U.S. patent office rules in favour of Mylan

The estimated market size for Copaxone in the U.S. is $3.3 bn for the 12 months ended June

Natco Pharma said the U.S. Patent and Trademark Office (PTO) has ruled in the favour of its marketing partner Mylan with regard to patent claims pertaining to multiple sclerosis drug Copaxone.

The patent office has ruled in favour of Mylan in its “inter partes review proceeding and found all claims of two related Copaxone 40 mg/ml patents to be unpatentable,” according to a statement from the Hyderabad-based firm.

Important ruling

The development assumes significance for Natco as it is pursuing a strategy of partnering leading pharmaceutical companies to develop and market products for the U.S. market. Marketing partnerships are de-risked arrangements in which the partner has agreed to undertake the responsibility of litigation and regulatory issues as well as securing the Abbreviated New Drug Application (ANDA) approval.

Yeda Research & Development Co. Ltd. that owns the two patents in question had licensed them to Teva Pharmaceuticals Industries Ltd. “A decision by the PTAB on Mylan’s third petition seeking inter partes review of another patent is expected on or before September 1, 2016,” Natco Pharma said. Earlier this month, the PTO’s Patent Trial and Appeal Board (PTAB) found Mylan’s application against a fourth Copaxone patent (US Patent No. 9155776) ineligible for post-grant review for procedural reasons. Mylan, however, believes that the favourable ruling in the two patents “strongly undermines the ‘776 patent as well. As such, Mylan will proceed with pursuing all avenues to challenge the ‘776 patent.”

Mylan believes that it is one of the first companies to have filed a substantially complete ANDA containing a paragraph IV certification for the drug, which is generically called Glatiramer Acetate. Mylan is expected to be eligible for 180 days of marketing exclusivity in the U.S. once it gets approval from the U.S. Food and Drug Administration, according to Natco Pharma.

USFDA inspection

The USFDA has cleared Natco Pharma Ltd’s Chemical Division in Chennai. This follows the inspection conducted by the regulator in February this year.