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Pharmaceutical Patents Supreme Court of the United States Pharmaceutical Industry

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

Fuerst Ittleman David & Joseph

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

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

McDonnell Boehnen Hulbert & Berghoff LLP

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

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

McDonnell Boehnen Hulbert & Berghoff LLP

Novartis Pharma AG v. Regeneron Pharmaceuticals, Inc. (Fed. Cir. 2024)

Ever since the Supreme Court's decision in Dickinson v. Zurko, federal courts (including the Federal Circuit) are compelled under the Administrative Procedures Act to review factual determinations by the U.S. Patent and...more

McDonnell Boehnen Hulbert & Berghoff LLP

Astellas Pharma, Inc. v. Sandoz Inc. (Fed. Cir. 2024)

One of the anticipated consequences of the Supreme Court's Loper decision is that it will unleash judges to impose their statutory interpretations of administrative agencies' applications of the law within their areas of...more

Proskauer - Minding Your Business

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

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

Lathrop GPM

Broad Biotech Patent Claims-the Saga Continues

Lathrop GPM on

There now is increased interest about the written description and enablement requirements for patent applications claiming antibodies. This may stem from the recent U.S. Supreme Court decision in Amgen v. Sanofi, finding lack...more

McDermott Will & Schulte

Pay for Delay Is Sometimes Okay

The US Court of Appeals for the Second Circuit affirmed the dismissal of a lawsuit against pharmaceutical companies accused of violating antitrust laws by using reverse payments to delay entry of a generic version of a...more

BakerHostetler

[Podcast] Biotechnology, Chemical and Pharmaceutical: Supreme Showdown

BakerHostetler on

In 2023, a lawsuit that had wound its way through the judicial system for nearly 10 years finally had its day in the U.S. Supreme Court – and made waves in the biotechnology, chemical and pharmaceutical communities. Our...more

Herbert Smith Freehills Kramer

Law360: Supreme Court Amgen Ruling's Major Effect On Enablement

Eight months ago, the U.S. Supreme Court interpreted the enablement requirement in the May 18, 2023, Amgen Inc. v. Sanofi decision.[1] Although the court did not change the law, affirming the U.S. Court of Appeals for the...more

McDonnell Boehnen Hulbert & Berghoff LLP

Sanofi-Aventis Deutschland GmbH v. Mylan Pharmaceuticals Inc. (Fed. Cir. 2023)

In those (in retrospect) halcyon days more than a decade ago (before Mayo, Myriad, Alice, and the subject matter eligibility quagmire arose), perhaps the most significant Supreme Court decision was KSR Int'l Co. v. Teleflex...more

Mintz - Intellectual Property Viewpoints

Can Enablement and Written Description Bars be Lower for Method-Of-Treatment Patent Claims?

Patent offices may reject a patent application with claims reciting using a composition to treat a disease, based on the requirement that the claimed treatment is not fully supported by the application. In the U.S., such...more

Smith Anderson

Stroke of Genus: Amgen Inc. v. Sanofi

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The U.S. Supreme Court recently struck down broad patent claims covering a “genus” of antibodies, reaffirming in a 9-0 decision that a patent must “enable” the full scope of its claims (Amgen Inc. v. Sanofi). Amgen, Inc.,...more

McDonnell Boehnen Hulbert & Berghoff LLP

Medytox, Inc. v. Galderma S.A. (Fed. Cir. 2023)

It is not surprising that the Federal Circuit has taken the opportunity to apply the Supreme Court's recent precedent in Amgen v. Sanofi regarding the sufficiency of disclosure needed to satisfy the statutory enablement...more

Buckingham, Doolittle & Burroughs, LLC

Amgen Ratifies CAFC’s Requirement to Enable a Claim’s Full Scope

The Court’s reasoning in Amgen v. Sanofi upholds the Federal Circuit’s long-standing requirement to enable the full scope of a claimed invention. Since the Patent Act of 1790, patent law has required describing inventions...more

Axinn, Veltrop & Harkrider LLP

Supreme Court confirms full scope enablement standard in Amgen v. Sanofi

This month, the Supreme Court issued its opinion in Amgen Inc. v. Sanofi, the closely watched case involving the enablement standard for patent claims, particularly as applied to functionally defined genus claims. Genus...more

Dinsmore & Shohl LLP

The More You Claim, The More You Must Enable: SCOTUS Delivers Amgen v. Sanofi Opinion

Dinsmore & Shohl LLP on

In May, the Supreme Court of the United States handed down its decision in Amgen Inc. v. Sanofi, which addressed the statutory enablement requirement for patents. The decision is consistent with ongoing efforts to strike a...more

BakerHostetler

Now What? The Supreme Court Addresses Enablement

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What do telegraphic communications, incandescent lamps, wood veneering glues, and antibodies have in common? Nothing. That is of course, until May 18, 2023, when the Supreme Court ruled that Amgen’s antibody claims, like...more

Hogan Lovells

SCOTUS won’t hear Teva v. GSK: Where does that leave us on FDA labeling carve-outs?

Hogan Lovells on

The Supreme Court of the United States has denied certiorari in the Teva v. GSK “skinny labeling” case, leaving intact the Federal Circuit’s August 2021 decision, which we summarized online here. In the article below, we...more

Carlton Fields

U.S. Supreme Court Unanimously Upholds the Federal Circuit’s Enablement Inquiry for Patent Claims

Carlton Fields on

On May 18, 2023, the U.S. Supreme Court handed down a unanimous decision in the much-anticipated Amgen Inc. v. Sanofi case. See 598 U.S. ___, No. 21-757, 2023 WL 3511533 (May 18, 2023). In so doing, the Court maintained the...more

Mintz - Intellectual Property Viewpoints

Supreme Court Unanimously Affirms Amgen Repatha® Antibody Patents Invalid for Lack of Enablement

On May 19, 2023, the Supreme Court in Amgen v. Sanofi, No. 21-757, unanimously held that the claims of two Amgen patents, both directed to a genus of potentially millions of antibodies, are invalid because the patents failed...more

Wilson Sonsini Goodrich & Rosati

Broad Genus Patents Must Be Enabled over the Full Scope of the Claims

Amgen Inc. et al. v. Sanofi et al., No. 22-157 (U.S. 2023) - The U.S. Supreme Court, in a unanimous decision, has affirmed the Federal Circuit’s decision invalidating Amgen’s patent claims covering a genus of antibodies...more

Dorsey & Whitney LLP

Supreme Court Upholds Patent Law Precedent

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The case of Amgen Inc. v. Sanofi, U.S., No. 21-757 dealt with patent law’s “enablement” requirement. Essentially, the Court affirmed 150 years of precedent requiring the invention to be described “‘in such full, clear,...more

Goodwin

Supreme Court Affirms Amgen Patents’ Invalidity in Closely Watched Enablement Case

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The U.S. Supreme Court has decided a closely watched case regarding patent law’s enablement requirement, Amgen Inc. v. Sanofi. The Supreme Court affirmed the Federal Circuit’s decision that Amgen’s patent claims were invalid,...more

Cooley LLP

Supreme Court Affirmance in Amgen v. Sanofi Leaves Legal Standard for Patent Enablement Undisturbed

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The legal standard for enablement – the statutory requirement under 35 USC § 112 that a patent must enable those skilled in the art to “make and use” the claimed invention – remains unchanged after the US Supreme Court...more

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