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  1. Professionals

Claire Fundakowski

Partner

Washington, DC

+1 202-282-5347

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  • Overview
  • Experience
  • Credentials
  • Insights & News

Claire draws on her experience as a pharmacist to represent clients in patent litigation, with a focus on the pharmaceutical and medical device sector. On three occasions, Am Law Litigation Daily named Claire as a “Litigator of the Week” runner-up in connection with her case victories. Prior to joining the firm, Claire served as a law clerk to Chief Judge Kimberly A. Moore at the U.S. Court of Appeals for the Federal Circuit.

Claire practices patent litigation and appeals with an emphasis on the pharmaceutical and medical device sector. She also routinely advises clients on competitive product development strategies in view of competitor patents and FDA regulations.

Coupled with her extensive knowledge of patent law, Claire leverages her background as a pharmacist to represent pharmaceutical and medical device companies in matters concerning an array of scientific issues. She has represented pharmaceutical companies in countless patent cases, including cases involving injectable, oral, and topical pharmaceutical compositions and concerning patents directed to lipid compositions, polymorphs, stereoisomers, formulations, processes for preparing compounds, nucleic acids, downstream purification processes, and methods of treatment. In this capacity, she has represented clients in matters related to the Hatch-Waxman Act, Biologics Price Competition and Innovation Act, and before the Patent Trial and Appeal Board.

As an experienced patent litigator, Claire has obtained multiple victories for clients across industries. She has experience throughout every stage of district court litigation, including taking and defending depositions, constructing invalidity and non-infringement defenses, authoring critical briefs, arguing substantive motions, and examining witnesses at trial. Claire has particular experience in the District of Delaware, where she has litigated over a dozen distinct patent cases involving numerous technologies.

Claire’s experience extends to cases before the Federal Circuit, where she has authored numerous briefs and regularly advises on appellate strategy. She clerked for Chief Judge Moore at the Federal Circuit for 20 months before joining the firm.

Key Matters

Claire’s representative experience includes the following:

  • Core member of a trial team that obtained invalidation of six patents for obviousness—affirmed on appeal—in a case involving a drug with annual sales of approximately US$1B.
  • Core member of a trial team that obtained a judgment of non-infringement of all asserted claims relating to the drug compound’s polymorphic form.
  • Lead damages counsel in litigation on behalf of a medical device company, successfully reducing damages to $1.
  • Orally argued and briefed claim construction on behalf of a generic pharmaceutical company to obtain a construction narrowed by prosecution history disclaimer.
  • Orally argued and briefed a successful Daubert motion on behalf of a medical device company.
  • Briefed successful patent challenges before the Patent Trial and Appeal Board to invalidate dozens of claims across six patents relating to methods of expressing enzymes in fungal cells.

Claire has also helped secure several favorable outcomes for her pro bono clients, including:

  • At the Supreme Court, briefed successful amicus brief outlining why the rescission of DACA was arbitrary and capricious in view of the government’s failure to consider serious reliance interests unique to DACA recipients and their families.
  • Briefed successful amicus brief on behalf of various civil rights organizations to support commuting a prisoner’s wrongful conviction through executive clemency.
  • Briefed successful amicus brief in appellate court to support protecting prisoners from the physical and psychological harms of solitary confinement.

  • IAM Patent 1000 (2024)
  • Benchmark Litigation US—Named on the “40 and Under List” for Dispute Resolution (2024–2025)
  • The American Lawyer—Recognized as “Litigator of the Week” Runner-Up (Jan. 2022; May 2022; Sept. 2023); Honorable Mention (Jan. 2023)
  • Law360—“Legal Lions of the Week” (Sept. 2023)
  • Best Lawyers: Ones to Watch in America®—Recognized for Patent Litigation (2022–2025); Litigation - Intellectual Property (2023–2025); and Intellectual Property Law (2021–2025)
  • Lawdragon’s “500 X – The Next Generation”— Recognized for IP Litigation (2024)
  • Super Lawyers—Recognized as a Washington, D.C. “Rising Star” (2020–2024)
  • Patexia—Recognized as a “Top ANDA Litigator” (2020–2023) and “Top 25 for Best Performance” (2023)
  • American Society for Pharmacy Law’s—“Larry M. Simonsmeier Writing Award” (2014)

Capabilities

Patent Litigation
Appellate & Critical Motions
Intellectual Property
Medical Devices
Life Sciences

Key Matters

Claire’s representative experience includes the following:

  • Core member of a trial team that obtained invalidation of six patents for obviousness—affirmed on appeal—in a case involving a drug with annual sales of approximately US$1B.
  • Core member of a trial team that obtained a judgment of non-infringement of all asserted claims relating to the drug compound’s polymorphic form.
  • Lead damages counsel in litigation on behalf of a medical device company, successfully reducing damages to $1.
  • Orally argued and briefed claim construction on behalf of a generic pharmaceutical company to obtain a construction narrowed by prosecution history disclaimer.
  • Orally argued and briefed a successful Daubert motion on behalf of a medical device company.
  • Briefed successful patent challenges before the Patent Trial and Appeal Board to invalidate dozens of claims across six patents relating to methods of expressing enzymes in fungal cells.

Claire has also helped secure several favorable outcomes for her pro bono clients, including:

  • At the Supreme Court, briefed successful amicus brief outlining why the rescission of DACA was arbitrary and capricious in view of the government’s failure to consider serious reliance interests unique to DACA recipients and their families.
  • Briefed successful amicus brief on behalf of various civil rights organizations to support commuting a prisoner’s wrongful conviction through executive clemency.
  • Briefed successful amicus brief in appellate court to support protecting prisoners from the physical and psychological harms of solitary confinement.

Credentials

Education

Claire received her Pharm.D., cum laude, from Massachusetts College of Pharmacy and Health Sciences in 2010. She received her J.D., cum laude, from Georgetown University Law Center in 2014, where she was notes editor of Georgetown Journal of Legal Ethics.

Claire is also a Registered Pharmacist in Virginia, where she practiced before obtaining her law degree. 

    Admissions
    • District of Columbia
    • Maryland
    Clerkships
    • USCA - Federal Circuit for the Honorable Kimberly A. Moore
    • USCA - Federal Circuit for the Honorable Kimberly A. Moore

    Related Insights & News

    Speaking Engagements

    • Speaker, ACI's Annual Passport to Proficiency on the Essentials of Hatch-Waxman and BPCIA (2024)
    • Moderator, Judicial Panel: PTAB’s LEAP Initiative for NextGen Lawyers (2020)
    Speaking Engagement
    Claire Fundakowski Presents at 2024 Hatch-Waxman and BPCIA Passport to Proficiency Series

    October 17, 2024

    Recognitions

    Winston & Strawn Recognized in 2025 Benchmark Litigation

    October 3, 2024

    Recognitions

    Winston Attorneys Recognized in Best Lawyers: Ones to Watch® in America 2025

    August 15, 2024

    Recognitions
    Winston Partners Named to Benchmark Litigation’s 2024 40 & Under List

    August 8, 2024

    Recognitions
    Winston Attorneys Featured on 2024 Lawdragon 500 X – The Next Generation List

    June 28, 2024

    Recognitions
    Winston Recognized in 2024 IAM Patent 1000 Rankings

    June 5, 2024

    Sponsorship
    Winston Charlotte Hosts Global ChIPs Leadership Retreat

    April 16, 2024

    Recognitions
    Three Winston Teams Featured in Litigator of the Week Column

    September 29, 2023

    Recognitions
    Winston Attorneys Recognized in Best Lawyers: Ones to Watch® in America 2024

    August 17, 2023

    Sponsorship
    Winston & Strawn Sponsors 2023 Federal Circuit Bar Association Bench & Bar Conference

    June 28, 2023

    Recognitions
    Winston Attorneys Recognized in Litigator of the Week Column

    January 6, 2023

    Press Release
    Winston & Strawn Names 19 New Partners

    December 6, 2022

    View All Insights & News

    Capabilities

    Patent Litigation
    Appellate & Critical Motions
    Intellectual Property
    Medical Devices
    Life Sciences
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