Sarah Cooleybeck

Partner - Boston

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Sarah Cooleybeck, a partner in the firm’s Business Department, has a broad life sciences practice that includes negotiation of complex licensing and collaboration agreements, intellectual property and licensing advice, and Hatch-Waxman and related regulatory strategy.

Sarah drafts and negotiates patent licenses, supply, manufacturing and quality agreements, collaboration and co-development agreements, and other strategic alliances, for both established and emerging companies. Sarah’s licensing work is complemented by her in-depth knowledge of the regulatory environment in which life sciences companies operate, and by her patent litigation experience.

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Education:

  • Harvard Law School, J.D., cum laude, 1995
  • University of Michigan, A.B., high honors, 1990

Representative Experience

  • Drafted and negotiated a broad range of licensing, collaboration, co-development and option agreements for medical device, pharmaceutical, biotechnology and other clients, including:
    • Represented Homology Medicines to license gene editing platform technology from City of Hope and AAV technology from Caltech
    • Advised medical diagnostics company Alere Inc. on licensing and intellectual property matters associated with potential sale of health care division
    • Negotiated licenses, sponsored research agreements, material transfer agreements, and options with academic institutions including MIT, Stanford, Michigan State and Caltech
  • Drafted and negotiated dozens of U.S. and international manufacturing, supply, quality, and distribution agreements in the life sciences industry, including:
    • Negotiated development, supply and distribution agreements for robotic surgical instruments on behalf of the U.S. subsidiary of a major Japanese conglomerate
    • Advised start-up company regarding agreements for development of device manufacturing processes, and manufacture and optimization of drug-filling equipment and processes
    • Represented drug delivery company on license of drug delivery device technology and related multi-party device and drug product supply agreements
  • Advised and represented life sciences companies on Hatch-Waxman, Paragraph IV, FDA regulatory, and related patent and licensing issues, including:
    • Represented pharmaceutical companies in seeking Hatch-Waxman patent term extension and FDA regulatory exclusivity
    • Represented large biotechnology company in various disputes arising out of complex collaboration and license agreements
    • Advised health care company in connection with Paragraph IV patent infringement litigation against generic drug companies regarding therapeutic drug for end-stage renal disease, and resolved dispute regarding supply agreement for same drug
  • Co-author “Checklist for Life Sciences Licensing and Development Agreements” Drafting & Negotiating Joint Venture, Licensing, Co-Development, Marking & Distribution Agreements (MCLE, Inc. 2014)
  • "Current Issues in Hatch-Waxman Litigation: Moving Beyond the Caraco Dispute to the Question of Induced Patent Infringement in the Marketplace," The IP Legal Browser (Winter 2012)

Honors

  • Harvard Law School, Harvard Law Review, Editor
  • Served as a law clerk to Judge Patti B. Saris of the United States District Court for the District of Massachusetts

Involvement

  • Counselor, Boston IP American Inn of Court 
  • Boston Patent Law Association
  • Boston Bar Association
  • American Intellectual Property Law Association (AIPLA)
  • “Overview of Patent and Trademark Issues:  IP Protection for Drugs and Biologics” at American Conference Institute (ACI) FDA Boot Camp (Sept. 2012)
  • “Marketing Exclusivities (Non-Patent): Challenges, Opportunities, and Current Controversies” at American Conference Institute (ACI) FDA Boot Camp Master Class (Sept. 2012)
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Bar Admissions

  • Massachusetts

Court Admissions

  • U.S. District Court for the District of Massachusetts
  • U.S. Court of Appeals First Circuit
  • U.S. Court of Appeals Federal Circuit