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Supreme Court of the United States Amgen v Sanofi

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

Threading the Needle: Navigating the Matrix Created by the U.S. Supreme Court and Unified Patent Court   

As a firm responsible for managing global portfolios for pharmaceutical companies, we closely follow and seek to stay abreast of developments regarding patentability in various jurisdictions. We recently reviewed the Unified...more

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

Brave New World: UPC Central Division’s First Opinion is a Revocation of Antibody Claims as Lacking Inventive Step

Following the U.S. Supreme Court’s invalidation of a counterpart U.S. patent in the same family for lack of enablement (21-757 Amgen Inc. v. Sanofi (05/18/23) (supremecourt.gov)), the UPC has now rendered a decision on its...more

Haug Partners LLP

FDLI’s Top Cases 2024 Featuring Partner Andrew Wasson

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Partner Andrew Wasson contributed a chapter to the Food & Drug Law Institute’s annual publication identifying the top food and drug cases of the year.  Andrew’s chapter relates to the Supreme Court case, Amgen v. Sanofi, 598...more

Manatt, Phelps & Phillips, LLP

Supreme Court Holds Invalid Cholesterol Drug Patent That Covered Millions of Undisclosed Antibodies

In Amgen Inc. v. Sanofi, the Supreme Court unanimously held that “[i]f a patent claims an entire class of processes, machines, manufactures, or compositions of matter, the patent specification must enable a person skilled in...more

BakerHostetler

[Podcast] Biotechnology, Chemical and Pharmaceutical: Supreme Showdown

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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

Haug Partners LLP

Written Description for Genus Claims Following Juno Therapeutics v. Kite Pharmaceuticals

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Section 112 of the Patent Act contains multiple requirements that relate to the adequacy of an inventor’s disclosure within a patent application.  The Supreme Court has offered some clarity to inventors seeking to patent...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

Federal Circuit IP Appeals: Summaries of Key 2023 Decisions (8th Edition)

2023 saw a return to business as usual for the Federal Circuit. Oral arguments are once again in-person and open to the public, and the Court has resumed its former practice of holding occasional sittings outside of...more

AEON Law

Patent Poetry: Patent Office Issues Guidelines for Enablement after Amgen

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The United States Patent and Trademark Office (USPTO) has published new Guidelines for Assessing Enablement in Utility Applications and Patents in View of the Supreme Court Decision in Amgen Inc. et al. v. Sanofi et al. ...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

Federal Circuit IP Appeals: Summaries of Key 2023 Decisions (8th Edition): Amgen Inc. v. Sanofi, 598 U.S. 594 (2023)

The Supreme Court’s lone patent case from last term does not break new ground on enablement law. The Court’s core holdings—that a patent specification must enable the full scope of the claimed invention and therefore that...more

Knobbe Martens

USPTO Says Wands Still Controls Enablement Analysis Post-Amgen

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On January 9, 2024, the USPTO published guidelines for its patent examiners when evaluating compliance with the enablement requirement in light of the U.S. Supreme Court’s recent decision in Amgen Inc. et al. v. Sanofi et...more

Venable LLP

New USPTO Guidelines: After the Supreme Court's Amgen Decision, In re Wands Factors Remain Applicable Enablement Framework

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On January 10, 2024, the United States Patent and Trademark Office (USPTO) issued "Guidelines for Assessing Enablement in Utility Applications and Patents in View of the U.S. Supreme Court Decision in Amgen Inc. et al. v....more

Womble Bond Dickinson

Enablement Post-Amgen and New USPTO Guidelines

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On January 10, 2024, the United States Patent and Trademark Office (USPTO) published Guidelines, applicable to any technology, for ascertaining compliance with the enablement requirement in view of the U.S. Supreme Court...more

Foley & Lardner LLP

USPTO Issues “Reasonable” Guidance on Enablement Under Amgen v. Sanofi

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The USPTO has issued “Guidelines for Assessing Enablement in Utility Applications and Patents in View of the Supreme Court Decision in Amgen Inc. et al. v. Sanofi et al.” The Guidelines set forth the U.S. Patent and Trademark...more

McDermott Will & Emery

PTO Continues to Wave Wands in Assessing Enablement

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In light of the 2023 Supreme Court of the United States decision in Amgen Inc. v. Sanofi, the US Patent & Trademark Office (PTO) published guidelines for PTO employees to use, regardless of technology, to ascertain compliance...more

Procopio, Cory, Hargreaves & Savitch LLP

USPTO Provides Guidance in Light of Amgen v. Sanofi

The U.S. Supreme Court’s May 2023 decision in Amgen, Inc. v. Sanofi (Amgen) sent shock waves through the patent world, particularly in the chemical and biotech segments, due to its invalidation of Amgen patents based on a...more

McDonnell Boehnen Hulbert & Berghoff LLP

USPTO Provides Guidance on Standards for Enablement Requirement

On January 10th, the U.S. Patent and Trademark Office published a Notice in the Federal Register (89 Fed. Reg. 1563) regarding proposed Guidance on how the Office will apply the enablement requirement under 35 U.S.C. § 112(a)...more

MoFo Life Sciences

USPTO Enablement Guidelines After Amgen V. Sanofi

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On January 10, 2024, the USPTO released new Guidelines for Assessing Enablement in Utility Applications and Patents in View of the Supreme Court Decision in Amgen Inc. et al. v. Sanofi et al. The guidelines clarify that the...more

Akin Gump Strauss Hauer & Feld LLP

In the Aftermath of Amgen v. Sanofi, Federal Circuit Finds Functional Antibody Claims Invalid for Lack of Enablement

Applying the Supreme Court’s Amgen v. Sanofi decision for the first time, the Federal Circuit recently affirmed a district court decision finding claims to antibodies characterized by their ability to bind a particular...more

Haug Partners LLP

Baxalta’s Antibody Patent Held Invalid under Amgen’s Enablement Standard by the Federal Circuit

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In Baxalta, Inc. v. Genentech, Inc., the Court of Appeals for the Federal Circuit upheld a summary judgment finding from the District of Delaware (Judge Timothy B. Dyk) that claims 1-4, 19 and 20 of Baxalta’s patent directed...more

A&O Shearman

First UPC Court of Appeal decision defines the time limit for filing a Preliminary objection or Statement of defence

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On 16 October 2023, the UPC Court of Appeal issued its first ever decision and addressed two interesting procedural issues resulting from the situation where a Statement of claim is served without the documents it refers to...more

McDermott Will & Emery

Beware Enablement of Genus Antibody Claims

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The US Court of Appeals for the Federal Circuit invalidated yet another set of antibody genus claims, finding the case “materially indistinguishable” from those in the 2023 Supreme Court of the United States case, Amgen v....more

McDonnell Boehnen Hulbert & Berghoff LLP

In the Wake of the Supreme Court's Amgen v. Sanofi decision: What’s Next for Biotechnology Claims?

Section 112 of the patent statute, which in earlier years was something of a backwater in patent law, has had a tumultuous quarter century beginning with the Federal Circuit decision in Regents of the University of California...more

Bradley Arant Boult Cummings LLP

More Antibody Claims Falling Under Post-Amgen Scrutiny

With only two precedential IP decisions coming down from the Federal Circuit in the second half of September, pickings were a little slim for blogging. That said, the opinion in Baxalta v. Genentech (2022-1461) — drafted by...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - September 2023 #3

Baxalta Inc. v. Genentech, Inc., Appeal No. 22-1461 (Fed. Cir. Sept. 20, 2023) Our Case of the Week focuses on the enablement requirement. It’s the first case to come before the Federal Circuit following the Supreme...more

Jenner & Block

Enablement Bar for Drug Patents

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On May 18, 2023, the Supreme Court affirmed the Federal Circuit’s (CAFC) decision on enablement in Amgen Inc. v. Sanofi, 987 F.3d 1080 (CA Fed. 2021). The Court thus left in place a significant CAFC decision making it more...more

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