Modafinil Cephalon Vs Orchid & Mylan (UK Case)

Yesterday high court of London has denied to grant interim injunction on Mylan marketing generic version of Modafinil (provigil) in UK. The final trial is pending on April 2011 (on expedite basis)


The Case was about whether Orchid’s API supplied to make Mylan generic product is infringing Cephalon’s patents (EP0731698 & EP0966962) or not? and Validity of EP1088549 in the view of WO9421371. Cephalon has not clearly established that Orchid API infringing claims of ‘698 and ‘962.

Final judgement is pending on April 2011 on this matter.

In 2005, Cephalon and Teva in the US and UK had settled on terms that that the Teva companies could enter the market with their own generic modafinil in October 2012.

The same API product is also supplied to Orifarm Generics A/S for marketing in Sweden and Denmark. The Swedish court has recently granted an interim injunction pending trial.

Updated 14/07/2011: Cephalon’s three patents were held invalid and also not infringed by Mylan’s product. The Court constructed claimed particle size as Bulk active agent, not as particle size in the manufactured tablet (Link).

About Guna

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