Mylan N.V. 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.
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 December 2, 2016, the US Patent and Trademark Office's US Patent Trial and Appeal Board (PTAB) reaffirmed a prior decision that three of these patents ('250, '413 and '302) 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.
Mylan CEO Heather Bresch commented, "Today's ruling by the US 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."
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.
Copaxone 40 mg/mL had US sales of approximately $3.3 billion for the 12 months ending November 30, 2016, according to IMS Health.
Mylan wins, us district court ruling related, copaxone 40 mg/ml patents
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