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  1. Capabilities

Life Sciences

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  • Overview
  • Experience
  • Related Insights & News
  • Key Contacts

    T. Reed StephensJustin LevyNimalka Wickramasekera
    View Our Full Team

    Resources

    Product Liability & Mass Torts Digest

    Winston has been a major player in the life sciences industry for decades. We represent market-leading clients across this broad sector, including companies involved in pharmaceuticals, biologics, biosimilars, biotechnology, and medical devices. Our attorneys are seasoned practitioners—many of whom have technical degrees in areas key to the life sciences sector, including biology, chemistry, pharmacy, and biomedical engineering—and bring a unique understanding of the industry and perspective to our representations.

    We understand the complexities inherent to the life sciences sector, which enables us to provide comprehensive counsel on the legal and business challenges in this highly regulated environment. The life sciences sector has faced unprecedented challenges throughout the last few years, and our team has been among the most active in helping clients respond to the evolving regulatory landscape. Our experience includes matters related to intellectual property, product liability and mass torts, consumer class actions, antitrust, international trade, privacy and data security, labor and employment, mergers and acquisitions, private equity, and commercial transactions. We also advise clients regarding regulatory and compliance matters— including government drug pricing and voluntary disclosures related to the Medicaid Drug Rebate Program, the VA’s Federal Supply Schedule Program, and the 340B Program—and defend them in government investigations brought by federal and state agencies.

    Key Contacts

    T. Reed StephensJustin LevyNimalka Wickramasekera
    View Our Full Team

    Areas of Focus

    We are unquestionably one of the premier law firms representing companies in the pharmaceutical sector. Our practice has been known as a leading player in the IP arena for decades and is “hands down the best generic-side ANDA/Hatch-Waxman patent litigation group” (U.S. News―Best Lawyers® “Best Law Firms”). Since 2020, we have appeared in 60 pharmaceutical patent cases and, over the years, we have obtained wins in matters involving blockbuster drugs such as Zubsolv®, Prozac®, Yasmin®, Baraclude®, Razadyne ER/Razadyne IR®, Temodar®, Amrix®, Amprya®, Sensipar®, and Testim®, among others.

    In addition to fiercely protecting our clients’ intellectual property and freedom to innovate, we are often tasked with defending clients’ products and reputations. Leading pharmaceutical companies repeatedly turn to us to serve in key roles—lead trial counsel, multidistrict litigation counsel, state-wide coordinating counsel, appellate counsel—to resolve their most critical product liability issues. Our lawyers have been involved in some of the most-watched, “bet-the-company” product liability and mass tort cases in recent history, such as serving as defense counsel for Pfizer Inc. in the wave of product liability cases regarding its two prescription non-steroidal anti-inflammatory medications, Celebrex® and Bextra®; trial counsel for Wyeth Pharmaceuticals in the Fen-Phen product liability litigation; co-lead counsel for Otsuka in the In re: Abilify (Aripiprazole) Products Liability Litigation MDL, various state-court actions brought by more than 4,000 plaintiffs, and the Abilify® and Rexulti® failure-to-warn and design defect cases; and national counsel for Hikma Pharmaceuticals in the national opiate litigation.

    Furthermore, our attorneys have extensive experience in matters involving state and federal government law enforcement and investigations. With former U.S. Department of Justice attorneys and in-house attorneys embedded in our Healthcare and Life Sciences Industry Group, we can leverage our practitioners’ experience to provide efficient and creative representation of our clients in a broad array of important False Claims Act (FCA) matters, including those covering such issues as drug price reporting of Average Wholesale Price and Medicaid Drug Rebate Best Price and sales to government purchasers on the Federal Supply Schedule. We also routinely guide clients through many of the industry’s most-litigated FCA issues in the current environment. These include dealing directly with regulators on litigated, non-intervened FCA qui tam matters involving complex Stark and anti-kickback issues, violation of drug-pricing allegations, and others.

    Our life sciences attorneys have deep experience with product development and commercialization across the leading sectors of the life sciences industry, including biotechnology. Our team recognizes that biotechnology is a highly diversified, complex, and regulated industry, and we partner with our clients to help them navigate the research, financing, and commercialization stages of product development. Our team is fully integrated with all the firm’s substantive practices, and we draw upon decades of experience to help bring important biotech products to market successfully.

    Since the Biologics Price Competition and Innovation Act (BPCIA), or Biosimilars Act, was enacted in March 2010, our attorneys have played a pivotal role in some of the first cases in district courts and in proceedings before the U.S. Patent and Trademark Office. We are one of the few firms with hands-on experience litigating these cases and regularly present on BPCIA issues at conferences and other industry events. Currently, we advise a number of clients on potential biosimilar applications under the BPCIA, analyzing and preparing patent opinions regarding validity, infringement, freedom to operate, and related issues, including determining how best to proceed under the particular client’s circumstances.

    Winston & Strawn has an impressive ability to handle complicated pharmaceutical patent litigation.

    Chambers USA, IP Client

    Related Capabilities

    Patent Litigation
    Government Program Fraud, False Claims Act & Qui Tam Litigation
    Intellectual Property
    Product Liability & Mass Torts
    Commercial Litigation & Disputes
    Employee Benefits & Executive Compensation
    Labor & Employment
    Litigation/Trials
    Environmental
    Mergers & Acquisitions
    Private Equity
    Privacy & Data Security
    Trade Secrets, Non Competes & Restrictive Covenants
    Healthcare
    Medical Devices

    Recent Experience

    Winston Represented Empower Clinic Services, LLC, in its Acquisition of a Pharmaceutical Manufacturing Facility
    Aileron Therapeutics Announces Acquisition of Lung Therapeutics
    Docter Inc. and Aimfinity Investment Corp. I Announce Definitive Merger Agreement
    Estrella Biopharma, Inc. Closes Business Combination with TradeUp Acquisition Corp.
    Winston Serves as Trial Counsel in Monsanto Roundup Litigation
    Defended Generic Drug Manufacturer in Trade Dress Infringement Case
    Rare Noninfringement Jury Verdict for Teva N.A. in Patent Infringement Case for Suboxone® Tablets

    Resources

    Product Liability & Mass Torts Digest

    Notable

    US$1B Jury Verdict on Behalf of Monsanto in Monsanto Co. v. E.I. duPont de Nemours & Co.

    Tier 1 General Patent Litigation and Hatch-Waxman Patent Litigation (Generic)

    LMG Life Sciences

     50+ Attorneys With Technical Degrees

    US$1B Jury Verdict on Behalf of Monsanto in Monsanto Co. v. E.I. duPont de Nemours & Co.

    LMG Life Sciences

    Tier 1 General Patent Litigation and Hatch-Waxman Patent Litigation (Generic)

     50+ Attorneys With Technical Degrees

    ResourceSurvey of State Transaction Notification Requirements
    This survey provides a comprehensive overview of Baby HSR laws throughout the United States, identifying which states have adopted premerger notification requirements and summarizing key details such as the types of transactions covered, the content of required notices, and the timing of the review. 
    Learn More
    ResourceSurvey of State Transaction Notification Requirements
    This survey provides a comprehensive overview of Baby HSR laws throughout the United States, identifying which states have adopted premerger notification requirements and summarizing key details such as the types of transactions covered, the content of required notices, and the timing of the review. 
    Learn More
    Law360T. Reed Stephens Named to Life Sciences Editorial Advisory Board
    Learn more

    Related Insights & News

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    Recognitions

    Winston & Strawn Recognized in The Legal 500 U.S. 2025

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    Winston Lawyers Named as 2025 IP Stars

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    Speaking Engagement
    Michael Kimberly Presents at AALA’s Annual Educational Symposium
    November 6, 2025
    News
    Key Takeaways from Winston’s Fifth Annual Health Care & Life Sciences Summit
    August 4, 2025
    Blog
    Delaware Supreme Court Reverses Trial Court Decision on Zantac Expert Testimony
    July 16, 2025
    Webinar
    The Revival of Most-Favored-Nation Pricing: What Pharma Needs to Know
    July 15, 2025
    Blog
    FDCA Preemption Has Teeth for Benzene Failure-to-Warn Claims
    June 24, 2025
    Recognitions

    Winston & Strawn Recognized in The Legal 500 U.S. 2025

    June 12, 2025
    Recognitions
    Winston Lawyers Named as 2025 IP Stars
    June 10, 2025
    Blog
    Toxic Tort Takedown: Court Demands Biologically Plausible Causation in Uniform Chemical Case
    May 30, 2025
    Seminar/CLE
    2025 Health Care & Life Sciences Summit
    May 13, 2025
    Speaking Engagement
    Partners Imad Khan and Keerthika Subramanian Discuss Hot Topics in International Arbitration and Strategic Transactions in India as Part of Practising Law Institute Program
    May 9, 2025
    Client Alert
    White House Memorandum Elaborates on Prior Executive Order with Requirements for “High-Impact AI” Used by Federal Agencies
    May 2, 2025
    Client Alert
    April 2025 Executive Order Targets Prescription Drug Price Reduction
    May 1, 2025
    View All Insights & News
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