US Supreme Court In Favour Of Teva In Multiple Sclerosis Drug Case

Teva Pharmaceuticals won a case in its fight with generic drugmakers over patent protections for Copaxone, its best-selling multiple sclerosis drug.An earlier appeals court ruling had invalidated the patent, which is due to expire in September 2015, but in the latest ruling, the justices said that the U.S. Court of Appeals for the Federal Circuit had taken an incorrect approach in analysing whether the patent was valid or not.The U.S. Court of Appeals for the Federal Circuit is a specialised court that hears a majority of the patent appeals in the United States.The Supreme Court, in a 7-2 decision, said that the Federal Circuit must be more deferential in reviewing facts made by trial judges presiding over patent litigation. Teva's case was sent back to the lower courts.Copaxone, an injection for multiple sclerosis, is the company's most profitable product. During the first nine months of 2014, Copaxone earned $3.1 billion. Teva's total revenue in the period was about $15.1 billion.Generic drugmakers, including Novartis's Sandoz and Mylan, have been forbidden from entering the multiple sclerosis drug market until Teva's patent expires later this year, 2015. The Federal Circuit had found the patent invalid in 2013.With the new ruling, Teva's shares rose 1.2 per cent at $58.44 on the NYSE.The version of Copaxone that is facing litigation is sold at 20 milligrammes per millilitre. Teva launched a version of Copaxone at double the dose last year. It had to be taken less frequently. The higher dose version is covered by patents that don't expire until 2030. Teva has therefore been trying to migrate patients to the higher dose version of Copaxone.Meanwhile, generic drugmakers believe that Teva's patents for the small dose version of Copaxone are invalid, and they intend to continue to challenge the patents in court.To contact the writer, email: sonali.raj@gmail.com