Novartis Filed Complaint for Patent Infringement against Lupin

Novartis has filed a complaint for patent infringement following a notification from Lupin Pharmaceuticals that it has filed an abbreviated new drug application (ANDA) under Para IV certification with the US FDA seeking marketing approval for generic Lotrel before expiry of Orange Book listed patent. In its complaint, Novartis alleged that Lupin’s ANDA No. 78-466 would be infringing the U.S. Patent No. 6,162,802 (the ‘802 patent) and subsequently demanded the district court to permanently enjoin Lupin from making , using, offering to sell, or importing the Lupin’s generic Lotrel until after the expiration of the ‘802 patent (including six month additional pediatric exclusivity period). Lotrel is a combination of amlodipine and benazepril hydrochloride, which is protected the ‘802 patent directed to a pharmaceutical composition consisting essentially of a range of ratios of specified amounts of benazepril and amlodipine (or pharmaceutically acceptable salts of either or both), as well as a method of treating condition selected from a group consisting of hypertension, in a human, consisting of administering a daily dose of a range of ratios of specified amounts of benazepril and amlodipine (or pharmaceutically acceptable salts of either or both). Lupin in its ANDA contended and certified that the ‘802 patent is invalid and/or will not be infringed by the Lupin proposed generic Lotrel product. The complaint has been filed in the U.S. District Court for the District of New Jersey and the U.S. District Court for the District of Maryland (Northern Division).