Editor's Note :

Editor's Note :

There is a possibility of opinions on Tuesday, April 25.
On Tuesday the court hears oral argument in Bristol-Myers Squibb Co. v. Superior Court of California, San Francisco County. Ronald Mann has our preview.
On Tuesday the court also hears oral argument in BNSF Railway Co. v. Tyrrell. Amy Howe has our preview.

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Amgen Inc. v. Sandoz Inc.

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Docket No. Op. Below Argument Opinion Vote Author Term
15-1195 Fed. Cir. Apr 26, 2017
TBD TBD TBD OT 2016

Issues: (1) Whether a biosimilar applicant is required by 42 U.S.C. § 262(l)(2)(A) to provide the reference product sponsor with a copy of its biologics license application and related manufacturing information, which the statute says the applicant “shall provide;” and (2) whether, where an applicant fails to provide that required information, the sponsor's sole recourse is to commence a declaratory judgment under 42 U.S.C. § 262(l)(9)(C) and/or a patent-infringement action under 35 U.S.C. § 271(e)(2)(C)(ii). CVSG: 12/07/2016.

SCOTUSblog Coverage

DateProceedings and Orders
Mar 21 2016Petition for a writ of certiorari filed. (Response due April 22, 2016)
Apr 18 2016Order extending time to file response to petition to and including May 17, 2016.
May 17 2016Brief of respondent Sandoz Inc. in opposition filed.
May 27 2016Reply of petitioners Amgen Inc., et al. filed.
May 31 2016DISTRIBUTED for Conference of June 16, 2016.
Jun 20 2016The Solicitor General is invited to file a brief in this case expressing the views of the United States.
Dec 7 2016Brief amicus curiae of United States filed. VIDED.
Dec 20 2016Supplemental brief of petitioners Amgen Inc., et al. filed. VIDED.
Dec 21 2016DISTRIBUTED for Conference of January 6, 2017.
Jan 9 2017DISTRIBUTED for Conference of January 13, 2017.
Jan 13 2017Petition GRANTED. The petition for a writ of certiorari in No. 15-1039 is granted. The cases are consolidated and a total of one hour is allotted for oral argument.
Jan 25 2017The following briefing schedule is adopted: Petitioner in No. 15-1039 will file an opening brief limited to the question presented in its petition, not to exceed 15,000 words, on or before Friday, February 10, 2017. Petitioners in No. 15-1195 will file a consolidated opening brief on the question presented in their petition and response brief, not to exceed 19,000 words, on or before Friday, March 10, 2017. Petitioner in No. 15-1039 will file a consolidated response brief and reply brief, not to exceed 10,000 words, on or before Friday, March 31, 2017. Petitioners in No. 15-1195 will file a reply brief, not to exceed 6,000 words, on or before Friday, April 14, 2017. Any brief of an amicus curiae in support of petitioner in No. 15-1039 or in support of neither party is to be filed on or before Friday, February 17, 2017, and the brief should bear a light green cover. Any brief of an amicus curiae in support of petitioners in No. 15-1195 is to be filed on or before Friday, March 17, 2017, and the brief should bear a dark green cover. An amicus curiae may file only a single brief in these cases. VIDED.
Jan 30 2017Joint motion of the parties to dispense with printing the joint appendix filed. VIDED.
Feb 17 2017SET FOR ARGUMENT ON Wednesday, April 26, 2017. VIDED.
Feb 17 2017Brief amici curiae of Apotex Inc. and Apotex Corp. filed. VIDED.
Feb 17 2017Brief amicus curiae of Coherus Biosciences, Inc. filed. VIDED.
Feb 17 2017Brief amicus curiae of America's Insurance Health Plans filed. VIDED.
Feb 17 2017Brief amicus curiae of United States filed. VIDED.
Feb 17 2017Brief amicus curiae of Biosimilars Council filed. VIDED.
Feb 17 2017Brief amicus curiae of Mylan Inc. filed. VIDED.
Feb 21 2017Motion to dispense with printing the joint appendix filed by petitioners GRANTED. VIDED.
Feb 24 2017Record requested from the U.S.C.A. for the Federal Circuit. VIDED.
Mar 10 2017Opening and Response Brief for Amgen Inc., et al. filed. VIDED.
Mar 17 2017Brief amicus curiae of AbbVie Inc. filed. VIDED.
Mar 17 2017Motion of the Acting Solicitor General for leave to participate in oral argument as amicus curiae and for divided argument filed. VIDED.
Mar 17 2017Brief amici curiae of Eleven Professors filed.
Mar 17 2017Brief amicus curiae of Janssen Biotech, Inc. filed. VIDED.
Mar 17 2017Brief amicus curiae of Biotechnology Innovation Organization. filed. VIDED.
Mar 17 2017Brief amicus curiae of Genentech, Inc. filed. VIDED.
Mar 22 2017CIRCULATED.
Mar 27 2017Record received from the U.S.C.A. for the Federal Circuit. The record is available on PACER, except for confidential materials transmitted separately. VIDED.
Mar 31 2017Consolidated Response and Reply Brief of Sandoz Inc. filed. VIDED. (Distributed)
Apr 13 2017Motion of the Acting Solicitor General for leave to participate in oral argument as amici curiae and for divided argument GRANTED. VIDED. Justice Gorsuch too no part in the consideration or decision of this motion.
Apr 13 2017Reply of petitioners Amgen Inc., et al. filed. (Distributed)
 
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