On behalf of farmers and seed companies — largely organic farmers and producers — the Public Patent Foundation filed a suit against Monsanto, seeking to invalidate 23 of Monsanto's transgenic seed patents. The lawsuit asks the court to declare that the plaintiffs cannot be found to infringe Monsanto's patents when Monsanto's patented traits are found in their fields and crops.
The Suit's Main Assertions
According to the Complaint, the suit arose out of the farmers' concerns that increased adoption of transgenic plants inevitably would lead to contamination of their fields and crops, which can result in lower prices for their crops and loss of USDA NOP Organic Certification. Threatened by inevitable transgenic seed contamination and Monsanto's aggressive assertion of its patent rights against farmers, the Plaintiffs assert that they fear they could be accused of patent infringement in the near future, if and when their crops become contaminated by Monsanto's seed.
The suit challenges Monsanto's patents as unconstitutional and failing to comply with the Patent Act's requirements of utility, double patenting, novelty and obviousness, written description, enablement, and best mode. Patent misuse due to market power and aggressive litigation strategies are also asserted. Comparing Monsanto's patent claims to those in Lowell v Lewis, an 1817 opinion by Justice Story (15 F.Cas. 1018 (C.C.D. Mass. 1817), the Complaint asserts that because Monsanto's transgenic seed is "injurious to the well-being, good policy, or sound morals of society" and threatens to "poison people," the transgenic seed patents are all invalid. Justice Story's full quote, shown below, demonstrates the wide scope of patent eligibility.
[a]ll that the law requires is, that the inventions should not be frivolous or injurious to the well-being, good policy, or sound morals of society. The word "useful," therefore is incorporated into the act in contradistinction to mischievous or immoral. For instance, a new invention to poison people, or to promote debauchery, or to facilitate private assassination, is not a patentable invention. But if the invention steers wide of these objections, whether it be more or less useful is a circumstance very material to the interests of the patentee, but of no importance to the public. If it be not extensively useful, it will silently sink into contempt and disregard.
The contradistinction to immorality became a short-lived requirement for a beneficial or moral component in patentable inventions, despite the paragraph's later reference to patentable inventions of no importance to the public. This was soundly overturned by the CCPA in an appeal involving a pharmaceutical patent application rejected by the USPTO because of serious potential for harm or possibly deadly side effects. The CCPA took judicial notice that many valued therapeutic substances entail certain risks or may have undesirable side effects, but they are useful to doctors and patients, and so are useful under the requirements of 35 U.S.C. Section 101. (In re. Watson, 517 F.2d 465 (CCPA 1975))
The Complaint against Monsanto further asserts the Plaintiffs cannot infringe Monsanto's patents because they don't intend to use Monsanto's transgenic seed; because Monsanto's rights in transgenic seed are exhausted by authorized distribution of seed to its customers; and because contamination of the Plaintiffs' fields with Monsanto's transgenic seed constitutes trespass by Monsanto.
Monsanto's website counters some of the plaintiff's arguments. While each of the Plaintiffs is described in the Complaint as "fearful that they could become contaminated by Defendant's transgenic seed and then be accused by Defendant of patent infringement," Monsanto's Commitment page on Farmers and Patents includes a statement contradicting that notion:
It has never been, nor will it be Monsanto policy to exercise its patent rights where trace amounts of our patented seed or traits are present in farmer's fields as a result of inadvertent means.
Monsanto's website also explains and counters some of the "Perils of Transgenic Seed" listed in the Complaint, including the alleged harm to human health of Monsanto's Roundup® and the prior suits against Mo Parr, Percy Schmeiser, Pilot Grove Co-Op, Troy Roush, Gary Rinehart, and Dave Runyon. According to the website, these prior suits involved use of saved seed and not inadvertent contamination, as suggested in the Complaint. The Biotechnology Industry Organization's website also appears to counter the Plaintiffs' fears, citing an impressive track record of coexistence between transgenic and non-transgenic seed in American agriculture:
Not one organically certified farm has lost its USDA certification due to the presence of comingled biotech plant material since the beginning of the federal National Organic Program.
Challenging the Value of Transgenic Technology
The Monsanto lawsuit asks the court to consider and decide the value of transgenic crops by challenging the technology at the level of patenting, the source of innovation's incentive, and basic funding. A similar challenge has already been presented to the pharmaceutical/diagnostic industry in Association for Molecular Pathology et al. v Myriad Genetics.
The Myriad Genetics case, also filed by the Public Patent Foundation, was recently argued at the Federal Circuit. Like the Monsanto case, Myriad Genetics is intended to invalidate gene patents, as described to CNN reports by Dan Ravicher, president and executive director of the Public Patent Foundation and counsel of record for plaintiffs in Myriad Genetics:
It is absolutely our intent that upon victory, this will rend[er] invalid patents on many other genes. We just had to pick one case as our case.
Plaintiffs' standing to assert declaratory judgment claims will likely be at issue in the Monsanto case as it is in Myriad Genetics. In both cases, the required showing of a real and immediate dispute between the parties is predicated on fear of being sued for patent infringement, generally based on a purported general understanding that the Defendant would aggressively enforce its patents. Justice Moore probed the standing question in oral argument of Myriad Genetics, asking counsel if the required showing of a real and immediate injury or threat of future injury caused by the plaintiff is satisfied when the plaintiffs have received no letters asserting infringement and appear tentative in their desire to practice the patented invention. Similar questions may be expected in the Monsanto case.
Invalidity of gene patents is asserted in both cases. Patent-eligible subject matter under 35 U.S.C. Section 101 is at issue in Myriad Genetics, centering on whether the claims are unpatentable as ineligible products of nature or eligible compositions.
The Monsanto Complaint raises utility as a primary invalidity argument, asserting that transgenic seed is harmful and therefore not "useful." As recently shown, the use of transgenic seed resulted in unprecedented double-digit growth in planted acres in 2010, the 15th anniversary of commercially available transgenic seed. ISAAA reports in its 2010 Global Status of Commercialized Biotech/GM Crops that 15.4 million farmers in 29 countries grew biotech crops on 366 million acres of land. The rapid adoption of transgenic plant technology is reported to be greater than that of any other technology in the history of modern agriculture, with a record 87-fold increase in hectares between 1996 and 2010. In 2010, more than 90% (14.4 million) of farmers growing biotech crops were small resource-poor farmers in developing countries. It would appear unlikely that patents for this technology could be found to lack utility, not only to the patentee but to society in general.
Both Monsanto and Myriad Genetics challenge established patent practices for the biotechnology industry, but any decisions will have a far greater impact because the U.S. patent law is technology-neutral. Interpretation of the patent law as applied to genes and seed will also be applied to chemicals and cells, to materials and plants, and to things that innovators have yet to imagine.