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.
/Passle/67196104ea6deed3d1072b7a/SearchServiceImages/2025-11-11-20-37-33-554-69139e8dd13d736fb03a081d.jpg)
Fusies en overnames in GLP-1-technologie: Praktische aanbevelingen en beste praktijken
Michele Simkin Highlighted for Insights from Foley GLP-1 Webinar
GLP-1 geneesmiddelen in beeld: Trends, behoeften en de toekomst
IAM erkent Foley-advocaten en -rechtsgebieden in editie 2025 van IAM Patent 1000: The World's Leading Patent Practitioners