Natco's partner Mylan invalidates third Teva Copaxone patent in US

Natco Pharma Limited on September 2, 2016 announced that the US Patent and Trademark Office (PTO) has ruled in favour of its marketing partner, Mylan, in its inter partes review (IPR) proceeding and found all claims of US Patent, which is owned by Yeda Research & Development Co Ltd and licensed to Teva Pharmaceuticals Industries Ltd, unpatentable. This is the third patent related to Copaxone 40 mg/mL (glatiramer acetate) to be found unpatentable in the last week.

On August, 24, 2016, the PTO's Patent Trial and Appeal Board (PTAB) found Teva's first two patents unpatentable in Mylan's IPR challenge of these patents.

Copaxone (glatiramer acetate) 40 mg dosage injection, used for the treatment of multiple sclerosis, had US sales of approximately $ 3.3 billion for the 12 months ending June 30, 2016, according to IMS Health.

Natco’s marketing partner Mylan believes it is one of the first companies to have filed a substantially complete Abbreviated New Drug Application (ANDA) containing a Paragraph IV certification for a three times per week glatiramer acetate injection 40 mg/mL, and expects to be eligible for 180 days of marketing exclusivity in the US upon final FDA approval.