Natco Pharma Ltd announced that it has successfully opposed a patent application in India that covers the composition of Glatiramer Acetate, the generic version of Teva Pharmaceutical Industries' Copaxone. The patent application was submitted to the Indian Patent Office, New Delhi, by Yeda Research & Development Company, which licensed the Glatiramer Acetate product to Teva.
Natco chairman and managing director Chowadary V Nannapaneni commented: '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 a high quality and more affordable version to MS (multiple sclerosis) patients in many countries of the world."
This victory opens the door to send the product from India to various countries as and when regulatory hurdles are cleared. On June 10, 2008, Natco announced that it signed a license and supply agreement with Mylan Inc. for Natco's Glatiramer Acetate that granted Mylan exclusive distribution rights in the United States and all major markets in Europe, Australia, New Zealand, Japan and Canada and includes an option to expand into additional territories.
Glatiramer Acetate, marketed in pre-filled syringes, is used to treat multiple sclerosis (MS). Natco has successfully commercialized its Glatiramer Acetate product in India and the Ukraine.
According to a Natco press release, the company challenged the Yeda patent application in the Indian Patent Office on several grounds including that it was obvious over the prior art. The Patent Office agreed with Natco's arguments and refused to grant the application because of 'obviousness and lack of inventiveness' over the prior art.