Mylan wins US District Court ruling related to Copaxone 40 mg/mL patents

Patents in question invalidated based on obviousness.

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

On 2 December 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 16 May 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.