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28 July 2015Big Pharma

Bayer successful in Finacea patent dispute

Bayer has claimed victory after a US district court ruled that a generic version of one of its skin treatment drugs proposed by Glenmark Pharmaceuticals infringed its patent.

The ruling was handed down by the US District Court for the District of Delaware yesterday, July 27.

Bayer had claimed in a 2013 lawsuit that an Abbreviated New Drug Application (ANDA) filed by Glenmark at the US Food and Drug Administration the previous year infringed its US patent number 6,534,070, called “Composition azelaic acid”.

Glenmark’s application was for a generic version of Bayer’s Finacea (azelaic acid) gel, which is used to treat the pimples and redness associated with chronic skin condition rosacea.

Bayer made around $95 million from sales of Finacea in 2012, according to drug information company IMS Health.

The ‘070 patent is currently assigned to Intendis, a subsidiary of Bayer, and was issued by the US Patent and Trademark Office in 2003.

In Glenmark’s ANDA, the company argued that the patent was invalid on the grounds of obviousness and that its proposed generic would not infringe it.

Bayer’s 2013 complaint meant that a decision on Glenmark’s ANDA was stayed until either 30 months after the initial application or until the lawsuit had been finalised.

Judge Sue Robinson, presiding over the case, said: “The court finds that defendants have not met their burden to prove, by clear and convincing evidence, that claims 1-12 of the ‘070 patent are invalid for obviousness,” adding that “defendants infringed the asserted claims of the ‘070 patent”.

Neither Bayer nor Glenmark had responded to a request for comment at the time of publication, but we will update the story should either company get in touch.

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