Strategies for Attacking and Defending Pharmaceutical Patents: A Modern Take on 'The Art of War'

摘要

For patent holders and their competitors in the pharmaceutical and biotechnology sectors, developing strategies for effective patent litigation is of great importance. Although prosecution of pharmaceutical and biotechnology patents has slowed in recent years, litigation in these areas has been on the rise. David K. Tellekson, Elizabeth A. Richardson, and Sandra S. Lee, the authors of this article, explain that, from a legal perspective, recent Federal Circuit decisions answer some questions affecting the pharmaceutical and biotechnology industries and raise many new ones. The authors assert that, to develop winning strategies for attacking and defending pharmaceutical and biotechnology patents, it is crucial for patent holders and their competitors to understand this evolving field and to become intimately familiar with the status of the law. This article discusses several topics of particular relevance to patent litigation strategies, including inequitable conduct, inherent anticipation, written description and enablement requirements under 35 U.S.C. § 112, public use defenses, claim construction, and prosecution history estoppel. To this end, the authors analyze recent decisions in patent cases from the Supreme Court and the Federal Circuit and consider their strategic implications for the pharmaceutical and biotechnology sectors.