Global research-driven pharmaceutical company Merck & Co has filed a patent infringement case over the active pharmaceutical ingredient Finasteride against Hyderabad-based Hetero Drugs in the United States District Court for the District of New Jersey. The company had filed a new drug application (NDA) for 1 mg for the active ingredient Finasteride, which is used in the treatment of male pattern baldness and sold in the US under the brand name Propecia. On October 6, 2010, Hetero sent a notice to Merck after filing an Abbreviated New Drug Application (ANDA) for Finasteride prior to the expiration of the patent which is on November 5, 2013.
When contacted, Hetero Drugs officials were unavailable for any comment.
Merck claims that Hetero was aware of the existence of the patent before filing for ANDA which constituted an act of infringement of the patent. However, the counsel for Hetero and Merck had negotiated a confidential access agreement by which Merck could gain access to Hetero?s complete ANDA, drug master file (DMFs) and active pharmaceutical ingredients (APIs). In the process, Merck claimed that Hetero did not produce the ANDA and DMF till November 10, 2010.
In the litigation, Merck claims there was a delay in obtaining the agreed tablets from Hetero which gave it on November 18, 2010. According to Hetero, its Finasteride tablets would not infringe Merck ?184 patent, but Merck says Hetero has infringed ?817, ?957, and ?184 patents.
Finasteride is marketed by Merck under the trademark names Proscar and Propecia. It was initially approved by the USFDA in 1992 under the brand name Proscar, a treatment for benign prostatic hyperplasia and later in 1997, the FDA approved finasteride to treat male pattern baldness (MPB) under the brand name Propecia. Some of the other companies such as Ajanta Pharma, Aleppo Pharmaceutical, Cipla, Dr Reddy’s, Intas Pharmaceuticals and Ranbaxy. The US market for Proscar is estimated at $406 million about few years back.