Merz Pharmaceuticals LLC, a maker of neurological drugs, sued Par Pharmaceutical Inc. for patent infringement, claiming the generic-drug company is copying a medicine that treats severe drooling in cerebral palsy patients.
Par, an affiliate of private equity company TPG Capital, violated the patent for the drug Cuvposa by applying for the right to make a generic version before Merz’s patent expired, Merz said in court papers filed yesterday in U.S. District Court in Wilmington, Delaware.
“Merz will be substantially and irreparably damaged and harmed,” if Par goes forward with its plan, Merz said in its complaint.
Before a generic-drug maker can begin a producing patented medicine, it must get permission from federal regulators. As part of its application, Par claimed that its plan either didn’t violate a current patent, or that the patent related to Cuvposa is invalid, according to the Merz complaint.
Stephen Mock, a spokesman for Par, declined to comment on the filing.
Cuvposa is classified by federal regulators as a so-called orphan drug because it treats a rare disorder with limited medical options, according to a Merz company statement. In August, Merz announced that it had bought the rights to the drug, which won federal approval in 2012.
Merz, an affiliate of German drugmaker Merz Pharma GmbH & Co., asked the court to halt Par’s effort to produce the drug. Cuvposa is the brand name for glycopyrrolate oral solution.
The case is Merz Pharmaceuticals LLC v. Par Pharmaceutical Inc., 12-cv-01723, U.S. District Court, District of Delaware (Wilmington).