US Patent Office Rules In Mylan's Favour, Invalidates Teva Patents: Natco

New Delhi: Drug firm Natco Pharma on Thursday said the US Patent and Trademark Office has ruled in favour of its marketing partner Mylan by invalidating two of Israel-based Teva Pharmaceuticals' patents related to multiple sclerosis drug Copaxone 40 mg/mL.

"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 40mg/mL patents to be unpatentable," Natco Pharma said in a filing to the BSE.

A decision by the PTO's patent Trial and Appeal Board (PTAB) on Mylan's third petition seeking IPR of US patent No. 8,969,302 is expected on or before September 1, 2016, it added.

Mylan believes it is one of the first companies to have filed a substantially complete (ANDA) abbreviated new drug application containing a paragraph IV certification for a three times per week Glatiramer Acetate injection 40mg/mL and expects to be eligible for 180 days of marketing exclusivity in US upon FDA approval, Natco Pharma said.

Copaxone 40mg/mL had sales of nearly $3.3 billion in US for the 12 months ending June 30, 2016, according to IMS health, it added.

In another filing to the bourses, Natco said it has received Establishment Inspection Report from the US health regulator after successful inspection of its chemical division in Chennai.

The company has received successful Establishment Inspection Report (EIR) from the United States Food and Drug Administration (USFDA) for the inspection conducted, during the period February 8 - February 12, 2016, at its Chemical Division, Chennai...," Natco Pharma said.

The chemical division was named Natco Organics Ltd, prior to amalgamation into the company, it added.

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