Legal Opinion
Amgen Inc. v. Apotex Inc.
Court of Appeals for the Federal Circuit
Decided July 5, 2016No. 2016-1308PublishedCited by 4 opinions
1Opinion of the Court
TARANTO, Circuit Judge.
This appeal involves an action brought by Amgen Inc. and Amgen Manufacturing Limited (collectively Amgen) against Apo-tex Inc. arid Apotex Corp. (collectively Apotex) under the Biologies Price Competition and Innovation Act of 2009 (Biologies Act or BPCIA). Apotex has an application pending with the Food and Drug Administration, filed under the Biologies Act, that seeks permission to begin marketing a product allegedly “biosimilar” to Amgen’s FDA-approved Neulasta®. For such an applicant, the Biologies Act lays out a step-by-step process for exchanging information and…
2Cases cited13 opinions
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- Porter v. Warner Holding Co.Supreme Court of the United States · 1946
- Lexecon Inc. v. Milberg Weiss Bershad Hynes & LerachSupreme Court of the United States · 1998
- Ali v. Federal Bureau of PrisonsSupreme Court of the United States · 2008
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3Cited by4 opinions
- Amgen Inc. v. Hospira, Inc.Court of Appeals for the Federal Circuit · 2017
- Janssen Biotech, Inc. v. Celltrion Healthcare Co.District Court, D. Massachusetts · 2016
- Janssen Biotech, Inc. v. Celltrion Healthcare Co.District Court, D. Massachusetts · 2017
- Takeda Pharmaceuticals U.S.A. v. Mylan Pharmaceuticals Inc.Court of Appeals for the Federal Circuit · 2020