Mylan N.V. has commented on a ruling by the US Court of Appeals for the Federal Circuit, which has found Teva Pharmaceutical Industries’ US Patent No. 5,800,808 (“the ‘808 patent”) for Teva’s Copaxone (glatiramer acetate injection) to be invalid as indefinite. Mylan is one of several companies seeking to market a generic version of Copaxone, Teva’s drug to treat multiple sclerosis and the company’s top-selling drug with 2014 revenues of $4.3 billion.

In commenting on the ruling, Mylan CEO Heather Bresch said, “We have stated all along that the ‘808 patent on Copaxone is invalid and are gratified that the Federal Circuit Court of Appeals has agreed and put this matter to rest. We continue to remain very confident in our application for our generic version of Copaxone and look forward to bringing our product to market upon approval from the US Food and Drug Administration.”

Sandoz, the generics arms of Novartis, earlier this month launched in the US Glatopa, a generic version of Teva Pharmaceutical Industries’ Copaxone 20 mg/ml one-time-daily multiple sclerosis therapy. Sandoz had received US Food and Drug Administration approval for the drug earlier this year, in April 2015. Glatopa, developed in collaboration with Momenta Pharmaceuticals and produced ly in the US, is indicated for the treatment of patients with relapsing forms of MS, including those who have experienced a first clinical episode and have magnetic resonance imaging features consistent with MS.

The US Orange Book patents covering Copaxone (20 mg) expired in May 2014. To combat generic-drug incursion for Copaxone, Teva developed a new formulation, Copaxone 40 mg/mL, which is administered three times a week. The new formulation, which was approved by the FDA in January 2014, allows for a less frequent dosing regimen administered subcutaneously for patients with relapsing forms of MS.

Source: Mylan