Patent Office upholds Natco's plea

Drug maker Natco on Monday said that the Patent Office has upheld the firm's opposition to an application of Yeda Research & Development Company for patenting a generic version of a product of Teva Pharmaceutical Industries.

"The Patent Office (at New Delhi) agreed with the company's arguments and refused to grant the application because of "obviousness and lack of inventiveness" over the prior art," Natco said in a filing to the Bombay Stock Exchange.

The patent application for glatiramer acetate was submitted before the Indian Patent Office by Yeda Research & Development Company, which licensed the product to Teva.

Glatiramer acetate, marketed in pre-filled syringes, is used in decreasing the frequency of relapses in patients with relapsing remitting multiple sclerosis (RRMS).

Natco had opposed the patent application on the grounds that it was obvious over the prior art.

"Natco has successfully commercialised its glatiramer acetate in India and the Ukraine," it said.

"We have long maintained that the composition claimed in this request was an obvious variation of compositions in the public domain and current decision removes a potential obstacle to providing a high quality and more affordable version of MS (multiple sclerosis) to patients in many countries of the world," Natco CMD V Nannapaneni said.

"The victory opens the door to send the product from India to various countries as and when regulatory hurdles are cleared," the company added.

Last year, the company had signed a licence and supply agreement with US-based generic pharmaceuticals company Mylan Inc for Natco's glatiramer acetate.

According to Natco, the agreement granted Mylan exclusive distribution rights in the US and all major markets in Europe, Australia, New Zealand, Japan and Canada and includes an option to expand into additional territories.