Overview

Michele M. Simkin is a partner and intellectual property lawyer with Foley & Lardner LLP and is a member of Foley’s Management Committee. Michele is also a member of the firm’s Chemical, Biotechnology & Pharmaceutical Practice and the Life Sciences Industry Team. She previously served as Chair of the firm’s Intellectual Property Department, overseeing a team of over 300 IP professionals.

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, including pharmaceutical companies such as Alkermes Pharmaceuticals and Celgene Corporation (recently acquired by Bristol Myers Squibb), mid-sized biotechnology companies such as Tmunity Therapeutics, EnGeneIC Ltd. and 22nd Century Group, Inc., 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 Inc., 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.

Publications and Presentations

Michele has lectured on and has authored a number of articles on intellectual property topics.

Recognition

  • Selected by her peers for inclusion in The Best Lawyers in America© in the field of Biotechnology and Life Sciences Practice (2008 - 2022)
  • Recognized in IAM Patent 1000 – The World’s Leading Patent Practitioners for her work in patent prosecution (2020-2021)
  • Recognized by The Legal 500 for her work in patent portfolio management and licensing and patent prosecution (2016)

Education

  • The George Washington University National Law Center (J.D., 1993)
  • University of Wisconsin-Madison (B.S., 1988)
    • Biochemistry and Molecular Biology

Memberships

  • American Bar Association

Admissions

  • U.S. Patent and Trademark Office
  • District of Columbia
  • U.S. Court of Appeals for the Federal Circuit
  • District Court for the District of Columbia