U.S. Patent and Trademark Office (PTO) has ruled in favor of Natco Pharma’s marketing partner, Mylan, in its inter partes review (IPR) proceeding and found all claims of U.S. Patent No. 8,969,302, which is owned by Yeda Research & Development Co. and licensed to Teva Pharmaceuticals Industries, un-patentable. This is the third patent related to Copaxone 40 mg/mL 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, U.S. Patent Nos. are 8,232,250 and 8,399,413, unpatentable in Mylan’s IPR challenge of these patents.
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 U.S. upon final FDA approval.
