S&D’s Hatch-Waxman trial lawyers have decades of litigation experience and lead teams of experienced litigators well versed in the Hatch-Waxman statutory regime.
Our 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. S&D has handled many first-filer/exclusive launch opportunities, covering products ranging from sterile injectables to solid orals to transdermal patches.
Focus On The Opportunity & Merits
The Firm’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.