Hyderabad-based Natco Pharma has successfully blocked a patent application in India for Copaxone, a branded drug to treat multiple sclerosis, marketed globally by Israel-based Teva Pharmaceuticals Industries.
The patent application was submitted to the Indian Patent office by Yeda Research & Development Company, which licensed the product to Teva. The patent office refused the request because of “obviousness and lack of inventiveness.” The patent covers the composition of Glatiramer Acetate (GA), the generic version of Teva’s Copaxone, marketed in pre-filled syringes.
According to India’s patent rules, amended in 2005 to allow a product patent regime that bars copying of innovator drugs, patents would not be issued to molecules invented before 1995 and for known innovations.
Patent experts said it was one of the first instances in which generic companies sparred over patent issues. “We are extremely pleased by the patent office’s decision to deny this application. We’ve long maintained that the composition claimed in this request was an obvious variation of compositions in the public domain, and the current decision removes a potential obstacle to providing high quality and more affordable version of MS (multiple sclerosis) drugs to patients in many countries of the world,” said Natco Chairman and Managing Director V Nannapaneni.
Sources said drugs for multiple sclerosis had a global market potential of over $37 billion. Patent experts said the Indian patent office’s decision would help Natco and its marketing partner, Mylan Industries of the US, to launch the product in the US and Europe, subject to regulatory approvals. On June 10, 2008, Natco had also signed a license and supply agreement with Mylan Inc for its GA that granted Mylan exclusive distribution right in the US and all major markets in Europe, Australia, New Zealand, Japan and Canada, besides an option to expand into additional territories.
Natco has commercialised its GA product in India and Ukraine and is selling the product in the domestic market for close to Rs 1000 per dose. Teva’s product is also available in the domestic market and is priced about Rs 3,000 per dose. The two brands together have a market size of close to Rs 60-70 crore in India.