Sandoz Inc. v. Amgen Inc.

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Sandoz Inc. v. Amgen Inc.

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Amgen Inc. v. Sandoz Inc.

Docket No.	Op. Below	Argument	Opinion	Vote	Author	Term
15-1039	Fed. Cir.	Apr 26, 2017 Tr.Aud.	Jun 12, 2017	9-0	Thomas	OT 2016

Holding: Section 262(l)(2)(A) of the Biologics Price Competition and Innovation Act of 2009 is not enforceable by injunction under federal law, but the U.S. Court of Appeals for the Federal Circuit on remand should determine whether a state-law injunction is available; an applicant may provide notice of commercial marketing under Section 262(l)(8)(A) prior to obtaining licensure.

Judgment: Vacated in part, reversed in part, and remanded, 9-0, in an opinion by Justice Thomas on June 12, 2017. Justice Breyer filed a concurring opinion.

Date	Proceedings and Orders (key to color coding)
Dec 23 2015	Application (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 2015	Application (15A672) granted by The Chief Justice extending the time to file until February 16, 2016.
Feb 16 2016	Petition for a writ of certiorari filed. (Response due March 21, 2016)
Mar 21 2016	Brief amicus curiae of Biosimilars Council filed.
Mar 21 2016	Motion for leave to file amici brief filed by Apotex, Inc., et al.
Mar 21 2016	Brief amici curiae of Hospira, Inc, et al. filed.
Mar 21 2016	Brief of respondents Amgen Inc., et al. in opposition filed.
Mar 21 2016	Brief amicus curiae of Mylan, Inc. filed.
May 31 2016	DISTRIBUTED for Conference of June 16, 2016.
May 31 2016	Reply of petitioner Sandoz Inc. filed. (Distributed)
Jun 20 2016	The Solicitor General is invited to file a brief in this case expressing the views of the United States.
Dec 7 2016	Brief amicus curiae of United States filed. VIDED.
Dec 20 2016	Supplemental brief of respondents Amgen Inc., et al. filed. VIDED.
Dec 21 2016	DISTRIBUTED for Conference of January 6, 2017.
Jan 9 2017	DISTRIBUTED for Conference of January 13, 2017.
Jan 13 2017	Petition 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 2017	Motion for leave to file amici brief filed by Apotex, Inc., et al. GRANTED.
Jan 25 2017	The 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 2017	Joint motion of the parties to dispense with printing the joint appendix filed. VIDED.
Feb 10 2017	Brief of petitioner Sandoz Inc. filed.
Feb 17 2017	SET FOR ARGUMENT ON Wednesday, April 26, 2017. VIDED.
Feb 17 2017	Brief amicus curiae of Adello Biologics, LLC filed.
Feb 17 2017	Brief amici curiae of Pharmaceutical Care Management Association, et al. filed.
Feb 17 2017	Brief amici curiae of Apotex Inc. and Apotex Corp. filed. VIDED.
Feb 17 2017	Brief amicus curiae of Biosimilars Council filed. VIDED.
Feb 17 2017	Brief amicus curiae of America's Health Insurance Plans filed. VIDED.
Feb 17 2017	Brief amicus curiae of United States filed. VIDED.
Feb 17 2017	Brief amici curiae of AARP Foundation, et al. filed.
Feb 17 2017	Brief amicus curiae of Coherus Biosciences, Inc. filed. VIDED.
Feb 17 2017	Brief amicus curiae of Mylan, Inc. filed. VIDED.
Feb 21 2017	Motion to dispense with printing the joint appendix filed by petitioners GRANTED. VIDED
Feb 24 2017	Record requested from the U.S.C.A. for the Federal Circuit. VIDED.
Mar 10 2017	Opening and Response Brief for Amgen Inc., et al. filed. VIDED.
Mar 17 2017	Brief amicus curiae of AbbeVie Inc. filed. VIDED.
Mar 17 2017	Motion of the Acting Solicitor General for leave to participate in oral argument as amicus curiae and for divided argument filed. VIDED.
Mar 17 2017	Brief amicus curiae of Janssen Biotech, Inc. filed. VIDED.
Mar 17 2017	Brief amicus curiae of Biotechnology Innovation Organization filed. VIDED.
Mar 17 2017	Brief amicus curiae of Genentech, Inc. filed. VIDED.
Mar 22 2017	CIRCULATED.
Mar 27 2017	Record 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 2017	Consolidated Response and Reply Brief for Sandoz Inc. Filed. (Distributed) VIDED.
Apr 13 2017	Motion 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 26 2017	Argued. For petitioner in No. 15-1039: Deanne E. Maynard, Washington, D. C.; and Anthony A. Yang, Assistant to the Solicitor General, Department of Justice, Washington, D. C. (for United States, as amicus curiae.) For petitioners in 15-1195: Seth P. Waxman, Washington, D. C. VIDED.
Jun 12 2017	Adjudged to be VACATED IN PART, REVERSED IN PART, and case REMANDED. Thomas, J., delivered the opinion for a unanimous Court. Breyer, J., filed a concurring opinion. VIDED.
Jul 14 2017	JUDGMENT ISSUED.

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Opinion analysis: Justices allow "peace cross" to stand – Amy Howe

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The Supreme Court released orders from the June 13 conference on Monday; the justices granted, vacated and remanded Klein v. Oregon Bureau of Labor and Industries.
Also on Monday, the justices released their opinions in four argued cases: Manhattan Community Access Corp. v. Halleck, Virginia Uranium Inc. v. Warren, Gamble v. United States and Virginia House of Delegates v. Bethune-Hill.
On Thursday, the justices released their opinions in four argued cases: Gundy v. United States, McDonough v. Smith, The American Legion v. American Humanist Association and PDR Network, LLC v. Carlton & Harris Chiropractic Inc.
Also on Thursday, the justices met for their June 20 conference; John Elwood's "Relist Watch" compiles the petitions that were relisted for this conference.
On Friday, the Supreme Court will release opinions in one or more argued cases at 10 a.m.
Major Cases
- Department of Commerce v. New York
  (1) Whether the district court erred in enjoining the secretary of the Department of Commerce from reinstating a question about citizenship to the 2020 decennial census on the ground that the secretary’s decision violated the Administrative Procedure Act, 5 U.S.C. 701 et seq; (2) whether, in an action seeking to set aside agency action under the APA, a district court may order discovery outside the administrative record to probe the mental processes of the agency decisionmaker -- including by compelling the testimony of high-ranking executive branch officials -- without a strong showing that the decisionmaker disbelieved the objective reasons in the administrative record, irreversibly prejudged the issue, or acted on a legally forbidden basis; and (3) whether the secretary’s decision to add a citizenship question to the decennial census violated the enumeration clause of the U.S. Constitution.
- Lamone v. Benisek
  In case in which the plaintiffs allege that a Maryland congressional district was gerrymandered to retaliate against them for their political views: (1) whether the various legal claims articulated by the three-judge district court are unmanageable; (2) whether the three-judge district court erred when, in granting plaintiffs’ motion for summary judgment, it resolved disputes of material fact as to multiple elements of plaintiffs’ claims, failed to view the evidence in the light most favorable to the non-moving party, and treated as “undisputed” evidence that is the subject of still-unresolved hearsay and other evidentiary objections; and (3) whether the three-judge district court abused its discretion in entering an injunction despite the plaintiffs’ years-long delay in seeking injunctive relief, rendering the remedy applicable to at most one election before the next decennial census necessitates another redistricting.
- Kisor v. Wilkie
  Whether the Supreme Court should overrule Auer v. Robbins and Bowles v. Seminole Rock & Sand Co., which direct courts to defer to an agency’s reasonable interpretation of its own ambiguous regulation.
- Rucho v. Common Cause
  (1) Whether plaintiffs have standing to press their partisan gerrymandering claims; (2) whether plaintiffs’ partisan gerrymandering claims are justiciable; and (3) whether North Carolina’s 2016 congressional map is, in fact, an unconstitutional partisan gerrymander.
- The American Legion v. American Humanist Association
  The Bladensburg Cross does not violate the establishment clause of the First Amendment.
- Gamble v. United States
  The dual-sovereignty doctrine – under which two offenses are not the “same offence” for double jeopardy purposes if prosecuted by separate sovereigns – is upheld.
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Recent Decisions
- Gundy v. United States TThe judgment of the U.S. Court of Appeals for the 2nd Circuit that 34 U. S. C. §20913(d) – which requires the U.S. attorney general to apply the Sex Offender Registration and Notification Act’s registration requirements as soon as feasible to offenders convicted before the statute’s enactment – is not an unconstitutional delegation of legislative authority is affirmed.
- McDonough v. Smith The statute of limitations for Edward McDonough’s 42 U. S. C. §1983 fabricated-evidence claim against his prosecutor began to run when the criminal proceedings against him terminated in his favor – that is, when he was acquitted at the end of his second trial.
- PDR Network, LLC v. Carlton & Harris Chiropractic Inc. The extent to which a 2006 Federal Communications Commission order interpreting the term “unsolicited advertisement” binds lower courts may depend on the resolution of two preliminary questions that the U.S. Court of Appeals for the 4th Circuit should address in the first instance: (1) whether the order is the equivalent of a legislative rule, which has the force and effect of law, or an interpretative rule, which does not; and (2) whether PDR Network, LLC had a “prior” and “adequate” opportunity to seek judicial review of the order.
- The American Legion v. American Humanist Association The Bladensburg Cross does not violate the establishment clause of the First Amendment.
- Gamble v. United States The dual-sovereignty doctrine – under which two offenses are not the “same offence” for double jeopardy purposes if prosecuted by separate sovereigns – is upheld.
- Manhattan Community Access Corp. v. Halleck Manhattan Community Access Corp., a private nonprofit corporation designated by New York City to operate the public access channels on the Manhattan cable system owned by Time Warner (now Charter), is not a state actor subject to the First Amendment.
- Virginia House of Delegates v. Bethune-Hill The House of Delegates lacks standing to appeal the invalidation of Virginia’s redistricting plan.
- Virginia Uranium, Inc. v. Warren The U.S. Court of Appeals for the 4th Circuit’s judgment that the Atomic Energy Act does not preempt Virginia’s prohibition on uranium mining in the commonwealth is affirmed.
see all this term’s cases »
Current Relists
- Atlanta Gas Light Co. v. Bennett Regulator Guards Inc. (1) Whether the U.S. Court of Appeals for the Federal Circuit erred in concluding that it had jurisdiction to review the Patent Trial and Appeal Board’s decision to institute inter partes review of respondent’s patent over respondent’s objection that it was time-barred; and (2) whether the U.S. Court of Appeals for the Federal Circuit erred when it rejected the longstanding principle that a dismissal without prejudice leaves the parties as if a suit had never been brought, splitting the circuits.
- Banister v. Davis (1) Whether Gonzalez v. Crosby extends to post-judgment motions filed under Federal Rule of Civil Procedure 59(e); (2) whether, if Gonzalez does apply, a timely filed Rule 59(e) motion should toll the time to file a notice of appeal under Federal Rule of Appellate Procedure 4(a)(4)(A)(iv); and (3) whether a pro se petitioner must be warned and given an opportunity to withdraw a post-judgment motion which has be recharacterized as a successive habeas petition if that recharacterization will effect his ability to file a timely notice of appeal.
- Department of Homeland Security v. Regents of the University of California (1) Whether the Department of Homeland Security’s decision to wind down the Deferred Action for Childhood Arrivals policy is judicially reviewable; and (2) whether DHS’s decision to wind down the DACA policy is lawful.
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Cases argued	69
Cases decided	53
Summary reversals	5
Merits cases granted to date	74

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6
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10
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13
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