Patenting Genes and Genetic Methods: What's at Stake?

The emergence of genetic medicine following decades of molecular biology research has been accompanied by the procurement of patent rights to many medically significant genes and methods for their use. The intellectual force of reductionism in the life sciences—to explain biological phenomena with molecular precision—generates direct conflicts with patent law’s exclusion of basic knowledge from patenting: laws of nature, natural phenomena, and abstract ideas must remain in the public domain. Patents have been obtained for the gene as an isolated DNA molecule, and for methods that rely on the assessment of genetic status to determine medical risk. Genetic testing can be used to identify disease susceptibility, establish diagnostic status, and design personalized therapeutic regimens in medical care. While many gene patents are managed so that wide access is facilitated, access to certain gene portfolios is quite restricted, preventing the development of a robust genetic testing climate for the relevant clinical conditions; this is most clearly observed for the BRCA1 and BRCA2 genes. This constriction affects patients seeking to make genetically-informed medical decisions, health care providers offering genetic testing options, and scientists performing genetic research. In the absence of explicit facilitated access to critical genes that are under restrictive patent management, the central question of patent eligibility and whether such patents are valid will continue to be litigated. This is a period of renewed attention to the issue of patentable subject matter in the life sciences. It is only recently that a direct legal challenge to © 2011 Eileen M. Kane. * Eileen M. Kane, Ph.D., J.D., Professor of Law, Penn State Dickinson School of Law. The author thanks Professor Lawrence Sung and the editors and staff of the University of Maryland School of Law Journal of Business and Technology Law for the invitation to participate in the April 2010 Symposium, "The Future of Genetic Disease and Diagnosis: Do Patents Matter?" The author also thanks Dennis Kergick for excellent research assistance. P G  G M: W’  S 2 JOURNAL OF BUSINESS & TECHNOLOGY LAW the patent eligibility of a gene as an isolated DNA molecule was undertaken, in the case of Association for Molecular Pathology v. United States Patent and Trademark Office. Recent developments in the patent eligibility of method claims for biochemical assays, including genetic tests, have emerged in such cases as LabCorp v. Metabolite, Prometheus v. Mayo, and Association for Molecular Pathology v. United States Patent and Trademark Office. Identification of the relevant legal standard has implications for several kinds of method claims in genetic testing, where a patent claim may cover quantitative relationships between molecules, the mechanisms of pharmaceutical metabolism, or the cause and effect relationship between genotype and phenotype. Further resolution of the eligibility controversies in genetic patenting has larger theoretical implications. The life sciences await a definitive and modern interpretation of the product of nature doctrine and its scope, and a contemporaneous analysis of whether and how correlations in the life sciences are defined as natural phenomena or laws of nature. The resolution of eligibility for genes has implications for the patenting of other biomolecules, while the resolution of the eligibility of genetic testing methods has implications for the contours of the preemption analysis as applied to subject matter in the life and physical sciences, including such scientific sectors as nanotechnology. The article will outline the current legal frameworks for judging whether genetic-related inventions are patentable subject matter and identify the analytic choices available to the courts to decide the patent eligibility question for composition claims to genes and process claims to methods for genetic analysis. A central challenge to the eligibility question for genes is whether the courts should utilize a general or specific patentable subject matter theory for DNA; the choice will determine whether a decision has implications for general patenting in biotechnology. A central challenge to the analysis of life science method claims arises from the fact that the dominant analytic tests have been derived from the business method patent controversies, and illustrates how the technological neutrality of patent law causes doctrines that originate from one technical field to influence judicial review in an unrelated field. The appellate courts confront an opportunity to update the set of “basic tools” for genetic science, and to settle these eligibility controversies for the benefit of scientists, medical practitioners, and patients who wish to use isolated genes and genetic correlations in research and medical care. As the courts enforce inventive precision through the proper application of 35 U.S.C. § 101, creative applications of fundamental knowledge will emerge