The Supreme Court agreed on Friday, November 4, 2022, to review the standard for enablement of genus claims after the Federal Circuit’s decision in Amgen, Inc. v. Sanofi. We have previously covered Amgen’s petition for a writ of certiorari and the multiple amicus curiae briefs submitted in the case. As detailed below, the Supreme Court’s decision to hear this case is contrary to the recommendations in a brief for the Solicitor General filed this September, and is a victory for Amgen in support of its patent claims covering antibodies that bind and block PSK9 (a receptor involved in LDL cholesterol metabolism).

The question to be reviewed by the Supreme Court 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, 35 U.S.C. § 112, 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.’ ”

Interestingly, the Court did not grant cert as to Question 1 of Amgen’s Petition, which sought review of whether enablement is a question of fact for the jury, rather than a question of law as the Federal Circuit has held.  The Court on Monday, November 7, 2022, denied cert to a petition filed by Juno Therapeutics (a subsidiary of Bristol Myers Squibb) and Sloan Kettering seeking review of the written description standard applied by the Federal Circuit in invalidating the petitioners’ patent on CAR-T immunotherapy. That Federal Circuit decision erased a $1.2B jury verdict finding Kite Pharma (now Gilead) guilty of patent infringement.

Recent Federal Circuit decisions, including Amgen v. Sanofi and Juno v. Kite, have made it increasingly difficult for patent owners to defend claims directed to discovery of a novel therapeutic target or epitope, requiring innovators to more narrowly claim specific sequences of therapeutic molecules. The Supreme Court’s decision to grant certiorari in the Amgen case raises the possibility that patent owners will see the pendulum shift back in favor of genus claims.

In the Brief for the United States as Amicus Curiae, the government recommended that the petition for writ of certiorari be denied. First, the government contended that the district court and court of appeals’ treatment of enablement as a question of law was not incorrect, as the enablement inquiry has both fact and legal components. The government stated, “[P]etitioners concede that a court may resolve a question initially decided by the jury on a motion for JMOL, and that is what the courts below did here.” Second, in addressing the degree of experimentation required to implement the full scope of the claims, the government stated that because the Patent Act requires a patent to enable the invention, where a patentee purports to invent an entire genus, it must enable the entire genus. The government stated that the Federal Circuit considered the degree of experimentation as only one of the Wands factors and emphasized that it was not “hold[ing] that the effort required to exhaust a genus is dispositive.” Because the Petitioners did not dispute that the Wands factors provided an appropriate framework for resolving questions of enablement and undue experimentation, nor did they propose an alternative standard for determining whether a patent adequately enables the claimed invention, the government recommended the petition be denied.

Petitioners responded to the government’s brief by stating that the government had rewritten the legal questions and then argued that its own questions did not warrant review. Petitioners noted that the government stated that enablement is a question of both law and fact, and that the Federal Circuit’s overturning of the jury’s verdict is not an ordinary application of JMOL. Additionally, the Petitioners pointed to the Federal Circuit’s admission that the enablement standard for genus claim may be raised if “substantial time and effort would be required to reach the full scope of claimed embodiments.” Petitioners alleged that the government never explained “why a claim should be invalidated based on the cumulative effort to make all claimed embodiments where, as here, it would not require undue experimentation for skilled artisans to make and use any individual embodiment.”

After the briefs were distributed for conference on November 4, the Supreme Court granted the petition as limited to Question 2—the enablement question.