Michele M. Simkin is a partner and intellectual property lawyer with Foley & Lardner LLP and is chair of the firm’s Intellectual Property Department. Michele is a member of the firm’s Chemical, Biotechnology & Pharmaceutical Practice and Life Sciences Industry Team. She previously served as chair of the formerly named Biotechnology & Pharmaceutical Practice.
Michele provides strategic business counseling to life sciences clients relating to all aspects of intellectual property, including patent procurement and portfolio management, licensing agreements, due diligence related to IP acquisitions or sales, and validity, non-infringement, and freedom to operate analyses.
Michele represents a diverse range of clients, from pharmaceutical companies such as Alkermes Pharmaceuticals and Celgene Corporation, mid-sized biotechnology companies such as EnGeneIC Ltd. and 22nd Century Group, Inc., and manufacturing companies such as Stoner, Inc. (maker of Invisible Glass products), universities such as University of Pittsburgh, and start-up ventures in both traditional pharmaceuticals and biotechnology applications, such as PLx Pharma, Enterin, Inc., and Bluewillow Biologics, Inc.
Michele started her patent career in 1988 as a patent examiner in the biotechnology group of the U.S. Patent and Trademark Office. Her technical experience encompasses drug delivery systems, pharmaceuticals, biologics, virology, immunology, genetics, and small molecules. While an undergraduate, Michele worked in the laboratory of Professor David L. Nelson, culturing and harvesting the protozoan Paramecium, which were used as a model to study signal transductions using biochemical, genetic, molecular genetic, cell biological, and electrophysiological tools.
Michele has been selected by her peers for inclusion in The Best Lawyers in America© every year since 2008 for her work in biotechnology law. She was recognized in IAM Patent 1000 – The World’s Leading Patent Practitioners for her work in patent prosecution in 2020. In 2016 she was recognized by The Legal 500 for her work in patent portfolio management and licensing and patent prosecution.
Michele graduated from the University of Wisconsin-Madison (B.S., biochemistry and molecular biology, 1988) and The George Washington University National Law Center (J.D., 1993).
She is registered to practice before the U.S. Patent and Trademark Office, and is admitted to practice in the District of Columbia, the U.S. Court of Appeals for the Federal Circuit, and the District Court for the District of Columbia. She is also a member of the American Intellectual Property Law Association and the American Bar Association.
Publications and Presentations
Michele has lectured on and has authored a number of articles on intellectual property topics.