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Merck defeats Mylan in Zetia-Vytorin patent lawsuits

Generic versions of cholesterol products delayed until April 2017

Merck & Co has won two cases in the US challenging the launch of generic versions of its Zetia and Vytorin cholesterol drugs by Mylan.

The US District Court Of New Jersey said the patent for ezetimibe, which is contained in both drugs, was “valid and enforceable” until its April, 2017 expiration. The Court also issued an injunction blocking the launch of Mylan's generic products until this date.

In a statement, Merck said that Mylan had “admitted that its product would infringe the patent”.

The case has been running for almost three years, after Merck went to court, first to block Mylan's application for US marketing approval of its generic version of Vytorin and later to take action when Mylan sought pre-patent approval to sell a version of Zetia.

Merck is also facing opposition to a patent challenge of its own.

The US firm, which is known as MSD outside the US and Canada, is being sued by Pfizer regarding plans to launch a Lipitor-plus-Zetia combination pill in the US.

Although generic versions of Lipitor (atorvastatin) were launched in the US in November 2011, Pfizer contends that some patents regarding its blockbuster cholesterol drug will not expire for several years, and it is on these which it is basing the Merck lawsuit.

The FDA has also requested more information for Merck's combination product in its marketing application, potentially delaying the drug's launch even if the company is successful in court.

Merck said it plans to discuss next steps with the agency in the near future, including new data that are expected to be available later this year and which the company believes may address the FDA's comments.

30th April 2012

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