Shares in Teva Pharmaceutical Industries Ltd. (NYSE: TEVA; TASE: TEVA) are up 7.95% at NIS 157.50 on the Tel Aviv Stock Exchange, following a victory by the comany in its campaign to prevent generic versions of its flagship product, multiple sclerosis treatment Copaxone. Yesterday, Teva announced that the US District Court for the Southern District of New York had found in its favor in its patent infringement lawsuit against Momenta Pharmaceuticals, Inc./Sandoz Inc. and Mylan Laboratories Inc./Natco Pharmaceuticals concerning Copaxone. Teva filed suit against Momenta/Sandoz and Mylan/Natco for infringement of several patents covering the chemical composition of Copaxone, methods of using the product, and processes for manufacturing it. This decision covers several patents, the last of which expires on September 1, 2015.
The judge rejected Momenta/Sandoz and Mylan/Natco’s claims that the Copaxone patents were invalid and unenforceable, and found that the purported generic versions of the drug for which Momenta/Sandoz and Mylan/Natco seek Food and Drug Administration (FDA) approval infringed those patents.
According to Teva, this ruling should prevent the FDA from approving, and the defendants from selling their purported generic versions of Coapxone in the US 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. Furthermore, the company says, any purported generic version of Copaxone will need to obtain FDA approval before being made available to the public.
Teva president and CEO Dr. Jeremy Levin said, “Teva is confident Copaxone will remain a proprietary, global market leading product for the reduction of relapses in patients with RRMS over the product’s lifecycle given the strength of its intellectual property rights.”
Teva's revenue from sales of Copaxone totaled $3.57 billion in 2011, 20.7% more than in 2010, the rise being partly accounted for by a rise in price. Sales of the drug are expected to reach a peak in 2012. In its annual report, Teva stressed its need to reduce its dependence on sales of Coapxone, which are estimated to be responsible for 30-50% of the company's profit.
Teva has a market cap on the New York Stock Exchange of $33 billion.
Published by Globes [online], Israel business news - www.globes-online.com - on June 24, 2012
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