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  1. Capabilities

Life Sciences

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  • Overview
  • Experience

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 Health Care 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
Health Care
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

View All Insights & News
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

Speaking Engagement
Kathi Vidal and Bryce Cooper Speak at the 2025 Paragraph IV Disputes Conference in New York

April 29, 2025

Blog
Supreme Court Has a Chance to (Re-)Clarify Albrecht Impossibility Preemption Test

April 3, 2025

Blog
Federal Jury Finds No Liability for SuperValu in FCA Case Remanded for Trial by SCOTUS

April 2, 2025

Speaking Engagement
Rand Brothers Discusses Microplastics: Regulation, Litigation, and Emerging Trends

April 1, 2025

Client Alert
HHS Announces Major Restructuring and Workforce Reductions

March 28, 2025

Sponsorship
Winston & Strawn Sponsors Healthcare Business International 2025

March 24, 2025

Recognitions
Law360 Names Winston Attorneys to 2025 Editorial Advisory Boards

March 20, 2025

Blog
BioZorb and the Power of Causation: Why Warnings Don’t Always Matter

March 17, 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
Speaking Engagement
Kathi Vidal and Bryce Cooper Speak at the 2025 Paragraph IV Disputes Conference in New York
April 29, 2025
Blog
Supreme Court Has a Chance to (Re-)Clarify Albrecht Impossibility Preemption Test
April 3, 2025
Blog
Federal Jury Finds No Liability for SuperValu in FCA Case Remanded for Trial by SCOTUS
April 2, 2025
Speaking Engagement
Rand Brothers Discusses Microplastics: Regulation, Litigation, and Emerging Trends
April 1, 2025
Client Alert
HHS Announces Major Restructuring and Workforce Reductions
March 28, 2025
Sponsorship
Winston & Strawn Sponsors Healthcare Business International 2025
March 24, 2025
Recognitions
Law360 Names Winston Attorneys to 2025 Editorial Advisory Boards
March 20, 2025
Blog
BioZorb and the Power of Causation: Why Warnings Don’t Always Matter
March 17, 2025
View All Insights & News
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