Patent reform in the US: what's at stake for pharmaceutical innovation?

Abstract

The current patent landscape in the US has not undergone major legislative reform since 1952. The US Senate version of the most recently proposed patent reform legislation puts forward a number of rule changes that could impact the pharmaceutical industry. Among the bill's major provisions are moving to a first-to-file system, changes to post-grant review and reexamination procedures, and damages reform. Various industries with a stake in patent reform have responded to the proposed changes. The need for balanced reform makes the stakes particularly high for the pharmaceutical industry which must invest a significant amount of time and money in the research and development process in exchange for already abbreviated patent lifetimes due to the lengthy clinical trial process.

Keywords::

• intellectual property
• patent reform
• patents
• pharmaceutical industry
• research and development
• therapeutic patents
• university research
• US patent law

Acknowledgment

S Patterson, director of research partnerships, The University of Tennessee, made editorial suggestions. J Harrison, independent author, editor and legal consultant, proofed the final version of grammatical errors.