Merck wins U.S. ZETIA® (ezetimibe) / VYTORIN® (ezetimibe/simvastatin) patent infringement lawsuit

Merck (NYSE: MRK), known as MSD outside the United States and Canada, announced today that the U.S. District Court for the District of New Jersey has ruled in Merck’s favor in two jointly related patent infringement suits against Mylan Pharmaceuticals Inc.

“The court appropriately ruled that the patent for ZETIA and VYTORIN in the U.S. is valid and enforceable,” said Bruce N. Kuhlik, executive vice president and general counsel of Merck. The patent at issue in this trial is RE 42,461 which covers ezetimibe, an active ingredient in both ZETIA and VYTORIN and expires April 2017.

In its decision, the court upheld Merck’s patent on ZETIA and VYTORIN and ruled that the patent was valid and enforceable. Mylan had admitted that its product would infringe the patent. The court also issued an injunction blocking the approval of Mylan’s generic versions until the expiration of the patent.

Mylan had been seeking U.S. Food and Drug Administration (FDA) approval to sell generic versions of ZETIA and VYTORIN. In December 2009, Merck filed the lawsuit against Mylan in respect of Mylan’s application to the FDA seeking pre-patent expiry approval to sell a generic version of VYTORIN and in June 2010, Merck filed a separate lawsuit against Mylan in respect of Mylan’s application seeking pre-patent approval to sell a generic version of ZETIA.

Judge Jose Linares presided over the trial. Merck was represented by Sidley Austin LLP, Lowenstein Sandler PC and Robinson, Wettre & Miller LLC.