Brands, Generics and Hatch-Waxman: New Challenges; Unabated Controversy

Program Description:

The Drug Price Competition and Patent Term Restoration Act of 1984, known as the Hatch-Waxman Amendments, continues to be one of the most litigated and generally contentious arenas of drug law. The constant array of lawsuits, petitions, and administrative challenges regarding 180-day exclusivity, patent listings, and patent-term extensions have addressed important issues during the last year, resolving some, but further complicating others. This program will provide an in-depth analysis of these ongoing issues. The Program will also address antitrust considerations associated with Hatch-Waxman patent and administrative challenges and the interplay between Hatch-Waxman and the newly authorized biosimilars approval pathway.