Biotechnology and Patent Infringement in the USA

Abstract

Patent systems attempt to stimulate innovation through a reward process that provides the right to exclude others from making, using, selling, or offering to sell the patented invention for a defined period of time. A critical dilemma is presented by the need to ensure at the same time that researchers have the opportunity to improve on what previous research has achieved. Patented inventions which have a significant – if not sole – usefulness in the pursuance of further research are at the centre of this dilemma. In this paper, the authors discuss this apparent conflict in the context of US biotechnology research and patent legislation. They briefly review the origins of the common law research exemption doctrine in the USA and discuss the research exemption of 35 USC Section 271(e)(1) and its judicial interpretation. They then consider a variety of proposals from commentators, and draw up their own recommendations for an approach which carefully balances the need to promote innovation through the granting of valid patents with the need to preserve research access to basic inventions which constitute valuable starting points for the furtherance of research or tools which improve researchers' ability to innovate.