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Supreme Court of the United States › Patent Litigation › Food and Drug Administration (FDA)

The United States Supreme Court is the highest court of the United States and is charged with interpreting federal law, including the United States Constitution. The Court's docket is largely discretionary... more +
The United States Supreme Court is the highest court of the United States and is charged with interpreting federal law, including the United States Constitution. The Court's docket is largely discretionary with only a limited number of cases granted review each term.  The Court is comprised of one chief justice and eight associate justices, who are nominated by the President and confirmed by the Senate to hold lifetime positions. less -
Jones Day

U.S. Supreme Court Invites Solicitor General to Submit Briefing on "Skinny Labels"

Jones Day on

On June 23, 2025, the Supreme Court invited the Solicitor General to submit a brief expressing the views of the United States—dramatically increasing the likelihood that the Court will eventually grant review—in Hikma...more

Haug Partners LLP

The Sole Meaning of “Solely”: Supreme Court Denies Certiorari on Edward Life Sciences v. Meril Life Sciences Pvt. Ltd. and Permits...

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This month the Supreme Court denied certiorari on Edwards Lifesciences Corp. v. Meril Life Sciences Pvt. Ltd., and in doing so, seemingly indicated its support for a broad interpretation of the Hatch-Waxman safe harbor...more

Fuerst Ittleman David & Joseph

Lilly v. FDA: Two Stories Collide to Make this GLP-1 Case a Tale of Our Time

Fuerst Ittleman David & Joseph on

I recently learned of Eli Lilly & Co.’s (“Lilly”) recent lawsuit against FDA from Nicole DeFeudis, who interviewed me for her Endpoints News story about the case. Lilly’s lawsuit, filed in September 2024 in the Southern...more

Haug Partners LLP

United Therapeutics Corporation Certiorari Petition Denied, Creates a Lose-Lose Situation

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On Monday, October 7, 2024, the U.S. Supreme Court (“SCOTUS”) denied United Therapeutics Corporation (“UTC”) petition for certiorari clearing the way for Liquidia Corporation (“Liquidia”) to launch its Yutrpia® drug product....more

Knobbe Martens

Federal Circuit Review | August 2024

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Specify the Steps of Information Manipulation or Lose under § 101 - In Mobile Acuity Ltd. v. Blippar Ltd. Appeal No. 22-2216, the Federal Circuit held that patent claims that merely recite result-orientated, functional...more

Proskauer - Minding Your Business

The Broad Impact of Edwards v. Meril on the Safe Harbor Provision

Proskauer - Minding Your Business on

The Federal Circuit’s decision in Edwards Lifesciences Corp. v. Meril Life Sciences Pvt. Ltd., has garnered significant attention, especially concerning the application of the “safe harbor” provision under 35 U.S.C. §...more

A&O Shearman

SCOTUS denies cert in skinny label appeal from the Federal Circuit

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On May 15, 2023, the Supreme Court of the United States denied Teva Pharmaceuticals USA, Inc.’s (“Teva”) petition for certiorari in Teva Pharmaceuticals USA, Inc. v. GlaxoSmithKline, LLC, ending a nearly nine-year court...more

Axinn, Veltrop & Harkrider LLP

Axinn IP Update: Supreme Court Denies Cert. in Skinny Label Case, but the Impacts from GSK v. Teva Continue

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Yesterday, the Supreme Court denied certiorari in Teva Pharms. USA, Inc. v. GlaxoSmithKline, LLC, 22-37, locking in the Federal Circuit’s second panel decision (hereafter “GSK v. Teva”), which held that Teva’s attempted...more

Foley Hoag LLP

Previewing Generic’s Skinny Label: Supreme Court to Rule on Teva’s Certiorari Petition

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The Supreme Court is expected to consider Teva’s pending petition for certiorari in the highly anticipated GlaxoSmithKline LLC v. Teva Pharms. USA, Inc. on May 11, 2023, a case that could carry enormous implications for the...more

Harris Beach Murtha PLLC

Important 2020 Patent Law Decisions from the Court of Appeals for the Federal Circuit

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Whether you are pursuing patents on your new technology, thinking about bringing patent infringement litigation or defending patent infringement claims in court, knowing the important developments in patent law will help you...more

Goodwin

Year in Review: Top Five Legal Developments of 2017

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Here are our picks for the top-five most significant legal developments regarding biosimilars in 2017...more

McDonnell Boehnen Hulbert & Berghoff LLP

Amgen Inc. v. Sandoz Inc. (Fed. Cir. 2017) -- One Last Dance . . .

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Last June, in Sandoz Inc. v. Amgen Inc., the Supreme Court handed down its interpretation of the Biologics Price Competition and Innovation Act ("BPCIA") for the approval of biosimilar drugs. As we reported at the time, the...more

Ladas & Parry LLP

Skipping The Patent Dance: U.S. Supreme Court In Amgen V Sandoz Makes It More Difficult For Patent Owners To Delay Marketing Of...

Ladas & Parry LLP on

On June 12, 2017, in a unanimous decision authored by Justice Thomas in Amgen Inc. v. Sandoz Inc., the United States Supreme Court considered the complex statutory scheme that attempts to expedite resolution of patent...more

Robinson+Cole Health Law Diagnosis

Supreme Court Decision Allows Faster Marketing of Biosimilars

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On Monday, June 12, 2017, the United States Supreme Court in a unanimous decision held that manufacturers making biosimilars of biologic drugs did not have to wait until after gaining federal approval of the biosimilar to...more

Hogan Lovells

ITC Section 337 – Quarterly Highlights

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SCOTUS Narrows Opportunity For ITC Section 337 Jurisdiction Over Imported Biosimilars Based On 180-Day Notice Provision - In Amgen Inc. v. Sandoz Inc., 794 F.3d 1347, 1357-58 (Fed. Cir. 2015), the Federal Circuit held that...more

McDermott Will & Emery

Supreme Court Analyzes Key Provisions of Biologics Price Competition and Innovation Act of 2009

McDermott Will & Emery on

In a unanimous decision, the United States Supreme Court has clarified certain portions of the Biologics Price Competition and Innovation Act of 2009 (BPCIA), concluding (1) that biosimilar makers do not have to wait for...more

BakerHostetler

Branded Biologic Products Lose 180 Days of Patent Exclusivity in Unanimous Decision From Supreme Court

BakerHostetler on

On June 13, 2017, the U.S. Supreme Court issued its opinion in Sandoz v. Amgen. In doing so, it answered two questions raised under the Biologics Price Competition and Innovation Act of 2009 (BPCI). First, is an injunction...more

Weintraub Tobin

U.S. Supreme Court Allows Early Notice For Biosimilars

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In SANDOZ INC. v. AMGEN INC. et al., the United States Supreme Court in a unanimous opinion ruled that biosimilar makers can give their required 180-day statutory notice of sales before their products win approval by the...more

Troutman Pepper Locke

Sandoz Inc. V. Amgen Inc. Clears The Way For Potential Earlier Launch Of Biosimilars

Troutman Pepper Locke on

In Sandoz Inc. v. Amgen Inc., No. 15-1039 (U.S. June 12, 2017) the Supreme Court held (i) that biosimilar applicants may provide the requisite 180-days’ notice of commercial marketing to the reference product sponsor even...more

Fish & Richardson

SCOTUS Unravels Some of the BPCIA Enigma — But Questions Remain

Fish & Richardson on

Reference product sponsors (RPSs) and biosimilar manufacturers were hoping the Supreme Court of the United States would clarify two aspects of the Biologics Price Competition and Innovation Act (“BPCIA”) in the Amgen v....more

Faegre Drinker Biddle & Reath LLP

Supreme Court Decides Sandoz, Inc. v. Amgen, Inc.

Faegre Drinker Biddle & Reath LLP on

On June 12, 2017, the Supreme Court decided Sandoz, Inc. v. Amgen, Inc., Nos. 15-1039, 15-1195, in which it held that (a) a manufacturer of a licensed biological product cannot obtain federal injunctive relief to enforce 42...more

Goodwin

BREAKING NEWS: U.S. Supreme Court Issues Decision in Sandoz v. Amgen

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We previously reported on the oral argument in Sandoz v. Amgen. Justice Thomas has delivered the opinion for a unanimous U.S. Supreme Court in Sandoz v. Amgen. Briefly, the Supreme Court held that notice of commercial...more

Jones Day

Supreme Court Hears Oral Arguments in Sandoz Inc. v. Amgen

Jones Day on

On April 26, 2017, the U.S. Supreme Court heard oral argument in Sandoz Inc. v. Amgen Inc. (Nos. 15-1039, 15-1195), on appeal from the Federal Circuit's July 21, 2015, opinion interpreting various provisions of the Biologics...more

Goodwin

Analysis: Supreme Court Oral Argument in Sandoz v. Amgen

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The transcript of the April 26 Supreme Court oral argument in Sandoz v. Amgen has been posted online. As we covered briefly, the questioning during today’s argument focused primarily on three points....more

Goodwin

Reminder: Supreme Court Arguments on April 26th in Amgen v. Sandoz

Goodwin on

As a reminder to our readers, tomorrow the Supreme Court will hear oral arguments in Amgen v. Sandoz regarding the following questions: ..Whether a biosimilar applicant is required by 42 U.S.C. § 262(l)(2)(A) to provide...more

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