Patented Roundup Ready genes have been found in a Canadian canola crop. Monsanto Canada has successfully sued farmer Percy Schmeiser for illegally using its patented invention. The ruling can be considered an historic step in the protection of this type of biotechnological product and shows the very weak position of farmers who have not purchased a GMO-herbicide package but nevertheless find genetically modified (GM) plants invading their conventional crops. This article discusses the court ruling and the increasing caution with which GM crops are being treated in North America.

Genetically modified canola (rapeseed) has been grown in Canada since 1996. Monsanto Canada is licensed to use Monsanto technology to make canola plants tolerant to the company's glyphosate broad-spectrum herbicide Roundup and market a GM variety known as Roundup Ready (RR) canola. As a farm management strategy the attractions of RR canola are claimed reductions in the cost of weed control. Canola is a major crop in Western Canada and until recently farmers were able to sell it successfully to international producers of cooking oil and cattle feed. Today, six years after the commercial release of GM canola, 40 per cent of farmers in Western Canadian have adopted it.

Schmeiser's canola

Percy Schmeiser has been growing canola for several decades and had developed his own local variety. Like many other Canadian farmers he relied on his own farm-produced seed. It gave him a good yield and was relatively disease resistant and weed free. Since 1996, many of his neighbours have adopted RR canola and signed technical agreements with Monsanto that outline reciprocal obligations and require farmers to pay a technology licensing fee for the right to use the company's invention.

In 1998, Monsanto informed Schmeiser that evidence of RR canola had been found in his fields and brought legal proceedings against him. The company claimed he had deliberately obtained RR canola from Monsanto licensees, planted and harvested it and kept seed from his 1997 harvest for replanting. Later, in court, Monsanto withdrew these allegations resting its case on the unauthorized presence of RR canola on Schmeiser's land. The company claimed infringement of its patent and damages comprising the cost of licensing fees, a percentage of the profits from the 1998 harvest, and a deterrent penalty.

In March 2001, Justice MacKay of the Federal Court of Canada ruled in favour of the patent holder, arguing that the evidence suggested that "the balance of probabilities showed Schmeiser had acted without permission from Monsanto" and that he knew or should have known he had GM canola on his land.

Establishing the case

In July 1997, Schmeiser sprayed Roundup as usual on the weeds and volunteer canola plants that had established themselves on the perimeters of his fields. He found that many stray canola plants growing in the vicinity of the main road and around the power poles and in ditches parallel to this road survived the treatment and also proved resistant to a second spraying two weeks later. At the end of the season Schmeiser harvested his crop, had the seed cleaned at a nearby commercial facility and, as usual, kept some seed for the following season.

In 1998, when Monsanto accused Schmeiser of infringing their patent his lawyer advised him not to use the seed from the 1998 harvest for planting in 1999 but to sell his whole crop. In this way he could avoid any further allegations of illegally growing GM canola. Nevertheless, his 1999 crop also showed signs of GM contamination. Whether this was because the new seed was already contaminated or Schmeiser's own soil contained wind-blown or self-seeded GM canola cannot be ascertained.

The gene responsible for glyphosate resistance is a dominant gene and canola is an open pollinated plant. When a GM plant crosses with conventional canola, herbicide resistance can be carried over into the following generation. Brian Ellis, co-chairman of the Expert Panel on the Future of Food Biotechnology of The Royal Society of Canada in a recently published report "Elements of precaution: recommendations for the regulation of food biotechnology in Canada" observed that on the Canadian Prairies, where canola growing is a multibillion dollar business, the plant has become a classic example of a super weed and its eradication a major problem.

During the court proceedings considerable time was spent trying to establish the percentage of RR canola on Schmeiser's land and the methods that had been used to obtain samples. Evidence presented during the court hearing - and reported in Judge MacKay's summation - showed different tests produced widely varying results. Schmeiser paid for independent analysis to be carried out by the local University of Manitoba. Results from these tests showed a contamination range of between 0 and 58 per cent while Monsanto samples showed a much higher level of contamination.

In court Schmeiser did not deny the possibility that RR canola might have established itself on his property. He argued that he had never deliberately planted GM seed. In his view Monsanto, although they hold the patent on the gene construct and possess the technical know-how, had done little to contain the invention they released into the environment. As a result Schmeiser's work as a seed developer, his seed variety, soil and profits had been seriously damaged.

Schmeiser rejected Monsanto's demand that he should pay royalties for using their patented invention. In answering the accusation of 'possession' he claimed that possession alone did not violate Monsanto's patent. The patent would only have been violated if he had sprayed Roundup and activated the gene that confers glyphosate resistance. Schmeiser regarded his crop as a conventional canola crop and as such vulnerable to Roundup.

Challenges

The Schmeiser case is Monsanto's first attempt to enforce its patent rights and in court it quickly became apparent that the legal system was being confronted by new and complex challenges. Industrial patenting law provided the context for judging the rights that can be claimed by patent holders when their patented gene becomes incorporated through random and autonomous natural processes in non- designated seed or becomes lodged on land used to produce conventional canola. For most observers this was the crux of the matter and the reason why the case has been followed so closely. It dramatically highlighted the way life science companies are defining new contexts for agriculture, medicine, and the environment and the inadequacies of legal systems based on industrial precedents that date from the nineteenth century to deal with self-replicating organisms such as plants. What redress do farmers have if their basic factors of production - in this case seed and soil - have been contaminated by patented genetic material released into the environment by a commercial company?

Common law

Monsanto produces GM canola seed under a patent that forbids the reuse of seed as planting material. The company regularly uses third parties to carry out spot checks to ensure no unlicensed plantings occur. Monsanto also encourages the reporting of any suspected illegal use of its patented product. It claimed that its inspectors received reports from neighbours and the local seed cleaning facility that Schmeiser had RR canola on his land and that samples had been taken to determine the presence and extent of infringement.

During the trial, reference was made to common law with respect to the lawfulness of this sampling procedure. Samples, for example, taken routinely by the seed cleaners for seed-quality control, were used to test whether Monsanto genes were present in Schmeiser's crop. The results of these spot checks and the way in which samples for expert analysis were obtained from Schmeiser's fields raise questions not only about the transparency of the sampling process but also about the extent to which - in patenting disputes - a farmer's individual property rights are protected under the common law of trespass. Under Canadian law, the patent holder would seem to have considerable power to access a farmer's property (seed and fields) in order to carry out policing and sampling checks.

Farmers and plant breeders rights

The age-old right of farmers to save and use seed to develop new varieties and for replanting can also be seen as rooted in common law. In the Canadian court ruling, no consideration was given to this or to the question of Plant Breeders Rights. The overriding argument being that, under Canadian law, a patent is considered "valid in the absence of any evidence to the contrary." The burden of proof is, therefore, on the defendant. Thus, Schmeiser had to prove where the contamination came from and whether or not he followed the procedures established by Monsanto to deal with the problem.

Plant Breeder's Rights also feature in the discussion as to whether the patent protection of plant characteristics (or genes) is justified. The judgement in the Schmeiser case seems to indicate that the patent protection on genes has been confirmed not only for the varieties into which they are introduced but also for those plant materials where the genes have been introduced by natural means such as cross fertilization. This goes against the spirit of Plant Breeder's Rights legislation that was established precisely because patent law was unable to deal with such matters as the self-replicating nature of the protected subject matter and the heterogeneity of plant varieties.

Judge MacKay argued in his summing up that

This ruling in effect means that farmers whose crops have been contaminated by patented GM seed forfeit the right to their harvest and to save seed to reproduce their crop. In addition, because inevitable seed residues cannot be easily removed, their land becomes unsuitable for non-GM crops. This presents particular problem for farmers producing for the organic or GM-free markets.

Professor Anne Clarke from the University of Guelph (Canada) observed that there was probably no farm in Western Canada that did not have RR canola in its soil and noted that after a contamination event canola seed in Canadian conditions could remain dormant for ten years or longer. This effectively disallowed farmers from growing conventional canola because if they did and patented GM canola germinated they would be vulnerable to prosecution.

Contamination

In Canada, Monsanto was granted permission to release the Roundup tolerance gene into the environment on the grounds that there was no essential difference between GM canola and non-GM canola and thus no indication that it would present a risk to humans or the environment - the principal of substantial equivalence.

It would seem, however, that farmers who specifically want to grow non-GM canola can do very little to avoid the type of contamination that took place on the Schmeiser farm. Even if canola seed is consistently hauled in covered wagons, and containment measures are extremely stringent, it is difficult to see how spread by natural means can be avoided in an open-field crop like canola.

Whilst biotech representatives say good farming practices can stop GM plants becoming super weeds, the Royal Society Expert Panel conclude that "This perspective may be unduly naïve. In the real world human error and expediency may often compromise guidelines for growing such crops."

Liability

It seems inevitable that a judge, following the strict prescriptions of patent law, would rule in favour of Monsanto in this case. Indeed the patented subject matter was found in the possession of a farmer who did not have a license or technical agreement. Monsanto regularly threatens litigation to protect its rights. The Schmeiser case is the first to go to trial and highlights the growing tension between farmers and large agricultural biotechnology companies whose high-tech crops are transforming the relations of agricultural production.

A spokesperson for the National Farmers Union of Canada - representing 300,000 farmers - stated that the Union was "extremely concerned by what liabilities may unfold for farmers, particularly with the cross pollination of genetically modified crops." The National Farmers Union of Canada has called for a moratorium on producing, distributing and importing GM foods, and the National Farmers Union in the USA supports a moratorium on the introduction, certification and commercialization of GM plant material because farmers are worried that issues of cross pollination, liability, commodity and stock segregation, and market acceptance had not been addressed adequately.

Concern about the consequences of planting GM crops is being expressed in other quarters too. In North Dakota (USA), for example, a bill backed by the State's wheat farmers is urging a moratorium on the GM wheat that Monsanto had hoped to introduce in 2003. In Oklahoma, another USA grain-belt state, the Secretary of Agriculture, David Howard , concluded:

North Dakota State University economist Dwight Aakre went further, pointing out that that responsibility for providing assurances of non-contamination with GMO material was being pushed back onto the individual.

Problems

Recently there have been a number of incidents that have demonstrated the potential problems associated with GM crops. Aventis Star Link corn, for example, was planted on less than 0.02 per cent of all USA cropland in 2000. It had been approved as feed, but had not for human consumption because it contains the protein Cry9c, which could cause allergic reactions. However, cross pollination or physical admixture of the Star Link variety with conventional maize seed resulted in the USA government having to allocate US$ 20 million of taxpayers money to buy back contaminated seed in 2001. According to an Aventis spokesperson, the USA food supply would be likely to contain trace amounts of unapproved Star Link Biotech corn for the foreseeable future although contamination levels would be so low they would pose "no possible health concern" .

In 1999, the Netherlands rejected a shipment of Terra Prima certified organic corn chips from the USA because they contained GMOs. Tests carried out by the Dutch importer resulted in the consignment being destroyed at a cost of US$ 147,000 to the company concerned.

Concerns about the stability of the future market for GM crops and evidence that GM crops can damage non-GM agriculture are worrying farmers. Keith Dittrich of the American Corn Growers Association (ACGA), referring to the Star Link incident, reflected the concern of many of his members when he observed that USA corn farmers could not be expected to pick up the bill for short-sighted USA biotech policy and it could not assume that foreign consumers and importers would ultimately be forced to accept GM products.

The Schmeiser case has also made farmers very aware of the financial and emotional costs of defending their rights in this type of case. The judge ruled that Schmeiser must not only reach an agreement with Monsanto to pay at least US$ 10,000 in user fees and up to US$ 75,000 on the profits from his 1998 crop, he also prohibited him from re-using his seed.

Future trends

Monsanto anticipates a 5 per cent growth rate in 2001 based on a projected increase in the sale of seed, Roundup herbicide and higher revenues from biotechnology traits. In 2000, Monsanto's GM products were planted on 41.6 million hectares of the world's farmland and American farmers grew 75 per cent of the world's commercial GM crops. While some economic analysts have observed that the dark clouds of negative public perception loom large over GM agricultural, Monsanto and other agrobiotech companies are putting their hope in 'carrying out the biotechnology acceptance strategy' and reducing consumer resistance.

Discussions presently taking place within major North American regulatory institutions, however, could make it more difficult to bring GM crops onto the market in future. The Schmeiser case comes at a time when both the USA and Canadian governments are reviewing their policy on the release of GM products into the environment. The Expert Panel of the Royal Society of Canada reporting to the Canadian Ministries of Health and Environment has indicated that the Canadian regulatory system and the capacity of the Federal Government should be strengthened to ensure the safety of GM agricultural products. Stricter scientific scrutiny of the effects of GMOs on the environment and the food chain are being recommended. The principal of substantial equivalence has been critically reviewed. The Panel found the concept to be ambiguous and lacking the specificity needed to provide an adequate basis for decision making. It urged a more precautionary approach "that accords special consideration to the protection of health and the environment, while also being scientifically rigorous and practical." There should be a rigorous testing of the potentially harmful outcomes of GMOs.

The United States Environmental Protection Agency (EPA) is scheduled to review its legislation of GMO releases in the autumn of 2001. The EPA also seems to be more critical of the principal of substantial equivalence favouring a more precautionary approach where the onus of proof lies with the producer wishing to release new GMOs into the environment.

Company perspective

Monsanto cannot afford to take its patent rights lightly. These rights are needed to keep both farmers and competing life seed companies at bay. In North America the patent on Roundup expired in September 2000, opening up Monsanto's mainstay product to increasing price pressure and competition. To hold on to its market share, the company has not only reduced the prices of Roundup products and introduced new variations, it has also put increasing emphasis on RR crops.

As the Monsanto's Chief Executive Officer indicates in the company's Annual Report 2000 , there are increasing problems with the acceptability of genetically engineered plant material.

Increasing the rules for isolation distance and reducing risks during transport and processing in the interests of identity preservation will involve complex infrastructure and substantial overheads, further adding to the cost of GMO products.

Larger issues

The attention this trial has received and Schmeiser's determination to link his experiences with those of farmers in areas of the developing world where GM crops are being introduced has brought home the wider implications of introducing GM field crops. In the South, farmers' livelihoods often depend on their ability and right to select and save seed appropriate to their own specific agroecological conditions. Schmeiser's experience is particularly relevant for those small farmers growing major crops such as maize, cotton, and rice. GM varieties of these crops are being introduced into important centres of cultivation where the chances of non-GMO crops, wild relatives and land races becoming contaminated cannot be ignored.

As a result of Monsanto's fight to enforce its patent, farmers and the general public have been made aware of the fact that within the space of five years it has become almost impossible either to grow or buy guaranteed GM-free canola seed in Western Canada. This, together with the larger issues raised by the Schmeiser case has caused great concern. Schmeiser has launched an appeal against Judge MacKay's ruling. The appeal process and outcome will have significant implications not only for the agrobiotech industry but also for farmers, consumers, and other members of civil society.

*Plant Research International. P.O. Box 16, 6700 AA Wageningen, Netherlands.
Phone +31-317-477.003, Fax +31-317-418.094,
E-mail n.p.louwaars@plant.wag-ur.nl

** Editor Biotechnology and Development Monitor
E-mail monitor@biotech-monitor.nl

Sources
Louwaars, N.P. (2000), "Seed regulations and local seed systems." Biotechnology and Development Monitor, No. 42, pp 12-14.
http://www.biotech-monitor.nl/4205.htm

Expert Panel on the Future of Food Biotechnology, The Royal Society of Canada (2001), Elements of precaution: recommendations for the regulation of food biotechnology in Canada.
http://www.rsc.ca/foodbiotechnology/indexEN.html

Justice MacKay (2001), Summation of the case Monsanto Canada and Monsanto Company USA and Percy Schmeiser and Schmeiser Enterprises Ltd. C29 March 2001, Federal Court of Canada. http://www.fct-cf.gc.ca

Clarke, E.A. (2001), "Letter to Editor of Crop choice" Crop Choice, USA 30 March 2001. http://www.cropchoice.com

Kaufman, M. (2001), "Farmers liable for growing biotech crops" Journal, Washington Post, 29 March 2001.

Notice of Appeal, Percy Schmeiser and Schmeiser Enterprises Ltd and Monsanto Canada Inc and Monsanto Co Federal Court of Appeal, Canada.. http://www.percyschmeiser.com

Monsanto (2000), Annual Report. http://www.monsanto.com