Legal Opinion

Purepac Pharmaceutical Co. v. Thompson

District Court, District of Columbia

Decided December 16, 2002No. CIV.A. 02-1657(ESH)PublishedCited by 16 opinions

1Opinion of the Court

MEMORANDUM OPINION

HUVELLE, District Judge.

This case arises out of the Food and Drug Administration’s (“FDA” or “the agency”) denial of Abbreviated New Drug Applications for generic formulations of the drug gabapentin submitted by plaintiff Purepac Pharmaceutical Co. (“Purepac”). The agency denied plaintiffs ANDAs because those applications failed to include the proper certification (a “paragraph IV certification”) regarding a method of use patent covering gabapentin owed by the Warner-Lambert Company (“Warner-Lambert”). Purepac has now moved for a preliminary injunction requiring the FDA to…

2Cases cited28 opinions

  1. Motor Vehicle Mfrs. Assn. of United States, Inc. v. State Farm Mut. Automobile Ins. Co.Supreme Court of the United States · 1983
  2. Bowman Transportation, Inc. v. Arkansas-Best Freight System, Inc.Supreme Court of the United States · 1975
  3. Amer Bioscience Inc v. Thompson, Tommy G.Court of Appeals for the D.C. Circuit · 2001
  4. Mova Pharmaceutical Corp. v. ShalalaCourt of Appeals for the D.C. Circuit · 1998
  5. Eli Lilly & Co. v. Medtronic, Inc.Supreme Court of the United States · 1990

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3Cited by16 opinions

  1. Apotex, Inc. v. Food & Drug AdministrationCourt of Appeals for the D.C. Circuit · 2004
  2. Wyeth, Inc. v. Danny Weeks and Vicki WeeksSupreme Court of Alabama · 2014
  3. John Doe 1 v. RumsfeldDistrict Court, District of Columbia · 2004
  4. In re: FBOP Execution Protocol CasesCourt of Appeals for the D.C. Circuit · 2020
  5. In Re Gabapentin Patent LitigationDistrict Court, D. New Jersey · 2009

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