Supreme Court building, Washington, DC

Without any comments, the Supreme Court has denied Juno Therapeutics’ Petition for Rehearing, which requested that the Court hold the case in abeyance pending the resolution of Amgen Inc. v. Sanofi, Aventisub LLC.

Juno filed its petition after the Federal Circuit held that Juno’s claims were invalid because the patent at issue “does not disclose representative species or common structural features to allow a person of ordinary skill in the art to distinguish between scFvs that achieve the claimed function and those that do not.” Juno Therapeutics, Inc. v. Kite Pharma, Inc., 10 F.4th 1330, 1342 (Fed. Cir. 2021), cert. denied, No. 21-1566, 2022 WL 16726060 (U.S. Nov. 7, 2022). According to the Federal Circuit, to satisfy the written description standard, “the inventors needed to convey that they possessed the claimed invention, which encompasses all scFvs, known and unknown, as part of the claimed CAR that bind to a selected target.” Id. at 1338. In its Petition for Writ of Certiorari, Juno requested that the Supreme Court address the following question:

Is the adequacy of the “written description of the invention” to be measured by the statutory standard of “in such full, clear, concise, and exact terms as to enable any person skilled in the art to make and use the same,” or is it to be evaluated under the Federal Circuit’s test, which demands that the “written description of the invention” demonstrate the inventor’s “possession” of “the full scope of the claimed invention,” including all “known and unknown” variations of each component?

After the Supreme Court denied certiorari, Juno requested rehearing and argued that the questions presented in its case and in Amgen Inc. v. Sanofi, Aventisub LLC are closely related because they involve the same sentence of the same statute (35 U.S.C. § 112(a)) and both ask whether written description and enablement are governed by the statutory standard or by the Federal Circuit’s “full scope” requirement:

These two cases involve the very same sentence of the very same statute, 35 U.S.C. § 112(a). Both ask whether the “make and use” language from the statute provides the proper statutory test, and both ask whether the Federal Circuit’s addition of a “full scope” requirement is an appropriate addition to Congress’s language choice. The issues presented are tightly related, and the outcome in Amgen is likely to at least affect, if not be outcome-determinative of, this case. Accordingly, rehearing should be granted.

Although the Supreme Court will be addressing what is required to have an enabling disclosure in the Amgen case, patent applicants are left with a written description standard that, according to the Federal Circuit, requires inventors to convey that they possessed the full scope of the claimed invention, including known and unknown variations of the invention. Time will tell if the Juno case was simply the wrong case and/or facts for the Supreme Court to address or whether the Supreme Court also believes that written description requires that inventors convey that they possessed the full scope of the claimed invention.