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Amgen v. Sanofi: Patent Enablement and the Implications of the Supreme Court’s Decision

Recording of a 90-minute premium CLE video webinar with Q&A

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Conducted on Thursday, June 15, 2023

Recorded event now available

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This CLE webinar will guide patent counsel on the recent Supreme Court decision in Amgen Inc. v. Sanofi and the implications of the decision. The panel will discuss the decision's impact on the patent enablement requirement. The panel will offer best practices for satisfying the patent enablement requirement or challenging that the requirement is met.


On May 18, 2023, in a unanimous decision, the Supreme Court in Amgen Inc. v. Sanofi held that Amgen's patent claims were invalid under the patent enablement requirement. The Court had not decided a case on patent enablement in almost 100 years. The Court held Amgen's broad claims covering a functional result--however achieved--failed to satisfy the enablement requirement when Amgen had comparatively few examples teaching how to achieve that claimed result out of the potential millions of unpredictable options available. In so doing, however, the decision gives mixed signals on how the enablement doctrine should be applied in other scenarios and how practitioners should best proceed when drafting, defending, or challenging patent claims.

Despite holding against Amgen, the Court agreed with Amgen on key issues. The Court stated that the statutory standard--in place for hundreds of years with little change--applies in all cases and that the amount of “cumulative” effort to make all the claimed embodiments does not control the enablement analysis. Yet Amgen’s claims still fell short.

In striking this balance, the decision provides lifelines to all sides on how enablement should be applied. For example, the decision arguably raises the bar for genus claims, stating “the more one claims, the more one must enable,” and specifying that “if a patent claims an entire class of processes, machines, manufactures, or compositions of matter, the patent’s specification must enable a person skilled in the art to make and use the entire class.” But at the same time, the decision stated that a patentee can do so through “an example” and without “specify[ing]” every facet of the claimed genus in their patent, and further stressed that “some” testing and “reasonable” experimentation--which will vary in every case--can be still required to enact an enabled invention. What’s more, the decision did not mention, much less overturn, existing Federal Circuit case law with similar flexible considerations, such as the seminal case of In re Wands that patentees have relied on for decades. Thus, the decision arguably preserves the existing flexibility in the enablement analysis, even for genus claims.

Given all this, patentees and patent challengers alike can point to aspects of the opinion to support their positions, but should also take heed to the Court’s statements on broad claims, especially those with functional claiming.

Listen as our authoritative panel of patent attorneys examines the Supreme Court's decision and its impact on the enablement requirement. The panel will offer best practices for satisfying the enablement requirement.



  1. The enablement requirement
  2. Amgen v. Sanofi
  3. Implications for enablement
  4. Best practices


The panel will review these and other critical issues:

  • What lessons can patent counsel draw from the Supreme Court's decision when making arguments of enablement?
  • What steps should counsel take to meet the enablement requirement when drafting patent applications?
  • How can patentees and patent challengers leverage the decision in invalidity/unpatentability challenges based on enablement?


Augustyn, John
John M. Augustyn

Leydig Voit & Mayer

John Augustyn successfully represents clients in high stakes intellectual property litigation, agreements, client...  |  Read More

Hamp, Eric
Eric J. Hamp

Banner Witcoff

Mr. Hamp assists clients in all aspects of intellectual property law, with a particular focus on the litigation and...  |  Read More

Sarnoff, Joshua
Professor Joshua D. Sarnoff

Professor of Law
DePaul University

Prof. Sarnoff has received numerous awards for his scholarship. He is an internationally recognized expert on the...  |  Read More

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