Creative Claiming Strategies

Angela Sebor, Director Intellectual Property, Tolmar, Inc., 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.

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.

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.