By James DeGiulio --
Medicis Pharmaceuticals Settles Solodyn Litigation with Mylan
Medicis Pharmaceuticals Corporation has reached settlement and license agreements with Mylan, Inc., thus resolving the patent litigation over Solodyn.
In 2009, Medicis brought suit against Mylan and several drug companies in the U.S. District Court for the District of Delaware, alleging infringement of U.S. Patent No. 5,908,838. Medicis has since settled with several defendants, and the strength of Medicis' position was given a boost once the U.S. Patent and Trademark Office upheld the validity of the '838 patent (see "Biotech/Pharma Docket," June 17, 2010).
On July 22, Medicis entered into a settlement and license agreement with Mylan, in which Mylan confirmed the validity and infringement of the '838 patent. According to the terms of the agreement, Mylan agreed to be permanently enjoined from further distributing the generic drug except under the license agreement. In return, Medicis will release Mylan from any liability related to the prior sales of their product, and Mylan will have the right to market minocycline ER in the U.S., beginning in November 2011. Medicis will receive royalties based on sales of Mylan's generic products.
Forest and Merz Pharma Settle Namenda Infringment Dispute
Merz Pharma and exclusive patent licensee Forest Laboratories have wrapped up their patent infringement suit over the Alzheimer's drug Namenda after reaching a settlement and licensing agreement with Mylan.
Forest initially brought suit against Mylan, Merz, Orchid, and a number of defendants in January of 2008 in the U.S. District Court for the District of Delaware following the filing of several ANDAs seeking FDA approval to market generic Namenda. Forest alleged infringement of U.S. Patent No. 5,061,703.
Under the settlement agreements, the first generic versions of memantine would be able to enter the market on January 11, 2015, three months prior to the April 11, 2015 expiration of the '703 patent. Forest and Merz will provide licenses to each of Amneal, Watson, Dr. Reddy's, Lupin, Mylan, Orchid, Sun, Teva, Upsher-Smith, and Wockhardt. The terms of its settlement agreements remain subject to review by the Federal Trade Commission.
Teva Agrees to Dismiss Suit with Eisai over Aricept Patent
Teva Pharmaceuticals USA Inc. agreed to suspend and dismiss its litigation with Eisai Co. over the Alzheimer's drug Aricept.
In 2005, Eisai filed suit in the U.S. District Court for the District of New Jersey in response to Teva's ANDA, alleging infringement of Eisai's U.S. Patent No. 4,895,841, which covers Aricept. Teva initially claimed the patent was invalid due to obviousness, but later changed its defense to inequitable conduct. Teva stipulated that its proposed generic infringed the claims of the '841 patent, but that those claims were unenforceable. In December, Magistrate Judge Salas denied Teva's motion to compel discovery of communications between Eisai and the USPTO over several patent applications not related to the suit. Teva appealed the order to Judge Brown, but agreed that Teva's request was too broad and unduly burdensome.
Judge Garrett Brown Jr. affirmed the settlement agreement, calling for the case to be suspended and eventually dismissed after the '841 patent expires in November 26, 2010. Teva has effectively given up its bid to manufacture a generic version of Aricept, for Eisai's 2008 preliminary injunction prohibiting Teva from manufacturing the drug remains in effect.
Judge Brown's order can be found here.
James DeGiulio has a doctorate in molecular biology and genetics from Northwestern University and is a graduate of Northwestern University School of Law. Dr. DeGiulio is a member of MBHB's 2010 associate class and he can be contacted at [email protected].
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