Sandoz Introduces Generic Copaxone After Court Nullifies Teva Patent

June 25, 2015

Sandoz wasted no time in launching its generic version of Copaxone in the U.S. after the U.S. Court of Appeals for the Federal Circuit again invalidated Teva’s patent on the blockbuster multiple sclerosis drug.

Sandoz announced the launch of Glatopa (glatiramer acetate) last Thursday, the same day the appeals court ruled 2-1 in Teva Pharmaceuticals, et. al. v. Sandoz, Inc. Momenta Pharmaceuticals, et. al., to set aside Teva’s patent claim. The ruling pushed up the release of a generic competitor by just over two months as the last of Teva’s patents is set to expire on Sept. 1.

Sandoz and Momenta Pharmaceuticals, the companies that developed the generic, received FDA approval in April but had to wait for the court ruling before marketing it.

The ruling reiterates the Federal Circuit’s July 2013 decision overturning a U.S. district court ruling that had upheld Teva’s patent. The case was appealed to the U.S. Supreme Court, which remanded it back to the Federal Circuit in January, saying the appeals court had erred in attempting to do its own research instead of relying on the district court’s ruling to determine the meaning of “molecular weight.” The Federal Circuit reviewed the case again and concluded the patent was invalid.

Teva’s patent was tied to a method of manufacturing that focused on the drug’s molecular weight, but the Federal Circuit found the claims invalid for indefiniteness. “Teva cannot transform legal analysis about the meaning or significance of the intrinsic evidence into a factual question simply by having an expert testify,” the court writes.

Sandoz’s once daily Glatopa is indicated for the treatment of patients with relapsing forms of MS.
Teva spokeswoman Denise Bradley says the company has planned for market entry of a generic version of Copaxone and expects patients to continue to value the branded drug. — John Bechtel