DC District Courthouse

Pharmaceutical Litigation

Sterne Kessler’s pharmaceutical and biopharmaceutical litigation practice integrates life science trial skills, technical depth and patent knowledge.

Sterne Kessler's integrated trial team brings together a deep bench of experienced litigators, technical experts and attorneys with specialized patent knowledge providing a fully synchronized approach to pharmaceutical cases. We represent both brand and generic pharmaceutical and biopharmaceutical companies involved in experimental and prescription drugs and biologics.

Selecting the right counsel is critical, particularly in an IP-related case, because of the inherent complexity of the subject matter. We know that in today's competitive marketplace, it is especially difficult to navigate the demands of FDA regulation, patent validity challenges and patent protection of small molecule and biologic drugs. Whether the challenge is gaining market access for a generic drug, maintaining exclusivity for a proprietary drug, or developing and launching a biosimilar, Sterne Kessler has the legal and technical depth to win.

Sterne Kessler is distinguished by its integrated trial team, which brings together a deep bench of experienced litigators, technical experts and attorneys and agents with specialized patent law knowledge that provides clients with a fully synchronized approach to their cases. Sterne Kessler professionals hold nearly 50 Ph.D.s and 30 master's degrees in substantive technical fields like organic chemistry, medicinal chemistry, biochemistry and molecular and cell biology. Our ANDA expertise includes over 50 Paragraph IV filings and over 500 opinions.

In pharmaceutical litigation matters, we provide early and ongoing analysis of the relevant patents, prior art and products involved. And, we formulate strong positions on invalidity, non-infringement and claim construction at the outset of the litigation, ensuring that our tactics achieve an agreed-upon set of goals.

Sterne Kessler represents both brand and generic pharmaceutical companies involved in experimental and prescription drugs and biologics.

We have acted as co-counsel in Hatch-Waxman cases involving:

  • Cholesterol drugs
  • Blood pressure drugs
  • Sleep aides
  • Chemotherapeutics
  • Urinary agents
  • ADHD drugs
  • Approved biologics
  • Respiratory disorder and asthma drugs
  • Dermatological drugs
  • Analgesics
  • Antihistamines
  • Mental disorder drugs
  • Treatments in the form of patches, creams, suspensions, topicals, orals, injectables, rings, suppositories and ODTs, to name a few