(586b) Bioproduction and Formulation Patents - Opportunities and Challenges for Biotherapeutic Development

Calvo, P., Sterne, Kessler, Goldstein & Fox

Patents that cover bioproduction methods and formulations are important for patent life cycle management of all biotherapeutics. However, there are patentability challenges associated with obtaining patents that cover aspects in addition to the drug composition. Thus, the importance of patents, as well as trade secrets, and an understanding of the opportunities/challenges they present is invaluable.  Moreover, recent changes to the US patent laws have introduced new avenues to challenge patents that were not previously available.  These new inter partes proceedings  may provide earlier resolution for patent conflicts, as well as bring about settlements that could avoid more costly litigation altogether.  A clear understanding of patent issues is absolutely vital in all areas of therapeutic development, especially in the area of biosimilars.  This presentation will use existing patents as examples to outline the opportunities and challenges for both originator and follow-on companies as they create portfolios to protect their compound, and/or plan design-around strategies to challenge these so-called second generation patents.