Natco Pharmaceuticals, the Hyderabad-based drug manufacturer, has won a patent case against Teva Pharmaceuticals of Israel.
The New Delhi High Court, on February 28, dismissed Teva’s suit seeking an injunction over the marketing of a generic version of multiple sclerosis drug, copaxone (glatiramer acetate) in the U.S. While Teva does not have a patent on the drug in India, the injunction sought to prevent Natco exporting it.
The decision could allow Natco to launch generic version of Teva’s Copaxone in the U.S., subject to approval from the U.S. Food & Drug Administration (USFDA).
The patent on the $4 billion sales drug, expires in the U.S. on May 24, 2014.
“We are still awaiting USFDA approval, and our plans in the U.S. depend on that,” M. Adi Narayana, Company Secretary & Vice President-Legal & Corporate Affairs, Natco Pharma, told The Hindu. Natco has been selling it in India since 2007, and plans to market it with partner U.S.-based pharma giant Mylan with whom it has a global marketing alliance since 2008.
Teva sued Natco, seeking an injunction as it alleged Natco’s move infringed on its process patent. Mr. Narayana said, “We are very pleased with the decision by the New Delhi High Court to dismiss and take no action in this matter. We continue to believe that the sole Indian process patent is invalid, as reinforced by the outcomes of numerous other legal proceedings. We are also pursuing other challenges against this patent”. Natco took on big global pharma in the past having won a case against Novartis for its blood cancer drug, Glivec last year and also receiving India’s first compulsory license (CL) on the kidney cancer drug Nexavar made by Bayer.
Mr. Narayana said Natco successfully completed a preferential issue to CX Securities for Rs.153 crore to retire old debt and had shareholder approval to raise capital to set up a facility in Mehbubnagar, Andhra Pradesh, to cater to Mylan’s requirements.