Sandoz Inc. v. Amgen Inc.

Linked with:

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.

SCOTUSblog Coverage

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.

Featured Posts

Academic highlight: Levitt on the collateral consequences of Department of Commerce v. New York – Amanda Frost

New rules mean tighter deadlines, fewer words – Amy Howe

Relist Watch: The Muller Report – John Elwood
Sponsored by Casetext
SCOTUStalk see all
Email Digest Sign-Up
Receive a daily email digest from Feedburner by entering your email.
Merits Case Pages and Archives

Archives

or

This Week at the Court
The Supreme Court will release orders from the April 18 conference on Monday at 9:30 a.m.; John Elwood's Relist Watch compiles the petitions that were relisted for this conference.
There is a possibility of opinions on Tuesday at 10 a.m.
On Monday, the justices hear oral argument in Food Marketing Institute v. Argus Leader Media and Fort Bend County, Texas v. Davis.
On Tuesday, the justices hear oral argument in Department of Commerce v. New York, Mitchell v. Wisconsin and Rehaif v. United States.
On Wednesday, the justices hear oral argument in Quarles v. United States and Taggart v. Lorenzen.
On Friday, the justices met for their April 26 conference.
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
  (1) Whether a 93-year-old memorial to the fallen of World War I is unconstitutional merely because it is shaped like a cross; (2) whether the constitutionality of a passive display incorporating religious symbolism should be assessed under the tests articulated in Lemon v. Kurtzman, Van Orden v. Perry, Town of Greece v. Galloway or some other test; and (3) whether, if the test from Lemon v. Kurtzman applies, the expenditure of funds for the routine upkeep and maintenance of a cross-shaped war memorial, without more, amounts to an excessive entanglement with religion in violation of the First Amendment.
- Gamble v. United States
  Whether the Supreme Court should overrule the “separate sovereigns” exception to the double jeopardy clause.
see all this term’s cases »
Recent Decisions
- Biestek v. Berryhill A vocational expert’s refusal to provide private market-survey data during a Social Security disability benefits hearing upon the applicant’s request does not categorically preclude the testimony from counting as “substantial evidence” in federal court under 42 U. S. C. §405(g).
- Bucklew v. Precythe Baze v. Rees and Glossip v. Gross govern all Eighth Amendment challenges alleging that a method of execution inflicts unconstitutionally cruel pain; Russell Bucklew’s as-applied challenge to Missouri’s single-drug execution protocol -- that it would cause him severe pain because of his particular medical condition -- fails to satisfy the Baze-Glossip test.
- Lorenzo v. Securities and Exchange Commission Dissemination of false or misleading statements with intent to defraud can fall within the scope of Securities and Exchange Commission Rules 10b–5(a) and (c), as well as the relevant statutory provisions, even if the disseminator cannot be held liable under Rule 10b–5(b).
- Republic of Sudan v. Harrison When civil process is served on a foreign state under the Foreign Sovereign Immunities Act of 1976, 28 U. S. C. §1608(a)(3) requires a mailing to be sent directly to the foreign minister’s office in the foreign state.
- Sturgeon v. Frost Alaska’s Nation River is not public land; and like all non-public lands and navigable waters within Alaska’s national parks, it is exempt under the Alaska National Interest Lands Conservation Act from the National Park Service’s ordinary regulatory authority.
see all this term’s cases »
Current Relists
- Altitude Express Inc. v. Zarda Whether the prohibition in Title VII of the Civil Rights Act of 1964, 42 U.S.C. § 2000e-2(a)(1), against employment discrimination “because of . . . sex” encompasses discrimination based on an individual’s sexual orientation.
- Barton v. Barr Whether a lawfully admitted permanent resident who is not seeking admission to the United States can be “render[ed] ... inadmissible” for the purposes of the stop-time rule, 8 U.S.C. § 1229b(d)(1).
- Bostock v. Clayton County, Georgia Whether discrimination against an employee because of sexual orientation constitutes prohibited employment discrimination “because of . . . sex” within the meaning of Title VII of the Civil Rights Act of 1964, 42 U.S.C. § 2000e-2.
More Petitions »
Recent Special Features
Statistical Snapshot

Cases argued 63

Cases decided 31

Summary reversals 4

Merits cases granted to date 74

see all »
Live Blog Archives
See all
Twitter Feed

Tweets by @SCOTUSblog

Full Calendar Submit Event

Apr. 2019

Su	Mo	Tu	We	Th	Fr	Sa
	1 Orders Opinions	2	3	4	5	6
7	8	9	10	11	12 Conference	13
14	15 Orders IANCU V. BRUNETTI (18-302) EMULEX CORP. V. VARJABEDIAN (18-459)	16 PARKER DRILLING MANAGEMENT SERVICES V. NEWTON (18-389) NORTH CAROLINA DEPARTMENT OF REVENUE V. KAESTNER FAMILY TRUST (18-457)	17 UNITED STATES V. DAVIS (18-431) MCDONOUGH V. SMITH (18-485)	18 Conference	19	20
21	22 Orders FOOD MARKETING INSTITUTE V. ARGUS LEADER MEDIA (18-481) FORT BEND COUNTY, TEXAS V. DAVIS (18-525)	23 MITCHELL V. WISCONSIN (18-6210) REHAIF V. UNITED STATES (17-9560) DEPARTMENT OF COMMERCE V. NEW YORK (18-966) Opinions	24 QUARLES V. UNITED STATES (17-778) TAGGART V. LORENZEN (18-489)	25	26 Conference	27
28	29 Orders	30

Orders/Opinions
Arguments
Conferences

Events
Holidays
Multiple

Download our App in the Apple Store
Videos see all

Justice Thomas at Pepperdine Law School

On March 30, Justice Clarence Thomas spoke with former clerk Brittney Lane Kubisch and Pepperdine University President-elect James Gash at Pepperdine University School of Law. Thomas told the audience that he had no plans to retire from the Supreme Court.

Peabody Award
Awarded the Peabody Award for excellence in electronic media.
Sigma Delta Chi
Awarded the Sigma Delta Chi deadline reporting award for online coverage of the Affordable Care Act decision.
National Press Club Award
Awarded the National Press Club's Breaking News Award for coverage of the Affordable Care Act decision.
Silver Gavel Award
Awarded the Silver Gavel Award by the American Bar Association for fostering the American public’s understanding of the law and the legal system.
American Gavel Award
Awarded the American Gavel Award for Distinguished Reporting About the Judiciary to recognize the highest standards of reporting about courts and the justice system.
Webby Award
Awarded the Webby Award for excellence on the internet.

Cases argued	63
Cases decided	31
Summary reversals	4
Merits cases granted to date	74

Editor's Note :

Sandoz Inc. v. Amgen Inc.

SCOTUSblog Coverage

Featured Posts

Academic highlight: Levitt on the collateral consequences of Department of Commerce v. New York – Amanda Frost

New rules mean tighter deadlines, fewer words – Amy Howe

Relist Watch: The Muller Report – John Elwood

Sponsored by Casetext

SCOTUStalk see all

Email Digest Sign-Up

Merits Case Pages and Archives

Major Cases

Recent Decisions

Current Relists

Conference of April 19, 2019

Recent Special Features

Live Blog Archives

Apr. 2019

Download our App in the Apple Store

Videos see all

Peabody Award

Sigma Delta Chi

National Press Club Award

Silver Gavel Award

American Gavel Award

Webby Award