Yesterday, the Federal Circuit issued its opinion in Amgen Inc. v. Sanofi, Aventisub LLC, a patent case we have been tracking because it attracted amicus briefs. Judge Lourie authored the unanimous opinion, which affirmed a district court’s judgment as a matter of law of lack of enablement. The Federal Circuit agreed that undue experimentation would be required to practice the full scope of antibody claims in Amgen’s patents. This is our opinion summary.
In this case, Amgen appealed a grant of JMOL based on the district court’s conclusion that its patent claims did not satisfy the enablement requirement of 35 U.S.C. § 112. Amgen argued on appeal that a person of skill in the art could make all the antibodies within the scope of the claims by following a roadmap using anchor antibodies, well-known screening techniques, and the patent specifications’ teachings. As mentioned, however, the panel ruled against Amgen and affirmed the district court’s grant of JMOL.
Judge Lourie summarized the background of the case:
Amgen owns the ’165 and ’741 patents, which describe antibodies . . . The claimed antibodies are defined by their function: binding to a combinations of sites (residues) on the PCSK9 protein, in a range from one residue to all of them; and blocking the PCSK9/LDLR interaction. Amgen filed suit against Sanofi, . . . alleging infringement. . . . At the close of the trial, the jury determined that the patents were not shown to be invalid for lack of enablement and written description. . . . Sanofi appealed to this court. Relevant to the current appeal, we held that the district court erred in its evidentiary rulings and jury instructions regarding Sanofi’s defenses that the patents lack written description and enablement, and we remanded. . . . The jury again found that Sanofi failed to prove that the asserted claims were invalid for lack of written description and enablement. . . . The district court granted Sanofi’s Motion for JMOL for lack of enablement.
The court noted that Amgen’s claims are composition claims defined, not by structure, but by functional limitations. The court began its analysis with a discussion of previous cases where antibody claims were limited by functionality. In those cases, the court found a lack of enablement where there were a large number of possible candidates within the scope of the claims and when the specification showed a lack of structural guidance. The court emphasized the importance of considering the quantity of experimentation, not only to use the limited number of embodiments the patent discloses, but also the full scope of the claim.
The court held that the district court was correct in finding that the specification did not enable preparation of the full scope of the claims without undue experimentation.
The court emphasized that the scope of the claims were broad, not merely in terms of the exact number of embodiments they covered, which was disputed by the parties, but in their functional breadth. Specifically, the court said that Amgen’s claims covered a much broader functional diversity than the examples they disclosed.
The court acknowledged Amgen’s roadmap, but agreed with the district court that, in light of the unpredictability of the field of science, a reasonable factfinder would conclude that the patent does not provide significant guidance to enable the full scope of the claims. The only way for a person to discover the undisclosed full scope, the court explained, would be through trial and error or by randomized uses of the roadmap.
As a result of its analysis, the court determined that the district court did not err in granting JMOL, finding that the asserted claims of the ’165 and ’741 patents were invalid for lack of enablement.