Creative Claiming Strategies

Tom Irving, Partner, Finnegan, 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.

Tom Irving has some 45 years of experience in intellectual property law. His U.S. pharma practice includes America Invents Act (AIA) post-grant proceedings, due diligence, counseling, patent prosecution, reissue, and reexamination. In addition to advising on procuring strong U.S. patents, Tom counsels clients on a wide range of mainly pharmaceutical matters, including pre-litigation, Orange Book listings of patents covering FDA-approved drugs, infringement issues, enforceability, supplemental examination, and validity analysis. He has served as lead counsel in numerous patent interferences, reissues, and reexaminations; as lead counsel in numerous AIA post-grant proceedings; and as an expert witness in patent litigation and patent procurement.

Finnegan, Henderson, Farabow, Garrett & Dunner, LLP is one of the largest IP law firms in the world. With offices in Atlanta, Boston, London, Munich, Palo Alto, Reston, Seoul, Shanghai, Taipei, Tokyo and Washington, DC, the firm practices all aspects of patent, trademark, and copyright law, including counselling, prosecution, licensing and litigation. Finnegan also represents clients in IP issues relating to advertising, trade secrets, European patents and trademarks, international trade, portfolio management, the Internet, e-commerce, government contracts, antitrust and unfair competition.