Amgen v. Sanofi and Patent Enablement One Year Later: Guidance for Drafting, Defending, Challenging Patent Claims

Description

The Supreme Court in Amgen Inc. v. Sanofi (2023) 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 gave 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. Given this, Courts have still relied on the Wands factors to assess enablement under the Amgen framework.

Listen as our authoritative panel of patent attorneys reviews the Supreme Court's decision and its impact on the enablement requirement after one year, including through discussion of illustrative cases applying Amgen and the U.S. Patent Office’s new enablement guidance. The panel will offer best practices for satisfying the enablement requirement.