Gene Patents Under Fire: Weighing the Costs and Benefits

Abstract

Gene patents form the intellectual property platform for companies to translate biomedical research into life-saving therapeutic and diagnostic agents. These patents are also controversial, with critics charging that gene patents are unjustified, and they substantially impede research and access to genetic diagnostic testing. Myriad Genetics, the exclusive licensee of patents relating to the BRCA breast cancer susceptibility genes, has been a lightning rod for much of the negative commentary on gene patents. The criticism has culminated in a lawsuit by the ACLU challenging the patent eligibility of Myriad’s gene patents, and by implication the eligibility of gene patents in general. On March 29, 2010, the district court ruled in favor of the ACLU, invalidating all of the challenged patent claims for encompassing subject matter ineligible for protection under Section 101 of the patent statute. As of November 2010 the case is at the Court of Appeals for the Federal Circuit, and thus the status of gene patents is still very much in play. This chapter explains what a gene patent is, and discusses the legal doctrine supporting the USPTO’s position that gene patents are valid. It also considers the societal costs and benefits of gene patents, their role in biotechnology research and development, and the ACLU’s challenge to Myriad’s patents. It explain why many of Myriad’s patent claims challenged by the ACLU for impeding BRCA genetic testing are likely invalid for lack of novelty or obviousness, or not infringed by BRCA testing as currently performed. It explains why the human gene patent thicket has for the most part failed to materialize, particularly with respect to basic research and the use of DNA hybridization arrays. It concludes with suggestions for more appropriate and measured alternatives to the doctrine of patent eligibility for reining in truly unworthy gene patents.