Legal Opinion

Sandoz Inc. v. Amgen Inc.

Court of Appeals for the Federal Circuit

Decided December 5, 2014No. 2014-1693PublishedCited by 19 opinions

1Opinion of the Court

TARANTO, Circuit Judge.

Sandoz Inc. sued Amgen Inc. and Hoffman-La Roche Inc. to obtain a declaratory judgment that two patents, owned by Hoffman-La Roche and exclusively licensed to Amgen, are invalid and unenforceable and will not be infringed if Sandoz uses, offers to sell or sells, or imports a drug product “biosimilar” to Amgen’s Enbrel®. At the time it brought suit, Sandoz had not (as it still has not) filed an application for approval of its contemplated product by the Food and Drug Administration (FDA) and had only just begun certain testing required for its contemplated FDA filing.…

2Cases cited22 opinions

  1. McNutt v. General Motors Acceptance Corp.Supreme Court of the United States · 1936
  2. MedImmune, Inc. v. Genentech, Inc.Supreme Court of the United States · 2007
  3. Skelly Oil Co. v. Phillips Petroleum Co.Supreme Court of the United States · 1950
  4. Texas v. United StatesSupreme Court of the United States · 1998
  5. Massachusetts v. Environmental Protection AgencySupreme Court of the United States · 2007

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3Cited by19 opinions

  1. Acorda Therapeutics Inc. v. Mylan Pharmaceuticals Inc.Court of Appeals for the Federal Circuit · 2016
  2. Arcelormittal v. Ak Steel CorporationCourt of Appeals for the Federal Circuit · 2017
  3. Apotex, Inc. v. Daiichi Sankyo, Inc.Court of Appeals for the Federal Circuit · 2015
  4. Aids Healthcare Foundation v. Gilead Sciences, Inc.Court of Appeals for the Federal Circuit · 2018
  5. Medical Components, Inc. v. Osiris Medical, Inc.District Court, W.D. Texas · 2016

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