Biopharmaceuticals: The Patent System and Incentives for Innovation

Abstract

This paper discusses the requirements for patentability as applied to biotechnology and pharmaceutical inventions. Focusing on case law from the Court of Appeals for the Federal Circuit, as well as guidelines issued by the United States Patent and Trademark Office, the Paper describes the requirements of utility, novelty, nonobviousness, written description, and enablement. The Paper then goes on to summarize literature on the economics of patents and the structure of the biotechnology industry. The Paper argues that strong patent protection is vital in order to ensure innovation in the biotechnology industry. Finally, the Paper addresses issues in patenting recent developments in biotechnology.