News & Analysis as of

Supreme Court of the United States › Petition for Writ of Certiorari › 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"

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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

Knobbe Martens

Edwards v. Meril at the Supreme Court: Testing the Scope of Hatch-Waxman’s Safe Harbor

Knobbe Martens on

On October 11, 2024, Edwards filed a petition for a writ of certiorari with the U.S. Supreme Court. The question presented, as framed by Edwards, is: “Whether, under Hatch-Waxman’s safe harbor, an infringing act is “solely...more

McDonnell Boehnen Hulbert & Berghoff LLP

In re Cellect in View of Supreme Court's "Long Conference"

McDonnell Boehnen Hulbert & Berghoff LLP on

In view of the Supreme Court's "long conference" on September 30th, it seems timely to review the arguments, pro, con, and amicus briefs submitted to the Court asking for certiorari over the Federal Circuit's In re...more

Troutman Pepper Locke

Industry Urges SCOTUS to Consider FDA Graphic Cigarette Warnings

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In August, a group of tobacco companies filed a petition for certiorari at the U.S. Supreme Court, seeking review of a lower court’s holding that the First Amendment does not prohibit the U.S. Food and Drug Administration...more

Foley & Lardner LLP

Master of Its Choice of Forum?

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On April 29, 2024, the U.S. Supreme Court agreed to review whether a plaintiff may compel the remand of a case removed on the basis of federal question jurisdiction by voluntarily amending its complaint to leave only state...more

Foley Hoag LLP

In Re Cellect: What’s The Issue and What to Expect

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What Congress has guaranteed, the courts have taken away - The Supreme Court is about to receive a Petition for Certiorari in a case that impacts how long a patent protects new inventions, we expect. Specifically, the case...more

McDonnell Boehnen Hulbert & Berghoff LLP

Solicitor General Files Brief Advocating Certiorari Grant in Teva Pharmaceuticals v. GlaxoSmithKline; Court Declines Invitation

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Today, the Supreme Court again disregarded the views of the Federal government regarding whether to grant certiorari, here in Teva Pharmaceuticals USA v. GlaxoSmithKline LLC, and in some ways the only positive outcome is that...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

Rothwell, Figg, Ernst & Manbeck, P.C.

Solicitor General Urges the Supreme Court to Reverse the Federal Circuit’s Teva v. GSK Decision

Rothwell, Figg, Ernst & Manbeck, P.C. on

After the Supreme Court invited the Solicitor General to file a brief expressing the views of the United States regarding Teva Pharms USA, Inc. v. GlaxoSmithKline LLC, et al., the Solicitor General filed its brief amicus...more

King & Spalding

Genus Medical Technologies LLC v. FDA: D.C. Circuit Holds FDA Cannot Regulate Devices as Drugs

King & Spalding on

FDA regulation of biomedical products can be like a very complex game theory decision tree. Choices made at each intersection impact the ultimate regulatory framework under which any given product is developed, seeks...more

Robinson+Cole Health Law Diagnosis

Supreme Court Order Indicates Interest in Reviewing Campie, the False Claims Act Outlier of the Ninth Circuit

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In an order issued on April 16, 2018, the U.S. Supreme Court invited the Solicitor General to file a brief “expressing the views of the United States” concerning the 2017 decision of the U.S. Court of Appeals for the Ninth...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

Goodwin

Supreme Court asks SG for views on Sandoz, Amgen petitions: Analysis and Next Steps

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As we posted on June 20, the Supreme Court has invited the Solicitor General to file briefs regarding the Sandoz v. Amgen and Amgen v. Sandoz petitions for certiorari. Below we provide further analysis and commentary on the...more

Foley & Lardner LLP

Amgen Hedges Its Bets With Cross-Petition For Certiorari Of Biosimilar Decision

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Although Amgen originally did not petition the Supreme Court for certiorari to review the first Federal Circuit decision interpreting the BPCIA framework for resolving biosimilar patent disputes, Amgen now has filed a...more

BakerHostetler

Sandoz Requests Supreme Court Review of the Federal Circuit’s Interpretation of Biosimilar Law

BakerHostetler on

On February 16, 2016, Sandoz Inc. filed a petition for a writ of certiorari with the U.S. Supreme Court, asking the Court to review the Federal Circuit’s interpretation of the Biologics Price Competition and Innovation Act...more

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