic Substances, which administers FIFRA and TSCA

OSTP = White House Office of Science and Technology Policy

OTA = (Congressional) Office of Technology Assessment.

PPA = Plant Pest Act of 2000 (this act repealed the Federal Plant Pest Act and the Plant Quarantine Act)

PPA = Plant Patent Act of 1930

PGR = Plant Genetic Resource

PTO = United States Patent and Trademark Office, or USPTO

PVPA = Plant Variety Protection Act of 1970

RAFI = Rural Advancement Foundation International; this is a Canadian nongovernmental organization (NGO)

rBST = (See, rGBH) recombinant bovine somatotropin

rGBH = (See also, rBST) recombinant bovine growth hormone

“Bovine somatotropin or bovine somatotrophin (abbreviated bST and BST), or bovine growth hormone (BGH), is a peptide hormone produced by cows’ pituitary glands.” (Wikipedia). Recombinant bovine somatotropin (rBST) and recombinant bovine growth hormone (rBGH) are genetically engineered forms of bovine growth hormone (BGH).

“In cows treated with rbGH, significant health problems often develop, including a 50% increase in the risk of lameness (leg and hoof problems), over a 25% increase in the frequency of udder infections (mastitis), and serious animal reproductive problems, such as infertility, cystic ovaries, fetal loss and birth defects. Because rbGH use results in more cases of mastitis, dairy farmers tend to use more antibiotics to combat the infections, the residues of which also may end up in milk and dairy products.” (See: “About rbGH,” by the Center for Food Safety)

RR = Roundup Ready (a GM plant that refers to a Monsanto brand, such as soy, corn, or alfalfa, that is able to withstand applications of the herbicide called Roundup with the active ingredient glyphosate).

SAP = Scientific Advisory Panel

T-GURT = Trait Genetic Use Restriction Technology.

“T-GURTs focus on a particular genetically modified (GM) trait within the plant, the strategy is that of modifying seeds so that plants do not pass on certain enhanced GM characteristics to the next generation, the plant without such characteristics continues to reproduce.” (See: “Terminator seeds, the right to food, corporate responsibility, business and human rights,” by Sinéad Corcoran, Sinead C bits and bobs (Blog); August 9, 2012)

TNC = Transnational corporation

TRIPS = Trade-Related Aspects of Intellectual Property Rights signed in Marrakesh, Morocco on April 15, 1994

TSA = Technology service Agreement

TSCA = Toxic Substances Control Act; the EPA has authority under the TSCA and FIFRA to regulate chemicals and pesticides associated with GMOs.

UPOV = The International Union for the Protection of New Varieties of Plants is an intergovernmental organization. UPOV was established by the International Convention for the Protection of New Varieties of Plants. The Convention was adopted in Paris in 1961 and it was revised in 1972, 1978 and 1991.

USAID = U.S. Agency for International Development

USDA = United States Department of Agriculture; it delegates most of the GMO responsibility and related issues to APHIS, a division of the USDA.

USFWS = United States Fish and Wildlife Service (or FWS)

USPTO = United States Patent and Trademark Office (Sometimes referred to as “PTO”)

V-GURT = Varietal Genetic Use Restriction Technology (See also GURT and T-GURT)

“Varietal Genetic Use Restriction Technology, often referred to as ‘Terminator Technology,’ [ ] produces plants that are ‘programmed’ to grow and produce seeds but the embryos of such seeds contain a toxin which (if the seed [is] planted) is released during embryonic development, preventing germination thus rendering the seeds sterile. Simply put, V-GURT infused seeds only produce one yield and the seeds of that yield die, forcing farmers and seed users to re-buy seeds each year. Widespread V-GURT use has the potential to drastically reduce crop genetic diversity. Genetic diversity is critically important for indigenous groups and traditional farmers, but also for the adaptability and resilience of the global food system. The introduction of V-GURTs into the global seed market has the potential to disrupt informal and traditional seed systems which rely on seed sharing, saving and the filtering down of seed from commercial suppliers. Developing world farmers who are dependent on re-using seeds from their local community could find themselves without seed and then food resources … As a threat to local crops but also entire seed systems, V-GURTs [Terminator seeds] are a substantial threat to global plant genetic diversity and ultimately a threat to global food security. Potentially it could so be concluded that it is the obligation of ALL state parties to prevent the progress of V-GURT technologies in the interest of the right to food of the entire global population.” [Emphasis added] (See: “Terminator seeds, the right to food, corporate responsibility, business and human rights,” by Sinéad Corcoran, Sinead C bits and bobs (Blog); August 9, 2012)

 

A good source for agricultural-related acronyms can be found here: “Acronyms: Ag Law Glossary,” by the National Agricultural Law Center; the same website also has a glossary: “Ag Law Glossary,” by the National Agricultural Law Center


 

[1] Several authors have written on the ethical nature of GMOs. Yet ethics have played no role at all in the creation of GMOs, in the regulation of GMOs, and in their proliferation around the globe. Consequently, millions of people have the same sentiments that are expressed in the following quotes:

“Is it right to assume that a few scientists can improve on the results of billions of years of natural evolution? Genetic engineering is seen by many people as ‘playing God’ or putting people in the place of the Creator, as it gives to a few people the ability to change the natural world completely. By genetically modifying organisms, a scientist assumes that this extremely new science is better for populating the world than God or any other Creator, including natural evolution and natural selection … Ethically, it is very wrong to proceed with genetic engineering. All of the above arguments have shown that it is not right for humans to change the world in an irreversible and radical manner.” (See: “Genetic Engineering: A Question of Ethics,” by Teresa Carlson, Mälardalen University, Sweden; November 2006 – 8 pages).

“Ethically and ecologically unjustified, seed patents grant exclusive rights for inventions; but, seed is not an invention. Further, GE seeds contaminate our farms, removing the option for GMO-free food. That’s untenable. It’s time for a declaration of independence that recognizes that seed is the source of life and seed freedom is the birthright of every farmer and food producer.” (See: “Remembering the Seeds of Freedom,” by Alice Cunningham, Huffington Post; July 8, 2016).

“The core issue behind the ethics of genetic engineering is that is it right to change the nature of life on earth to suit man’s desires better? … From a theological point of view, genetic engineering is intrinsically wrong. Genetic engineering is unnatural. Anything that is going against the laws of nature is questionable and immoral … Genetic engineers are gambling with their unproven introductions. … As citizens, we must take responsibility for the future. We are at a time in our world’s history where we can no longer afford to violate the laws of nature in our haste for progress. We must not only acknowledge, but also honor the intimate relationship we share with everything in the universe. There is an order in the universe, a seamless web that nourishes and connects us all from the tiniest seed, to the beating of our hearts, to the stars in the galaxies. Every time we act without reference to this underlying intelligence of natural law, we harm ourselves, we harm each other, and we harm our planet.” (See: “Sikh Perspective on Modern Scientific Technology,” by Dr. Surjit Kaur, Institute of Sikh Studies, Chandigarh; 2010).

“Any adequate ethical framework for dealing with genetic engineering must be based on our contemporary understanding of the relationship between humans and the rest of the natural world. Our evolutionary history makes it very clear that humans are not separate from the rest of nature. Rather we are an integral part of the community of living beings and non-living reality. Each of us depends on the well-being of the whole and so we have to have respect for the community of living beings, for people, animal, plants and for the preservation of earth, water and soils.” (See: “Engineering Life: Ethics and Genetic Engineering,” by Father Sean McDonagh, Columban Fathers; June 23, 2011).

“From a Catholic perspective, the biotechnology patent regime must be reigned in and resituated in the moral economy. At this time, advocating a prohibition on the patenting of life may seem quixotic, but two hundred years ago, so too did the movement to abolish slavery. The unprecedented expansion of life patents raises troubling issues in social ethics. The privatization of germplasm formerly considered the common heritage of humankind is incompatible with notions of the common good and economic justice.” [Citation omitted] (See: “Are Life Patents Ethical? Conflict between Catholic Social Teaching and Agricultural Biotechnology’s Patent Regime,” by Keith Douglass Warner, Journal of Agricultural and Environmental Ethics, Vol. 14; 2001 – 20 pages).


 

“It’s time we ask ourselves: How long are we going to let Monsanto bully farmers and politicians into controlling the very source of life on earth? How long will we tolerate the growing monopolization and genetic engineering of seeds by an aggressive cabal of chemical and pesticide corporations who pose a deadly threat to our health, our environment and the future of our food? And when does ‘how long’ become too late? … The fable that GMOs are feeding the world has already led to large-scale destruction of biodiversity and farmers’ livelihoods. It is threatening the very basis of our freedom to know what we eat and to choose what we eat. Our biodiversity and our seed freedom are in peril. Our food freedom, food democracy and food sovereignty are at stake.”

See: “Costing Life: Air, Water and Food,” by Janek Ratnatunga, Jamar, Vol. 12, No. 1; 2014 (12 pages)

Please note: I have indicated that (the majority of) quotes have citations omitted, and sometimes emphasis is added, usually by making the words & sentences bold. I also edited some quotes, replacing “Food and Drug Administration” with “FDA”; I have sometimes replaced “United States Department of Agriculture” with “USDA”; and sometimes I also abbreviated “Environmental Protection Agency” as “EPA.”

सत्यमेव जयते – Satyameva Jayate

(Truth Ultimately Triumphs)

 

Re-posting is encouraged, provided the URL of the original is posted with attribution to the original author and all links are preserved to the referenced articles, reports, etc. on their respective websites.

 

Copyright © Jeff Kirkpatrick 2016 Ban GMOs Now All rights reserved.

 

5 thoughts on “GMO Law Review Articles (Including Notes and Comments)

    • Thanks John. I have already collected over 200 articles (and comments and notes) to put here. So as time permits, I will continue to add more and more. I am also finding new ones (and new older ones) every week, so the list is getting bigger. I also have a few that deal with Canada and some that focus on other countries as well.

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