Legal Opinion

Spectrum Pharmaceuticals, Inc v. Sylvia Burwell

Court of Appeals for the D.C. Circuit

Decided June 3, 2016No. 15-5166PublishedCited by 7 opinions

1Opinion of the Court

GRIFFITH, Circuit Judge:

In this case, Spectrum Pharmaceuticals claimed that the Food and Drug Administration’s approval of a cancer drug violated Spectrum’s exclusive marketing rights. The district court granted summary judgment against Spectrum, and we affirm.

I

Levoleucovorin is better known by the brand-name Fusilev, which Spectrum has sold since 2008 for the purpose of counteracting liver damage during a type of chemotherapy known as methotrexate therapy (the “Methotrexate Indications”). Fusilev is an “orphan drug,” so called because it is designed to treat a rare disease or condition that…

2Cases cited16 opinions

  1. Chevron U. S. A. Inc. v. Natural Resources Defense Council, Inc.Supreme Court of the United States · 1984
  2. Federal Communications Commission v. Fox Television Stations, Inc.Supreme Court of the United States · 2009
  3. United States v. ShimerSupreme Court of the United States · 1961
  4. Serono Labs Inc v. Ferring Pharm. Inc.Court of Appeals for the D.C. Circuit · 1998
  5. Global Crossing Telecommunications, Inc. v. Metrophones Telecommunications, Inc.Supreme Court of the United States · 2007

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3Cited by7 opinions

  1. Eagle Pharmaceuticals, Inc. v. Alex Azar, IICourt of Appeals for the D.C. Circuit · 2020
  2. Loan Syndications & Trading Ass'n v. SEC. & Exch. Comm'nCourt of Appeals for the D.C. Circuit · 2018
  3. Catalyst Pharmaceuticals, Inc. v. Xavier BecerraCourt of Appeals for the Eleventh Circuit · 2021
  4. Catalyst Pharmaceuticals, Inc. v. AzarDistrict Court, S.D. Florida · 2020
  5. Jazz Pharmaceuticals, Inc. v. BecerraDistrict Court, District of Columbia · 2024

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