Copaxone Patent Stuck in Supreme Court Stalemate

the Neurology Advisor take:

The battle over patents for a popular multiple sclerosis drug are heating up as the U.S. Supreme Court decides whether to overturn a ruling by the U.S. Court of Appeals, which ruled in favor of the generic drug companies that are creating cheaper forms of Teva Pharmaceutical’s Copaxone.

So far, several justices have expressed concern over challenging the appeals system, in which the Appeals Court holds much weight over the findings of lower courts.

In a previous ruling, a lower court had ruled in favor of Teva. However, that ruling was overturned by the Court of Appeals in favor of Sandoz Inc. and Momenta Pharmaceuticals, who are developing a generic drug. Mylan Inc. and Natco Pharma are also developing generic versions of the drug.

The Supreme Court justices are primarily concerned by the Appeals court decision, since the lower federal court actually heard arguments and examined evidence first-hand before passing down a decision in favor of Teva.

While the Supreme Court decides its course of action, Teva is extremely vulnerable; since the Appeals court deemed Teva’s patent as invalid, Copaxone is not currently patent-protected, and Mylan said it could launch its drug before the end of 2014.

In the meantime, Teva is switching patients currently on Copaxone to a new patent-protected formulation of medication.