15 March 2013Americas

Bayer sues Glenmark over generic Finacea

Pharmaceutical companies Bayer, Intendis and Intraserv have filed a patent infringement lawsuit against Glenmark after it applied to market a generic version of rosacea treatment Finacea.

In press release published on Thursday, March 14, Glenmark confirmed that it has filed an Abbreviated New Drug Application (ANDA) at the US Food and Drug Administration (FDA) for a generic version of Bayer’s azelaic acid gel, which is used to treat the pimples and redness associated with chronic skin condition rosacea.

Glenmark believes it could be the first to file an ANDA for the generic gel and so may be entitled to 180 days of generic market exclusivity.

But in a complaint filed on March 14 at Delaware’s district court, Intendis, Intraserv and Bayer have requested a declaration of infringement and an injunction blocking US sales of the generic until their composition patent for Finacea expires in 2018.

The patent is owned by Intendis and licensed exclusively to Intraserv. Bayer is the exclusive distributor of Finacea, which had US sales of $95 million in 2012.

The lawsuit means that FDA approval of the treatment will now be delayed for either 30 months or until the case concludes.

Bayer sues USPTO

In a separate case, Bayer has also sued the US Patent and Trademark Office challenging the patent term extension granted to its  US patent for vardenafil hydrochloride trihydrate which is used to treat erectile dysfunction.

Under the American Inventors Protection Act, companies are entitled to patent term extensions if the life of their patent is reduced by processing delays – for example, if the USPTO fails to issue a patent within three years of the filing date.

But in a complaint filed at the US District Court for the Eastern District of Virginia on Tuesday, March 12, Bayer alleges that the USPTO “arbitrarily and capriciously granted Bayer a patent term adjustment of only 1481 days, although [it] is entitled to a patent term adjustment of 1981 days”.

Bayer has requested that the judge order the USPTO to correct its adjustment.

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