Several technological waves of genetic modification of crops have ensued over the last several decades. Genetic engineering has generally referred to the insertion of genetic material into an existing organism (often described as transgenic). Genetic editing is a later wave of genetic intervention, involving the direct alteration of a gene’s sequence on site (this CRISPR-fueled technology taking off since about 2012). A conceptual question of recent origin is whether both transgenic and genetically edited crops are classified as genetically modified organisms (GMOs). In the U.S., regulators have decided that genetically edited crops will not require any specific regulation, unlike transgenic organisms. In
March, the U.S. government announced that it would not impose any
particular regulation on genetically edited crops, regarding such crops as closer to those derived from traditional mutagenenesis. The U.S. Department of Agriculture (USDA) stated:
Under its biotechnology regulations, USDA
does not regulate or have any plans to regulate plants that could
otherwise have been developed through traditional breeding techniques as
long as they are not plant pests or developed using plant pests. This
includes a set of new techniques that are increasingly being used by
plant breeders to produce new plant varieties that are indistinguishable
from those developed through traditional breeding methods. The newest
of these methods, such as genome editing, expand traditional plant
breeding tools because they can introduce new plant traits more quickly
and precisely, potentially saving years or even decades in bringing
needed new varieties to farmers.
A new ruling from the European Court of Justice addresses whether genetically edited crops fall within the 2001 E.U. Directive on the Deliberate Release of Genetically Modified Organisms:
In today’s judgment, The European Court of Justice takes the view, first of all, that organisms obtained by mutagenesis are GMOs within the meaning of the GMO Directive, in so far as the techniques and methods of mutagenesis alter the genetic material of an organism in a way that does not occur naturally. It follows that those organisms come,in principle, within the scope of the GMO Directive and are subject to the obligations laid down by that directive.
In keeping with its more stringent regulation of genetically engineered (transgenic) crops, the E.U. has decided to maintain a cohesive scheme for modern genetic technologies, classifying genetically edited crops as GMOs. In contrast, the U.S. has bifurcated its oversight of genetically altered crops, with recent decision-making that allows genetically edited crops to advance quickly in field testing.
The National Academies of Sciences, Engineering, and Medicine (NAS) has issued a report on gene drive technology, Gene Drive Research in Non-Human Organisms: Recommendations for Responsible Conduct. A gene drive is a method by which specific genetic mutations (or alleles) are preferentially inherited, and over time, the effect is to eliminate other competing alleles. This has population-wide consequences for an organism, and can permanently alter (or reduce) the genetic diversity of a species. The phenomenon of a gene drive occurs in nature, and has been observed in many organisms:
In nature, certain genes ‘drive’ themselves through populations by increasing the odds that they will be inherited.
Now, however, advances in gene-editing technology have facilitated the development of deliberately engineered gene drives. From the report summary:
A wide variety of gene drives occur in nature. Researchers have been studying these natural mechanisms throughout the 20th century but, until the advent of CRISPR/Casfor gene editing, have not been able to develop a gene drive. Since early 2015, laboratory scientists have published four proofs-of-concept showing that a CRISPR/Cas9-based gene drive could spread a targeted gene through nearly 100% of a population of yeast, fruit flies, or mosquitos.
In other words, use of gene drive technology can impose a specific genetic allele (variant) on a population and eliminate all other forms of the gene. Effectively, the population is now homozygous for the preferred variant. That is both the attraction and the concern regarding the use of this technique. Genetic traits could be eliminated, and at its most extreme, whole populations could be "driven" out of existence. It is simple to imagine particular uses of the technology that would eliminate undesirable traits in a target population, such as the ability of mosquitos to spread malaria, or very currently, the ability of the Aedes aegypti mosquito to transmit the Zika virus. The report summarizes possible applications and the requirement for a deliberative approach to use of the technique:
Gene-drive modified organisms hold promise for addressing difficult-to-solve challenges, such as the eradication of insect-borne infectious diseases and the conservation of threatened and endangered species. However, proof-of-concept in a few laboratory studies to date is not sufficient to support a decision to release gene-drive modified organisms into the environment. The potential for gene drives to cause irreversible effects on organisms and ecosystems calls for a robust method to assess risks. A phased approach to testing, engagement of stakeholders and publics, and clarified regulatory over-sight can facilitate a precautionary, step-by-step approach to research on gene drives without hindering the development of new knowledge.
The report did not recommend a moratorium on research, despite noting the potential for adverse consequences. Instead, it endorsed continued research on the technology with some limited field evaluations:
Although there is insufficient evidence available at this time to support the release of gene-drive modified organisms into the environment, the likely benefits of gene drives for basic and applied research are significant and justify proceeding with laboratory research and highly-controlled field trials.
The current regulatory landscape for gene drive applications is summarized:
In the United States, regulation of gene-drive modified organisms will most likely fall under the Coordinated Framework for the Regulation of Biotechnology, which includes the U.S. Food and Drug Administration, the U.S. Department of Agriculture, and the U.S. Environmental Protection Agency. However, the diversity of potential gene-drive modified organisms and contexts in which they might be used reveals a number of regulatory overlaps and gaps. The U.S. government will need to clarify the assignment of regulatory responsibilities for field releases of gene-drive modified organisms, including the roles of relevant agencies.
At the present time, the patchwork structure for biotechnology regulation is currently under formal review by the Obama administration (see earlier post for more background). In general, as the new products of genetic engineering have been developed over the years, they encounter oversight from any one (or more) of three agencies: the FDA, EPA, or USDA. As the regulatory framework is redesigned, we could expect that various applications of gene drive technology will face an approval process customized to the particular goal and purpose of the technology. The report states:
It is important to note that a one-size-fits-all approach to governance is not likely to be appropriate. Each phase of research activity—from developing a research plan to post-release surveillance—raises different levels of concern depending on the organism being modified and the type of gene drive being developed.
The NAS report has received criticism from opponents of field testing, who noted that precise control of such experiments is not possible, and wider, possiblly uncontrolled spread of altered organisms could occur. Other criticisms suggest that the scope of the report is too limited, and does not adequately address possible dual-use concerns (malevolent uses of the technology). The report has some conceptual overlap with efforts of the World Health Organization (WHO) has previously released a guidance framework for how to introduce genetically engineered mosquitoes that are reproductively disabled, thus reducing the population of a malaria vector. In summary, the NAS panel has cautiously endorsed further gene drive research in the U.S., and contemplates eventual field trials of engineered organisms.
The National Academies of Sciences, Engineering and Medicine (NAS) have released a report on the safety and impact of genetically engineered (GE) crops: Genetically Engineered Crops: Experiences and Prospects. This was an extensive evaluation by a committee comprised of academic experts to consider health and/or environmental effects of GE crops (note that the term "genetically modified organism/GMO" is used widely as well). As the authors described the scope of the report:
The committee examined almost 900 research and other publications on the development, use, and effects of genetically engineered characteristics in maize (corn), soybean, and cotton, which account for almost all commercial GE crops to date.
Here is a summary conclusion from the report:
[T]he study committee found no substantiated evidence of a difference in risks to human health between current commercially available genetically engineered (GE) crops and conventionally bred crops, nor did it find conclusive cause-and-effect evidence of environmental problems from the GE crops.
The committee noted that the majority of GE crops in commercial use are engineered to carry just a few additional genetic traits:
The committee used evidence accumulated over the past two decades to assess purported negative effects and purported benefits of current commercial GE crops. Since the 1980s, biologists have used genetic engineering to produce particular characteristics in plants such as longer shelf life for fruit, higher vitamin content, and resistance to diseases. However, the only genetically engineered characteristics that have been put into widespread commercial use are those that allow a crop to withstand the application of a herbicide or to be toxic to insect pests.
The fact that only two characteristics have been widely used is one of the reasons the committee avoided sweeping, generalized statements about the benefits and risks of GE crops. Claims about the effects of existing GE crops often assume that those effects would apply to the genetic engineering process generally, but different characteristics are likely to have different effects. A genetically engineered characteristic that alters the nutritional content of a crop, for example, is unlikely to have the same environmental or economic effects as a characteristic for herbicide resistance.
There is a reiteration of the basic U.S. regulatory paradigm, which focuses on the nature of a GE product, rather than a process-based approach:
All technologies for improving plant genetics – whether GE or conventional -- can change foods in ways that could raise safety issues, the committee’s report notes. It is the product and not the process that should be regulated, the new report says, a point that has also been made in previous Academies reports.
In determining whether a new plant variety should be subject to safety testing, regulators should focus on the extent to which the novel characteristics of the plant variety (both intended and unintended) are likely to pose a risk to human health or the environment, the extent of uncertainty about the severity of potential harm, and the potential for human exposure – regardless of whether the plant was developed using genetic-engineering or conventional-breeding processes. ” –omics” technologies will be critical in enabling these regulatory approaches.
The United States’ current policy on new plant varieties is in theory a “product” based policy, but USDA and EPA determine which plants to regulate at least partially based on the process by which they are developed. But a process-based approach is becoming less and less technically defensible as the old approaches to genetic engineering become less novel and as emerging processes — such as genome editing and synthetic biology — fail to fit current regulatory categories of genetic engineering.
On the contentious issue of labeling food derived from GE crops (see here), the committee did not find a compelling scientific basis to require labeling, but noted that there are other considerations:
[T]he issue involves social and economic choices that go beyond technical assessments of health or environmental safety; ultimately, it involves value choices that technical assessments alone cannot answer.
The report therefore endorses the existing product-based framework, but coupled with a nuanced determination of what products should receive enhanced oversight. Critically, the report notes a fact which is not widely appreciated, which is that GE crops largely contain only two added traits: insect or herbicide resistance. Both of these characteristics serve agronomic ends, in contrast to alteration of product attributes, such as nutritional enhancement. As a result, the NAS committee notes that other GE traits could be introduced and require specific regulatory focus. This could be especially true when the goal of a GE alteration is a deliberate change in food composition. Finally, and not insignificantly, the committee finds that GE crops, on balance, have not led to increased yields, and notes the development of resistance in both insects and weeds. These latter conclusions will feature prominently as the cost/benefit calculus for the use of GE crops continues to be debated.
Genetic alteration since the beginning of the biotechnology age has largely relied on the introduction of new genetic material into an organism to create a genetically engineered (GE) bacterium, plant or animal (also known as a genetically modified organism, GMO). Regulatory schemes reflected that dominant paradigm. Now, however, the use of gene-editing technology for genetic manipulation in plants can result in genetically altered plants that bypass the regulatory requirements for the introduction of standard GE plants into the marketplace. The traditional genetic engineering of crops employed the introduction of foreign genetic material into the crop; such gene transfer generally triggered formal review of the altered product because of the phenotype conveyed by the introduced gene(s), or because of the use of a vector that had plant pest characteristics. A GE plant product would trigger review if the newly introduced trait posed environmental or other safety-related risks. The review was conducted by the Animal and Plant Health Inspection Service (APHIS) of the USDA, pursuant to its statutory authority under the Plant Protection Act of 2000. (Depending on the product, additional oversight by the FDA or EPA could be required). Today, genetic alteration has moved beyond simple gene transfer into more precise techniques for changing the genome of an organism. Now, in a regulatory first, APHIS has made a determination that a white button mushroom altered by CRISPR/Cas9 gene editing technology to exhibit reduced browning is an “unregulated article” that will not require the kind of formal review usually applied to traditionally genetically engineered products containing foreign DNA:
APHIS does not consider CRISPR/Cas9-edited white button mushrooms as described in your October 30, 2015 letter to be regulated.
Here, CRISPR/Cas9 gene editing technology was used to introduce a small deletion in a polyphenol oxidase gene in the mushroom, with the result that the altered enzyme cannot produce the browning that shortens shelf life. The final product has no foreign DNA and no plant pest characteristics. This decision by APHIS follows earlier determinations that have resulted in at least 10 genetically altered products being approved without requiring a formal review. These products have been produced with, e.g., techniques that did not rely on the introduction of new genetic material using any plant pest vector, or non-CRISPR gene editing technologies. This shift in regulation highlights how modern genetic alteration writ large encompasses multiple technologies, some of which fall into an existing regulatory mandate, and some of which do not. The central theme of biotechnology regulation to date has been to focus on the product, not the process. As far back as the introduction of the federal Coordinated Framework for Regulation of Biotechnology in 1986, the prevailing scheme ensured that genetically engineered products would not be singled out for heightened review simply because of the way they were produced. The product was the focus; more precisely, the actual phenotypes of the GE plants or insects were evaluated to identify traits that required additional oversight. The traditional dichotomy between product-based or process-based paradigms for regulation biotechnology products has been criticized as a poor fit for the realities of the biotech marketplace. Evidence for an evolution of the regulatory scheme has been provided by the Obama administration’s announcement of a deliberative process to overhaul and modernize the regulation of biotech products, with the recruitment of the FDA, EPA, and USDA in the process (see earlier post). This regulatory renewal will no doubt eliminate a strict focus on gene transfer as the only genetic technology producing altered organisms, and strive to broaden the definition of the field of genetic alteration to reflect new realities, such as CRISPR and other gene-editing technologies. Then the calculus of risk/benefit analysis will need to be applied, in the context of emerging genetic technologies where risk profiles are not yet established.
The federal regulation of biotechnology products is grounded in a design that was first announced in 1986 as the Coordinated Framework (CF) for the Regulation of Biotechnology, later updated in 1992. Those documents have largely shaped the the federal regulatory regime for biotechnology. A key concept in this original framework was that products produced through genetic engineering (or recombinant DNA) techniques would not receive special oversight because of the processes used to produce them. Instead, a risk-based approach was instituted that focused on the characteristics of actual products, not underlying production techniques. In 2015, the White House, through its Office of Science and Technology (OSTP), announced that it would launch an overhaul of the 1992 policy. In the memorandum, the OSTP provided a definition of “biotechnology products” to be included in the review:
For the purpose of this memo, “biotechnology products” refers to products developed through genetic engineering or the targeted or in vitro manipulation of genetic information of organisms, including plants, animals, and microbes. It also covers some of the products produced by such plants, animals, and microbes or their derived products as determined by existing statutes and regulations. Products such as human drugs and medical devices are not the focus of the activities described in this memorandum.
Since the 1980’s, the existing coordinated framework has divided the primary regulation of biotechnology products among three agencies: the U.S. Environmental Protection Agency (EPA), the U.S. Department of Agriculture (USDA), and the U.S. Food and Drug Administration (FDA). The OSTP is involved in a more general role as overseer of the regulatory design, rather than as a formal regulatory body. In the memorandum sent to the heads of the EPA, FDA and USDA, the OSTP alludes to the regulatory overlap, redundancy and confusion that has arisen with the multi-agency design:
Each of the Federal regulatory agencies with jurisdiction over the products of biotechnology has developed regulations and guidance documents to implement its authority under existing laws, resulting in a complex system for assessing and managing health and environmental risks of the products of biotechnology. While the current regulatory system for the products of biotechnology effectively protects health and the environment, in some cases unnecessary costs and burdens associated with uncertainty about agency jurisdiction, lack of predictability of time frames for review, and other processes have arisen.
As part of the modernization initiative, the Administration held 3 meetings organized by the relevant agencies to receive feedback on the proposed overhaul. Two documents were issued that are helpful to understanding the current climate that is precipitating calls for redesign: a table of current agency responsibilities, and a series of case studies illustrating how a singular GE product can be subject to multi-agency review. Pursuant to the OSTP charge, a committee formed by the National Academy of Sciences, Medicine and Engineering was commissioned to conduct a formal study, “Future Biotechnology Products and Opportunities to Enhance Capabilities of the Biotechnology Regulatory System.” This committee has set the following objectives:
Describe the major advances and the potential new types of biotechnology products likely to emerge over the next 5-10 years.
Describe the existing risk analysis system for biotechnology products including, but perhaps not limited to, risk analyses developed and used by EPA, USDA, and FDA, and describe each agency’s authorities as they pertain to the products of biotechnology.
Determine whether potential future products could pose different types of risks relative to existing products and organisms. Where appropriate, identify areas in which the risks or lack of risks relating to the products of biotechnology are well understood.
Indicate what scientific capabilities, tools, and expertise may be useful to the regulatory agencies to support oversight of potential future products of biotechnology.
The first public meeting of the NAS committee will be held on April 18, 2016. The agenda for the meeting is posted here.
As genetic engineering emerged from laboratories in the 1970’s into the biotechnology industry in the 1980’s, the possibility of government regulation arose, with a central question of whether a drug, for example, produced by genetic engineering rather than conventional chemical synthesis, required a distinct regulatory response. In another version of that same question: did a genetically modified plant require a distinct biotechnology regulatory treatment or could the plant fit into established oversight routes for plants produced through convention breeding techniques? In its most generic form, the debate that began in the 1980's wrestled with whether biotechnology processes produce inherently distinct products that demanded novel regulatory responses. According to the Coordinated Framework for the Regulation of Biotechnology announced by White House Office of Science and Technology Policy (OSTP) in 1986, the answer was generally no; a product or an engineered organism could be evaluated by the traditional agencies and laws that already existed to identify and manage risk. The
coordinated framework thus divided the primary regulation of
biotechnology products among three agencies – the Department of
Agriculture’s Animal and Plant Health Inspection Service (APHIS), the Environmental Protection Agency (EPA), and the Food and Drug
Administration (FDA). That scheme was updated in 1992, and that document continued to be the last word in regulatory design. Now the White House OSTP has announced that it will initiate a modernization of the 1992 policy. In a just-published memorandum to the three federal agencies, the OSTP first provides a definition of “biotechnology products” that will be the targets of the review:
For the purpose of this memo, “biotechnology products” refers to products developed through genetic engineering or the targeted or in vitro manipulation of genetic information of organisms, including plants, animals, and microbes. It also covers some of the products produced by such plants, animals, and microbes or their derived products as determined by existing statutes and regulations. Products such as human drugs and medical devices are not the focus of the activities described in this memo.
In a briefing document on its blog, the OSTP has described the process ahead:
The goal of the effort is to ensure public confidence in the regulatory system and improve the transparency, predictability, coordination, and, ultimately, efficiency of the biotechnology regulatory system. Here is a bit more detail about the effort’s three components:
First, the Administration will update the Coordinated Framework, after public input, by clarifying the current roles and responsibilities of the EPA, USDA, and FDA in the regulatory process. This update will help clarify which biotechnology product areas are within the authority and responsibility of each agency and outline how the agencies work together to regulate products that may fall under the authorities of multiple agencies.
Second, the Administration will develop a long-term strategy, after public input, to ensure that the Federal regulatory system is well-equipped to assess efficiently any risks associated with the future products of biotechnology. This will include performing periodic horizon-scanning of new biotech products, coordinating support for the science that informs regulatory activities, developing tools to assist small businesses as they navigate the regulatory system, and creating user-friendly digital tools for presenting the agencies’ authorities, practices, and basis for decision-making.
Third, the Administration will commission an outside, independent analysis of the future landscape of the products of biotechnology. The Administration has already asked the National Academies of Sciences, Engineering, and Medicine to conduct such an analysis.
A modernized jurisdictional design could address some overlap between the responsible agencies, while also considering newer technologies and their placement into the scheme. For example, new organisms or products from the more recent field of synthetic biology might not fit the traditional category of “genetically engineered” which contemplated a small number of discrete and planned changes into an existing organism. A recent study from the Venter Institute on the regulatory challenges raised by synthetic biology endorsed the basic earlier principle that a product should be evaluated for its own discrete risk profile even when produced through synthetic biology; however, the study notes that specific jurisdictional boundaries between the three federal agencies and specific legal authorities need to be updated to account for an expanding portfolio of genetic engineering modalities that will produce even more novel organisms than the first wave of genetic engineering.
A federal judge in Oregon has rejected an initial challenge to the ban on the planting of genetically engineered/modified (GMO) crops in Jackson County, Oregon. Jackson County Ordinance 635 was a ballot initiative put to a vote in May, 2014 and it passed by a 2-1 margin. In Schultz Family Farms, LLC v. Jackson County, (D. Ore. 2015) a group of local alfalfa farmers challenged the ban, due to go into effect later this year, citing Oregon’s Right to Farm Act. Right to farm laws have generally insulated existing farming activities from later-enacted prohibitions that would declare farming activities to be a nuisance or trespass. The plaintiffs claimed that they would be required to remove about 300 acres of herbicide-resistant “Roundup Ready” alfalfa in order to comply with the ordinance. The plaintiffs also claimed that the ordinance was prohibited by a recently enacted state law, Senate Bill 863 (the Seed Bill), that preempted any local bans on the planting of GMO crops. However, in the ruling, the judge stated:
It is clear from the text and context of the Seed Bill that the Oregon legislature meant to preempt counties and other local governments from enacting laws banning the use of GE seeds so that the GMO issue could be addressed on a state-wide, uniform basis.In other words, the Seed Bill preempts laws precisely like the Ordinance. However, it is equally clear that the legislature meant to carve out a specific exception authorizing Jackson County Ordinance 635.
Thus, the judge denied summary judgment for the farmers, finding that the challenged ban had specifically survived the statewide prohibition on local ordinance banning the planting of GMO crops, and Jackson County can continue with enforcement of the ordinance. The judge agreed, however, that Oregon now has a statewide preemption against any other similar ordinances. The order notes that Ordinance 635 contemplates possible interference with farming activities because of the planting of GMO crops, thus inadvertently aligning with the purpose of the more traditional right to farm laws:
Section 2 of the Ordinance states the "findings" and gives the primary purposes of the Ordinance, one of which is to protect local farmers from "significant economic harm to organic farmers and to other farmers who choose to grow non-genetically engineered crops" that can be caused by "genetic drift" from GE crops.
There are a few other jurisdictions with bans on the cultivation of GMO crops. Several California counties have bans in place, including Marin, Santa Cruz, Mendocino, Trinity, and Humboldt. Last year, a federal judge in Hawaii ruled that an ordinance banning cultivation of GMO crops in Kauai County was preempted by state law. Efforts continue to enact GMO crops bans in some jurisdictions; however, just last month, a ballot initiative banning GMO cultivation in Benton County, Oregon, was defeated by an over 2-1 margin. It is possible that the plaintiffs could pursue a regulatory taking challenge now to Ordinance 635, if they can demonstrate loss of all economic value of their property (Lucas v. South Carolina Coastal Council) or meet the demanding requirements of a balancing test derived from Penn Central Transportation Co. v. New York City. However, for now, this ruling is significant for its determination that a ban on GMO planting can coexist with a right to farm statute.
The 2014 midterm elections contained a number of state ballot measures on policy issues involving biotechnology. Not surprisingly, the issue of whether foods containing genetically engineered ingredients should be labeled appeared on two state ballots. In Oregon, Measure 92 was apparently narrowly defeated (50% to 49%) (Oregon had also rejected a similar ballot measure in 2002). However, the narrowness of the vote has now resulted in this week's order of a recount. With respect to Colorado's proposed labeling measure, the vote was not so close: Proposition 105 was defeated 65%-34%. These defeats mean that the current status of state labeling measures is that Vermont has fully passed a labeling law that takes effect in 2016; Connecticut and Maine have also passed labeling laws but their implementation is conditionally linked to a trigger where neighboring states passing similar measures (which has not yet occurred). A second issue with implications for biotechnology on the ballots this month was the issue of fetal personhood: two such initiatives on the ballots in North Dakota and Colorado would have declared personhood to begin at the moment of conception; these and similar measures have been crafted by anti-choice groups in order to elevate the constitutional status of the unborn and effectively criminalize abortion as a result. However, conception-triggered personhood also has implications for the field of human embryonic stem cell (hESC) research: the use of such cells requires their removal from an early-stage embryo, and under a fetal personhood statute, effectively becomes a criminal act against a legally-declared person. As a result, these initiatives have also threatened hESC research. The measures in North Dakota and Colorado were both rejected (by almost identical margins of 65% to 35%). To date, all fetal personhood ballot measures in the states have failed. A third issue on the November ballots was agricultural, relating to the presence of genetically engineered crops: several county-wide ballot measures that would ban the planting and cultivation of genetically engineered crops (on the ballots as "genetically modified organisms") were passed in Humboldt County, California and Maui County, Hawaii. Lastly, a bond measure in Maine to authorize funding
"to discover genetic solutions for cancer and the diseases of aging" passed overwhelmingly. The 2014 elections continued the ongoing attention to GMO labeling and fetal personhood initiatives as the most contentious state-based legislative battles affecting biotechnology.
Two counties in Oregon recently passed bans on the planting of genetically engineered (GE) crops; the Jackson and Josephine County measures passed handily. The Jackson County ordinance:
It is a county violation for any person or entity to propagate, cultivate, raise or grow genetically engineered plants in Jackson County.
These efforts began in Jackson County where proponents of the ban (local farmers) gathered enough signatures in 2013 to put a local GE ban on the ballot in the spring of 2014. That effort stirred opposition from seed companies and other parties, which reacted by pushing for a legislative fix to preempt such local agricultural governance. The result is that both of these newly-enacted county bans exist against the backdrop of a recently enacted state law that prohibits local counties from interfering with agricultural choice:
A local government may not enact or enforce a local law or measure, including but not limited to an ordinance, regulation, control area or quarantine, to inhibit or prevent the production or use of agricultural seed, flower seed, nursery seed or vegetable seed or products of agricultural seed, flower seed, nursery seed or vegetable seed.
The Oregon county measures are in line with other counties around the country that have enacted such bans (e.g., in Washington, Hawaii, California). In Oregon and the other states with such bans, the rationales advanced for the ban on GE crops include the avoidance of genetic contamination of non-GE crops by neighboring GE crops (e.g., pollen drift). (Several years ago, an apparent genetic contamination of the wheat crop in eastern Oregon elevated concerns about other potential instances of genetic contamination). A further motivation for a GE ban arises from the nature of the engineering itself – these crops are generally engineered for herbicide resistance (Monsanto's Roundup Ready technology) – meaning that the crops can withstand widespread application of these weed-killers. As a result, heavy use of potentially dangerous herbicides is encouraged by the planting of these GE crops, and proponents of such a ban point to the potential environmental and health complications from widespread use of the herbicide. The Oregon counties also have significant numbers of organic farming operations which could face exposure to GE materials or herbicides, scenarios that conflict with established principles of organic farming.
An apparent clash between the new county ordinances (at least for Josephine County) and the state’s new preemption statute looms, lodged against a backdrop of the significant home rule environment for localities that is found in Oregon; Jackson County was granted a waiver from the state law because the ballot initiative had been established before the law was passed. A similar legal showdown could emerge in Hawaii, which has passed a state preemption statute following the enactment of local GE crop bans. The shifting legal landscape between assertions of local governance and reactive preemption is also occurring with respect to state mandates for the labeling of GE food and pending federal preemption efforts to nullify such laws (see earlier post here). In a further sign of Oregon's attention to the legal issues raised by GE crops and GE food, a citizens' effort is underway to get a mandatory GE food labeling law on the ballot for November, 2014.
The Federal Circuit has issued its opinion in Organic Seed Growers and Trade Association (OGSATA) v. Monsanto, a declaratory judgment (DJ) action in which OGSATA and other plaintiffs (growers, seed selling businesses, and agricultural organizations) sought to litigate the question of whether inadvertent contamination of their crops by patented Monsanto (GE) seeds could give rise to a potential patent infringement claim by Monsanto. The threshold issue for the plaintiffs has been to establish standing for the suit, relying on their assertions that the prospect of infringement litigation from Monsanto has caused them to limit or halt their farming activities. In 2012, the lower federal court ruled that the plaintiffs could not meet the threshold showing for sustaining a DJ action, and dismissed the case. In the appeal to the Federal Circuit, the oral argument focused on determining whether a “substantial controversy between parties having adverse legal interests of sufficient immediacy and reality" – as required by the Supreme Court in Medimmune v. Genentech (2007) – exists. If so, a DJ action allows the plaintiffs to ask a court to adjudicate whether inadvertent contamination rises to the level of patent infringement, and whether the Monsanto patents are invalid under numerous patent law doctrines. Because patent infringement is generally regarded as a strict liability tort (intention irrelevant), passive contamination of an agricultural field by a patented product could be characterized as a patent infringing use. The plaintiffs argued that their concern over future litigation was warranted by Monsanto’s legal actions to date (between 1997 and 2010, 144 suits and 700 settlements related to unauthorized use of patented seed) and by Monsanto’s refusal to grant the plaintiffs a covenant not to sue. However, Monsanto did make representations of disinterest in pursuing patent infringement claims for instances of trace contamination, such as those contemplated by the plaintiffs. In response to a direct question from the court in oral argument, counsel for Monsanto agreed that representations in the court regarding the lack of the company’s intention to sue for trace contamination might give rise to judicial estoppel for plaintiffs to rely on later. From the opinion:
Taken together, Monsanto’s representations unequivocally disclaim any intent to sue appellant growers, seed sellers, or organizations for inadvertently using or selling “trace amounts” of genetically modified seeds…..We conclude that Monsanto has disclaimed any intent to sue inadvertent users or sellers of seeds that are inadvertently contaminated with up to one percent of seeds carrying Monsanto’s patented traits.
According to the Federal Circuit, those representations effectively extinguished the claim of legal threat by the plaintiffs:
In sum, Monsanto’s binding representations remove any risk of suit against the appellants as users or sellers of trace amounts (less than one percent) of modified seed. The appellants have alleged no concrete plans or activities to use or sell greater than trace amounts of modified seed, and accordingly fail to show any risk of suit on that basis. The appellants therefore lack an essential element of standing.
The Federal Circuit was quite clear in characterizing the nature of Monsanto's representations that plaintiffs had no basis for apprehension:
While Monsanto’s representations are not a covenant not to sue, they have a similar effect. If we rely on Monsanto’s representations to defeat the appellants’ declaratory judgment claims (as we do), those representations are binding as a matter of judicial estoppel.
In response to the ruling, OGSATA has stated that “we’re encouraged by the court’s determination that Monsanto does not have the right to sue farmers for trace contamination.” For the plaintiffs, the failure to establish a declaratory judgment action also means that their allegations of the patent invalidity of a number of Monsanto patents will not be heard (e.g., contentions that the patents lacked utility under 35 U.S.C. 101). Plaintiffs may appeal to the Supreme Court (which recently considered the patent exhaustion doctrine in the context of patented genetically engineered seeds in Bowman v. Monsanto; see here).
Yesterday, the Supreme Court issued its opinion in Bowman v. Monsanto, a patent infringement case that tested how the doctrine of patent exhaustion applies to self-replicating patented inventions such as genetically engineered (GE) seeds. The patented invention is the Monsanto Roundup Ready soybean, which contain a gene that encodes EPSPS, a glyphosate-tolerant enzyme. The genetically modified plants express the enzyme and thus exhibit resistance to the herbicide glyphosate– specifically, to the application of the Monsanto glyphosate product, sold as Roundup. A license restriction accompanies the sale of the Roundup Ready seeds, and it prohibits the use of second-generation seeds in later plantings. Farmer Vernon Bowman was accused of patent infringement by buying GE commodity seed from a grain elevator (not directly from Monsanto) which he then used for replanting (replication); Monsanto characterized his activities as an unauthorized use of a patented invention because it involved the “making” of a patented article. The doctrine of patent exhaustion operates to limit the control that an inventor holds over the life of a lawfully sold patented article – the first sale of a patented invention is authorized, and that act exhausts the control that the patent holder retains over subsequent uses of the article (absent some valid conditional sale agreement that accompanies the sale). Did that doctrine extend to a claim that a later sale of originally-patented GE seed to Bowman and his use in planting became an act of patent infringement because the seed replicates and he “made” an infringing article? In 2011, the Federal Circuit ruled that Bowman’s planting of the GE seed he purchased became an act of patent infringement, rejecting an interpretation of the exhaustion doctrine that would recognize the special attributes of seeds, which embody the property of replication and “manufacture” of an originally-patented invention (see earlier post). Did the company’s patent rights extend to this later series of events, or did they exhaust upon the first sale of the patented seed? Although one can freely “use” a product after patent exhaustion, does that authorize a use that results in the creation of a new copy of the patented article, which is generally viewed as an act of patent infringement? In the unanimous opinion authored by Justice Kagan, the Supreme Court said no:
Reproducing a patented article no doubt “uses” it after a fashion. But as already explained, we have always drawn the boundaries of the exhaustion doctrine to exclude that activity, so that the patentee retains an undiminished right to prohibit others from making the thing his patent protects.
What does not exhaust is the ability of patent holder to enforce one of the rights of exclusion, that is, the ability to prevent unauthorized replication of a patented invention. No exception applied here to GE seeds in this scenario, despite Bowman's invocation of self-replication by the product itself. Justice Kagan did note, however, that the decision was limited to this set of facts:
Our holding today is limited—addressing the situation before us, rather than every one involving a self-replicating product. We recognize that such inventions are becoming ever more prevalent, complex, and diverse. In another case, the article’s self-replication might occur outside the purchaser’s control. Or it might be a necessary but incidental step in using the item for another purpose.
This restraint from the Court at least references analogous scenarios in computer software, where use of a lawfully obtained program often requires the making of a copy on a host computer; Congress has address this with an amendment to copyright law (17 U.S.C. 117) that immunizes users from copyright infringement in such circumstances. There is some pushback in Congress with respect to patented seeds and the restrictions that accompany their sale; H.R.19, the Seed Availability and Competition Act of 2013 was introduced this year and it authorizes second generation plantings of patented seeds, effectively establishing a compulsory license, but setting a royalty mechanism for payments to the patent holder. This is unlikely to garner significant support in Congress, but it indicates that there are legislative approaches that can theoretically modulate patent rights for certain technologies, if the political will exists to do so.
The U.S. Department of Agriculture's Animal and Plant Health Inspection Service (APHIS) has announced this week that it will heighten its regulatory review for the possible introduction of the next wave of herbicide-resistant genetically engineered (GE) crops. Using its authority under the Plant Protection Act, APHIS regulates genetically engineered crops because it has determined that they may pose a risk as plant pests. Companies seeking to introduce a new crop to market file an application for deregulated status with APHIS. In this case, the applications seeking APHIS deregulation are for Dow Chemical’s corn and soybeans genetically engineered for resistance to the herbicide 2,4-D and Monsanto’s cotton and soybeans genetically engineered for resistance to dicamba. In addition to compliance with the Plant Protection Act, APHIS must also comply with the National Environmental Policy Act (NEPA).
Under the National Environmental Policy Act, APHIS is required to evaluate the potential environmental impacts from a "major Federal Action" - that can include the deregulation of new GE plants by the Agency. If APHIS finds that its potential regulatory decision may significantly affect the quality of the human environment, the Agency must prepare an EIS (environmental impact statement) before making a decision on the proposed Federal action.
APHIS had prepared a draft environmental assessment for the crops in the Dow petition. Petitions for deregulation of these crops (which would allow commercial release) had been submitted to APHIS and published for public comments; APHIS noted that significant numbers of comments had been received. APHIS has thus concluded:
With regard to these new herbicide-resistant plants, through its analysis of information submitted by the developers, as well as public comments, APHIS has determined that its regulatory decisions may significantly affect the quality of the human environment. APHIS therefore believes it necessary under NEPA to prepare these two EIS's to further assist the Agency in evaluating any potential environmental impacts before we make a final determination regarding the products' regulatory status.
Several points are worth noting about the APHIS decision and the larger debate over the use of genetically engineered crops (which are largely engineered for agronomic, not dietary purposes). In
contrast to several other proposed deregulations over the last several
years (alfalfa, sugar beets), where APHIS did not conduct an EIS, and
was sued for noncompliance with NEPA, here APHIS is triggering an EIS of
its own accord. The use of genetically engineered glyphosate-resistant crops (most famously, Monsanto Roundup Ready corn, soybeans) since the 1990’s led to extensive litigation over how APHIS managed its NEPA requirements; ultimately, judicial action compelled APHIS to prepare an EIS, and it then deregulated the crops. In the decade or more since the Roundup approach to weed management, glyphosate-resistant weeds have emerged, thus undermining the viability of this strategy for weed containment. Debate continues over whether successive waves of genetic engineering related to designated herbicides will adequately provide effective weed management (one research group describes an “accelerated transgene facilitated herbicide treadmill”). Criticism is also directed at the environmental consequences from the use of the herbicides; litigation against the Environmental Protection Agency attempted to rescind its approval of 2,4-D. However, it is notable that APHIS specifically cabins the focus of the EIS:
While the EIS’s will look more broadly at potential impacts to the environment as a whole, APHIS’ regulatory authority is based on The Plant Protection Act and the Agency’s oversight is specific to evaluating the potential for the GE plants to pose a plant pest risk to crops or other plants.
While technically true, APHIS is also charged by NEPA with an evaluation that considers how a “potential regulatory decision may significantly affect the quality of the human environment.” The decision by APHIS suggests that the agency might have anticipated immediate litigation if it had not prepared an EIS, and due to the delays that previous cases have imposed, may have decided that direct preparation of an EIS was more efficient. That, of course, does not predict the outcome of the EIS. However, it will take place against the backdrop of some of the limitations to genetically engineered weed management that have been revealed by earlier containment strategies.
The Federal Circuit heard oral arguments this week in a case where organic farmers are attempting to proactively litigate any potential infringement liability related to Monsanto patents on genetically engineered (GE) seeds (see here and here). The case is Organic Seed Growers and Trade Association (OGSATA) v. Monsanto, a declaratory judgment (DJ) action in which OGSATA and other plaintiffs seek to litigate the question of whether inadvertent contamination of their crops by Monsanto (GE) seed could give rise to a potential patent infringement claim by Monsanto. The threshold issue for the plaintiffs has been to establish standing for the suit, relying on their assertions that the prospect of infringement litigation from Monsanto has caused them to limit or halt their farming activities. In 2012, a lower federal court ruled that the plaintiffs could not meet the threshold showing for sustaining a DJ action, and dismissed the case. In the appeal to the Federal Circuit, the oral argument focused on determining whether a “substantial controversy between parties having adverse legal interests of sufficient immediacy and reality" – as required by the Supreme Court in Medimmune v. Genentech (2007) – exists. If so, a DJ action allows the plaintiffs to ask a court to adjudicate whether inadvertent contamination rises to the level of patent infringement, and whether the Monsanto patents are invalid under numerous patent law doctrines. Because patent infringement is generally regarded as a strict liability tort (intention irrelevant), passive contamination of an agricultural field by a patented product could be characterized as a patent infringing use. During the oral arguments, both parties faced skepticism from the court – the plaintiffs (farmers) were challenged as to how imaginary their fear of suit might be, and whether they had real instances of legal threat or action that supported their claim; the defendant (Monsanto) faced questions over what standard they would apply to elevate a case of trace contamination into a legal complaint of patent infringement, or whether a farmer who discovered contamination could then use contaminated seed (because it might be too difficult to cull from the rest of the crop) without being accused of patent infringement, or whether farmers would need to engage in genetic testing of their fields to help defend themselves against any allegations of infringement. Without knowing how the court will rule, perhaps the litigation has provided a measure of relief for the farmers: in response to a direct question from the court in oral argument, counsel for Monsanto agreed that representations in the court regarding the lack of the company’s intention to sue for trace contamination might give rise to judicial estoppel for plaintiffs to rely on later. The litigation was undertaken because the farmers had been unable to secure any enforceable covenant not to sue from Monsanto.
There is an update on the lawsuits brought by a coalition of food safety and environmental advocates to challenge the U.S. Fish and Wildlife Service (FWS) for their practice of granting permission for the planting of genetically engineered (GE) soybeans and corn in the national wildlife refuges (see here). The national wildlife refuges are a "national network of lands and waters for the conservation, management, and where appropriate, restoration of the fish, wildlife, and plant resources." The legal actions were filed on a regional basis and alleged that FWS has allowed the planting of GE crops in refuges without conducting an Environmental Impact Statement (EIS) as required by the National Environmental Policy Act (NEPA). These plantings are part of a FWS program that designates a portion of a refuge for agricultural purposes. One of the concerns is that many of the GE crops are Roundup Ready crops, engineered for herbicide-resistance, and GE crop plantings result in more introduction of herbicides into the natural habitat. Thus, the plaintiffs have alleged two forms of harm to a refuge from GE crops: genetic contamination of natural species and chemical harms from the herbicides. NEPA, passed in 1970, requires that any action undertaken by a federal agency that may have environmental consequences be thoroughly evaluated by conducting a rigorous environmental review (the EIS) of possible impacts and consideration of alternatives. NEPA effectively allows for citizen challenges to a broad range of federal actions that pose environmental risk through the use of a procedural objection, as exemplified by these lawsuits.
To date, the plaintiffs' coalition has won rulings in earlier challenges to the planting of GE crops in the national refuges, where the courts have ordered FWS to conduct the requisite EIS (e.g., the Northeast region). In two recent rulings that illustrate the regionally-specific analyses, Judge Boasberg in D.C. District Court upheld the challenge to the Southeast region plantings, ruling that an FWS phaseout in 2013 was not an adequate response to an allegation of incomplete environmental review. In a parallel challenge to GE crop planting in the Midwest region, Judge Boasberg ruled that FWS had made an adequate environmental assessment in view of its stated objective). One might guess that the FWS would decide as a matter of national policy to prepare an EIS for any proposed designation of refuge property for GE plantings. The FWS, however, has been unwilling to establish such a national policy that would routinely institutionalize EIS preparation - instead, has contended with individual lawsuits seeking to get an EIS prepared or to get an environmental assessment evaluated. On balance, it is likely that national wildlife refuge policy is evolving to conclude that the planting of any GE crop on land that is designed to house and maintain natural habitats is no longer compatible with the introduction of GE crops. Certainly, the widespread use of GE crops in general practice undermines any need for a national refuge to be a repository for such species.
In a case that presents a novel question regarding the scope of patent rights in a biotechnology invention, the Supreme Court has agreed to hear the appeal in Bowman v. Monsanto (Fed. Cir. 2011). Here, Monsanto sued an Indiana farmer, Vernon Hugh Bowman, for patent infringement for his use of patented seed for the growth of second-generation genetically engineered (GE) soybeans. The patented crop is the Monsanto Roundup Ready soybeans, which contain a gene that encodes EPSPS, a glyphosate-tolerant enzyme. The genetically modified plants express the enzyme and thus and exhibit resistance to the herbicide glyphosate– specifically, to the application of the Monsanto product, glyphosate, sold as Roundup. The purpose is to create a crop through genetic engineering that can withstand the application of the herbicide (weed-killer). Bowman was accused of patent infringement by buying GE commodity seed from a grain elevator which he then used for replanting (replication), which Monsanto characterized as an unauthorized use of a patented invention. The doctrine of patent exhaustion in patent law generally operates to limit the control that an inventor holds over the life of a lawfully sold patented article – the first sale of a patented invention is authorized, and then exhausts the control that the patent holder retains over subsequent uses (absent some valid conditional sale agreement that accompanies the sale). Would that doctrine extend to a claim that a later sale of originally-patented GE seed to Bowman and his use in planting became an act of patent infringement because the seed replicates and he “made” an infringing article? In 2011, the Federal Circuit ruled that Bowman’s planting of the GE seed he purchased created an act of patent infringement, rejecting an interpretation of the exhaustion doctrine that would recognize the special attributes of seeds, which embody the property of replication and “manufacture” of an originally-patented invention. Did the company’s patent rights extend to this later series of events, or did they exhaust upon the first sale of the patented seed? In his petition, Mr. Bowman presented the following question to the Supreme Court:
Whether the Federal Circuit erred by (1) refusing to find patent exhaustion in patented seeds even after an authorized sale and by (2) creating an exception to the doctrine of patent exhaustion for self-replicating technologies?
The Supreme Court has provided some recent guidance on patent exhaustion in Quanta v. LG (2008), where they held that a sale that “substantially embodies” the patented invention exhausts the patent rights. Interestingly, the U.S., as amicus curiae, urged the Court not to take the case, warning that “if this Court granted certiorari, however, its decision could also affect the enforcement of patents for man-made cell lines, DNA molecules, nanotechnologies, organic computers, and other technologies that involve self-replicating features.” The Court did take the case, however, and it signals that it does wish to consider the prospect that the inherent property of self-replication in some biotech-related inventions does not demand unexhausted patent rights.
There is an update in the litigation that involves a challenge to various Monsanto patents on genetically engineered (GE) seeds (Organic Seed Growers and Trade Association v. Monsanto). The lawsuit was filed by a coalition of farmers, seed businesses and agricultural organizations who are concerned with potential allegations of patent infringement if GE crop material inadvertently travels onto their properties. See here for earlier background on this case. The lawsuit was dismissed in federal district court in March.The judge ruled that the plaintiffs lacked standing, not presenting a sufficient immediate controversy to the courts to warrant declaratory judgment jurisdiction. An appeal was lodged at the Federal Circuit and the plaintiffs’ appellate brief has now been filed at the court. The plaintiffs elaborate on their injury, asserting that they have to forego the use of property in order to reduce their risk of contamination by adjacent GE crops and/or they must undertake expensive genetic testing to monitor the appearance of a GE contaminant in their native crops.The brief goes to lengths to detail the specific circumstances of some named plaintiffs as they face imminent potential contamination of their crops, and it asserts that any countervailing measures that plaintiffs take to reduce potential contamination do not defeat their right to standing. The governing standard provided by the Supreme Court in Medimmune v. Genentech is “whether the facts alleged, under all the circumstances show that there is a substantial controversy between parties having adverse legal interests, of sufficient immediacy and reality to warrant the issuance of a declaratory judgment.” The defendants have offered a statement that renounces an intention to sue the plaintiffs; however, this has not allayed their concerns and the litigation moves forward. Note that this threshold dispute over standing is simply a predicate to the merits of the complaint; should plaintiffs win on standing, they gain the right to fully contest the validity of the Monsanto patents.
The proximity of genetically engineered (GE) crops to organic farming operations (non-GE) poses problems for possible contamination of the non-GE crops through the drift of pollen from the GE fields onto the non-GE plantings. Complicating this scenario is the possibility that contamination occurs through migration of patented GE materials, leading to potential claims of patent infringement. A closely watched lawsuit, Organic Seed Growers et al., v. Monsanto, was launched by a coalition of organic farmers seeking a preemptive ruling (declaratory judgment) of non-infringement and patent invalidity in contemplation of possible inadvertent contamination of their fields by Monsanto's patented transgenic seed materials (sometimes referred to as genetic trespass). Last month, a judge in the Southern District of New York ruled that no sufficient controversy existed to provide a basis for the plaintiffs’ lawsuit. As expected, the plaintiffs have now filed an appeal with the Federal Circuit seeking to reinstate their right to litigate the Monsanto patents in view of their apprehension of legal action from Monsanto. The standard for standing in declaratory judgment actions, applied in the context of a patent lawsuit, was set by the Supreme Court in Medimmune v. Genentech, where the Court pronounced a more flexible “all circumstances” that replaced the more rigid injury-nexus-relief test that had evolved from its earlier decision in Lujan v. Defenders of Wildlife. Yet, the Federal Circuit has recently applied this standard, in the context of AMP v. USPTO (challenging the Myriad Genetics gene patents): “this court has held that, to establish an injury in fact traceable to the patentee, a declaratory judgment plaintiff must allege both (1) an affirmative act by the patentee related to the enforcement of his patent rights,” and “(2) meaningful preparation to conduct potentially infringing activity.” In AMP v. USPTO, the Federal Circuit declared that only one plaintiff, Dr. Harry Ostrer, qualified for standing, in view of active assertion by Myriad’s active enforcement of its patent rights against Dr. Ostrer, and his stated intention to resume his genetic testing activities if the threat of patent infringement were lifted. In the farmers’ lawsuit, both of these elements for standing as emphasized by the Federal Circuit appear harder to prove: no direct legal actions by Monsanto against these plaintiffs (although the pattern of Monsanto patent enforcement has evidenced a willingness to convert contamination into patent infringement); and this absence of nexus then undermines the plaintiffs' assertion of preparation for activities that might constitute infringement (yet some plaintiffs are alleging refraining from farming due to their fear of litigation). Nonetheless, if the plaintiffs can successfully argue that the Supreme Court deliberately crafted a more flexible standard for standing in Medimmune – certainly recognizing a public interest in the adjudication of potentially invalid patents – that encompasses this novel factual pattern of perceived threat and potential assertion of rights, they may have a chance to revive the suit.
There is a ruling in the federal lawsuit brought by a large coalition of organic farmers against Monsanto, seeking a preemptive ruling (declaratory judgment) of non-infringement and patent invalidity in contemplation of possible inadvertent contamination of their fields by Monsanto's patented transgenic seed materials (sometimes referred to as genetic trespass). To date, Monsanto has vigorously enforced its seed patents against farmers (patent infringement can be alleged whether the use of a patented invention is deliberate or inadvertant). In this case, Judge Buchwald has ruled that the plaintiffs are not entitled to seek a declaratory judgment because a sufficient controversy has not developed to warrant the court’s involvement (noting “plaintiffs’ transparent effort to create a controversy where none exists”); she also placed weight on a letter from Monsanto in which it indicated that it had no intention of suing the plaintiffs (the judge called this “a source of comfort rather than worry”). Thus, the judge has not regarded the controversy as particularly acute or immediate, and will not entertain the lawsuit. Early reaction from the plaintiffs is that they will appeal the ruling to the Federal Circuit. The case has been closely watched as it placed the farmers in a proactive stance, seeking to clarify their legal position and, if successful, remove what they consider to be the ongoing legal threat of a patent infringement lawsuit for activities (involuntary contamination of crops) that were not deliberate or welcome. The judge effectively did not regard the plaintiffs' contention that they refrain from certain plantings due to patent enforcement implications as warranted, given her view of the defendant's likely response, and certainly not indicative of any legal injury. Although unrelated cases, there is some overlap with the contentions of the plaintiffs in the gene patent case, AMP v. USPTO, in which plaintiffs allege that they could not conduct genetic testing due to fear of patent infringement litigation (AMP is cited by the judge, but some of this works against the farmers here, who cannot point to the same direct assertion of patent rights that Myriad Genetics displayed and which then structured plaintiffs' activities).
