In this Article, I argue that a new approach to biotechnology patenting is necessary to fully realize the tremendous potential of recent advances in our understanding of the human genome. Part I places the gene patenting debate in context by highlighting the key landmarks that have shaped the biotechnology industry and outlining the products and stakeholders that comprise the industry. Part II describes the current state of the law on biotechnology patents, summarizing the Federal Circuit's application of the various doctrines that collectively define the patent landscape's parameters. In this Part, I explain how the Federal Circuit's jurisprudence is tied to its inaccurate characterization of the "person having ordinary skill in the art" (PHOSITA) of biotechnology. Part III discusses theoretical concerns raised by the Federal Circuit's jurisprudence regarding biotechnology discoveries and proposals that have been offered to ameliorate these concerns. In Part IV, I assert that the Supreme Court's recent decision in KSR v. Teleflex should serve as the impetus for the Federal Circuit to abandon its rigid, dogmatic treatment of biotechnology in favor of a flexible approach that will allow the court to align patent doctrine with the current state of the art. The Supreme Court's mandate to insert "common sense" into the obviousness analysis should compel the Federal Circuit to reexamine its depiction of the biotechnology PHOSITA. This may impact the court's application of patent doctrines conceptually linked to the obviousness standard and lead to changes in both the number and scope of biotechnology patents. Such alterations in the patent landscape will have an overall positive effect on the biotechnology industry by alleviating inefficiencies and impediments to scientific and commercial progress engendered by the existing patent regime.
Anna B. Laakmann,
Restoring the Genetic Commons: A Common Sense Approach to Biotechnology Patents in the Wake of KSR v. Teleflex ,
Mich. Telecomm. & Tech. L. Rev.
Available at: https://repository.law.umich.edu/mttlr/vol14/iss1/2