Natco Pharma has said that a US District Court has ruled in favour of its marketing partner Mylan by invalidating Israel-based Teva Pharmaceuticals’ patents related to a multiple sclerosis drug Copaxone. It is an injectable drug to treat relapsing forms of multiple sclerosis which damages the central nervous system. “The United States District Court for the District of Delaware issued a decision finding all asserted claims of four Orange Book-listed patents related to Copaxone 40 mg/mL invalid based on obviousness,” Natco Pharma said in a BSE filing.
To recall, Natco had agreed to partner with Mylan to challenge Teva’s Copaxone 20 mg and 40 mg patents. As per the agreement, Natco supplies the drug and Mylan markets it in the US and both the companies will share the profits.
It further said: “The invalidated patents are owned by Yeda Research and Development Company and licensed to Teva Pharmaceuticals Industries.” In December 2016, the US Patent and Trademark Office (PTO) had ruled in favour of Mylan and three patents related to Copaxone 40 mg/mL were found unpatentable.
Quoting IMS Health data, the company said Copaxone 40 mg/mL had US sales of approximately $3.3 billion for the 12-month ended November 30, 2016. On August 24, 2016, the US Patent and Trademark Office (PTO) has ruled in favour of Mylan in its inter partes review (IPR) proceedings and found all claims of two related Copaxone 40 mg/mL patents to be unpatentable.