Een vrouw met lang bruin haar die een blazer met donkere structuur en een gouden speld draagt, glimlacht naar de camera tegen een wazige achtergrond van een advocatenkantoor.

Michele M. Simkin

Partner

Michele M. Simkin biedt strategisch zakelijk advies aan cliënten in de biowetenschappen, farmaceutische industrie en medische hulpmiddelen met betrekking tot alle aspecten van intellectueel eigendom, waaronder de verwerving en het beheer van octrooien, licentieovereenkomsten, due diligence met betrekking tot de verwerving of verkoop van intellectueel eigendom, evenals analyses van geldigheid, niet-inbreuk en freedom to operate. Ze is partner in de chemische, biotechnologische en farmaceutische praktijk van het kantoor. Eerder was ze voorzitter van de afdeling Intellectueel Eigendom van het kantoor, waar ze toezicht hield op een team van meer dan 300 IE-professionals, en momenteel is ze lid van het Management Committee van het kantoor.

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.

Representatieve ervaring

  • 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.

Prijzen en erkenning

  • 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 (2020-2024)
  • 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)

Affiliaties

  • Amerikaanse Orde van Advocaten

Presentaties en publicaties

  • Author, “GLP-1 Receptor Agonists: The Surge of M&A Activity and the Future of Metabolic Health,” Health Care Law Today (June 3, 2025)
  • Author, “Cancer Drugs: Deals and Licensing for Antibody-Drug Conjugates,” Health Care Law Today (June 5, 2024)
  • Lectured on and has authored a number of articles on intellectual property topics.
11 november 2025 Gezondheidsrecht vandaag

Fusies en overnames in GLP-1-technologie: Praktische aanbevelingen en beste praktijken

Dit artikel verscheen oorspronkelijk op Pharmaceutical Online in november 2025. De GLP-1-revolutie heeft het draaiboek voor metabole...
29 september 2025 In het nieuws

Michele Simkin Highlighted for Insights from Foley GLP-1 Webinar

Foley & Lardner LLP partner Michele Simkin insights from a recent firm health care and life sciences webinar are quoted in the PharmaVoice article, "As obesity M&A heats up, pharmas could get ‘blinded by opportunity’"
18 september 2025 Evenementen

GLP-1 geneesmiddelen in beeld: Trends, behoeften en de toekomst

De sectoren Health Care & Life Sciences en Innovative Technology van Foley nodigen u uit voor een webinar over hoe uw organisatie kan navigeren op het kruispunt van GLP-1's en zich kan voorbereiden op dit veranderende landschap.
5 juni 2025 Onderscheidingen

IAM erkent Foley-advocaten en -rechtsgebieden in editie 2025 van IAM Patent 1000: The World's Leading Patent Practitioners

Zeventien advocaten en vijf rechtsgebieden van Foley & Lardner LLP zijn opgenomen in de 2025-editie van IAM Patent 1000: The World's Leading Patent Practitioners.
A doctor in a white coat and stethoscope shakes hands with a person in a suit, illustrating a professional partnership between healthcare experts and chicago lawyers for litigation support.
3 juni 2025 Gezondheidsrecht vandaag

GLP-1 Receptor Agonists: The Surge of M&A Activity and the Future of Metabolic Health

Over the past decade, the global pharmaceutical industry has witnessed a transformation in the treatment landscape for metabolic disorders, particularly type 2 diabetes and obesity.
March 11, 2025 PharmaPatents

Leveraging USPTO Delays To Maximize Patent Term

Before the USPTO was subject to a hiring freeze, it assumed it would onboard 400 new examiners between fiscal year 2025 and fiscal year 2026, and still predicted an increase in the backlog of unexamined patent applications.