Patent Controls on GM Crop Farming

Patents on genetically modified (GM) crop technology arm their owners with powerful control over farmers\u27 ability to grow, harvest, distribute, and profit from GM crops. No clearer example exists than the April 2004 decision of the U.S. Court of Appeals for the Federal Circuit in Monsanto Co. v. McFarling, in which the court upheld Monsanto\u27s licensing practice of forbidding farmers to save seed from patented GM crops for replanting. By forcing farmers to buy new GM seed each season, the McFarling II decision disproportionately impacts small farmers and concentrates GM crop growth among larger agribusinesses better positioned to bear the financial burden. Notably, the McFarling II court\u27s finding of no misuse by Monsanto was conditioned on the unique circumstance that Monsanto\u27s patents cover both the first-generation GM seed and the second-generation crop grown therefrom. Absent such facts, McFarling II strongly suggests that a use restriction on goods made by, yet not incorporating, a licensed good is not a legitimate field of use restriction. That Monsanto prevailed in this case is certainly consistent with the Federal Circuit\u27s propensity to side with patent owners facing a patent misuse defense. Nevertheless, the court\u27s summary dismissal of McFarling\u27s affirmative tying allegation under the antitrust laws bears further scrutiny, as does McFarling\u27s charge that the patent exhaustion doctrine limits Monsanto\u27s ability to enforce post-sale restrictions on the use of its patented GM seed

Commentary: Willful Patent Infringement and the Federal Circuit\u27s Pending En Banc Decision in Knorr-Bremse v. Dana Corp., 3 J. Marshall Rev. Intell. Prop. L. 218 (2004)

The Federal Circuit’s recent sua sponte grant of rehearing en banc in Knorr-Bremse v. Dana Corporation has catalyzed a vocal debate concerning the nature and consequences of willful patent infringement. Subject to virtually unanimous condemnation is the Federal Circuit’s “adverse inference” rule, which forces a party accused of willful infringement to choose between two unpalatable options: (i) disclosing privileged advice of counsel to mount a willfulness defense, or (ii) not disclosing such information and being subjected to an adverse inference that an exculpatory opinion was not or could not be obtained. This commentary concurs that the adverse inference rule should be abandoned, for its provenance is far from clear and the harm it works to attorney-client privilege is substantial. More broadly, this commentary questions whether the notion of willful infringement remains defensible in a patent system marked by significant uncertainties as to the boundaries of literal claim scope and the doctrine of equivalents. At a minimum, the question of willfulness should no longer be given to juries. The analyses of willfulness and damages enhancement are inextricably bound together and both should be decided by the courts. Practical benefits and policy considerations support this proposal and Seventh Amendment concerns do not preclude it

No Dilettante Affair : Rethinking the Experimental Use Exception to Patent Infringement for Biomedical Research Tools

Scientists who require multiple research tools (i.e., laboratory resources such as transgenic animals and biological receptors) to develop new drugs and medical diagnostic products are frequently finding that these tools are patented or subject to other proprietary constraints. Stacking royalty obligations and heightened transaction costs resulting from the proliferation of patents on research tools threaten to slow or stop the development of new drugs and devices critical to public health. Because U.S. courts have very narrowly interpreted the common law experimental use defense of patent law as limited to dilettante uses of inventions for mere amusement or philosophical inquiry, scientists face the daunting choice of either negotiating numerous licenses or risking the possibility that their research and development will be enjoined. In response to this dilemma of mounting transaction costs and increasingly restricted access to patented research tools, this Article argues for a broadened rule of development use that would permit scientists to use certain patented research tools without prior authorization, but require that the research tool patent owner be paid an ex post royalty based on the ultimate commercial success of the new drugs orotherproducts developed through use of the tool. This reach-through royalty approach maintains incentives forthe development and patenting of new research tools, but alleviates the access restrictions and up-front costs currently associated with their acquisition and use

At Sea in a Black Box: Charting a Clearer Course for Juries Through the Perilous Straits of Patent Invalidity, 1 J. Marshall Rev. Intell. Prop. L. 3 (2001)

When jurors decide whether a putative patent infringer is liable under the doctrine of equivalents, Federal Circuit law requires that the patent owner’s trial presentation provide “particularized evidence” and “linking argument” with respect to each prong of the classic tripartite test for liability (i.e., substantial identity of “function,” “way,” and “result” between each element of the claimed invention and accused device). The court has recognized that absent such evidentiary roadmapping, jurors are “put to sea without guiding charts.” In its August 2001 decision in Monsanto Co. v. Mycogen Plant Science, Inc., the Federal Circuit refused to extend this same evidentiary framework to an accused infringer’s affirmative defense that the patent in suit was invalid for prior invention under 35 U.S.C. § 102(g)(2). This article contends that the Federal Circuit in Monsanto improvidently deprived jurors of analytical guideposts that are essential to the kind of fully informed fact-finding that should underlie any verdict on the validity or invalidity of an issued patent. The article proposes that the evidentiary requirements for contextualization, particularization, and application of pertinent facts to applicable law, as previously required for liability determinations under the doctrine of equivalents, should likewise be mandated for all cases in which patent validity is challenged before a jury. The jury’s deliberational task is no less complex in the validity phase of a patent trial than in the liability phase, and is further informed by the presumption of validity that attaches to issued patents. The risks of juror error that warrant imposition of particularized evidentiary requirements for liability determination are even more potent in the validity setting, for a jury’s decision to sustain or invalidate an asserted patent affects not only the parties to the lawsuit but also the public at large. In keeping with its mandate to enhance predictability and uniformity in patent disputes, the Federal Circuit has the power and the responsibility to improve patent jury trial practice by requiring that validity challenges be tried under the same evidentiary ground-rules as those that the court has already established for equivalents liability

Patent Controls on GM Crop Farming

Patents on genetically modified (GM) crop technology arm their owners with powerful control over farmers\u27 ability to grow, harvest, distribute, and profit from GM crops. No clearer example exists than the April 2004 decision of the U.S. Court of Appeals for the Federal Circuit in Monsanto Co. v. McFarling, in which the court upheld Monsanto\u27s licensing practice of forbidding farmers to save seed from patented GM crops for replanting. By forcing farmers to buy new GM seed each season, the McFarling II decision disproportionately impacts small farmers and concentrates GM crop growth among larger agribusinesses better positioned to bear the financial burden. Notably, the McFarling II court\u27s finding of no misuse by Monsanto was conditioned on the unique circumstance that Monsanto\u27s patents cover both the first-generation GM seed and the second-generation crop grown therefrom. Absent such facts, McFarling II strongly suggests that a use restriction on goods made by, yet not incorporating, a licensed good is not a legitimate field of use restriction. That Monsanto prevailed in this case is certainly consistent with the Federal Circuit\u27s propensity to side with patent owners facing a patent misuse defense. Nevertheless, the court\u27s summary dismissal of McFarling\u27s affirmative tying allegation under the antitrust laws bears further scrutiny, as does McFarling\u27s charge that the patent exhaustion doctrine limits Monsanto\u27s ability to enforce post-sale restrictions on the use of its patented GM seed

The Tiger Awakens: The Tumultuous Transformation of India’s Patent System and the Rise of Indian Pharmaceutical Innovation

The first day of January 2005 marked a dramatic turning point in the history of India. By deliberately excluding pharmaceutical products from patent protection for the previous 34 years, India became a world leader in high-quality generic drug manufacturing. But India’s entry into the global economy at the end of the 20th century, as evidenced by membership in the World Trade Organization (WTO), compelled the nation to once again award patents on drugs. Moreover, India henceforth would have to apply internationally-accepted criteria for granting patents, and the term of its patents would have to extend twenty years beyond filing

Reply to: New Meta- and Mega-analyses of Magnetic Resonance Imaging Findings in Schizophrenia: Do They Really Increase Our Knowledge About the Nature of the Disease Process?

This work was supported by National Institute of Biomedical Imaging and Bioengineering Grant No. U54EB020403 (to the ENIGMA consortium)