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Merck blocks Mylan’s generic Zetia and Vytorin after appeal

Keeps patents of cholesterol medicines protected until April 2017

US Court of Appeals for the Federal Circuit

A US appeals court has upheld the patent for Merck & Co's cholesterol-lowering medicines Zetia and Vytorin, following a challenge from generics company Mylan.

Merck had previously won a case in April last year to block Mylan launching copies of the two drugs, with the US District Court Of New Jersey stating the patent for ezetimibe, which is contained in both products, was “valid and enforceable” until its expiration in April 2017.

Following this, Mylan appealed the decision, but the original decision has been upheld by the US Court of Appeals for the Federal Circuit, which released a concise statement affirming the judgement.

Zetia (ezetimibe) and Vytorin (ezetimibe/simvastatin), which are approved in the US to reduce cholesterol, are big sellers for Merck, respectively making $2.5bn and $1.7bn during 2012.

Generic competition from Mylan would have made a massive dent in these figures, but Merck now has another four years of protection.

As reported by Reuters, Merck spokesman Ron Rogers said: "We invest heavily in the R&D that is needed to discover innovative medicines like Vytorin and Zetia, and we will vigorously defend our intellectual property rights.”

Ahead of the original decision in April last year, the case had been running for three years, when Mylan first applied for US marketing approval for a generic Vytorin product.

This was later followed by a request for pre-patent approval to sell a version of Zetia, which was also challenged by Merck.

The decision comes not long after Merck received less welcome news regarding another one of its patents, when Canadian generics manufacturers Apotex won a lawsuit to launch a generic version of Merck's allergy spray Nasonex.

Although the US District Court for the District of New Jersey upheld product's patent, it decided that the copy from Apotex did not infringe Merck's rights as its version would not contain water, making it sufficiently different.

8th February 2013

From: Sales, Regulatory

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