Editor's Note :

Editor's Note :

We expect orders from the April 21 conference on Monday at 9:30 a.m. There is a possibility of opinions on Tuesday, April 25.
On Monday the court hears oral argument in McWilliams v. Dunn. Amy Howe has our preview.
On Monday the court also hears oral argument in Davila v. Davis. Steve Vladeck has our preview.

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Sandoz Inc. v. Amgen Inc.

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Docket No. Op. Below Argument Opinion Vote Author Term
15-1039 Fed. Cir. Apr 26, 2017
TBD TBD TBD OT 2016

Issue: (1) Whether notice of commercial marketing given before Food and Drug Administration approval can be effective; and (2) whether, in any event, it is improper to treat Section 262(l)(8)(A) – the Biologics Price Competition and Innovation Act of 2009's “Notice of commercial marketing” provision which states that a biosimilar applicant shall provide notice to the incumbent seller of the biological product “not later than 180 days before the date of the first commercial marketing of the biological product licensed under” an abbreviated pathway for biosimilars – as a stand-alone requirement and as creating an injunctive remedy that delays all biosimilars by 180 days after approval. CVSG: 12/07/2016.

SCOTUSblog Coverage

DateProceedings and Orders
Dec 23 2015Application (15A672) to extend the time to file a petition for a writ of certiorari from January 14, 2016 to February 16, 2016, submitted to The Chief Justice.
Dec 29 2015Application (15A672) granted by The Chief Justice extending the time to file until February 16, 2016.
Feb 16 2016Petition for a writ of certiorari filed. (Response due March 21, 2016)
Mar 21 2016Brief amicus curiae of Biosimilars Council filed.
Mar 21 2016Motion for leave to file amici brief filed by Apotex, Inc., et al.
Mar 21 2016Brief amici curiae of Hospira, Inc, et al. filed.
Mar 21 2016Brief of respondents Amgen Inc., et al. in opposition filed.
Mar 21 2016Brief amicus curiae of Mylan, Inc. filed.
May 31 2016DISTRIBUTED for Conference of June 16, 2016.
May 31 2016Reply of petitioner Sandoz Inc. filed. (Distributed)
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 respondents 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. 15-1195 is granted. The cases are consolidated and a total of one hour is allotted for oral argument.
Jan 13 2017Motion for leave to file amici brief filed by Apotex, Inc., et al. GRANTED.
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 10 2017Brief of petitioner Sandoz Inc. filed.
Feb 17 2017SET FOR ARGUMENT ON Wednesday, April 26, 2017. VIDED.
Feb 17 2017Brief amicus curiae of Adello Biologics, LLC filed.
Feb 17 2017Brief amici curiae of Pharmaceutical Care Management Association, et al. filed.
Feb 17 2017Brief amici curiae of Apotex Inc. and Apotex Corp. filed. VIDED.
Feb 17 2017Brief amicus curiae of Biosimilars Council filed. VIDED.
Feb 17 2017Brief amicus curiae of America's Health Insurance Plans filed. VIDED.
Feb 17 2017Brief amicus curiae of United States filed. VIDED.
Feb 17 2017Brief amici curiae of AARP Foundation, et al. filed.
Feb 17 2017Brief amicus curiae of Coherus Biosciences, Inc. 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 AbbeVie 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 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 for Sandoz Inc. Filed. (Distributed) VIDED.
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.
 
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