Mylan wins court ruling for Copaxone 40mg/mL patents

Global generic and specialist pharmaceuticals company Mylan has won a US District Court Ruling with regards to its Copaxone 40mg/mL patents.

The court for the District of Delaware issued a decision finding all asserted claims of four of the company’s Orange Book-listed patents relating to Copaxone invalid based on obviousness.

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

Mylan CEO Heather Bresch said: "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 40mg/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 US Patent and Trademark Office's Patent Trial and Appeal Board (PTAB) reaffirmed a prior decision on 2 December last year that the 250, 413 and 302 patents are unpatentable in its inter partes review (IPR) proceedings initiated by Mylan.

The company also challenged the 776 patent in an IPR proceeding.

The institution ruling by PTAB is expected to be issued on the '776 patent IPR by 16 May this year.

Mylan stated that it has filed a complete abbreviated new drug application for a three times per week Glatiramer Acetate Injection 40mg/mL.

According to IMS Health, Copaxone had sales in the US of approximately $3.3bn for the 12 months ending 30 November last year.

Mylan offers a portfolio of more than 2,700 generic and branded pharmaceuticals, including anti-retroviral therapies, and markets its products in more than 165 countries and territories.