By Suresh Pillai --
Settlement Announced in Ethyol® Infringement Suit
Sun Pharmaceutical Industries, Ltd. and Medimmune LLC have announced a settlement of their patent dispute regarding Sun's manufacture and marketing of a generic version of the Medimmune drug Ethyol®, a cancer therapy drug. Medimmune first filed suit in 2004, alleging that Sun and its U.S. affiliate, Caraco Pharmaceutical Laboratories Ltd., had infringed Medimmune's patents covering Ethyol®, U.S. Patent Nos. 5,424,471 and 5,591,731. The U.S. District Court for the District of Maryland, having noted that Medimmune stated that Sun and Caraco had not infringed any of the process claims of the '471 patent, granted summary judgment of noninfringement with respect to the '471 patent alone but denied Sun's motion for a finding of noninfringement with respect to the '731 patent. Medimune subsequently refiled suit in February 2009 in order to preserve the right to appeal an earlier ruling of noninfringement (see "Court Report," March 1, 2009).
Sun and Caraco have been marketing and selling their generic version of Ethyol® since 2008 following FDA approval. Under the terms of the settlement, Medimmune has agreed to grant a license that would allow Sun and Caraco to continue to market their generic version of the drug. The terms of the settlement are confidential, but both companies have stated that the settlement resolves all litigation over the patents-in-suit.
Settlement Announced in Ortho Tri-Cyclen® Patent Dispute
Teva Pharmaceutical Industries, Inc. and Ortho-McNeil Pharmaceuticals have announced a settlement in their long running patent suit over the birth control pill Ortho-TriCyclen®. This settlement comes on the heels of the District Court's granting of Ortho's request for a preliminary injunction barring Barr from marketing or selling its generic version of Ortho-TriCyclen® Lo. Both parties now await action from the U.S. District Court for the District of New Jersey, as the settlement will not take effect until the Court enters judgment upholding the validity and enforceability of the patent-in-suit, U.S. Patent No. 6,214,815. Ortho originally filed suit in October 2003, claiming that Barr Pharmaceuticals, which has since been acquired by Teva, had infringed Ortho's patent rights upon Barr's filing of an ANDA in which Barr sought permission to sell a generic version of Ortho-TriCyclen®. Barr's ANDA also included a Paragraph IV certification stating that Ortho's patents were invalid, unenforceable, or would not be infringed.
Under the terms of the settlement, Ortho will grant Teva a release for past sales by Barr in exchange for a royalty payment based upon sales. Ortho would also grant Teva a license to sell its generic version of the drug in 2015 (or earlier provided certain conditions are met).
Solvay and Watson Seek to Overturn FTC Ruling on AndroGel®
Solvay Pharmaceuticals Inc. and Watson Pharmaceuticals Inc. have jointly filed a motion in the U.S. District Court for the Northern District of Georgia seeking to overturn the FTC's findings that patent settlements over AndroGel® were illegal. In the original litigation, Solvay sued Watson, Par Pharmaceuticals, and Paddock Laboratories, Inc. for infringement of its patented testosterone supplement, AndroGel®. The litigation was terminated by a settlement agreement among the parties that provided, among other things, that the generic companies refrain from bringing a generic version of AndroGel® to the market until at least 2015. Solvay also agreed to pay Par and Paddock $60 million. Following the settlement of this litigation, the FTC filed suit against all parties involved in the original litigation, alleging that the settlement agreement was the foundation of an anticompetitive scheme to illegally maintain Solvay's monopoly.
In their motion seeking to overturn the FTC complaint, the companies contend that the FTC's complaint failed to allege that the patent-in-suit was procured by fraud or that the conduct of the parties under the settlement agreements extended beyond the patent's exclusionary scope. The companies also claim that the settlements are legal under Eleventh Circuit law, which, in the past, has validated other reverse payment agreements between patent holders and generic pharmaceutical manufacturers.
Medtronic and Abbott Announce Settlement in Stent Patent Infringement Suits
Medtronic announced that it has reached a settlement with Abbott Laboratories to resolve all litigation related to coronary stent and stent delivery systems. Under the terms of the settlement, Medtronic has agreed to pay Abbott $400 million dollars and another $42 million dollars to evYsio, from whom Medtronic licenses key stent patents. In its original complaint, Medtronic alleged that Abbott's Promus® stent infringed upon two patents from the evYsio patent family, U.S. Patent Nos. 6,858,037 and 7,094,255.
Under the terms of the agreement, the companies have also agreed to a 10-year moratorium on filing suit over current and future coronary stent and stent delivery systems, provided that certain confidential conditions are met.
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