Valeant Pharmaceuticals announced the U.S. District Court for the District of New Jersey has granted a motion for partial summary judgment of validity of a formulation patent for RELISTOR (methylnaltrexone bromide) Injection. The ruling prevents generic competition in the United States until 2024.
Plaintiffs in the case, including Progenics Pharmaceuticals, Salix Pharmaceuticals, Inc., Valeant and Wyeth LLC, had filed a motion for summary judgment on challenges to the validity of Claim 8 of U.S. Patent No. 8,552,025, which protects the formulation of RELISTOR Injection.
Defendants in the case, which include Mylan Inc., Mylan Laboratories LTD., Mylan Pharmaceuticals, Inc. and Actavis LLC., had previously stipulated to infringement of Claim 8 and have no remaining invalidity defenses.
In the upcoming trial on June 4, the court will decide the infringement and validity of other patents that could prevent generic RELISTOR vials until 2029 and generic RELISTOR syringes until 2030.
Valeant will continue to defend its intellectual property in these and other claims.