On May 18, 2023, the Supreme Court issued a decision in Amgen Inc. et al. v. Sanofi et al., Number 21-757, holding that a patent claiming an entire class of processes, machines, manufactures, or compositions of matter must teach those skilled in the art to “make and use the entire class,” while noting that the “specification may call for a reasonable amount of experimentation to make and use a patented invention.”
The patents at issue in the case involve antibodies that can reduce levels of low-density lipoprotein (LDL) cholesterol by inhibiting PCSK9 - a protein that binds to and degrades LDL receptors in the bloodstream. In 2011, Amgen obtained a patent for the antibody deployed in its cholesterol drug Repatha, and in 2014 it obtained related additional patents. These later patents claimed “the entire genus” of antibodies that (1) “bind to specific amino acid residues on PCSK9,” and (2) “block PCSK9 from binding to [LDL receptors].” Amgen brought suit against Sanofi for infringement relating to its cholesterol drug Praluent. The district court and Federal Circuit found for Sanofi, finding that Amgen’s specification would not enable a person skilled in the art to make and use “the entirety of the claimed invention.”
On appeal, the issue before the Court involved “enablement;" specifically whether the specification must enable those skilled in the art to reach the full scope of claimed embodiments without undue experimentation. The Court held that “If a patent claims an entire class of processes, machines, manufactures, or compositions of matter, the patent’s specification must enable a person skilled in the art to make and use the entire class. In other words, the specification must enable the full scope of the invention as defined by its claims.”
“The Court agrees in principle that there is one statutory enablement standard, but the Federal Circuit’s treatment in this case is entirely consistent with Congress’s directive and this Court’s precedents.” The Court further stated that “ … since 1790 Congress has included an enablement mandate as one feature among many designed to achieve the balance it wishes to strike between incentivizing inventors and ensuring the public receives the full benefit of their innovations. In this case, the Court’s duty is to enforce the statutory enablement requirement according to its terms.”
Beyond the antibody claims at issue in Amgen v. Sanofi, the Court’s decision will have significant implications regarding the disclosure requirements supporting genus claims. While expressing the view that “the more a party claims for itself, the more it must enable,” the Court essentially confirmed that enablement requires a person skilled in the art be able to make and use the claimed invention without “undue experimentation,” and acknowledged that “a specification may call for a reasonable amount of experimentation to make and use a claimed invention, and reasonableness in any case will depend on the nature of the invention and the underlying art.”
Please feel free to contact us if you have any questions or would like to discuss how this decision affects your IP strategy.