Renewable Agriculture: Transgenic Contamination and Patent Enforcement Threats

Vol. 26 No. 3

Christina L. Nargolwala, an attorney in the securities industry in New York, is the vice-chair for Public Service, SEER Ethics Committee.

Organic farming systems rely on ecologically based practices such as cultural and biological pest management, and exclusion of all synthetic chemicals, antibiotics, and hormones in crop and livestock production. For agricultural products to be labeled or represented as organic, farms must be in compliance with United States Department of Agriculture (USDA) regulations. USDA’s National Organic Program regulates any farm, wild crop harvesting, or handling operation that wants to sell an agricultural product as organically produced. See National Organic Program, 7 C.F.R. pt. 205 (2000). Organic certification may be suspended or revoked for noncompliance; indeed, USDA publishes a list of producers whose organic certification has been suspended or revoked.

An organic farm is based on organic seed stocks which differ from “transgenic seeds.” Transgenic seeds involve purposeful genetic modification or engineering of a plant’s genetic material. Transgenic seeds are altered when the genes of one species are put into the DNA of another species. Transformation is achieved when the foreign genetic material permanently alters the receiving seed’s DNA to make the plant, for example, resistant to herbicides or pesticides. During the life cycle of the plant, the transformed, genetically engineered material is then replicated and transferred through the plant’s natural life cycle processes. Organic Seed Growers et al. v. Monsanto, No 11-cv-2163-NRB (S.D.N.Y.) First Amended Complaint (June 1, 2011), ¶¶ 101–103 [hereinafter First Amended Complaint].

Organic (and conventional) farming ecosystems are jeopardized when “transgenic” seeds contaminate the farm’s natural crops. Making matters worse, patent law protects the patent and property rights of industrial transgenic seed “makers.” Transgenic seed patents give the patent holder the ability to enforce patent protection for genetically modified seeds. Farmers, both conventional and organic, who do not wish to use the transgenic products are vulnerable to costly and disruptive patent enforcement actions when transgenic seeds contaminate their natural crops.

Contamination of an organic farm or its organic seed stock results in the destruction of sustainable or renewable agriculture within the larger ecosystem. Indeed, the reference in this article’s title to “renewable” agriculture is somewhat ironic, since for millennia agriculture was presumed to be “renewable,” absent a catastrophic event. Farmers routinely saved seeds and developed hardy crop species through crop breeding and hybrids. See Charles Siebert, Food Ark, Nat’l Geographic Mag. (July 2011); Haley Stein, Intellectual Property and Genetically Modified Seeds: The United States, Trade, and the Developing World, 3 Nw. J. Tech. & Intell. Prop. 160, 162–163 (Spring 2005).

The challenge of protecting an organic farming ecosystem from transgenic seed contamination is illustrated by the allegations in Organic Seed Growers, an action brought by the nonprofit, public-interest Public Patent Foundation. Plaintiffs in Organic Seed Growers are organic seed growers and savers, organic and conventional farmers, and related trade groups representing farmers who choose not to grow crops from transgenic seeds. They allege that their livelihood is threatened by contamination from transgenic seeds (for instance, through pollen or scatter blown onto their fields), and by aggressive patent enforcement actions brought by defendant Monsanto even when the contamination is wholly unintended—and unwanted—by plaintiffs.

Plaintiffs aver that transformed genes persist in all of the seeds the altered crop produces, and they argue that the transformed genetic plant material spreads through natural pollination to nontransgenic cultivated crops, and even to wild native plants. Plaintiffs allege that if contamination occurs or cannot be ruled out, they will be unable to satisfy certification standards for organic crops; and they will be unable to sell their produce as organic, with severe financial consequences, including possible loss of livelihood. Plaintiffs also fear the threat to their farming life from the risk of patent infringement actions that could be brought against them by Monsanto. First Amended Complaint ¶ 103.

Defendants are Monsanto Company and Monsanto Technology LLC (collectively, Monsanto). Since the 1980s, patents have been granted to Monsanto or companies it acquired for transgenic plants or crops. Monsanto is a dominant supplier of transgenic seed:Monsanto widely markets transgenic seed to the public under the trade name Roundup Ready. Monsanto sells Roundup Ready seed for corn, canola, soybean, sugar beet, alfalfa and cotton. Monsanto dominates the market for transgenic seeds and traits. Monsanto currently holds the largest percentage of the global proprietary seed market of any company.” First Amended Complaint ¶ 104.

Plaintiffs assert that the “first sale” or “patent exhaustion” doctrine should insulate them from patent liability. The “patent exhaustion” doctrine provides a buyer of a product with the freedom to dispose of the purchased product or item, while the patent holder otherwise continues to retain distribution rights under the intellectual property regime Quanta Computer, Inc. v. LG Electronics, Inc., 553 U.S. 617 (2008) (the doctrine of patent exhaustion applies to an authorized sale by the patent holder.) Under plaintiffs’ theory in Organic Seed Growers regarding transgenic patents, after the initial sale of Monsanto’s patented transgenic seeds, Monsanto is not entitled to enforce its patents when its transgenic seeds are found to be in a farmer’s crop through unintended contamination as opposed to intentional use without a license or in violation of a license. First Amended Complaint ¶ 149–150. Plaintiffs also allege abusive litigation practices and anticompetitive licensing agreements. First Amended Complaint ¶¶ 151–156.

Farmers who obtain transgenic seeds from Monsanto, however, do so under license, which may afford fewer rights than would be obtained in connection with an outright sale, particularly if post-sale conditions are imposed under contract law. When Monsanto licenses its transgenic seeds, the licensees agree not to save seeds from one growing season to the next. Monsanto views saving seeds, if it includes their transgenic seeds, as “seed piracy.” See Saved Seed and Farmer Lawsuits, Pilot Grove Co-op Settlement. Monsanto has been allowed to enforce its license agreements. Monsanto Co. v. McFarling, 302 F.3d 1291 (Fed. Cir. 2002), cert. denied, 537 U.S. 1232 (2003). In that case Monsanto sued a farmer who had licensed transgenic seeds and then saved seeds in violation of the technology licensing agreement. The federal patent appeals court held that patent exhaustion/first sale doctrine did not apply to saved seeds or second-generation seeds when the transgenic seeds were licensed from the patent holder.

Monsanto has been permitted to enforce its transgenic seed patents into the next generation (progeny crops and seeds) against a farmer who has unknowingly purchased patented seeds and then grew crops which were at least in part derived from the patented seeds. Monsanto Co. v. Bowman, 686 F. Supp. 2d 834 (S.D. Ind. 2009). In that case the district court enforced Monsanto’s patents against a farmer who had purchased seeds from a grain elevator seller, which had purchased crops from licensee-farmers of Monsanto. The court held that patent exhaustion did not apply, even though Monsanto had sold its patented seeds to licensee-farmers in an authorized transaction, and the license did not prohibit the licensees from in turn selling the resulting crops to a third party. Some commentators are troubled by this result. See, e.g., Yee Wah Chin, Inexhaustible Patents on Self-Replicating Technologies, Landslide, Vol. 3, No. 5, May/June 2011 (questioning whether the patent exhaustion/first sale doctrine should be applied to second-generation progeny of self-replicating crop progeny when patented technology was obtained in an authorized sale.)

Monsanto enforces its patents even when a farmer inadvertently uses transgenic seed:

Farmers have been sued [by Monsanto] after their field was contaminated by pollen or seed from someone else’s genetically engineered crop; when genetically engineered seed from a previous year’s crop has sprouted, or “volunteered,” in fields planted with non-genetically engineered varieties the following year; and when they never signed Monsanto’s technology agreement but still planted the patented crop seed. In all of these cases, because of the way patent law has been applied, farmers are technically liable. It does not appear to matter if the use was unwitting or a contract was never signed.

Center for Food Safety, Monsanto vs. U.S. Farmers (2005).

Between 1997 and 2010, Monsanto filed 144 actions against farmers in 27 American states for alleged infringement of its transgenic seed patents and/or breach of its license to those patents. First Amended Complaint ¶ 129. This allegation is consistent with two-year-old figures provided on Monsanto’s website: “Enforcing patent infringement involving seed piracy is not much different from the enforcement of other laws. . . . Since 1997, Monsanto has filed suit against farmers for seed piracy 138 times (as of July 2009) in the United States. Of these lawsuits, Monsanto proceeded through trial only nine times, winning each case.” (Emphasis supplied.)

Plaintiffs also argue that Monsanto’s patents are or should be held to be invalid and unenforceable. Substantively, plaintiffs argue that transgenic seeds subject to patents awarded to Monsanto do not represent a “useful” invention as required by long-standing patent law because the product is harmful to human health. Moreover, plaintiffs argue, Monsanto has improperly extended a monopoly by “double patenting.” First Amended Complaint ¶¶ 144–145. Double patenting refers to the unjustified extension of patent exclusivity beyond the term of a patent. See U.S. Patent & Trademark Office, Manual of Patent Examining Procedure, 804 - Definition of Double Patenting [R-5] and related discussion.

Naturally cultivated nontransgenic crops are vulnerable to contamination by transgenic seed in several ways, such as through seed “drift” or “scatter,” through unintentional cross-pollination, through use of tainted harvesting or processing equipment, during transportation, and during storage. Monsanto asserts that it “does not enforce [its] patent rights where trace amounts of [its] patented seeds or traits are present in a farmer’s fields as a result of inadvertent means.” Monsanto’s Commitment (describing Monsanto’s “commitment to farmers when reviewing, evaluating and investigating [patent infringement] matters.”). However, plaintiffs fear that because the terms “trace amounts” and “inadvertent means” are not expressly defined by Monsanto, the threat of litigation remains. First Amended Complaint ¶¶ 158–159.

Organic farmers in Organic Seed Growers worry that the taint of transgenic seeds, whether crop contamination is proven or not, may result in suspension or revocation of USDA certification. Transgenic contamination also can effectively close certain markets to produce from contaminated farms. Many countries are “adamantly opposed to the marketing of genetically altered foods. There are also [global] fears of increased resistance to pesticides, adaptation of insects, unknown environmental impacts, and detrimental effects on the plants’ gene pool.” See Stein, Intellectual Property and Genetically Modified Seeds, at 161. Mindful of a global controversy regarding human consumption of transgenic crops, some public interest organizations working on food supply issues have hesitated to employ transgenic techniques. See, e.g., the review of research on plant yields and micronutrients by Harvest Plus, a nonprofit entity that employs nontransgenic plant breeding techniques to fortify crops with micronutrients but is considering whether to test transgenic crops.

Yet transgenic seeds are not uniformly viewed as harmful. Current research in the manipulation of natural plant genetic material seeks to increase greater food crop yields in the developing world. See, e.g., Flood-Tolerant Rice Plants Can Also Survive Drought, Science Daily, Mar. 4, 2011, at and Justin Gillis, A Warming Planet Struggles to Feed Itself, The N.Y. Times, June 4, 2011.

The Organic Farm as a System: How Do We Define a System?

When we speak of a “system,” what do we mean? A system is an interconnected set of elements that is coherently organized in a way that achieves something identifiable and distinct. A system is comprised of elements, interconnections, and a function or purpose. Donella Meadows, Thinking in Systems: A Primer 11 (2008). To qualify as a system, there must be an integrity or wholeness, and an active set of mechanisms to maintain that integrity; systems are characterized by “interconnections, the relationships that hold the elements together.” Id. at 12–13. Successful systems are resilient, and may even be adaptive, but if inherent characteristics are changed the entity may still exist yet may no longer be able to survive for its intended purpose.

Elements which comprise a distinct system need not be physical things, but their role in defining something as a system rather than simply a collection of things must be observable or verifiable. The observer asks: “Can you identify the parts? Do the parts affect each other, and do the parts produce an effect that is different from the effect of each element on its own?” If so, how robust is the combined effect? Id. at 13.

A system’s stock is comprised of measurable and observable elements, yet a stock need not be physical (for example, a company’s goodwill or reputation is intangible yet identifiable, distinct, and valuable to the enterprise). A system’s stock may change over time as a result of “flows.” Flows represent the inflow and outflow of the stock. Id. at 17–20. One could say that the stock of a system is the system’s presently available source material or resources, such as the farmer’s store of seeds from prior crop seasons. Flows represent elements such as material or information that enter and leave the system. Id. at 187. A key function of almost every system is to ensure its own perpetuation. Id. at 15. I would describe this function as the system’s ability to ensure its own survival with its defining characteristics intact. I refer to this goal as Intact Survival.

Generally speaking, a change in stock can affect Intact Survival. For instance, if a stock changes gradually, then the effects of a change to the inflow or outflow of the stock may be difficult to see and verify. Thus, it may be difficult to determine when a particular system has changed so much that it can no longer claim Intact Survival with a functioning, distinct system. Contamination of a system with inflow that changes the fundamental characteristics of the system may cause a sudden change, or a change that can only be corrected over a long period of time; during that time of correction the system may no longer be able to maintain Intact Survival. Conversely, a slower rate of change in a stock may permit adjustments and demonstrate the resiliency of a given system. (For example, ocean fish stocks are not depleted in a brief span of time and are affected by many factors.)

“Interconnections” may be more difficult to discern. Interconnections may be physical (such as water drawn in by a plant’s root system) or may be a flow of information. Id. at 14. When the interconnections illustrate defining characteristics of the system, they are key to maintaining a system as a distinct entity and ensuring its Intact Survival.

What of the system’s purpose or function? If a system exists exclusively in nature and is discovered rather than created or cultivated by human society, the purpose or function may not be immediately evident. Consequently, the best way to identify a particular system’s purpose or function may be through observation of its behavior under different circumstances or conditions. See id. at 14.

An organic farm represents a distinct ecosystem within the larger systems of community, nature, and the biosphere (the biosphere being the ecosystem comprising the entire earth and the living organisms that inhabit it). We can see evidence of this from the effect on the farm qua system in the example of transgenic seed contamination. What are the consequences to the organic farm as a self-sustaining system from the invasion of transgenic seeds or spores (contamination of seed stocks)? Changing the purpose or function of the system from, for instance, cultivating organic crops and seeds that can meet organic certification standards, to cultivating whatever grows from spores blown in on the wind, results in the system no longer being successful at its distinct purpose and function. Consequently, because of contamination the system has failed at Intact Survival.

Maintaining a seed stock from season to season permits adjustment based on inflows and outflows of crops. The system is consequently not dependent on the success of a particular season for the system’s Intact Survival. A crop failure may not be catastrophic if sufficient system-defining seed stock is available. The seed stock should be of the characteristic type, meaning in an organic farm the seed stock must be nontransgenic with a traceable agricultural lineage.

Farmers who maintain an organic farm as a distinct system and who grow nontransgenic crops have several reasons to preserve the systemic integrity of their farms and ensure Intact Survival. Transgenic contamination (real or perceived) may result in a lower price for the crop, loss of third-party organic certification, rejected shipments or import bans, diminished consumer demand, and the risk of legal liability for alleged patent infringement from actions brought by a transgenic patent holder. First Amended Complaint ¶ 107.

How might an organic farmer determine if suspected transgenic contamination is present on the farm? By its very nature, a visual inspection would be of little help in confirming whether or not transformation of plant genetic material through cross-pollination or other means has occurred. The farmer would have to resort to expensive genetic testing. For example, an organic dairy farmer wanted to certify his product as GMO-free; “To root out the genetically modified corn, [the farmer] spent several months and about $10,000 testing, re-testing and tracing back his products: from his own dairy’s milk, to other dairies that supply some of his milk, to the brokers who sell them feed, to their mills that grind the corn, to farmers who grow it.” When Organic Isn’t Organic, Time, Mar. 14, 2007.

Systems often have a self-regulating or self-organizing ability. If the self-maintaining capacity of the original system diminishes or erodes, then a destructive reinforcing feedback loop may be set in motion. See Meadows at 133–134. As the system deteriorates, its inability to self-regenerate or self-maintain accelerates, and the system becomes less able to maintain its Intact Survival. In the context of the organic farm as a distinct system, normally the system is maintained by verified organic seed stock, flow of sufficient water, nutrient-rich soil, natural pest control, and seasonal growth and harvest in a continuing positive feedback loop. The threat of transgenic contamination to the system, however, represents an existential threat. The difficulty and expense of rooting out plants or crops derived from or contaminated by transgenic seeds results may be prohibitively expensive or may actually destroy the farm’s organic system, putting the farmer out of business.

Biodiversity and the Food System

The award of patents on transgenic plant material should be considered in the context of the need to protect biodiversity and the world food supply. The Food and Agricultural Organization of the United Nations recently reported that over the past century, about 75 percent of natural plant genetic resources has been lost, and one-third of today’s already diminished plant diversity could disappear by 2050. UN FAO, Save and Grow Overview (2011).

Sustainable development addresses risks through the precautionary and intergenerational equity principles, which should be applied to the risks to biodiversity of altering natural plant genetic material, particularly the rendering of seeds sterile and resistant to Monsanto’s related herbicide or pesticide products. The precautionary principle is defined in Principle 15 of the UN Conference on Environment and Development, which states: “Where there are threats of serious or irreversible damage, lack of full scientific certainty shall not be used as a reason for postponing cost-effective measures to prevent environmental degradation.” The Rio Declaration principle of intergenerational equity (Principle 3) applies to the transgenic seed threat to the organic farm as a distinct system which preserves biodiversity: “The right to Development must be fulfilled so as to equitably meet developmental needs of present and future generations.” UN Doc. A/CONF. 151/26Rev. 1 (Vol. I) Annex I, Rio Declaration on Environment and Development (1992).

Ecological Economics and Systems Thinking

Plaintiffs in Organic Seed Growers argue that Monsanto’s patents should be declared unenforceable principally because the patented products, even if otherwise patentable, are not “useful”; and “only technology with a beneficial societal use may be patented.” First Amended Complaint ¶ 4 (citations omitted). Proponents argue to the contrary that patented transgenic seeds demonstrate their social utility by significantly increasing crop yield. Even if transgenic seed patent holders such as Monsanto are correct regarding yield, however, and yield is improved through use of such seeds, systems thinking as filtered through the discipline of ecological economics would argue that uneconomic growth is unsustainable and therefore undesirable.

What is meant by uneconomic growth? Conventional economics sees the macroeconomy as the whole or the system. Ecological economics sees the macroeconomy as part of a larger system, the Earth, comprised of its atmosphere and its ecosystems. See Herman Daly & Joshua Farley, Ecological Economics: Principles and Applications 15 (2004). According to these ecological economists, there can be such a thing as “uneconomic growth,” when the costs of growth are weighed unfavorably against the value of sustainable spending of natural capital. Id. at 16. “Monocropping vast fields with the same genetically uniform seeds helps boost yield and meet immediate hunger needs. Yet high-yield varieties are also genetically weaker crops that require expensive chemical fertilizers and toxic pesticides.” Charles Siebert, Food Ark, Nat’l Geographic Mag. (July 2011). Polluting the environment, depleting biodiversity beyond the point of replenishment, and the extinction of heritage seed varieties are examples of undesirable consequences of uneconomic growth.

Organic farming, which seeks to preserve biodiversity and agricultural heritage, is an example of a distinct system. Organic farmers employ traditional farming practices such as seed saving and sharing and nontransgenic plant breeding, a form of sustainable agriculture, which promote biodiversity. Organic farms represent valuable natural capital. The organic farm—a distinct system that can demonstrate its Intact Survival—is threatened by the ability of transgenic seed sellers to enforce patent infringement claims against unwitting users whose crops are inadvertently contaminated.

Current law, which awards and protects patents on transgenic seeds or plants, does not recognize the rights of the organic farmer to protect and maintain the farm as a distinct system. Instead, the current legal regime permits transgenic seed patent holders to enforce the patent against farmers—even in those instances when there is no intentional infringement. Reliance on the patent holder’s selective enforcement simply dodges or postpones the issue. Legal recognition and protection should be afforded to the organic farm as a distinct system. Currently the law’s property model allows an industrial seed “maker” to enforce patent rights, rather than seeing such a seed “maker” as tampering with a natural, renewable resource. Creating support for legal protections to benefit sustainable agricultural systems threatened by industrial transgenic seed patents is, like the cultivation of crops itself, a process and not a conclusion.

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