Legal Opinion
Cumberland Pharmaceuticals Inc. v. Mylan Institutional LLC
Court of Appeals for the Federal Circuit
Decided January 26, 2017No. 2016-1155, 2016-1259PublishedCited by 16 opinions
1Opinion of the Court
TARANTO, Circuit Judge.
Cumberland Pharmaceuticals, Inc. owns U.S. Patent No. 8,399,445, which describes and claims acetylcysteine compositions substantially free of chelating agents. It is listed in the Food and Drug Administration’s Approved, Drug Products with Therapeutic Equivalence Evaluations (the Orange Book) as covering Cumberland’s ehelating-agent-free formulation of Aceta-dote®, an intravenous antidote for overdoses of acetaminophen. When Mylan Institutional LLC filed an abbreviated new drug application to market its own chelating-agent-free acetylcysteine formulation, Cumberland…
2Cases cited21 opinions
- Richard C. Price v. Dale R. SymsekCourt of Appeals for the Federal Circuit · 1993
- Burroughs Wellcome Co. v. Barr Laboratories, Inc., and Novopharm, Inc. And Novopharm, Ltd.Court of Appeals for the Federal Circuit · 1994
- Eli Lilly and Company v. Aradigm Corporation, Defendant-CrossCourt of Appeals for the Federal Circuit · 2004
- Intelligent Bio-Systems, Inc. v. Illumina Cambridge Ltd.Court of Appeals for the Federal Circuit · 2016
- Kinetic Concepts, Inc. v. Smith & Nephew, Inc.Court of Appeals for the Federal Circuit · 2012
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3Cited by16 opinions
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- W. Plastics, Inc. v. Dubose Strapping, Inc.District Court, E.D. North Carolina · 2018
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- Baxalta Incorporated v. Bayer HealthCare LLCDistrict Court, D. Delaware · 2021
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