The US Supreme Court has sent back to a federal Circuit Court a patent case over the multiple sclerosis treatment drug, Copaxone. The move could be a blow for generic drug manufacturers such as Natco Pharma, Sandoz, Mylan and Momenta Pharma since it seems to be in favour of Israel-based Teva Pharma.
“The US Supreme Court remanded the case relating to Teva’s patent no 5,800,808 back to the US Court of Appeals for the Federal Circuit for that court to review the patent’s validity in accordance with a partially modified standard of review. The Supreme Court made no finding as to the validity of the US808 patent, but instead sent the case back to the Federal Court to consider the matter in view of the modified standard,” Natco said in a filing to the BSE.
Natco had entered into an exclusive licensing and supply pact with Mylan for glatiramer acetate, the generic version of Teva’s Copaxone, in June 2008. It, however, faced patent litigation from Teva. Copaxone is indicated for treating patients with relapsing forms of multiple sclerosis. In 2013, Teva sold $4.3 billion worth of the drug. Analysts say this is a blow for generic manufacturers. “The court’s ruling is a loss for generic companies Mylan, Momenta Pharmaceuticals, Natco Pharma and Sandoz. These companies failed to convince a federal judge in New York that Teva’s patent claim, based on the drug’s molecular weight, was too ambiguous,” analysts said.
In 2011, a New York trial judge upheld the validity of a Teva patent on the drug and prevented generic drug makers, including Novartis AG’s Sandoz unit and Mylan from entering the market until the patent expired. This was, however, reversed by the Federal Circuit Court ruling in 2013 stating the patent was invalid.