Creative Claiming Strategies
Tom Irving, Partner, Finnegan, USA
Stacy Lewis, Law Clerk, Finnegan, USA
Angela Sebor, Director Intellectual Property, Tolmar, Inc., USA
Xiaoguang Michelle Gao, Associate VP - Assistant General Patent Counsel, Eli Lilly and Company, USA
Innovator companies in the biopharmaceutical space are looking to their patent counsel for creative patent claiming strategies to protect their assets. In this article, using the Federal Circuit opinions in Teva Pharms. v. Corcept Therapeutics, Vanda v. West-Ward, and Sanofi v. Watson as a foundation, we describe a strategy of enhancing chances of success against generic or biosimilar challengers by claiming clinical trial protocols and results, and other information that appears on a drug product label, i.e., by claiming what was approved by the FDA. The article will also explore creative claim strategies that take advantage of 35 U.S.C. 112(f)’s means-plus-function terminology. These strategies could help create strong US patents and provide additional protections for biopharmaceutical innovations.
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