TitlePatentability of Biotechnology Inventions Under the Patent and Trademark Office (PTO) Utility Guidelines: Still Uncertain after all these Years
AuthorsKaplan W. A., Krimsky S.
PublicationJournal of Biolaw and Business. 2001 Jan; 4(Special Supplement):34-48.
AbstractThe U.S. Patent and Trademark Office ("PTO) recently published its final version of guidelines to be used by its patent examining corps in determining the patentable utility of an invention (the "Guidelines). This article discusses some implications of the Guidelines. The utility requirement of U.S. patent law serves to increase the likelihood that a patent will issue whose scope is well-defined and serves to increase the certainty that prior knowledge can correctly predict the utility of a new invention. The desire to manage unpredictability forms the basis of the tripartite utility test which introduces the idea of a 'credible' use to the already-established 'specific' and 'substantial' use tests. The Guidelines introduce some procedural and substantive uncertainty that will need to be sorted out over time. Specific biotecnology issues in this regard relate to the patentable utility of ESTs, SNPs, research tools and the concept of utility based on DNA/protein database homologies. The utility Guidelines also highlight the larger context of access to biotechnology patents. Several biotecnology-related business and legal decisions are discussed that arise from the Guidelines. The Guidelines are a step in the right idrection but uncertainties remain, given the nature of much of the technology that interacts with them.