Teva Pharmaceutical Industries Ltd. (NYSE: TEVA; TASE: TEVA) has announced that US District Court for the District of New Jersey has ruled in its favor in the Azilect patent infringement case against Mylan Inc. (Nasdaq: MYL). The court has upheld the validity of Teva’s patent for the Parkinson's disease treatment, and Teva anticipates the court will enter judgment that prevents Mylan from launching its generic version of Azilect until Teva’s patent expires in 2017.
Teva sued Mylan in October 2010, and later filed similar patent infringement suits against Watson Pharmaceuticals (now part of Actavis Inc. (NYSE: ACT)), Canada's Apotex Inc., India's Orchid Chemicals & Pharmaceuticals Ltd. (BSE: 524372), and Novartis AG (NYSE:NVS; LSE: NOV; SWX: NOVZ) generics unit Sandoz. Teva settled with Watson, Apotex, and Orchid earlier this year, and Sandoz has agreed that it will be bound by the final ruling in the Mylan case.
US Food and Drug Administration (FDA) records show that it has approved in the past few weeks three generic versions of Teva's Azilect. However, the FDA approval only clears one of the hurdles - the regulatory hurdle - en route to market. There is also the legal aspect of patent protection. As is usual in these cases, Teva has initiated patent infringement legal action.
Azilect had $180 million in sales in the first half of 2013, and Teva projects that full-year sales will be $340-380 million.
"Teva is pleased with the ruling, which further confirms the strength of Teva’s Azilect intellectual property rights. Azilect has an established efficacy, safety and tolerability profile in Parkinson' disease patients since its launch in 2006 and Teva is confident it is well positioned in the marketplace," said Teva in a statement.
Published by Globes [online], Israel business news - www.globes-online.com - on September 23, 2013
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