Apotex Inc. v. Amgen Inc.

Petition for certiorari denied on December 12, 2016
Docket No. Op. Below Argument Opinion Vote Author Term
16-332 Fed. Cir. N/A N/A N/A N/A OT 2016

Issue: (1) Whether the U.S. Court of Appeals for the Federal Circuit erred in holding that biosimilar applicants that make all disclosures necessary under the Biologics Price Competition and Innovation Act for the resolution of patent disputes (viz. 42 U.S.C. § 262(l)(2)(A)) must also provide the reference product sponsor with a notice of commercial marketing under 42 U.S.C. § 262(l)(8)(A); and (2) whether the Federal Circuit improperly extended the statutory 12-year exclusivity period to 12 1/2 years by holding that a biosimilar applicant cannot give effective notice of commercial marketing under 42 U.S.C. § 262(l)(8)(A) for its biosimilar product until it receives a Food and Drug Administration license and therefore may not commercially market its biosimilar product for 180 days after receiving its license.

SCOTUSblog Coverage

DateProceedings and Orders (key to color coding)
Sep 9 2016Petition for a writ of certiorari filed. (Response due October 14, 2016)
Sep 27 2016Order extending time to file response to petition to and including November 8, 2016.
Oct 3 2016Consent to the filing of amicus curiae briefs, in support of either party or of neither party, received from counsel for the petitioners,
Oct 14 2016Brief amicus curiae of The Biosimilars Council filed.
Oct 14 2016Brief amicus curiae of Mylan Pharmaceuticals Inc. filed.
Nov 8 2016Brief of respondents Amgen Inc., et al. in opposition filed.
Nov 17 2016Letter of November 17, 2016, from counsel for petitioners received waiving the 14-day waiting period for the distribution of the petition pursuant to Rule 15.5.
Nov 21 2016DISTRIBUTED for Conference of December 9, 2016.
Nov 21 2016Reply of petitioners Apotex Inc., et al. filed. (Distributed)
Dec 12 2016Petition DENIED.
 
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