U.S. District Court of Delaware ruling invalidating all asserted claims of the ‘250, ‘413, ‘776 and ‘302 patents for COPAXONE® (glatiramer acetate injection) 40 mg/mL by TEVA. The patent infringement case involved five of six Abbreviated New Drug Application (ANDA) filers. Teva plans to appeal the decision.
On Dec. 2, 2016, the U.S. Patent and Trademark Office's U.S. 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 NATCO's marketing partner 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
“We intend to move forward with an immediate appeal,” said Erez Vigodman, Teva President and CEO. “We will continue to vigorously protect our COPAXONE® franchise against further challenges and through the duration of this process.
Separately, a suit was filed against all six ANDA filers on December 19, 2016 in the U.S. District Court for the District of Delaware to assert a fifth Orange Book patent, U.S. Patent 9,402,874. Additionally, Teva has brought suit against multiple ANDA filers to assert a non-Orange Book process patent, U.S. Patent No. 9,155,775, in various jurisdictions
