Boost for Natco as court says Teva plea on drug not in its jurisdiction

Hyderabad-based Natco Pharma received a shot in the arm in its legal battle over Israeli drug-major Teva’s block-buster drug Copaxone, used to treat multiple sclerosis.

The Delhi High Court has returned Teva Pharmaceutical’s plea saying that it was not within its jurisdiction, a lawyer familiar with the development said. Teva was seeking an injunction to prevent Natco from exporting the drug, the source explained.

Natco has been selling the drug in India since 2007, and its export prospects on the drug depend on how the case unravels. In fact, Teva does not have a patent on the drug in India, following a pre-grant opposition by Natco at the Patent Controller’s office, the lawyer said.

Copaxone (Glatiramer Acetate) is a $4-billion drug and it is not clear if Teva will appeal this ruling. The patent on the drug expires in the US in May.

An email query to Teva on the company’s future action on the drug did not receive a response, before going to press. An inflammatory disease, multiple sclerosis affects the brain and spinal cord and its early symptoms include weakness, tingling, numbness, and blurred vision, said a health-information website. Other symptoms included muscle stiffness, thinking problems, and urinary problems, it added.

Natco has a global marketing alliance with American generic drugs and speciality company Mylan to market this drug overseas. They are waiting for the US Food and Drug Administration’s approval for selling it in the US. In fact, in its annual report 2012-13, Natco said that the launch of its version of Copaxone was “likely to push the company into (the) big league, resulting in a significant increase in sales as well as profits.”

Big ticket challenges are not new to Natco. It was part of the high-profile legal challenge on Novartis’ blood-cancer drug Glivec, besides being the first recipient of the country’s first compulsory licence (CL) on Bayer’s kidney cancer drug Nexavar. The CL allows Natco to make its generically similar version of Bayer’s Nexavar, on the payment of a revised 7 per cent royalty to Bayer.