Hatch-Waxman Litigation

Latham & Watkins’ senior Hatch-Waxman trial lawyers have more than 130 years of combined litigation experience and lead teams of experienced litigators well versed in the Hatch-Waxman statutory regime.

Latham’s lawyers, many of whom have technical backgrounds in chemistry and biological sciences, understand the strategic and tactical implications that are particular to Hatch-Waxman cases, including:

  • Managing exclusivity and forfeiture
  • Navigating the interrelationship between the US Food & Drug Administration (FDA) strategy and litigation strategy
  • Understanding the business and antitrust aspects of settlements and other transactions

The group provides invaluable objective input into each client’s assessment of market opportunities and critical path to launch. Latham’s lawyers have handled nearly 70 such litigations, involving several trials and appeals, and including more than two dozen first-filer/exclusive launch opportunities, covering products with combined annual sales of over US$ 53 billion.

Focus On The Opportunity & Merits

Latham’s litigation approach is tailored to the clients’ business and strategic objectives. In the Hatch-Waxman context, the team clearly understands the opportunity and tactical differences between cases involving a first-filed ANDA, a multi-defendant NCE-1 and a distant second-filer in a market where the first-filer and an AG have already launched. 

The firm’s Hatch-Waxman litigators never lose sight of where each case ranks within a client’s portfolio of opportunities as well as the fact that at the heart of every contested market opportunity lie the merits of an infringement claim and the defenses thereto. Latham excels in assessing, litigating and trying those claims and defenses.

Latham’s Hatch-Waxman Litigation Practice is supported by the firm’s FDA Regulatory Practice and the Supreme Court & Appellate Practice.


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