Wednesday, August 14, 2013

Lupin Invalidates Allergan patents on Zymaxid

The various patents protecting Allergan Zymaxid expire in June 2015 (Patent '283) and February 2020 (Patent '045).  Lupin has already received a tentative approval for marketing Zymaxid in the US and is believed to have a first to file status. Zymaxid generates about $50m in annual sales.  In its ruling the court announced defendants infringe claims 6, 12-16 and that claims 6, 12-16 of the '045
patent (expiring in 2020) are invalid for obviousness.

Litigation Background

In 2011, after Lupin and Hi-Tech each filed an ANDA with the FDA seeking approval to market a generic version of Zymaxid ® , Allergan received paragraph 4 invalidity and non-infringement certifications from Lupin and Hi-Tech, contending that the '045Patent and the '283 patent are invalid or not infringed by the proposed generic products. The Company, with Senju and Kyorin, filed a complaint against Lupin and Hi-Tech in the U.S. District Court for the District of Delaware alleging infringement of the '045 Patent and the '283 Patent. The U.S. District Court consolidated the Lupin
Zymar® and Lupin Zymaxid ®cases. The Company, Senju and Kyorin dismissed the claims 
related to the '283 Patent.


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