Mylan Wins U.S. Court Ruling On Copaxone 40 Mg/mL Patents

(RTTNews) - Mylan N.V. (MYL) announced the United States District Court for the District of Delaware issued a decision finding all asserted claims of four Orange Book-listed patents relating to Copaxone 40 mg/mL invalid based on obviousness.

Mylan CEO Heather Bresch said, "Today's ruling by the U.S. District Court is yet another positive step in our effort to bring to market a more affordable generic version of Copaxone® 40 mg/mL. We will continue to challenge the validity of patents as a way to expedite the availability of generic drugs and help deliver access and savings to patients and the overall healthcare system."

The invalidated patents are United States Patent Numbers 8,232,250; 8,399,413; 8,969,302; and 9,155,776, which are owned by Yeda Research & Development Co., Ltd. and licensed to Teva Pharmaceuticals Industries, Ltd.

On Dec. 2, 2016, the U.S. Patent and Trademark Office's U.S. Patent Trial and Appeal Board reaffirmed a prior decision that three of these patents are unpatentable in its inter partes review (IPR) proceedings initiated by Mylan. Mylan also challenged the '776 patent in an IPR proceeding. The PTAB is expected to issue its institution ruling on the '776 patent IPR by May 16, 2017.

Copaxone 40 mg/mL had U.S. sales of approximately $3.3 billion for the 12 months ending Nov. 30, 2016, according to IMS Health.

Separately, Teva Pharmaceutical Industries Ltd. (TEVA) confirmed the U.S. District Court for the District of Delaware ruling invalidating all asserted claims of the '250, '413, '776 and '302 patents for COPAXONE (glatiramer acetate injection) 40 mg/mL. The patent infringement case involved five of six Abbreviated New Drug Application (ANDA) filers. Teva plans to appeal the decision.