![]() ![]() I 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. Bayer 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. Dissenting opinion filed by Circuit Judge NEWMAN. LUPIN LTD Opinion for the court filed by Circuit Judge BRYSON. _ Before NEWMAN, PLAGER, and BRYSON, Circuit Judges. SIPES, Covington & Burling LLP, of Washington, DC, for amicus curiae Pharmaceutical Research and Manufacturers of America. GRIFFITH, Leydig, Voit & Mayer, LTD., of Chicago, Illinois, and JAMAICA P SZELIGA, of Washington, DC, for defendants-appellees Lupin Ltd, et al. 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, California, argued for all defendants-appellees. BENSINGER, JR., Bartlit, Beck Herman Palenchar & Scott, LLP, of Chicago, Illinois, argued for plaintiffs-appellants. LUPIN LTD 2 Appeal from the United States District Court for the Southern District of New York in Case Nos. SANDOZ, INC., Defendant-Appellee, AND WATSON PHARMACEUTICALS, INC., AND WATSON LABORATORIES, INC., Defendants-Appellees. BAYER SCHERING PHARMA AG AND BAYER HEALTHCARE PHARMACEUTICALS, INC., Plaintiffs-Appellants, v. LUPIN, LTD., AND LUPIN PHARMACEUTICALS, INC., Defendants-Appellees. United States Court of Appeals for the Federal Circuit _ BAYER SCHERING PHARMA AG AND BAYER HEALTHCARE PHARMACEUTICALS, INC., Plaintiffs-Appellants, v. The district court entered judgment of noninfringement. Defendants filed ANDAs to market generic versions and certified that three patents would not be infringed, arguing that their ANDAs related only to contraceptive use and not to claimed methods for treating hirsutism or acne or reducing water retention. Bayer markets Yasmin, an oral contraceptive, approved by NDA in 2001. For patents that will not expire prior to proposed marketing, the applicant can include a statement that the applicant is not seeking approval for the method of use claimed in the patent or can certify that the patent is invalid or will not be infringed. An ANDA for a generic drug must address each patent in the Orange Book that relates to that drug. 355(b)(1), for publication in the Orange Book. Every NDA must identify every patent that could reasonably be asserted in an infringement action, 21 U.S.C. It is an act of infringement to file an ANDA for a drug or use of the drug claimed in a patent, 35 U.S.C. Combined pharmaceutical revenues would be around $10.8 billion.A drug manufacturer can obtain FDA permission to market a generic version of an approved drug by Abbreviated New Drug Application (ANDA), rather than full New Drug Application (NDA). The Bayer/Schering deal creates a new company with 15 billion euros in annual sales and a pharmaceutical division - Bayer-Schering Pharmaceuticals - that will rank among the top 12 in the world. Merck had amassed a more-than-20% stake in the company, and only sold it to Bayer in return for certain cooperative arrangements - as well as a tidy profit of 400 million euros. The 17 billion-euro bid for Schering went right up to the wire, with only a last gasp deal between Bayer and Merck allowing it to go through. However, for Merck KGaA – which lost out in a bidding war to acquire Schering – the development could delay or even scupper its plans to replace Schering on the DAX. This means that while the integration of the companies can begin, Schering will remain listed on the Frankfurt DAX exchange as a separate entity for the time being.Īnalysts cited by Reuters said a short delay in closing the acquisition would result, but that this would likely be insignificant. German company Bayer has all but completed its takeover of specialty pharmaceutical concern Schering AG, holding 92.4% of the latter’s shares according to a statement released yesterday.īut Bayer failed to reach the 95% ownership that would have forced minority shareholders to part with their stakes. ![]()
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