Creative Claiming Strategies

June 2022

Abstract

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.

Authors

Xiaoguang Michelle Gao

Associate VP - Assistant General Patent Counsel , Eli Lilly and Company, USA

Dr. Gao is Assistant General Patent Counsel at Eli Lilly and Company, supporting biologics and genetic medicine assets. She obtained her Ph.D. in Molecular Biology from Northwestern University, and J.D. from the University of Illinois. Prior to joining Eli Lilly, she was a Patent Attorney at Novartis Institutes for BioMedical Research, where she supported ImmunoOncology and Neuroscience programs. She also worked for Fish & Richardson as an associate, focusing her practice on biopharma-related patent prosecution and litigation there.

Angela Sebor

Director Intellectual Property, Tolmar, Inc., USA

Angie Sebor is the Director Intellectual Property at Tolmar, Inc., a Colorado-based, fully integrated pharmaceutical company focused on developing innovative, specialty pharmaceutical products in the areas of urology, oncology, pediatric endocrinology and dermatology. Angie is a registered U.S. patent agent with a Ph.D. in Immunology and more than 25 years’ experience in patent law, both as an in-house practitioner and in private practice, primarily in the areas of biotechnology and pharmaceuticals.

Stacy Lewis

Law Clerk, Finnegan, USA

Stacy Lewis is called to the bar in New York and has worked as a law clerk at Finnegan since 1995. She focuses on research and writing, particularly in the life sciences. She is the coordinating editor of the books Global Patent Litigation: How and Where to Win and Design Patent Law, as well as the coursebook Chemical Patent Practice. Stacy sits on the AIPLA Quarterly Journal and IPO Law Journal editorial boards. She can be reached at stacy.lewis@finnegan.com.

Companies

Eli Lilly and Company

Lilly was founded in 1876 by Colonel Eli Lilly, a man committed to creating high-quality medicines that met real needs in an era of unreliable elixirs peddled by questionable characters. His charge to the generations of employees who have followed was this: "Take what you find here and make it better and better." More than 145 years later, we remain committed to his vision through every aspect of our business and the people we serve starting with those who take our medicines, and extending to health care professionals, employees and the communities in which we live.

Tolmar, Inc.

Tolmar is a Northern Colorado based pharmaceutical research, development, manufacturing and commercial operations company. Tolmar develops and manufactures both proprietary and generic pharmaceutical products with specific focus in dermatology, oncology, and specialty injectable therapeutic areas.

Finnegan

Finnegan, Henderson, Farabow, Garrett & Dunner, LLP is one of the largest IP law firms in the world. From offices in Atlanta, Boston, London, Munich, Palo Alto, Reston, Seoul, Shanghai, Taipei, Tokyo, and Washington, DC, the firm practices European, German, UK, and U.S. IP law. In addition to services related to all aspects of patent, trademark, and copyright law, including counseling, prosecution, licensing, and litigation, Finnegan provides counseling and litigation services in advertising, privacy, and a wide spectrum of additional IP-adjacent commercial matters, including trade secrets, international trade, the Internet, e-commerce, government contracts, antitrust, and unfair competition.

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Owner & Principal, BioPharma Law Group PLLC, USA

Tom Irving

Partner, Marbury Law Group, USA

Stacy Lewis

Law Clerk, Finnegan, USA

Mark Feldstein

Partner, Finnegan, USA

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