News & Analysis as of

Amgen v Sanofi Patents Enablement Inquiries

McDonnell Boehnen Hulbert & Berghoff LLP

Agilent Technologies, Inc. v. Synthego Corp. (Fed. Cir. 2025)

An argument could be made that one of the most significant Supreme Court decisions in U.S. patent law in the last thirty years was Dickinson v. Zurko.  In that case the Court held that the Federal Circuit was bound by the...more

Wolf, Greenfield & Sacks, P.C.

Practical Guide to Claiming Small Molecules with Functional Language

Patent claims reciting compounds where at least one group of a compound genus is defined by its function are common. For example, familiar claim terms such as “chelating moiety,” “linker,” and “binding moiety” describe a...more

Goodwin

Issue 44: PTAB Trial Tracker

Goodwin on

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

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

Goodwin on

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

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

BakerHostetler

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

BakerHostetler on

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

Haug Partners LLP

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

Haug Partners LLP on

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

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

Jenner & Block on

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

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

Smith Anderson on

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

Buckingham, Doolittle & Burroughs, LLC

Amgen is Not the End of Chemical Innovation

Some chemical innovators have found the recent Supreme Court decision in Amgen v. Sanofi to suggest that chemical inventions will be subject to new and draconian disclosure standards going forward. A few have even suggested...more

Womble Bond Dickinson

Unpredictability In The Art: Amgen v. Sanofi In View Of “Simultaneous Conception And Reduction To Practice”

Womble Bond Dickinson on

After reading the Supreme Court’s decision in Amgen v. Sanofi, I thought of the doctrine of simultaneous conception and reduction to practice, given both the decision’s and the doctrine’s focus on unpredictability in the art....more

Levenfeld Pearlstein, LLC

Enablement Unchanged: Amgen v. Sanofi and the Future of Software Patents

In a unanimous ruling, the Supreme Court of the United States (SCOTUS) addressed the enablement requirement under Section 112 of the Patent Act, placing this into sharper focus with the Amgen v. Sanofi case. This landmark...more

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