Juno Therapeutics (Juno) has filed a Petition for Rehearing with the Supreme Court, requesting that the Court vacate its previous order denying Juno's petition for certiorari and hold the case in abeyance pending the resolution of Amgen Inc. v. Sanofi, Aventisub LLC.
Just days after agreeing to review the scope of the enablement requirement in Amgen Inc. v. Sanofi, Aventisub LLC, the Supreme Court denied Juno's request to review the scope of the written description requirement. In granting certiorari in the Amgen case, the Supreme Court agreed to address:
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."
In denying certiorari in the Juno case, however, the Supreme Court refused to 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?
In its Petition for Rehearing, Juno argues that the questions presented in the two cases 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.
According to Juno, if the Court concludes that the Federal Circuit erred in importing a "full scope" requirement into the enablement inquiry, it "will call into serious question that court's 'possessed the full scope' test that it applies to assess written description."
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