Novartis Corp. et al v. Dr. Reddy’s Labs Inc. et al.

Novartis has filed a civil action in the US District Court for the District of New Jersey for the infringement of the US Patent No. 6,162,802 (the ‘802 patent) against Hyderabad-based Dr. Reddy’s Laboratories which earlier filed an Abbreviated New Drug Application (ANDA) No. 77-183 with the US Food and Drug Administration, seeking approval to market amlodipine besylate and benazepril hydrochloride capsules. 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 Paragraph IV certification as to the ‘802 patent, seeking approval prior to the expiration of the ‘802 patent. The ‘802 patent is related to synergetic combination therapy using benazapril and amlodipine for the treatment of cardiovascular disorders for which Novartis holds an New Drug Application (NDA) under the brand name Lotrel.