Supreme Court Upholds Copaxone Patent

The U.S. Supreme Court upheld Teva Pharmaceuticals’ patent on its multiple sclerosis drug Copaxone, overturning an appeals court ruling and preventing Sandoz from launching a generic of the drug.

The crux of the case turns on the words “molecular weight.” Novartis’ Sandoz generics arm claimed Teva’s patent on Copaxone (glatiramer acetate) relied on the molecular weight of a component of the drug, and because molecular weight could be interpreted in three potentially different ways, the product was unpatentable.

Justices Robert Breyer, John Roberts, Antonin Scalia, Anthony Kennedy, Ruth Bader Ginsburg, Sonia Sotomayor and Elena Kagan invalidated a federal appeals court’s July 2013 ruling in favor of Sandoz, claiming that the court had attempted to do its own research rather than reviewing the previous ruling for mistakes.

The 7-2 ruling gives Teva more time to protect Copaxone sales; the drug brought in $1.4 billion in the third quarter of 2014. Though the Israeli drugmaker’s patent on its original 20 mg Copaxone formulation expires in September, the company is pushing hard to switch patients over to a new 40 mg formulation that won FDA approval in January 2014.

As of October, Teva had managed to switch about 56 percent of its patients over to the new formulation, potentially making it next to impossible for Sandoz to market a viable generic until the patent on the 40 mg product expires.

View the Supreme Court opinion at www.fdanews.com/01-20-15-Tevaopinion.pdf. — Lena Freund