The US District Court for the Southern District of New York has found in favor of Israel’s Teva Pharmaceutical Industries (Nasdaq: TEVA) in the company’s patent infringement lawsuit against USA-based Momenta Pharmaceuticals (Nasdaq: MNTA)/Sandoz – a unit of Swiss drug major Novartis (NOVN: VX) and Mylan Laboratories (Nasdaq: MYL/India’s Natco Pharmaceuticals (524816: BY) regarding Teva’s relapsing-remitting multiple sclerosis drug Copaxone.
Teva filed suit against Momenta/Sandoz and Mylan/Natco for infringement of multiple patents covering the chemical composition of Copaxone, methods of using the product and processes for manufacturing the product. This decision covers several patents, the last of which expires on September 1, 2015. Teva recently forecast that worldwide sales of Copaxone would reach $3.8 billion in the current year (The Pharma Letter May 25)
The judge rejected Momenta/Sandoz and Mylan/Natco’s claims that the Copaxone patents are invalid and unenforceable and found that the purported generic versions of the MS drug for which Momenta/Sandoz and Mylan/Natco seek Food and Drug Administration approval infringe those patents. This ruling should prevent the FDA from approving, and the defendants from selling their purported generic versions of Copaxone in the USA until the Orange Book patents expire on May 24, 2014. As a result of this ruling, Teva also believes that the defendants will be enjoined from selling their products until the process patent expires on September 1, 2015.
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