Michele M. Simkin


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 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/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., 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 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. 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.

Representative Experience

  • Representation of EnGeneIC in obtaining over 30 U.S. patents and 200 patents worldwide, with the claimed technology encompassing products in clinical trials for treating Glioblastoma Multiforme (GBM), malignant pleural mesothelioma, non-small cell lung cancer, and recurrent/refractory solid or CNS tumors. The novel EDV nanocell technology is a first-in-class cyto-immunotherapy platform targeting cancer tumors directly as well as leveraging the patient’s own immune system for improved efficacy and outcome.
  • Representation of Enterin, Inc. in obtaining multiple U.S. and international patents, covering both products and methods of treatment, directed to aminosterol compounds useful in treating neurodegenerative diseases such as Parkinson’s Disease. Enterin’s lead molecule, ENT-01, recently met its primary endpoint in a Phase 2b study for patients with Parkinson’s Disease.
  • Representation of MacroGenics in obtaining U.S. and international patent protection for Retifanlimab, which is an investigational, humanized, proprietary anti-PD-1 monoclonal antibody being developed for use as monotherapy as well as in combination with other potential cancer therapeutics.

Awards and Recognition

  • Selected by her peers for inclusion in The Best Lawyers in America© in the field of Biotechnology and Life Sciences Practice (2008-2024)
  • Recognized in IAM Patent 1000 – The World’s Leading Patent Practitioners for her work in patent prosecution (2020-2023)
  • Recognized by Leaders League Intelligence Report & Rankings, as a Top Tiered Leading Practitioner for Patent Prosecution, and in Best Law Firm for Patent Prosecution: (2021, 2022)


  • American Bar Association

Presentations and Publications

  • Lectured on and has authored a number of articles on intellectual property topics.
08 December 2023 Innovative Technology Insights

FDA Approves Two Gene Therapies to Treat Sickle Cell Disease Including a CRISPR-Based Therapy

These new therapies harness the power of stem cells to help patients with sickle cell disease avoid vaso-oclusive events and crises.
17 August 2023 Honors and Awards

Foley Attorneys Recognized in 2024 Best Lawyers in America

Foley & Lardner LLP proudly announced today that 236 of the firm’s attorneys across 20 U.S. offices have received recognition in the 2024 edition of The Best Lawyers in America©.
06 June 2023 Events

Foley 2023 BIO International Convention Reception

On June 6, Foley & Lardner’s Health Care & Life Sciences and Innovative Technology Sectors hosted a networking reception in conjunction with the BIO International Convention in Boston, MA.
18 August 2022 Press Releases

Foley Attorneys Recognized in 2023 Best Lawyers in America

Foley & Lardner LLP proudly announced that 250 of our attorneys across 20 offices have received recognition in the 2023 edition of The Best Lawyers in America.
19 August 2021 Press Releases

Foley Attorneys Recognized in 2022 Best Lawyers in America

Foley & Lardner LLP announced today that 236 of the firm’s attorneys from 18 U.S. offices have been recognized in the 2022 edition of The Best Lawyers in America©, and 46 lawyers from 13 offices were included in the Best Lawyers: Ones to Watch list. Additionally, 14 of the firm’s attorneys received the special designation of “Lawyer of the Year,” an honor earned by only one lawyer in each practice area and metropolitan region.
15 July 2021 In the News

Intellectual Asset Management Recognizes Foley Attorneys in 2021 Patent 1000 Guide

Intellectual Asset Management (IAM) has recognized 15 Foley attorneys in the 10th edition of its Patent 1000 – The World’s Leading Patent Professionals guide.