US Court rules in Mylan’s favor, another decision against Teva

Israel’s largest drugmaker, Teva, has came up short yet again against a US courts regarding patent infringement cases.

On Monday, Teva and Mylan confirmed the U.S. District Court for the District of Delaware decided in Mylan’s favor, invalidating all asserted claims for Copaxone, involving five of six Abbreviated New Drug Application (ANDA) filers. Teva said it plans to appeal the decision.

“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.”

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.”

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 patentz. Additionally, Teva has brought suit against multiple ANDA filers to assert a non-Orange Book process a patent in various jurisdictions.

The invalidated patents 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 (PTAB) reaffirmed a prior decision that three of these patent are unpatentable in its inter partes review (IPR) proceedings initiated by Mylan. Mylan also challenged another patent in an IPR proceeding. The PTAB is expected to issue its institution ruling on that patent IPR by May 16, 2017, Mylan noted.

“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,” the company says.

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.

Other recent court rulings against Teva included Aralez’s charges on Teva’s infringing its four patents  covering Yosprala (aspirin and omeprazole), Eli Lilly’s claim on the vitamin regimen patent, for which the court said is valid and would be infringed by the generic Teva’s proposed products. Late December, Teva agreed to pay U.S. government $519M over foreign bribery charges.

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