As part of its strategy to fight out generics copies of the leading high blood pressure medicine, Lotrel, the Novartis Corp. has filed patent infringement litigation against the Hyderabad based Dr Reddy's Laboratories in the US District Court for the District of New Jersey. The US drug major has filed complaint against the generic drug companies including Teva pharmaceuticals in 2004 against the Mumbai based Lupin in early 2007.

In its complaint, Novartis alleged that submission of Dr Reddy's ANDA would constitute an act of infringement of the '802 patent pursuant to 35 USC § 271 (e) (2) which includes Para IV certification as to the '802 patent.

Novartis Corp. complained that Dr Reddy's is violating the US Patent No 6,162,802 (the '802 patent) through filing ANDA No. 77-183, which seeks approval to market amlodipine besylate and benazepril hydrochloride capsules.

According to this, the ANDA filing indicates that the company is seeking approval for the generic prior to the expiration of the '802 patent, which is valid upto December 2017.

The '802 patent is related to synergetic combination therapy containing angiotensin converting enzyme (ACE) inhibitor benazepril hydrochloride and the calcium channel blocker (CCB) amlodipine besylate in a single tablet to treat cardiovascular disorders. Lotrel has an annual sale of USD 1.5 billion in US.

The company has already initiated civil action against Teva Pharmaceuticals, which is the first ANDA filer and Watson pharmaceuticals, Par pharmaceuticals and Lupin on the infringement of the '802 patent. The company sources affirmed, "Novartis will continue to vigorously defend its intellectual property rights, including the validity of the Lotrel patent, against any generic challengers."