The Court of Justice of the European Union recently concluded in Monsanto Technology LLC v. Cefetra BV that a patent with claims drawn to isolated DNA, or transgenic products containing that sequence, cannot be infringed if the DNA is not functional at the time of the alleged infringement.This paper discusses how the Cefetra judgment may unintentionally inflict serious economic harm on the European biotechnology industry because countless biotechnology products may no longer be protected by what are otherwise valid and enforceable patent claims. After Cefetra, an accused infringer may deny infringement by simply asserting that the patented sequence does not perform its function at the time of alleged infringement because many genes are only temporarily functional or only functional in certain tissues and organs. Further, the judgment may extend far beyond the biotechnology industry. The Cefetra decision may very well change the landscape of gene patents in Europe if seen as a sister case to the Myriad Genetics case in the U.S. The Myriad Court held that “isolated DNA” is not patent eligible because it is not “markedly different” from native, endogenous DNA. Cefetra is surprising because the court relied on Article 9 of Directive 98/44/EC which was intended to define patentable subject matter of living and replicating organisms, rather than thescope of enforceable rights in patent infringement. In this paper, the authors assert that a claim should be infringed so long as the patented genetic information is present in a commercial product regardless of activity and function at the time of the alleged infringement. The paper concludes by discussing the best practices for biotechnology companies seeking protection in Europe, such as: (1) providing careful attention to obtaining Plant Breeder’s Rights protection pursuant to the International Convention for the Protection of New Varieties of Plants; (2) using product-by-process claims in utility patents; and (3) claiming the product’s characteristics and traits without reference to the genetic material responsible.
Vid Mohan-Ram, Richard Peet & Philippe Vlaemminck, Biotech Patent Infringement in Europe: The "Functionality" Gatekeeper, 10 J. Marshall Rev. Intell. Prop. L. 540 (2011)