一位棕色长发的女士身着深色质感西装外套,佩戴金色胸针,在模糊的律师事务所背景下对着镜头微笑。

Michele M. Simkin

合作伙伴

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.

代表经验

  • 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.

奖项与表彰

  • 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)

附属机构

  • 美国律师协会

演讲和出版物

  • 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.
2025 年 11 月 11 日 今日医疗保健法

GLP-1 技术的并购:实用建议和最佳实践

本文最初发表于 2025 年 11 月的《医药在线》。GLP-1革命改写了新陈代谢的游戏规则...
2025 年 9 月 29 日 新闻

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’"
2025年9月18日 活动

GLP-1药物聚焦:趋势、需求与未来展望

福莱国际医疗健康与生命科学及创新技术业务部诚邀您参加网络研讨会,探讨贵机构如何在GLP-1类药物发展的十字路口把握机遇,为不断演变的行业格局做好准备。
2025 年 6 月 5 日 荣誉与奖励

IAM在2025年版《IAM专利1000:世界领先专利从业者》中表彰富理达律师和司法管辖区

Foley & Lardner LLP 的 17 名律师和 5 个司法辖区入选 2025 年版《IAM Patent 1000:世界领先专利从业者》(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.
June 3, 2025 Health Care Law Today

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.