Spectrum Pharmaceuticals, Inc v. Sylvia Burwell
Court of Appeals for the D.C. Circuit
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…
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