Michele M. Simkin provides strategic business counseling to life sciences, pharmaceutical, and medical device clients relating to all aspects of intellectual property, including patent procurement and portfolio management, licensing agreements, due diligence related to IP acquisitions or sales, as well as validity, non-infringement, and freedom to operate analyses. She has particular expertise in developing and executing intellectual property strategies for companion diagnostics, including claim drafting and portfolio structuring to support regulatory approval pathways, market access, and lifecycle management, as well as strategies designed to extend and enhance product exclusivity. Michele also advises clients on intellectual property issues arising from the use of artificial intelligence and machine learning in drug discovery and development, including protection of AI-enabled inventions, data-driven innovation, and related freedom-to-operate considerations. She is a partner in the firm’s Chemical, Biotechnology & Pharmaceutical Practice. She previously served as chair of the firm’s Intellectual Property Department, overseeing a team of over 300 IP professionals, and she is currently a member of the firm’s Management Committee.

Michele represents a diverse range of clients, including pharmaceutical and biotechnology companies such as Alkermes Pharmaceuticals, 10x Genomics, Inc., and Celgene Corporation (now part of Bristol Myers Squibb), mid-sized biotechnology companies such as MacroGenics, Inc. and EnGeneIC Ltd., manufacturing companies such as Stoner, Inc. (maker of Invisible Glass products), universities such as the University of Pittsburgh, and start-up ventures in both traditional pharmaceuticals and biotechnology applications, including Enterin, Inc. and BlueWillow Biologics, Inc.

Michele began her patent career in 1988 as a patent examiner in the biotechnology group of the U.S. Patent and Trademark Office. As an undergraduate, she worked in the laboratory of Professor David L. Nelson, culturing and harvesting the protozoan Paramecium, which was used as a model system to study signal transduction using biochemical, genetic, molecular genetic, cell biological, and electrophysiological tools.