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Merck & Co defeated in Apotex patent suit

Canada-based generics firm allowed to launch copy of allergy spray Nasonex

Merck & Co has lost a US lawsuit brought against Canadian generics manufacturers Apotex regarding a copycat version of Merck's allergy spray Nasonex.

The US-based pharma firm had attempted to stop the launch of a generic version of the product by claiming Apotex had infringed the patent of the drug's active ingredient mometasone furoate monohydrate in its request to the US Food and Drug Administration (FDA) for marketing approval.

At stake for Merck are US sales that ran to $161m in the first quarter of this year, amounting to a significant chunk of Nasonex's $375m global revenues in the period.

However, despite upholding the patent of Nasonex, the US District Court for the District of New Jersey said Apotex' copy did not infringe Merck's rights and should be allowed to reach the US market.

Apotex has a history of aggressively targeting pharma patents and its was the first company to launch a generic version of Sanofi and Bristol-Myers Squibb's Plavix in 2006, six years before the drug's patent was due to expire. However, Apotex subsequently lost a patent infringement suit and had to halt manufacturing and pay costs.

In its latest case the generic firm argued its nasal spray was sufficiently different from Nasonex because its version would not contain water, meaning Merck's patent was not infringed.

In addition, US District Judge Peter Sheridan, who presided over the case, said that Merck had “failed to present credible evidence” to back its claims of patent infringement.

In a statement, Merck said it disagreed with the decision, and argued that Apotex's product would still infringe the patent that provides exclusivity for the form of mometasone used in Nasonex. This patent should be valid until April 3, 2018, Merck said and the company vowed to continue its fight to protect its products.

"Today's decision reflects just one step in the lengthy patent litigation process, and we plan to review all of our options, including a likely appeal of the decision," said Bruce Kuhlik, executive vice president and general counsel of Merck.

The company's recent litigation history has been more positive for Merck, after it gained victory over Mylan after the patent of cholesterol drugs Zetia and Vytroin were challenged.

18th June 2012

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