The U.S. Supreme Court turned away an effort by Momenta Pharmaceuticals Inc. and Novartis AG (NOVN)’s Sandoz to halt sales of a competing generic version of the blood-thinner Lovenox.
The high court today declined to hear their appeal of a ruling that let Actavis Inc. (ACT:US) and Amphastar Pharmaceuticals Inc. sell the copycat medicine while a patent-infringement case is pending in federal court. The patent covers a way to analyze the drug during the manufacture process to ensure it follows certain quality controls required by regulators.
A lower-court decision limited the right of patent owners to claim infringement of processes needed to maintain approval of generic medicines by the U.S. Food and Drug Administration. It expanded the scope of a federal law that prohibits infringement suits over actions taken to gain FDA approval.
The Supreme Court case is Momenta Pharmaceuticals Inc. (MNTA:US) v. Amphastar Pharmaceuticals Inc., 12-1033.
The appeals court case is Momenta Pharmaceuticals Inc. v. Amphastar Pharmaceuticals Inc., 12-1062, U.S. Court of Appeals for the Federal Circuit (Washington). The lower court case is Momenta Pharmaceuticals Inc. v. Amphastar Pharmaceuticals Inc., 11cv11681, U.S. District Court for the District of Massachusetts (Boston).
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