Legal Liability Issues in Agricultural Biotechnology

Abstract

CROP PHYSIOLOGY & METABOLISM

Legal Liability Issues in Agricultural Biotechnology

Drew L. Kershen*

The University of Oklahoma Law Center, Andrew M. Coats Hall, 300 Timberdell Road, Norman, OK 73019-0701

* Corresponding author (dkershen@ou.edu ).


This article presents an overview of the legal liability issues in torts and patent law that arise from the use of transgenic crops produced by agricultural biotechnology. Torts—A tort is a civil legal action whereby the claimant alleges injury or wrong, arising independent of contract, to the person or property of the claimant. The article begins with legal liability claims for damage to property, damage to persons, and damage to economic interests (markets) that may arise with the use of transgenic crops. The tort theories discussed include the legal claims of trespass, strict liability, negligence, private nuisance, and public nuisance. With respect to each tort theory, the discussion points out unique legal issues that are likely to exist specifically because the litigation involves agricultural biotechnology. Patent Infringement—The article ends by focusing on four patent infringement cases that courts in Canada and the USA have decided regarding farmers who used patented seed from agricultural biotechnology without permission of the patent holder. As of May 2003, these are the only four patent infringement cases that have resulted in formal legal opinions by courts construing patent and antitrust laws in the context of farmers saving seeds protected by patents.

Published in Crop Sci. 44:456-463 (2004).


Introduction

INTRODUCTION 

AS AMERICAN AGRICULTURE adopts plants created by biotechnology, questions arise as to what legal risks accompany this adoption of transgenic crops. More specifically for this article, questions arise as to what torts (a private civil action alleging injury or wrong to person or property) might exist that may impose legal liability relating to the growing of transgenic crops. In addition, questions arise as to what patent claims exist that may impose legal liability on farmers growing transgenic crops. This article focuses on these tort and patent questions to discuss legal liability in agricultural biotechnology. Legal liability is discussed about the growing and marketing of transgenic crops generally, although at times seed production, coexistence with organic farming, and pharmaceutical crops are the examples used to illustrate the legal liability issues. The article begins with torts and ends with patents.



Tort Liability

 

Legal liability in tort law should be contrasted with regulatory approval. Regulatory approval focuses on whether a particular transgenic crop, microorganism, or animal is safe to humans and the environment. Regulatory approval deals with whether and under what conditions agricultural biotechnology crops and animals may be produced, marketed, and used. By contrast, before or after regulatory approval, a particular transgenic plant, microorganism, or animal possibly could cause damage to property, persons, markets, the environment, or to social structures. Legal liability in tort addresses the kinds of liability that may exist for these possible damages. Those who produce or use agricultural biotechnology products need to know about the legal standards by which they may be held accountable for damages. In addition, those who might potentially be damaged by agricultural biotechnology need to be aware of the kinds of claims that they might assert to establish legal liability against producers and users of this technology (Grossman, 2002, p. 227–239).

Damage to Property
Property damage most likely will be alleged on two fact patterns: pollen flow from the transgenic crop to nontransgenic crops and mixing of seeds or plant parts during harvest, storage, and transportation. Any farmer, particularly those engaged in growing a specialty crop for a specific contract, may allege that pollen flow or mixture from another crop (transgenic or not) has damaged that particular farmer's crop.

Pollen flow has generated the most discussion, including discussion among crop scientists. With regard to pollen flow, property damage may occur most often in two contexts: seed production and organic production. Organic producers may claim that transgenic pollen flow has damaged their organic production, rendering it no longer "organic." Seed producers may claim that transgenic pollen flow has damaged the purity of their seeds, rendering them no longer certifiable for specified purity as required by law.

Trespass.
If seed producers or organic producers believe that they have suffered damages from transgenic pollen flow, they may bring a common law cause of action based in trespass (Grossman, 2002; Repp, 2000). Trespass involves the physical invasion of the possessory interests of the property (land) of the person claiming damages with the damages being caused by the farmer of the transgenic crops. The physical spread of transgenic pollen to neighboring fields may be enough by itself to establish the physical invasion element of trespass.

Pollen flow between cultivars of the same crop or between related plant species is a biological fact. Hence, if pollen flow by itself gave rise to legal liability for trespass on a neighbor's crops, all farmers would be exposed to legal liability for trespass for almost every crop they grow. This biological fact of pollen flow means that if trespass through pollen flow becomes a widely adopted source of legal liability, organic and conventional farmers too will be subject to legal liability for pollen flow from their crops to transgenic crops, if the pollen flow from the organic or conventional crop causes damages to the transgenic crop. To differentiate between pollen flow that constitutes trespass and pollen flow that is accepted as a biological fact of farming, the law requires that the physical invasion cause damages.

In the USA, the Association of Official Seed Certifying Agencies (AOSCA), the recognized expert body, sets "the minimum standards for genetic purity and identity and recommended minimum standards for seed quality for the classes of certified seed" (AOSCA website, http://aosca.org; verified 5 September 2003). The Nebraska Crop Improvement Association (NCIA) is a state affiliate of AOSCA and its seed standards are typical of those used in the USA. In Nebraska, to gain seed certification, seed producers must comply with requirements related to land use (such as isolation distances from fields of the same crop and the use of buffer rows), agronomic practices (such as roguing of undesired plants, weed control, and detasseling), and produce a seed crop that meets the tolerance levels for genetic purity (NCIA website, http://www.unl.edu/ncia/; verified 5 September 2003).

In the USA, federal law sets organic standards through the National Organic Program (NOP) of the USDA. NOP Section 205.2 specifically states that among the excluded methods of production are "methods used to genetically modify organisms" (USDA-NOP, 2000). However, in the comments accompanying the official rule, the USDA wrote with specific reference to pollen flow.

When we are considering drift issues, it is particularly important to remember that "organic standards are process based. Certifying agents attest to the ability of organic operations to follow a set of production standards and practices that meet the requirements of the act and the regulations. This regulation prohibits the use of excluded methods in organic operations. The presence of a detectable residue of a product of excluded methods alone does not necessarily constitute a violation of this regulation. As long as an organic operation has not used excluded methods and takes responsible steps to avoid contact with the products of excluded methods as detailed in their approved organic system plan, the unintentional presence of the products of excluded methods should not affect the status of an organic product or operation" (USDA-NOP, 2000, p. 80556).

In a similar vein, USDA declined to set a tolerance threshold for the presence of transgenic crops in organic production and stated that the regulations do not establish a "zero tolerance" standard. The presence of transgenic crops in organic production does not constitute a violation of USDA organic production standards so long as the organic producer follows the producer's own approved organic system plan.

By reviewing the seed production standards and the organic production standards, two unique issues emerge regarding a trespass claim for damages for transgenic pollen drift. First, both sets of standards place the burden on the person engaged in the production operation to comply with the required production standards. Failure to follow the production standards causes the producer to lose the certification, not the pollen flow from neighbor's crops. Second, neither set of standards makes the presence of transgenic crops per se a violation of the standards. Seed crops and organic crops may have the presence of transgenic crops without losing certification. Hence, seed producers and organic producers may face significant difficulties in proving that the farmer growing transgenic crops caused damage.

Strict Liability.
Persons who believe that their land or crops has been damaged by a neighbor's transgenic crops may bring a tort claim in strict liability—i.e., liability without fault and despite the exercise of utmost care—if the activity of growing transgenic crops is abnormally dangerous (3. Restatement of the Law,1977, §§ 519–524; Enders, 2000; Grossman, 2002; Repp, 2000).

As is obvious, a crucial question for the application of strict liability to transgenic crops is whether transgenic crops are abnormally dangerous. Restatement of the Law,1977, Section 520, sets forth the relevant factors as follows.

In determining whether an activity is abnormally dangerous, the following factors are to be considered: "(a) existence of a high degree of risk of some harm to the person, land or chattels of others; (b) likelihood that the harm that results from it will be great; (c) inability to eliminate the risk by the exercise of reasonable care; (d) extent to which the activity is not a matter of common usage; (e) inappropriateness of the activity to the place where it is carried on; and (f) extent to which its value to the community is outweighed by its dangerous attributes" (Restatement of the Law, 1977, p. 36).

In the USA where the basic policy decision is that agricultural biotechnology is not different in kind from other agricultural breeding technologies, those alleging a strict liability claim may have difficulty establishing the existence and likelihood of factors (a) and (b). Moreover, as American farmers have planted significant acreage to transgenic crops, those alleging strict liability may also have difficulty in establishing factors (d) and (e).

In addition, organic farmers may face an additional hurdle to establishing strict liability against transgenic crops. Section 524A of the Restatement of the Law (1977) states "There is no strict liability for harm caused by an abnormally dangerous activity if the harm would not have resulted but for the abnormally sensitive character of the plaintiff's activity" (p. 51).

Recall that organic farmers do not lose their organic certification under USDA-NOP standards for the presence of transgenic crops. However, some private, nongovernmental organic organizations may impose stricter standards that denies the private certification for even the presence of transgenic crops. These stricter standards may show "an abnormally sensitive character" for those organic growers who adhere to these private, nongovernmental organic organizations.

It is important to differentiate between transgenic commodity crops {such as canola (Brassica napus L. var. napus), corn (Zea mays L.), cotton (Gossypium ssp.), and soybeans [Glycine max (L.) Merr.]} and transgenic crops that produce a nonfood product—e.g., a transgenic pharmaceutical crop. If damage occurs, biotechnology companies and farmers are probably at greater risk (when compared with commodity transgenics) that a court, using the factors of Section 520, will rule that a pharmaceutical transgenic crop is abnormally dangerous. However, Section 520(f) allows courts to engage in social-utility balancing in making an abnormally dangerous classification, which means that a court could decide against strict liability and in favor of a negligence liability standard even for transgenic pharmaceutical crops. Whether a court classifies a transgenic pharmaceutical crop as abnormally dangerous may also be influenced by whether the regulatory agency approving the production of the crop has established a tolerance for the presence of the pharmaceutical crop in commodity crops intended for food and feed.

Negligence.
Persons who believe their crops or property have been damaged because a neighbor growing transgenic crops failed to take adequate precautions may have a claim for negligence against the farmer and the agricultural biotechnology company that created the crop. Negligence is a fault-based claim with the fault arising from the fact that the negligent person failed to take adequate precautions. Using more technical legal language, Section 282 of the Restatement (Second) of Torts defines negligence as "... conduct which falls below the standard established by law for the protection of others against unreasonable risk of harm" (Restatement of the Law, 1965, § 282, 1965). Plaintiffs have the burden to prove four traditional elements of a negligence: duty of care to the plaintiff, breach of that duty by unreasonable conduct, causation (both factual and proximate) of the damages claimed, and damages (a harm or injury valued in a monetary amount) (Enders, 2000; Grossman, 2002; Repp, 2000).

If presence alone of transgenic crops (pollen or volunteer plants) on another person's land does not constitute a trespass or a strict liability claim, negligence liability for growing transgenic crops would not differ from negligence for growing nontransgenic crops. In other words, farmers in both instances would owe their neighbors the duty to exercise reasonable care so as to avoid causing injury or harm to the neighbor's land or crops. Farmers would have no new or additional negligence liability solely because they decided to grow transgenic crops.

With respect to certain transgenic crops, biotechnology companies and farmers growing transgenic crops may have the obligation to take additional reasonable precautions if, for example, the agronomic evidence showed that a particular transgenic crop(s) caused weediness, pollen flow, or volunteer plants to a greater degree than nontransgenic crops. Moreover, the companies and farmers would probably have the duty to adopt additional reasonable precautions if the transgenic crop, such as a transgenic pharmaceutical crop, needed to be segregated from commodity crops destined for food or feed. As these possible, additional duties are presently foreseeable, biotechnology companies and farmers are developing techniques to prevent pollen flow and volunteer plants. By developing these preventive techniques, the companies and farmers may establish that they have taken adequate reasonable measures and thereby avoid negligence liability to a neighbor. Examples of these preventive techniques are set forth in the following three paragraphs.

Scientists at universities and biotechnology companies are working to engineer the transgenic crop to have biological barriers against pollen flow or volunteer survival. To mention several possible biological barriers that may become agronomically feasible, the transgenic crops may have male sterility to produce infertile pollen, seed sterility to prevent volunteer crops, or control of flowering time to prevent cross-pollination (Daniell, 2002; Eastham and Sweet, 2002).

Biotechnology companies and farmers of transgenic crops may also adopt agronomic practices that they hope are best management practices to prevent pollen flow or volunteer plants. Examples of these best management practices could include isolation distances between fields, barrier crops, border rows, refugia, or agronomic zones for transgenic and nontransgenic crops. To show reasonable care, biotechnology companies would probably have the duty to educate farmers about these best management practices and, possibly, have the obligation to police their farmers through contractual and monitoring arrangements. By contract, farmers would have the obligation to implement these agronomic practices. If a farmer failed to implement contractual best management practices, the farmer would be at increased risk of negligence liability being imposed. (Abramson and Carrato, 2001; Nachtigal, 2001). If biotechnology companies and farmers of transgenic crops that create additional risks fail to adopt best management practices and consequently cause damage, they might face legal liability through negligence claims.

The fact that a person has complied with federal regulatory requirements does not necessarily mean that the person has acted reasonably as evaluated under negligence. However, with regard to transgenic crops, USDA-APHIS evaluates transgenic crops for potential to do harm (e.g., tendency toward weediness). During this evaluation, the USDA-APHIS either may refuse to authorize the growing of the transgenic crop or may impose conditions on the transgenic crop as a risk management strategy to address potential harms. This is true for field trials and commercial release. All transgenic crops have undergone this USDA-APHIS evaluation. (e.g., USDA-APHIS, 1992 [field test release]). As for pharmaceutical crops, USDA has imposed additional, more stringent risk management conditions. (USDA-APHIS, 2003). Consequently, by complying with federal regulations, biotechnology companies and farmers have probably gone a significant distance toward avoiding negligence liability. Of course, failure to comply with regulatory risk-management conditions exposes the companies and the farmers to significant risk of negligence liability being imposed.

Private Nuisance.
The common law claims of trespass, strict liability, and negligence focus on the conduct or the activity that causes harm to the property of another. By contrast, the common law claim of private nuisance focuses not on conduct but on the interest to be protected—i.e., the private use and enjoyment of land free from nontrespassory invasion by others (Restatement of the Law, 1979, § 821D; Enders, 2000; Grossman, 2002; Repp, 2000). By focusing on the use and enjoyment of land, nuisance may overlap with the other common law claims that focus on conduct, but nuisance is a distinct and independent basis for legal liability.

Fundamental to the nuisance claim is the idea that neighbors must not interfere with neighbors using and enjoying their own land and property. As each neighbor is entitled to the use and enjoyment of its own land, the legal claim of nuisance recognizes that neighbors must be accommodating to one another so as to allow a peaceable coexistence in use and enjoyment (Ellickson, 1986).

Persons bringing a legal claim for nuisance must provide proof that nearby fields of transgenic crops have unreasonably interfered with the use and enjoyment of their own land. In light of the wide-spread planting of transgenic crops under regulatory permission in the USA, persons bringing a nuisance claim are unlikely to establish that transgenic crops per se are unreasonable. Thus, persons bringing a nuisance action are likely to have difficulty using private nuisance against biotechnology companies. However, the legal claim of nuisance is oriented to the specific facts and circumstances between neighbors and to a definition of "unreasonableness" in the context of those specific facts and circumstances. While private nuisance may be a more viable legal claim against a neighbor growing transgenic crops, the courts are unlikely to endorse a private nuisance claim that insists on zero tolerance of pollen flow or volunteer plants. Courts expect neighbors to have reasonable tolerances toward one another as the court engages in the balancing of gravity of the harm against the social utility of each neighbor's use and enjoyment of their own land (Restatement of the Law, 1979, §§ 826–828).

Persons bringing a private nuisance claim must also establish that the invasion caused significant harm. The case law gives two components to the significant harm: its gravity and its normality in a particular locality (Restatement of the Law, 1979, § 821F). Persons claiming private nuisance will not be able to establish the significant harm element if their harm is primarily personal disgust or opposition to transgenic crops.

Damage to the Person
Persons claiming personal damage arising from transgenic crops might assert harm based on toxicity of the transgenic crop or its food product, an allergic response to these crops or their food products, or a claim that long-term exposure to transgenic crops or their foods caused ill-effects to health. In the USA, concerns about the health effects of transgenic crops and their food products explain why the Food and Drug Administration (FDA) and the Environmental Protection Agency (EPA) exercise regulatory control over transgenic crops (FDA, 1992; EPA, 2001).

In light of the regulatory approvals from FDA and EPA, if transgenic crops or their food products had toxic effects, the crop and food would probably be denied approval for the market. As for long-term health effects, reviewing reports of alleged effects is at present the most feasible response. Consequently, the most likely personal damage claim now or in the near future would involve a claim that the transgenic crop caused an allergic response in the person alleging damages. Personal damage claims for allergic responses could involve legal liability claims based on strict liability, products liability, nuisance, or negligence with the same elements and burdens of proof as discussed regarding property damage claims.

With regard to personal damage claims, the presently approved transgenic crops and their food products have created no new or additional legal liability risks for food safety than the risks that exist for nontransgenic crops and their foods. Indeed, failure to use transgenic crops as food ingredients when these crops reduce food safety risks means that food companies could be exposed to legal liability for design defect in products liability law (Kershen, 2000, p. 633–637).

In the one instance in the USA in which persons made adverse effects reports (AERs) from a transgenic crop and its food products (StarLink corn), the transgenic corn was not approved for human consumption as food. Regarding StarLink and allergic responses in consumers, the Center For Disease Control concluded "Although the study participants may have experienced allergic reactions, based on the results of this study alone, we cannot confirm that a reported illness was a food-associated allergic reaction. Although our results do not provide any evidence that the allergic reactions experienced by the people who filed AERs were associated with hypersensitivity to Cry9c [StarLink] protein, we cannot completely rule out this possibility, in part because food allergies may occur without detectible serum IgE to the allergens" (CDC, 2001).

In light of the lack of approval for StarLink in human food and the CDC report, a class-action lawsuit on behalf of consumers alleging that they ate food not fit for human consumption was successfully concluded with a settlement against Aventis (Strasbourg, France), the owner of StarLink (Harris, 2002; StarLink Litigation, 2002a). Transgenic crops that have not been approved for human consumption, thus present the legal liability risk of claims from consumers even if the consumer has not suffered a toxic, allergic, or other health-related harm.

As for legal claims for damages to the person, pharmaceutical transgenic crops most likely present the greatest legal risk to the biotechnology companies and their growers (Redick, 2002). In many (if not most) instances, the pharmaceutical trait from the transgenic crop will need to be kept out of food and feed crops to protect against claims of toxic, allergic, and unfit food harms. In light of this fact, regulatory authorities in the USA have recently proposed new guidelines for the segregation of pharmaceutical transgenic crops from food and feed crops (USDA-APHIS, 2003; FDA, 2002; OSTP, 2002; Gillis, 2002). However, these regulatory measures should be viewed as minimum measures and biotechnology companies will assuredly need to develop contractual provisions with their growers for segregation measures, for control of volunteer plants, and for identity preservation of the pharmaceutical crop from the field to the pharmaceutical processing facilities (Redick, 2002; Smyth and Phillips, 2002). If biotechnology companies and their growers comply with regulatory requirements and if biotechnology companies develop effective stewardship contractual programs with their growers, the companies and their growers may be able to minimize the risk of legal liability.

Damage to Economic Interests (Markets)
Several lawsuits have been filed against agricultural biotechnology companies by farmers who did not grow transgenic crops (StarLink Litigation, 2002b; Blades v. Monsanto, 2001; Sample v. Monsanto, 2001). In these lawsuits, the farmers claiming damage emphasize the legal claim that the introduction of transgenic crops increased their production and equipment costs and depressed the price for their agricultural products. These farmers claim that, while their particular crops have suffered property damage through cross-pollination, their more significant damage claim is that the presence alone of the transgenic crops in the agricultural sector has affected market access and the market prices for their nontransgenic crops generally.

In discussing damages for economic interests (markets), the potential claims can be more easily understood if the fact patterns are distinguished between crops approved for limited uses in the USA, crops approved for all uses in the USA, and crops approved in the USA but unapproved in major export markets. Moreover, it is worthwhile to note that lawsuits arising from transgenic crops and claiming damage to economic interests will almost always be against the agricultural biotechnology companies. Only agricultural biotechnology companies place transgenic crops on the market and by so doing arguably affect market access and market prices for nontransgenic crops.

Transgenic Crops Approved for Limited Use in the USA.
Of the transgenic crops approved thus far for commercial sale in the USA, the only crop to have a been given a limited use approval was StarLink. When the Cry9C gene was found in foods, the options open to the EPA were three: to grant an exemption from a tolerance, to set a tolerance level for the Cry9C gene in foods, or to deny a tolerance and have the foods considered adulterated. When the EPA decided against an exemption and against a tolerance, the EPA effectively created a zero tolerance for the Cry9C gene in the food supply (Uchtmann, 2002a).

With zero tolerance as the regulatory standard, it is no surprise that the trial judge in the multidistrict, class-action litigation in the Northern District of Illinois allowed the case to proceed to trial on the tort legal liability claims of negligence, negligence per se (statutory violations), strict liability, private nuisance, and public nuisance (StarLink Litigation, 2002c). At trial, the plaintiffs (farmers alleging damages to economic interests) and defendant (Aventis Corporation) would have presented evidence establishing and rebutting, respectively, the elements of these torts that must be proven to create legal liability. No trial will occur because the parties reached a settlement in February 2003 to compensate farmers growing non-StarLink corn for property damage and economic loss based on pollen flow or mixing of StarLink corn with non-StarLink corn.

In March 2001, the EPA stated that it will no longer grant limited registrations for transgenic crops (Uchtmann, 2002a, p. 205). Consequently, the precise situation of StarLink should not recur. However, as transgenic crops come into field trials and commercial production for pharmaceutical products, the FDA will face the similar issue—a split approval for pharmaceutical use but not for food or feed use. If the FDA adopts a zero tolerance standard for the pharmaceutical traits in the food supply, the biotechnology companies will have three options: grow the pharmaceutical crop in contained and confined structures only, grow the pharmaceutical crop in fields but subject to the tort claims almost identical to those being pursued in the StarLink Corn Products Liability Litigation, or abandon the transgenic crop as a production method for pharmaceutical products. However, potential tort claims arising from transgenic crops with pharmaceutical traits have two factual differences that assuredly will affect the legal arguments and legal decisions– first, these pharmaceutical transgenic crops are not intended for food and feed commodity agriculture and, second, these crops will be much more heavily regulated (USDA-APHIS, 2003).

Transgenic Crops Approved for All Uses in the USA.
The multidistrict, class action lawsuit in the Eastern District of Missouri presents the questions of legal liability in tort for an agricultural biotechnology company for fully approved transgenic crops (Sample v. Monsanto, 2001). The plaintiff-farmers in the Missouri case allege that the presence of transgenic genes in the corn and soybean supply (that have either cross-pollinated with their own nontransgenic crops or been mixed with their crops during harvesting and storage) has increased the plaintiff's costs of production and depressed the prices for corn and soybeans.

With respect to negligence, private nuisance, and strict liability, the farmers in the Missouri case must prove the same elements of these torts as has been discussed previously in this article. But in addition, farmers who claim damages to economic interests may face an additional defense—the defense called the "economic loss" doctrine.

In the StarLink Corn Products Liability Litigation, the court ruled that the economic loss doctrine did not apply because, if proven, the unapproved crop cross-pollinated or was mixed with the nontransgenic crop of the farmer-plaintiffs, thereby damaging the property (nontransgenic corn) of the farmers who did not grow StarLink corn because it could not be sold for food (StarLink Litigation, 2002c, p. 832–837). In discussing the issue, the court wrote several paragraphs that may have particular significance when the fact pattern involves fully approved transgenic crops that can be sold for all uses. The court wrote "What these [bridge or road closure access] cases share in common with traditional economic loss doctrine jurisprudence is the lack of property damage. Moreover, because the only harms alleged were profits lost due to customer's inability to access the premises, these damages fit neatly within the rubric of ‘disappointed commercial expectations’" (StarLink Litigation, 2002c, p. 835).

"Still, as the access cases aptly demonstrate, the economic loss doctrine has grown beyond its original freedom-of-contract based policy justifications. Farmers' expectations of what they will receive for their crops are just that, expectations. Absent a physical injury, plaintiffs cannot recover for drops in market prices. Nor can they recover for any additional costs, such as testing procedures, imposed by the marketplace. But if there was some physical harm to plaintiffs' corn crop, the lack of a transaction with defendants affects what will be considered ‘other property’" (StarLink Litigation, 2002c, p. 837).

In addition to the negligence claim, the farmers in the Missouri case also have sued under the doctrine of public nuisance. Public nuisance should be distinguished from private nuisance that was discussed earlier in this article.

As stated in the Restatement of Law (1965, § 821B) public nuisance is an unreasonable interference with a right common to the general public. By focusing on public rights, the tort of public nuisance is not limited to plaintiffs who must prove damages to their interests in land. Plaintiffs who can prove a harm different in kind from the general public may use public nuisance to recover damages for themselves while simultaneously protecting public rights for themselves and others (Restatement of Law, 1965, § 821C).

In determining whether growing a fully approved transgenic crop is a significant, unreasonable interference with a right common to the general public, the courts will probably consider two questions as decisive. First, what is the effect of compliance with the regulations applicable to transgenic crops, if proven true by the agricultural biotechnology companies? Second, has there been an identified harm that, whatever the general utility of transgenic crops, it would be unreasonable to allow the identified harm without compensating for it? This second question raises the deeper policy issue called the "socialization of harm"—i.e., even if an identifiable harm exists, when should society as the whole bear the harm (MfE, 2002, p. 59–64; Burk and Boczar, 1994)?

Transgenic Crops Approved in the USA But Not Approved in Major Export Markets.
If a particular transgenic crop is approved in the USA but is not approved in a major export market, agricultural biotechnology companies and their growers face an export market that has established either a zero tolerance or a trace-level tolerance for that particular transgenic crop. Hence, the agricultural biotechnology companies and the farmers who would like to grow approved transgenic crops face the following choice: forgo the benefits of the approved transgenic crop or attempt to satisfy a zero–trace tolerance standard for agricultural exports to the unapproving export market. The second option assuredly requires strict segregation of the U.S.-approved transgenic crop from the agricultural commodities destined for the export market where the crop has not received approval. The second option of segregation also involves more than the biotechnology companies and farmers because everyone in the chain of commerce would have to segregate the crop to protect the export market where the transgenic crop is not approved.

In a lawsuit brought by nontransgenic farmer or commodity organizations to prevent the introduction into field testing or commercial growing of a transgenic crop that is not approved in a major export market, the plaintiffs are most likely to rely prominently on the doctrine of public nuisance previously discussed. Those bringing the public nuisance lawsuit would allege that the introduction of the transgenic crop without export market approval would cause such wide-spread economic losses or economic costs for segregation that a court should rule that the unapproved-in-export market transgenic crop is an unreasonable interference with the public peace, the public comfort, or the public convenience. The plaintiffs bringing this public nuisance suit would allege that the export market with its zero–trace tolerance standard can best be protected (and possibly only be protected) through an injunctive remedy that the public nuisance liability claim allows (Restatement of the Law, 1965, § 821C).

A court handling a public nuisance lawsuit requesting protection of export markets faces a daunting decision. If the court protects the export market, the court is effectively overruling the USA approval of the transgenic crop and allowing the hostility of export markets to control what agricultural biotechnology may be used in the USA. Moreover, especially when considering field trials and commercial production of pharmaceutical transgenic crops, the court would be ruling that export markets are more important than the development of new medicines and drugs. While such a decision would have significant impact for Americans, the impact may be even greater on the citizens of the developing world (Singer and Daar, 2001; Daar et al., 2002). By contrast, if the court protects the field testing and commercialization of transgenic crops approved in the USA, the court is subjecting American farmers to rejection in export markets that have a zero tolerance or trace-level tolerance for transgenic crops that are unapproved in the export market. Courts will immediately and intuitively sense the difficult, complex, and future-defining policy issues involved in a public nuisance injunction lawsuit against transgenic crops.


Patent Infringement Cases

 

Farmers may face legal liability issues in agricultural biotechnology also in legal disputes involving intellectual property. More particularly, companies that create transgenic crops have intellectual property rights, usually patents, in those crops and take legal action against farmers who grow the transgenic crops without the companies' permission (Uchtmann, 2002b). However, one should not forget that seed companies also protect their patents in nontransgenic seeds and plants. Patent infringement cases in agriculture are not unique to transgenic seeds and plants (J.E.M. Ag. Supply, Inc. v. Pioneer Hi-Bred International, Inc., 2001).

As of May 2003, four cases for patent infringement regarding transgenic crops have resulted in written opinions by courts in Canada and the USA: Monsanto Canada Inc. v. Schmeiser (Monsanto Canada Inc., 2001); Monsanto Company v. Trantham (2001); Monsanto Company v. McFarling (2002) and Monsanto Company v. Swann (2003).

The Schmeiser Case
The Canadian courts found the following as factually true. Mr. Schmeiser sprayed three or four acres of his canola in 1997 with Roundup (Monsanto Corp., St. Louis) herbicide because he thought his canola field contained Roundup Ready canola. Sixty percent of the sprayed area survived the herbicide, thereby showing herbicide tolerance. Mr. Schmeiser separately harvested and stored the canola seed from the sprayed acres. In 1998, Mr. Schmeiser decided to use the canola from the sprayed acres as his seed canola for the 1998 crop. When Monsanto Canada pursued Mr. Schmeiser for these actions in a lawsuit, the grow-out and DNA tests of Schmeiser's 1998 crop showed 95 to 98% Roundup Ready (Monsanto Corp., St. Louis) canola from tests conducted by Monsanto, 95 to 98% Roundup Ready canola on the 1998 crop from a Canadian laboratory, 63 to 70% Roundup Ready canola from grow-out tests by Mr. Schmeiser himself on 1997 and 1998 crops; and 0% to 98% on various samples from the 1997 and 1998 crops submitted by Mr. Schmeiser to the University of Manitoba, with the 1997 saved seed specifically testing in the 95 to 98% range.

The Canadian courts held that Mr. Schmeiser infringed the Monsanto patents after consideration of two defenses. First, the courts ruled that the fact that Mr. Schmeiser did not use Roundup herbicide was irrelevant to the patent violation. The court stated that the Monsanto patent claims related to the gene and cells of the canola plants and this particular patent had nothing to do with the herbicide. In light of the patent relevant to this lawsuit, Mr. Schmeiser could only grow these patented seeds if he had permission to do so. Mr. Schmeiser admitted that he had not signed a technology use agreement with Monsanto. Second, the court ruled that regardless of the origin of the 1997 seeds—for example pollen drift, seed spills from bags, or wind-blown from truck beds, Mr. Schmeiser infringed the patent when he knew or should have known that he was planting Roundup Ready canola in 1998. The court rejected Mr. Schmeiser's claim as an innocent grower because his actions demonstrated that he was not innocent—i.e., he knew or should have known that he was growing patented seeds. The court left undecided whether Monsanto would have an infringement claim against a truly innocent grower.

The Trantham, Swann, and McFarling Cases
In these three U.S. cases, the farmers defended against Monsanto's infringement claims relating to saved seed by arguing that U.S. antitrust law blocked Monsanto from pursuing legal remedies against farmers who saved seed from one crop year to the next. The arguments can be conflated into three main points about the interplay between antitrust law and patent law.

First, the U.S. courts ruled that the patent law allows Monsanto to condition its permissive use of patented seeds through technology use agreements prohibiting the saving of seeds and authorizing the growing of seeds for one crop year only for commercial sale as a commodity crop. In other words, Monsanto does not create an illegal monopoly solely because Monsanto grants permission through technology use agreements that impose use restrictions.

Second, the courts held that the farmers were free to buy or not to buy Monsanto patented seeds each crop year. The courts stated that the fact that the farmers desired to use Monsanto's patented seeds in future years signified only superior performance of patented technology, not an illegal tying arrangement under antitrust law.

Finally, the courts held that Monsanto does not violate U.S. antitrust law on the basis of the fact that Monsanto markets its Roundup Ready seeds differently in the USA than in Argentina. The court noted that Monsanto is responding to different market circumstances in the USA, where patents on seeds exist, than in Argentina, where patents on seeds do not exist. Under U.S. law, Monsanto is entitled to enforce its U.S. patents.



Conclusion

CONCLUSION 

Agricultural biotechnology raises significant legal liability issues in both tort and patent law. Although these legal liability issues also exist, and have always existed, with respect to nontransgenic crops, the emergence of transgenic crops has brought tort and patent law liability issues into prominence. Just as U.S. agriculture is shaped and affected by weather, markets, and technology, U.S. agriculture will now also be shaped and affected more profoundly by issues of legal liability.

NOTES

© 2002 Drew L. Kershen, all rights reserved. This material is based on work supported by the USDA, under Agreement No. 59-8201-9-115. Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the author and do not necessarily reflect the view of the USDA. Full text of the USDA supported work is available at www.NationalAgLawCenter.org, posted November 2002.

Received for publication December 18, 2002.


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