By James DeGiulio --
Apotex's Generic Provigil Found Not to Infringe Cephalon Patent
Apotex received a favorable ruling on summary judgment in its dispute with Cephalon regarding the narcolepsy drug Provigil after the U.S. District Court for the Eastern District of Pennsylvania determined that Apotex's proposed generic does not infringe one of two Cephalon patents at issue in the case. The conflict between Cephalon and Apotex arose out of an earlier dispute between Cephalon and four other generics. That earlier litigation began when Barr, Mylan, Teva, and Ranbaxy filed ANDAs seeking FDA approval to market generic versions of Provigil on December 24, 2002. In response, Cephalon filed suit against all four generic companies, alleging infringement of U.S. Patent Nos. 7,297,346 and RE37,516. Cephalon, however, reached settlements with all four defendants, giving them 180-day exclusivity to market their generics since all four companies filed their ANDAs on the same day.
In 2006, Apotex filed against Cephalon seeking a judgment of non-infringement with respect to the '516 patent and alleging antitrust claims against Cephalon with respect to the settlements with Barr, Mylan, Teva, and Ranbaxy. Apotex later sought a judgment of non-infringement with respect to the '346 patent as well. Apotex, and other drug suppliers, alleged that Cephalon asserted patents that it knew were weak and then offered the generics payoffs to stay off the market. The plaintiffs contended that Cephalon and the other generics companies all benefited from Cephalon's alleged payoff, which amounted to an conspiracy to suppress generic Provigil.
On March 15, Judge Mitchell S. Goldberg issued an Order granting Apotex's motion for summary judgment, ruling that its generic did not infringe the '346 patent. Cephalon also moved for summary judgment, indicating that it had only asserted the RE'516 patent against Apotex's ANDA and thus that there was no controversy concerning the '346 patent. However, that motion was denied, and Cephalon conceded that Apotex's product would not infringe the '346 patent. Judge Goldberg reminded Apotex that it needed a ruling of noninfringement on both patents in order to trigger the statutory 180-day exclusivity period. The infringement trial pertaining to the '516 patent has yet to be held.
Cephalon Drops Patent Suit Against Actavis over Nuvigil Generic
Cephalon and Actavis have agreed to settle their infringement suit over the narcolepsy drug Nuvigil after Actavis made the decision not to market a generic version of armodafinil. In December 2009, Cephalon filed suit against Actavis in the U.S. District Court for the District of Delaware, claiming infringement of U.S. Patent No. 7,132,570 (see "Court Report," December 13, 2009). In December 2010, the case was consolidated with several other infringement actions over Nuvigil. Other defendants include Apotex, Teva, Mylan, Watson, Lupin, and Sandoz. While Cephalon asserted the '570 patent in all seven of the consolidated suits, it also alleged that Sandoz and Apotex infringe U.S. Patent Nos. 7,297,346 and RE37,516.
On March 16, Judge Gregory Sleet issued an Order approving the stipulation between the two parties, thus ending Cephalon's case against Actavis. According to the agreement, Actavis will wait to market its generic Nuvigil product until the expiration of the '570 patent. Actavis can also enter the market if a final, nonappealable judgment is entered finding the '570 patent invalid or unenforceable.
OSI, Genentech, and Pfizer Settle Tarceva Patent Litigation with Teva
Astellas and subsidiary OSI Pharmaceuticals, along with Roche, Genentech, and Pfizer, have ended a case against Teva covering patents for the lung cancer drug Tarceva. The case began in March 2009, when OSI sued Teva in the U.S. District Court for the District of Delaware, accusing Teva of infringing U.S. Patent Nos. 6,900,221, 7,087,613, and 5,747,498 through its ANDA filing and plans to market generic erlotinib (see "Court Report," March 29, 2009). OSI markets the drug with Genentech, and Pfizer co-owns the '498 patent with OSI. In May 2009, the Teva suit was consolidated alongside the plaintiffs' claims against Mylan. Mylan remains as the sole defendant in the litigation. On March 15, one day after beginning trial, Judge Sue L. Robinson signed off on the parties' consent order of dismissal. Details of the agreement remain confidential.
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