April 11 (Reuters) - A U.S. appeals court on Thursday
affirmed a decision for Bausch Health ( BHC ) that barred rival
drugmaker Alvogen from marketing a proposed generic version of
Bausch's diarrhea treatment Xifaxan until 2029.
A Delaware federal court had determined that Alvogen
subsidiary Norwich Pharmaceuticals' generic would infringe
patents owned by Bausch's Salix Pharmaceuticals. It blocked the
U.S. Food and Drug Administration from approving the generic
until the last Xifaxan U.S. patent expires in October 2029.
Representatives for Bausch and Alvogen did not immediately
respond to requests for comment on the decision.
Bausch has said the litigation could affect its plans to
spin off its eye-care business Bausch + Lomb ( BLCO ). Analysts at
Jefferies said on Thursday that the decision removes a "key
barrier" for the spinoff.
Bausch has separately agreed to allow Xifaxan generics from
Teva Pharmaceuticals, Sun Pharmaceuticals and
Sandoz starting in 2028 after settling related patent
disputes.
Xifaxan is approved to treat traveler's diarrhea and
irritable bowel syndrome (IBS) and can be used to prevent the
liver-related brain disorder hepatic encephalopathy (HE).
Salix sued Norwich for patent infringement over its proposed
generic in 2020. A Delaware federal judge determined in 2022
that the generic would infringe three Salix patents related to
treating HE while declaring other Salix patents invalid.
Norwich asked the U.S. Court of Appeals for the Federal
Circuit to reverse the district court's decision to block its
generic based on the infringement, while Salix appealed the
decision to invalidate its other patents.
The FDA tentatively approved Norwich's generic last year but
declined to grant its final approval because of the Delaware
court order.
Norwich has also appealed a loss in a separate lawsuit in
Washington, D.C. federal court, where it sought to force the FDA
to fully approve its drug.