March 29, 2012

Organic Farmers Appeal Dismissal of Challenge to Monsanto Patents

The proximity of genetically engineered (GE) crops to organic farming operations (non-GE) poses problems for possible contamination of the non-GE crops through the drift of pollen from the GE fields onto the non-GE plantings. Complicating this scenario is the possibility that contamination occurs through migration of patented GE materials, leading to potential claims of patent infringement. A closely watched lawsuit, Organic Seed Growers et al., v. Monsanto, was launched by a coalition of organic farmers seeking a preemptive ruling (declaratory judgment) of non-infringement and patent invalidity in contemplation of possible inadvertent contamination of their fields by Monsanto's patented transgenic seed materials (sometimes referred to as genetic trespass). Last month, a judge in the Southern District of New York ruled that no sufficient controversy existed to provide a basis for the plaintiffs’ lawsuit. As expected, the plaintiffs have now filed an appeal with the Federal Circuit seeking to reinstate their right to litigate the Monsanto patents in view of their apprehension of legal action from Monsanto. The standard for standing in declaratory judgment actions, applied in the context of a patent lawsuit, was set by the Supreme Court in Medimmune v. Genentech, where the Court pronounced a more flexible “all circumstances” that replaced the more rigid injury-nexus-relief test that had evolved from its earlier decision in Lujan v. Defenders of Wildlife. Yet, the Federal Circuit has recently applied this standard, in the context of AMP v. USPTO (challenging the Myriad Genetics gene patents): “this court has held that, to establish an injury in fact traceable to the patentee, a declaratory judgment plaintiff must allege both (1) an affirmative act by the patentee related to the enforcement of his patent rights,” and “(2) meaningful preparation to conduct potentially infringing activity.” In AMP v. USPTO, the Federal Circuit declared that only one plaintiff, Dr. Harry Ostrer, qualified for standing, in view of active assertion by Myriad’s active enforcement of its patent rights against Dr. Ostrer, and his stated intention to resume his genetic testing activities if the threat of patent infringement were lifted. In the farmers’ lawsuit, both of these elements for standing as emphasized by the Federal Circuit appear harder to prove: no direct legal actions by Monsanto against these plaintiffs (although the pattern of Monsanto patent enforcement has evidenced a willingness to convert contamination into patent infringement); and this absence of nexus then undermines the plaintiffs' assertion of preparation for activities that might constitute infringement (yet some plaintiffs are alleging refraining from farming due to their fear of litigation). Nonetheless, if the plaintiffs can successfully argue that the Supreme Court deliberately crafted a more flexible standard for standing in Medimmune – certainly recognizing a public interest in the adjudication of potentially invalid patents – that encompasses this novel factual pattern of perceived threat and potential assertion of rights, they may have a chance to revive the suit.

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