Practitioners Mostly Agree Amgen Won’t Be a Sea Change, But Some Predict Grim Consequences

Director William H. Milliken was quoted in the article “Practitioners Mostly Agree Amgen Won’t Be a Sea Change, But Some Predict Grim Consequences,” published by IPWatchdog. Will provided the following commentary on the oral argument heard before the US Supreme Court in Amgen Inc. v. Sanofi on March 27, 2023:

“Based on the Justices’ questions—and, maybe more importantly, the advocates’ answers—it seems unlikely that the Supreme Court’s ultimate decision will effect a sea change in enablement law. Both parties and the United States appear to agree on the following: “undue experimentation” is the appropriate standard; the eight Wands factors are a useful guide in determining whether undue experimentation would be required to practice the claimed invention; the full scope of the claims must be enabled; and there is no requirement that a skilled artisan be able to cumulatively identify all embodiments within the claims without undue experimentation for the claims to be enabled. Given the agreement on these principles, the Court is unlikely to disturb any of them, meaning the law after this decision will probably look pretty similar to the law as it stands now. That is not to say the Supreme Court’s decision is unimportant; any time the Court provides guidance on one of the requirements of patentability, it is enormously consequential for patent practitioners. But the tenor of the argument today does suggest that the basic structure of enablement law—along with much of the existing precedent about it—will remain generally intact.

The apparent agreement between the parties and the Court that the 1988 Wands decision provides the proper lens th[r]ough which to analyze enablement is a particular point of pride for those of us at Sterne Kessler Goldstein & Fox. The firm’s Jorge Goldstein successfully represented Wands in the appeal that led to that seminal decision.”