Mylan N.V. announced that the U.S. Patent and Trademark Office (PTO) has ruled in favor of Mylan in its inter partes review (IPR) proceeding and found all claims of two related Copaxone® 40 mg/mL patents to be unpatentable. The U.S. Patent Nos. are 8,232,250 and 8,399,413, which are owned by Yeda Research & Development Co., Ltd. and licensed to Teva Pharmaceuticals Industries Ltd. A decision by the PTAB on Mylan's third petition seeking inter partes review of U.S. Patent No. 8,696,302 is expected on or before September 1, 2016.
On Aug. 15, the PTO's Patent Trial and Appeal Board (PTAB) found Mylan's application against a fourth Copaxone 40 mg/mL patent, U.S. Patent No. 9,155,776, ineligible for post-grant review for procedural reasons. However, Mylan believes that today's favorable ruling in the IPR against the '302 patent strongly undermines the '776 patent as well. As such, Mylan will proceed with pursuing all avenues to challenge the '776 patent.
Mylan CEO Heather Bresch commented, "We believe the Board's decision is comprehensive, well-reasoned, and highly persuasive in detailing the bases for the invalidity of Teva's 40 mg patents, and we look forward to further demonstrating the invalidity of the patents covering Copaxone 40 mg/mL".
Mylan believes it is one of the first companies to have filed a substantially complete abbreviated new drug application 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.
Copaxone 40 mg/mL had U.S. sales of approximately $3.3 billion for the 12 months ending June 30, 2016, according to IMS Health.