Michele M. Simkin
Partner
Michele M. Simkin berät Kunden aus den Bereichen Biowissenschaften, Pharmazie und Medizintechnik in allen Aspekten des geistigen Eigentums, einschließlich der Beschaffung von Patenten und des Portfoliomanagements, Lizenzvereinbarungen, Due-Diligence-Prüfungen im Zusammenhang mit dem Erwerb oder der Veräußerung von geistigem Eigentum sowie Analysen der Rechtsbeständigkeit, der Nicht-Verletzung und der Betriebsfreiheit. Sie ist Partnerin im Bereich Chemie, Biotechnologie und Pharmazie der Kanzlei. Zuvor war sie Vorsitzende der Abteilung für geistiges Eigentum der Kanzlei, wo sie ein Team von über 300 Fachleuten für geistiges Eigentum leitete, und ist derzeit Mitglied des Managementausschusses der Kanzlei.
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.
Repräsentative Erfahrung
- 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.
Auszeichnungen und Anerkennungen
- 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)
Zugehörigkeiten
- Amerikanische Anwaltsvereinigung
Präsentationen und Veröffentlichungen
- 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.
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Fusionen und Übernahmen in der GLP-1-Technologie: Praktische Empfehlungen und Best Practices
Michele Simkin für Erkenntnisse aus dem Foley GLP-1-Webinar ausgezeichnet
GLP-1-Medikamente im Fokus: Trends, Bedürfnisse und Ausblick
IAM würdigt Foley-Anwälte und Gerichtsbarkeiten in der Ausgabe 2025 von IAM Patent 1000: The World's Leading Patent Practitioners