Legal Opinion

Ranbaxy Labs Ltd v. Leavitt, Michael O.

Court of Appeals for the D.C. Circuit

Decided November 14, 2006No. 06-5154PublishedCited by 23 opinions

1Opinion of the Court

Opinion for the Court filed by Chief Judge GINSBURG.

GINSBURG, Chief Judge.

The Hatch-Waxman Amendments to the Food, Drug, & Cosmetic Act provide a period of marketing exclusivity to the first drug manufacturer that either successfully challenges a patent listed by the Food and Drug Administration for an approved, branded drug and markets an approved generic version of that drug or prevails in litigation establishing that the patent is valid or not infringed. Ranbaxy Laboratories Limited and Ivax Pharmaceuticals, Inc., the latter since acquired by Teva Pharmaceuticals, USA, Inc., applied for…

2Cases cited7 opinions

  1. Chevron U. S. A. Inc. v. Natural Resources Defense Council, Inc.Supreme Court of the United States · 1984
  2. MCI Telecommunications Corp. v. American Telephone & Telegraph Co.Supreme Court of the United States · 1994
  3. Mova Pharmaceutical Corp. v. ShalalaCourt of Appeals for the D.C. Circuit · 1998
  4. Mylan Laboratories, Inc. v. Tommy G. Thompson, Secretary, United States Department of Health and Human ServicesCourt of Appeals for the D.C. Circuit · 2005
  5. Teva Pharmaceutical Industries Ltd. v. CrawfordCourt of Appeals for the D.C. Circuit · 2005

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3Cited by23 opinions

  1. Meijer, Inc. v. Biovail Corp.Court of Appeals for the D.C. Circuit · 2008
  2. Teva Pharmaceuticals USA, Inc. v. SebeliusCourt of Appeals for the D.C. Circuit · 2010
  3. Teva Pharmaceuticals, USA, Inc. v. LeavittCourt of Appeals for the D.C. Circuit · 2008
  4. Hi-Tech Pharmacal Co. v. United States Food & Drug AdministrationDistrict Court, District of Columbia · 2008
  5. United States v. SBC Communications, Inc.District Court, District of Columbia · 2007

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