Merck Wins U.S. ZETIA® (ezetimibe)/ VYTORIN® (ezetimibe/simvastatin) Patent Infringement Lawsuit


April 27, 2012 5:05 pm ET

WHITEHOUSE STATION, N.J.–(BUSINESS WIRE)–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.

About Merck

Today’s Merck is a global healthcare leader working to help the world be well. Merck is known as MSD outside the United States and Canada. Through our prescription medicines, vaccines, biologic therapies, and consumer care and animal health products, we work with customers and operate in more than 140 countries to deliver innovative health solutions. We also demonstrate our commitment to increasing access to healthcare through far-reaching policies, programs and partnerships. For more information, visit and connect with us on Twitter, Facebook and YouTube.

Forward-Looking Statement

This news release includes “forward-looking statements” within the meaning of the safe harbor provisions of the United States Private Securities Litigation Reform Act of 1995. Such statements may include, but are not limited to, statements about the benefits of the merger between Merck and Schering-Plough, including future financial and operating results, the combined company’s plans, objectives, expectations and intentions and other statements that are not historical facts. Such statements are based upon the current beliefs and expectations of Merck’s management and are subject to significant risks and uncertainties. Actual results may differ from those set forth in the forward-looking statements.

The following factors, among others, could cause actual results to differ from those set forth in the forward-looking statements: the possibility that all of the expected synergies from the merger of Merck and Schering-Plough will not be realized, or will not be realized within the expected time period; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; Merck’s ability to accurately predict future market conditions; dependence on the effectiveness of Merck’s patents and other protections for innovative products; and the exposure to litigation and/or regulatory actions.

Merck undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Merck’s 2011 Annual Report on Form 10-K and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (

Ron Rogers, 908-423-6449
Carol Ferguson, 908-423-4465

Unsubscribe from email alerts