어두운 질감의 블레이저와 금색 핀을 착용한 긴 갈색 머리를 한 여성이 흐릿한 법률 사무실을 배경으로 카메라를 향해 미소를 짓고 있습니다.

미셸 M. 심킨

파트너

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.

대표 경험

  • 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.

수상 및 표창

  • 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)

제휴

  • 미국 변호사 협회

프레젠테이션 및 출판물

  • 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.
2025년 11월 11일 오늘날의 의료법

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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’"
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IAM, 2025년판 'IAM 특허 1000: 세계 최고의 특허 실무자'에서 폴리 변호사와 관할 지역을 인정받다

폴리 앤 라드너 LLP의 17명의 변호사와 5개의 로펌이 2025년판 IAM 특허 1000: 세계 최고의 특허 전문가에 선정되었습니다.
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.
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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

USPTO 지연을 활용하여 특허 기간 최대화하기

USPTO는 고용 동결 조치를 받기 전, 2025 회계연도부터 2026 회계연도까지 400명의 신규 심사관을 충원할 것으로 예상했지만 여전히 미심사 특허 출원 백로그가 증가할 것으로 예측했습니다.