Last week, the U.S. Court of Appeals for the Federal Circuit issued an opinion in Amgen Inc. v. Sanofi, 20-1074 (Feb. 11, 2021). The opinion affirms a decision by the district court finding the patents invalid as not enabled under 35 U.S.C. § 112.
The patents at issue claimed compositions with antibodies defined by two functions: (1) binding to “combinations of sites (residues)” on a specific protein “in a range from one residue to all of them;” and (2) blocking that protein’s role in elevating the presence of LDL cholesterol in the body. The district court concluded the specifications of the patents did not enable the full scope of the double-function claims without undue experimentation, applying the “go to” precedent for evaluating such claims as set forth by In Re Wands, 858 F.2d 731 (Fed. Cir. 1988).
Amgen argued on appeal that a proper analysis of the Wands factors supported enablement because embodiments disclosed in the patents were “structurally representative for the purposes of fulfilling the written description requirement.” Sanofi responded by contending that “there are millions of antibody candidates within the scope of the claims,” and that the quantity and extent of experimentation needed to know whether any such antibody satisfied both of the claimed functions was impermissibly vast.
The Federal Circuit explained that “it is important to consider the quantity of experimentation that would be required to make and use, not only the limited number of embodiments that the patent discloses, but also the full scope of the claim.” Ultimately, the Court held that the claims at issue were “far broader in function and diversity than the disclosed examples,” and that “the use of broad functional claim limitations raises the bar for enablement.”
Accordingly, the Court agreed that “no reasonable jury could conclude under these facts that anything but ‘substantial time and effort’ would be required to reach the full scope of these claims,” affirming the district court’s decision.