Legal Opinion

Teva Pharmaceuticals, USA, Inc. v. United States Food & Drug Administration

Court of Appeals for the D.C. Circuit

Decided July 20, 1999No. 99-5022 and 99-5027PublishedCited by 44 opinions

1Opinion of the Court

Opinion for the Court filed by Circuit Judge ROGERS.

ROGERS, Circuit Judge:

Teva Pharmaceuticals and Purepac Pharmaceutical Company appeal the denial of injunctive relief requiring the Food and Drug Administration (“FDA”) to recognize the dismissal of a declaratory judgment complaint for patent infringement as a “court decision” under the Abbreviated New Drug Application (“ANDA”) statute. See 21 U.S.C. § 355(j)(5)(B)(iv)(II) (Supp. Ill 1997). Appellants are “subsequent” ANDA applicants hoping to market ticlopi-dine tablets, a generic version of the name-brand drug “Ticlid,” used to treat stroke…

2Cases cited27 opinions

  1. Chevron U. S. A. Inc. v. Natural Resources Defense Council, Inc.Supreme Court of the United States · 1984
  2. Securities & Exchange Commission v. Chenery Corp.Supreme Court of the United States · 1947
  3. Seminole Tribe of Florida v. FloridaSupreme Court of the United States · 1996
  4. Robinson v. Shell Oil Co.Supreme Court of the United States · 1997
  5. Mova Pharmaceutical Corp. v. ShalalaCourt of Appeals for the D.C. Circuit · 1998

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3Cited by44 opinions

  1. Rodi v. Southern New England School of LawCourt of Appeals for the First Circuit · 2004
  2. Forman, Paul v. Small, Lawrence M.Court of Appeals for the D.C. Circuit · 2001
  3. County of Los Angeles, a Political Subdivision of the State of California, Owner and Operator of Los Angeles County/usc Medical Center, Harbor/ucla Medical Center, Martin Luther King Jr./drew Medical Center, Olive View Medical Center and High Desert Hospital Appellees/cross-Appellants v. Donna E. Shalala, Secretary, U.S. Department of Health and Human Services Appellant/cross-AppelleeCourt of Appeals for the D.C. Circuit · 1999
  4. Andrx Pharmaceuticals, Inc. v. Biovail Corp. InternationalCourt of Appeals for the D.C. Circuit · 2001
  5. Mylan Pharmaceuticals, Inc. v. ShalalaDistrict Court, District of Columbia · 2000

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