Global Patent Strategies Biologics Spotlight: Enablement and Patent Eligibility, It’s All in the Details

Global Patent Strategies Biologics – Spotlight: Enablement and Patent Eligibility, It’s All in the Details

Biologics key stakeholders face a dilemma: first-to-file versus a disclosure sufficient to enable and claim patent-eligible subject matter. In the decade since the enactment of the Biologics Price Competition and Innovation Act (BPCIA), patent protection for biologics has become increasingly important. In order to draft comprehensive patent applications with adequate detail and disclosures to both enable and overcome potential patent ineligibility issues, aligning and timing business objectives, R&D efforts, and clinical trials are imperative.


April Abele Isaacson, Partner, Kilpatrick Townsend & Stockton LLP
April has 25 years of experience as a trial lawyer and is a registered patent attorney. Her practice focuses on pharmaceutical, biotechnology, and chemical patent litigation, particularly Hatch-Waxman cases on behalf of drug innovators. She has tried cases in several federal district courts throughout the United States and also provides counseling on patent and related regulatory issues faced by the biopharma industry. April previously served as in-house counsel at a public specialty pharmaceutical company where she provided broad intellectual property and regulatory strategic counseling during all stages of product development and managed numerous patent infringement litigations. You can learn more

Tiffany B. Thomas, Ph.D., Patent Agent, Kilpatrick Townsend & Stockton LLP

Tiffany is a senior patent agent with nearly twenty years of experience who focuses her practice on patent prosecution, counseling, and management for companies, universities, and institutions of all sizes in the life sciences, medical technology, chemistry, and biotechnology industries. Tiffany’s law firm and in-house experience at Illumina, Inc. provides her with a deep understanding of intellectual property issues, including the areas of competitive landscape analysis, due diligence, freedom-to-operate, opinion writing, and patent portfolio counseling and management. You can learn more at