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 filers can pursue challenges using both of these routes at the same time, although some courts may stay litigation pending the outcome of the AIA challenge. The proposed legislation would modify the Food & Drug Cosmetic Act (not AIA) to require the ANDA filer to confirm at the time of making its Par. IV certification that neither the ANDA applicant nor any party in privity has filed, or will file, a petition to institute an IPR or PGR challenge of any patent claiming the reference listed drug.