Tag Archives: hatch-waxman

New Estoppel Concern For Petitioners Raised In BTG v. Amneal

The Court of Appeals for the Federal Circuit is poised to decide a case which may create new estoppel concerns for AIA petitioners under 35 USC § 315(e)(2).   The appeal resulted from a Hatch-Waxman litigation in BTG v. Amneal, in which the lower court found that the patent claims at issue were invalid over the same … Continue reading this entry

Proposed Legislation Would Require Choice Between ANDA Litigation Or AIA Challenges

On June 13, 2018, Sen. Hatch (R-Utah) introduced an amendment that would require generic ANDA filers to choose between litigating validity in Hatch-Waxman district court litigation or an AIA challenge (IPR or PGR), and on June 14th, the Senate Judiciary Committee voted 16-5 to bring it to the Senate floor for a vote.  Presently, generic ANDA … Continue reading this entry