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Today the Supreme Court granted the petition for certiorari in Amgen Inc. v. Sanofi, Aventisub LLC, a patent case raising questions related to the enablement requirement. Although the petitioner requested review of two distinct questions, the Court granted review only for the second question presented. That question asks “[w]hether 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.’” Notably, the Supreme Court granted review of this question despite the contrary view of the Solicitor General. Here are the details.

The petitioner presented the following two questions for the Court to review:

  1. “Whether enablement is ‘a question of fact to be determined by the jury,’ Wood v. Underhill, 46 U.S. (5 How.) 1, 4 (1846), as this Court has held, or ‘a question of law that [the court] review[s] without deference,’ Pet. App. 6a, as the Federal Circuit holds.”
  2. “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,’ Pet. App. 14a (emphasis added).”

As we previously discussed, the Solicitor General filed its amicus brief providing the view of the United States that the petition for writ of certiorari should be denied. In its brief, the government maintained that, as to the first question presented, “[t]he enablement inquiry includes both legal and factual components.” Contrary to Amgen’s argument that the Federal Circuit “usurped the jury’s role by overturning its verdict as a matter of law,” it contended that “a court may resolve a question initially decided by the jury on a motion for JMOL.” As to the second question presented, the government maintained that, “[w]hen, as here, a patent claims an entire genus based on its function, the patent must enable that entire genus.” It argued that the Federal Circuit does not, as Amgen claims, “apply ‘a different,’ more stringent ‘enablement test for genus claims’ than for other types of claims.” 

Despite the government’s view that the Court need not review either question, today the Supreme Court granted review with respect to the second question.

As we previously reported, following the government’s brief Amgen filed its own supplemental brief addressing the Solicitor General’s views. With respect to the first question presented, Amgen contended that the government’s “mixed question of law and fact” view “[c]ontradict[s] this Court’s view that enablement is a fact question, and the Federal Circuit’s view that it is a legal issue.” Amgen maintained that “the government never addressed whether that ‘mixed question’ should be reviewed deferentially as ‘factual,’ or de novo as ‘legal.’” With respect to the second question presented, Amgen argued that the Federal Circuit’s enablement standard “raise[d] the bar” for genus claims. It contended that the government “never explains what in §112’s text suggests enablement turns on the cumulative time and effort required to make all variations of the invention one-by-one.”

The Supreme Court’s grant of review indicates the Court intends to review the Federal Circuit’s interpretation of the statutory text governing the enablement requirement. But the underlying policies loom large. And, unlike many recent Supreme Court cases on patent law, it is noteworthy that the Court granted review to consider arguments that include the alleged pernicious impact on inventors.

Amgen’s call for clarity and focus on the alleged negative impact on inventors were echoed in the amicus briefs filed in this case that we have previously summarized. In one amicus brief, for example, the Association of University Technology Managers, Inc. argued for review because the Federal Circuit allegedly replaced the statutory enablement standard with an “artificially elevated and uncertain standard,” which will compel inventors “to divert precious resources away from making new discoveries . . . devoting them instead to making and testing additional examples of their invention and adding information already known to skilled artisans to their patent applications.” In another amicus brief, Glaxosmithkline similarly asserted that “[t]he decision below joins a trend of Federal Circuit decisions that impose obstacles preventing innovators from receiving commensurate protection for their contributions to science.” A third amicus brief filed by various Intellectual Property professors throughout the United States likewise argued that the “Federal Circuit has changed the law dramatically in recent years, to the point where it is no longer possible to have a valid genus claim in the chemical and biotechnology industries.”

We will continue to keep track of this case and report on developments, including upcoming merits briefs.