The Supreme Court is set to hear oral arguments in Amgen, Inc. v. Sanofi (No. 21-757) on Monday, March 27, 2023. The highly contentious question before the high court focuses what an applicant must show to meet the enablement requirement of patent law. The specific issue at hand is:
whether enablement is governed by the statutory requirement that the specification teach those skilled in the art to “make and use” the claimed invention, or whether it must instead enable those skilled in the art “to reach the full scope of claimed embodiments” without undue experimentation—i.e., to cumulatively identify and make all or nearly all embodiments of the invention without substantial “time and effort.”
The appeal comes from a February 2021 decision from the Federal Circuit that upheld the District of Delaware’s finding that Amgen’s asserted claims in U.S. Patent No. 8,829,165 and U.S. Patent No. 8,859,741 were invalid for lack of enablement. Amgen’s claims to isolated monoclonal antibodies that lower cholesterol levels (marketed as Repatha®) were initially found to be valid under 35 U.S.C. § 112. However, Judge Richard Andrews granted Sanofi’s JMOL motion based on the finding that Amgen’s claims are defined by their function (as opposed to structure) and the specification did not enable a skilled artisan to reach the full scope of the claims without undue experimentation.
The Federal Circuit held that “[w]hether a claim satisfies the enablement requirement of [Section 112] is a question of law that we review without deference” and found no error by the lower court in its conclusion “that undue experimentation would be required to practice the full scope of these claims.” Amgen takes the position that the Federal Circuit’s full scope of the claimed embodiments test for enablement (Full Scope Test) improperly raises the bar above and beyond the text of § 112. Sanofi’s argument is based on the purported overbreadth of the claims and the lack of enablement of every species in the claimed genus.
Some pundits have opined that the high court is poised to strike down the Full Scope Test. Indeed, since SCOTUS has taken issue with other tests used by the Federal Circuit for being too rigid, it may also deem the Full Scope Test as too stringent. Moreover, some commenters contend that the high court would not have granted certiorari simply to affirm the lower courts’ decisions. That said, SCOTUS will take the solicitor general’s support of Sanofi’s position very seriously when making its decision.
Many believe that, if the high court decides in Amgen’s favor, the decision could change the patentability of pharmaceutical/life science inventions and have a disruptive effect on innovation in general. In addition, the decision may indicate whether and how the Supreme Court plans to address concerns related to the other prong of 35 U.S.C. § 112 — the written description requirement. In fact, the Federal Circuit has, in recent years, similarly required the written description to support the full scope of the claims. While the decision will likely not come out until summer 2023, we will post with updates. Stay tuned.