On Demand

Hatch Waxman Litigation

1h 30m

Created on October 25, 2016




The Hatch-Waxman Act, formally, the Drug Price Competition and Patent Term Restoration Act of 1984, P.L. 98-417, provides an expedited process for generic drug approval and has successfully created a strong and vibrant generic drug industry. Join Fitzpatrick Partner Ha Kung Wong and Fitzpatrick Of Counsel John Kirkland as they walk through the intricacies of the Act, discuss industry trends and the development of the law regarding induced infringement. Mr. Wong and Mr. Kirkland also explore how the Leahy-Smith America Invents Act (AIA), signed into law in 2011, has impacted Hatch-Waxman litigation.

Learning Objectives:

  1. Understand the Hatch-Waxman Act, including: Generic approval process; exclusivities available for brand and generic drugs; certifications available to generic drug applications; forfeiture of generic exclusivities; patent term extension; and framework for litigation
  2. Comprehend the intricacies of induced infringement
  3. Discuss the AIA and Hatch-Waxman litigation
  4. Gain best practices and tips

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