News & Analysis as of

Amgen v Sanofi

Manatt, Phelps & Phillips, LLP

U.S. Patent Office Enablement Guidelines in View of Supreme Court Amgen v. Sanofi Decision

The U.S. Patent Office has published updated examination guidelines regarding the enablement requirement in view of the Supreme Court’s May 2023 decision in Amgen v. Sanofi. The guidelines generally reiterate that (1)...more

Jones Day

Epitope Claims Live On at the European Patent Office

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While the genus antibody claim was effectively killed by the U.S. Supreme Court in Amgen v. Sanofi, it lives on in Europe despite a few recent setbacks at the European Patent Office ("EPO") and the Unified Patent Court...more

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

Goodwin

Issue 44: PTAB Trial Tracker

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The availability of post-grant proceedings at the Patent Trial and Appeal Board (PTAB) has changed the face of patent litigation. This periodic digest is designed to keep you up-to-date by highlighting interesting PTAB,...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

AEON Law on

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.

Introduction (Federal Circuit IP Appeals: Summaries of Key 2023 Decisions)

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

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

Goodwin

USPTO Publishes Enablement Guidelines in view of Amgen v. Sanofi

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On January 10, 2024, the USPTO published guidelines for assessing enablement in view of Amgen v. Sanofi and other recent court cases (“the Guidelines”). The Guidelines state that they are not intended to “announce any major...more

Sheppard Mullin Richter & Hampton LLP

2024 Top-of-Mind Issues for Life Sciences Companies

As we reflect on 2023 and make predictions for 2024, it is remarkable the number of significant events occurring this past year that will be impactful for the activities of the life sciences industry going forward. Although...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

Venable LLP on

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

Womble Bond Dickinson on

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

McDermott Will & Emery on

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

MoFo Life Sciences on

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

BakerHostetler

In the Wake of the Amgen Decision, the USPTO Will Continue To Use the Wands Factors when Evaluating Enablement

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In the wake of the U.S. Supreme Court’s decision in Amgen Inc. v. Sanofi, 598 U.S. 594 (2023) (Amgen), in which the Court addressed whether Amgen’s functional antibody genus claims satisfy the enablement requirement, the U.S....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

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