Cephalon Inc., maker of the sleep-disorder drug Provigil, can’t block Mylan Inc. and Orchid Chemicals & Pharmaceuticals Ltd. from selling generic versions of the drug in Britain before a patent trial, a judge ruled.
Barring the sales would likely cause “greater and more unquantifiable” harm to Mylan and Orchid if they later won the case, Justice Christopher Floyd ruled today in the High Court in London. Floyd said an expedited trial on Cephalon’s patent- infringement claims should take place in April 2011.
“The parties clearly need business certainty as soon as possible,” Judge Floyd said in the ruling. “The balance of convenience comes down in favor of allowing the defendants to take advantage of their market position for the short period of time until trial.”
Cephalon, based in Frazer, Pennsylvania, filed the lawsuit in September to protect a drug that was its biggest seller last year. The company in March lost a bid to dismiss U.S. antitrust lawsuits related to patent settlements with generic drugmakers, including Mylan, to delay generic Provigil in the country.
Marie-Dominique de La Salle, a spokeswoman for Cephalon in Paris, didn’t immediately return a call for comment.
Mylan, based in Canonsburg, Pennsylvania, and Orchid, based in Nungambakkam, India, won regulatory approval in January to sell generic Provigil in the U.K. under the name of its active ingredient, modafinil, according to the ruling. Mylan’s product is manufactured by Orchid, it said.
Swedish, Danish Cases
Cephalon won a preliminary injunction in a separate case in Sweden and seeks another in Denmark after the generic companies’ product was sold to Orifarm Generics A/S in those countries, according to today’s ruling.
Cephalon in 2005 settled a similar case in the U.S. and U.K. with generics maker Teva Pharmaceutical Industries Ltd. The deal gave Teva the exclusive right to sell generic Provigil in the U.K. in 2012 -- three years before the expiration of one of the drug’s European patents, according to the ruling.
In the U.S., Cephalon is accused by the U.S. Federal Trade Commission of improperly delaying generic competition to Provigil, its biggest product, which generated $961 million in U.S. sales last year. Cephalon denies violating antitrust law.
The case is Cephalon Inc. v. Orchid Europe Ltd., HC10C02910, High Court of Justice, Chancery Division (London).