Pharmaceutical Patent Litigation

Clients turn to Sterne Kessler to handle their pharmaceutical IP litigation because we know what it takes to win across any venue—with the trial skills, technical depth, and patent knowledge that delivers results.

In the last five years, Sterne Kessler has acted as litigation counsel in more than 150 patent cases across 27 jurisdictions in federal district court. We are also one of the top five most active firms at the U.S. Court of Appeals for the Federal Circuit in that same time frame. Our award-winning team has a deep bench of experienced litigators representing biosimilars as well as generic and specialty brand pharmaceutical companies in high-profile patent litigation, including blockbuster Abbreviated New Drug Application (ANDA) and Biologics Price Competition and Innovation Act (BPCIA) matters.

The Sterne Kessler Advantage

Industry Focused Trial Teams

We are trial lawyers who know the science behind our clients’ products. Many of our team members hold Ph.D.s or advanced degrees in fields such as medicinal chemistry, biochemistry, pharmacology, immunology, and molecular and cell biology so we can quickly grasp the science and technologies at issue in a case. Our industry knowledge and insight are used to develop effective legal strategies and to explain complex technology and IP concepts to both judges and juries in a compelling way.

We understand the advancements in life sciences that are shaping the IP landscape and excel at handling the most complex, bet-the-company cases. Our litigation experience covers a wide variety of conditions, from dry eye and gastrointestinal disease to cancer and psychological disorders. We are also experienced with a broad list of products, ranging from topical emulsions to therapeutic antibodies. In addition, we manage cases involving related technology such as DNA sequencing and drug delivery devices.

Tailored Legal Strategies

Whether you are anticipating generic or biosimilar competition for key products, or contemplating a generic or biosimilar product launch, we understand the sophisticated IP issues that can arise in litigation. Our lawyers have particular depth of experience at the interface between patent law and the Food and Drug Administration’s (FDA) drug approval process. We excel at every phase of the ANDA or BPCIA process, helping innovators or companies contemplating generics or biosimilars to achieve their commercial objectives. Our team develops strong positions early in litigation, preparing a detailed case roadmap to identify essential discovery, and drive discovery to fill gaps in that roadmap. We have litigated cases involving formulations, methods of treatment, label carve-outs, and more.

Leaders Across Venues

We are particularly skilled at coordinating actions across multiple venues when a multi-venue strategy can be favorable for our clients, including in federal district and appellate courts and the International Trade Commission. We also collaborate with our Post-Grant Practice Group to challenge patents in inter partes review and post-grant proceedings before the Patent Trial and Appeal Board.

Working With Sterne Kessler

  • Your goals always come first. We know that our pharmaceutical clients’ strategic goals vary from case to case, and we tailor our approach to achieve those goals as efficiently as possible. From the outset, we align our strategy with your business objectives and focus on your ideal outcome. Whether you are seeking early settlement or planning to take a case through trial, our team has the proven experience to guide you through any type of IP dispute.
  • We help you expect the unexpected. Before the start of any matter, we work with you to define phases, assess risk, and identify important milestones. We can anticipate potential obstacles over the life of a case and develop a strategic plan to overcome them. By providing early and ongoing analysis of relevant patents, prior art, and products, we formulate strong positions on invalidity, non-infringement, and claim construction at the outset of litigation.
  • Communication is our highest priority. Litigation can be unpredictable, and we develop a communication plan with our clients to keep them well-informed through the life of a case. We regularly report on matters in an efficient and cost-effective way. We are also committed to developing budgets that align with your needs and expectations.

Awards & Rankings

  • Highly Recommended/Tier 1 for Hatch-Waxman Litigation, LMG Life Sciences (2017-2023)
  • Winner of “Hatch-Waxman Impact Case of the Year” award for Adapt Pharma v. Teva (Fed. Cir. 2022), LMG Life Sciences Americas Awards (2022)
  • Tier 1 for Biotechnology Law (National) and Patent Litigation (Regional, Washington, D.C.), U.S. News – Best Lawyers® Best Law Firms (2023)

Related News & Insights

Speaking Engagement

June 20, 2024 11:30 AM - 12:30 PM PST

15th Summit on Biosimilars & Innovator Biologics

Press Release

June 10, 2024

Sterne Kessler and 18 Directors Garner Top Rankings for World-Class Patent Work in 2024 IAM Patent 1000

Sterne, Kessler, Goldstein & Fox