Indian paper “Financial Express” reports that Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) has sued Ranbaxy Laboratories Ltd. (BSE: 500359), Dr. Reddy’s Laboratories Ltd (NYSE: RDY; BSE: 500124), Lupin Ltd. (BSE:500257), Orchid Chemicals & Pharmaceuticals Ltd. (BSE:524372), Cadila Pharmaceuticals Ltd. (BSE:524372), USV Ltd. and Wanbury Ltd. (BSE:524212), for alleged infringement of its patent for carvedilol active pharmaceutical ingredient (API), the main constituent in Coreg, GlaxoSmithkline plc’s (NYSE; LSE:GSK) cardiac drug.
“Financial Express” says, “In separate cases filed on June 21 and 22 with the US District Court for the District of New Jersey against the Indian carvedilol API manufacturers, as well as Coreg generic drug manufacturers, Teva, which owns various patents on carvedilol API, informed the court that the defendants had not provided it with samples of their carvedilol API or furnished information regarding the processes by which carvedilol API is made, despite Teva’s offer of confidentiality.
“The US Food and Drug Administration (FDA) has granted nine companies -including Teva, Dr Reddy’s, Ranbaxy, Zydus Pharma USA and Caraco Pharma - tentative approval to manufacture copycat versions of Coreg. The companies may get final approval on September 5, 2007, when GSK’s pediatric exclusivity for Coreg ends.”
The “Financial Express” quotes USV executive KG Rajendran as saying, “We received Teva’s notification two days ago and are yet to take a decision on it.” Other companies refused to respond to queries.
The “Financial Express” adds that on May 8, 2007, Teva notified all defendants of its patents on carvedilol API and sought information allowing it to ascertain whether their API fell within the scope of one or more of the patents. But the companies refused to provide the required data. The paper quotes Teva as saying, “Without the requested information, we are unable to determine whether the defendants’ API infringes our patents in suits. In the absence of sufficient response, we have no choice but to resort to the judicial process.” Teva added, “We request the court to declare that our various patents on carvedilol are valid. Hence, the defendants will infringe the patents.”
Published by Globes [online], Israel business news - www.globes.co.il - on July 4, 2007
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