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

The Drug Price Competition and Patent Term Restoration Act of 1984, known as the Hatch-Waxman Amendments, continues to be 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.

Hogan Lovells Partner David Fox will speak on patent certification and litigation on Friday, June 24 from 1:00 - 3:00 pm.


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