![]() ![]() ![]() That "artificial" act of infringement creates jurisdiction for a court to entertain an action by the patentee against the ANDA applicant in which issues of patent infringement and validity can be resolved. The Act makes it an act of infringement to file an ANDA for a drug or for a use of the drug that is claimed in a patent. In the case of drugs that enjoy patent protection, the Hatch-Waxman Act creates a mechanism that allows for prompt judicial determination of whether the ANDA applicant's drug or method of using the drug infringes a valid patent. The ANDA process streamlines FDA approval by allowing the generic manufacturer to rely on the safety and efficacy studies of a drug that has previously been approved upon a showing that the generic version and the relevant listed drug share the same active ingredients and are bioequivalent. A manufacturer seeking to market a generic drug is entitled to submit an Abbreviated New Drug Application ("ANDA"), rather than submitting a full New Drug Application ("NDA"). 1585, creates a procedure by which a drug manufacturer can obtain permission from the Food and Drug Administration *1318 ("FDA") to market a generic version of a previously approved drug. The Drug Price Competition and Patent Term Restoration Act of 1984 ("the Hatch-Waxman Act"), Pub. and Lupin Pharmaceuticals, Inc., (collectively, "Lupin"). In the second case, the court dismissed similar patent infringement claims against Lupin Ltd. In the first case, the court dismissed Bayer's patent infringement claims against Watson Pharmaceuticals, Inc., and Watson Laboratories, Inc., (collectively, "Watson") and Sandoz, Inc. Opinion for the court filed by Circuit Judge BRYSON.ĭissenting opinion filed by Circuit Judge NEWMAN.īayer Schering Pharma AG and Bayer HealthCare Pharmaceuticals, Inc., (collectively, "Bayer") appeal from two judgments of the United States District Court for the Southern District of New York. ![]() Ford.īefore NEWMAN, PLAGER, and BRYSON, Circuit Judges. Sipes, Covington & Burling LLP, of Washington, DC, for amicus curiae Pharmaceutical Research and Manufacturers of America. Szeliga, of Washington, DC, for defendants-appellees Lupin Ltd., et al.Ĭhristopher N. Griffith, Leydig, Voit & Mayer, Ltd., of Chicago, IL, and Jamaica P. ![]() Hynds and Steven Lieberman, Rothwell, Figg, Ernst & Manbeck, P.C., of Washington, DC, for defendant-appellee Sandoz Inc. Cooklin, of Washington, DC, for defendant-appellees Watson Pharmaceuticals, Inc., et al. Jansen, Kilpatrick Townsend and Stockton, LLP, of San Francisco, CA, argued for all defendants-appellees. Bensinger, Jr., Bartlit, Beck Herman Palenchar & Scott, LLP, of Chicago, IL, argued for plaintiffs-appellants. United States Court of Appeals, Federal Circuit. Watson Pharmaceuticals, Inc., and Watson Laboratories, Inc., Defendants-Appellees. LUPIN, LTD., and Lupin Pharmaceuticals, Inc., Defendants-Appellees.īayer Schering Pharma AG and Bayer Healthcare Pharmaceuticals, Inc., Plaintiffs-Appellants, 676 F.3d 1316 (2012) BAYER SCHERING PHARMA AG and Bayer Healthcare Pharmaceuticals, Inc., Plaintiffs-Appellants, ![]()
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