In our earlier post, we questioned whether the Federal Circuit would continue to invalidate genus claims directed to biologics, and the answer is yes. Not surprisingly, the Federal Circuit panel in Amgen v. Sanofi affirmed the district court’s judgment as a matter of law, finding Amgen’s claims in U.S. Patent Nos. 8,829,165 and 8,859,741 invalid and continuing its line of decisions over the last thirty years focusing on full scope enablement of claims to biotechnology inventions.¹ In the decision penned by Judge Lourie, the Court held claims to a genus of therapeutic antibodies defined by functional limitations lacked enablement to their full scope.

Echoing one of Judge Lourie’s comments during the oral argument, the decision notes claims with functional limitations “pose high hurdles in fulfilling the enablement requirement” and notes the Amgen claims are “double-function claims”—related to both binding a range of amino acid residues on PCSK9 (proprotein convertase subtilisin/kexin type 9 enzyme) and blocking binding of PCSK9 to LDL receptors to regulate degradation of the LDL receptors. The decision relied on several recent cases in which biotechnology claims reciting function instead of structure were found to lack enablement to the full scope of the claims.² In addition, the decision analyzed the Wands factors but distinguished the facts in In re Wands³ from the claims at issue. In particular, the Amgen court noted that, although Wands held antibody screening to be enabled, the Amgen opinion does not overrule Wands. Rather, the Amgen decision points to the absence of evidence provided by either party in Wands regarding undue experimentation for screening hybridomas and reasons that, given the facts in evidence in Amgen, “no reasonable factfinder could conclude that there was adequate guidance beyond the narrow scope of the working examples that the patent’s ‘roadmap’ produced.”⁴

Thus, the Federal Circuit continues to determine validity of genus claims using the full scope possession theory. The decision reaffirms the Federal Circuit’s decisions finding that genus claims reciting functional limitations are not enabled if the full scope of the claim is not enabled, which places a heavy burden on the applicant to disclose and enable the entire genus that is claimed. Biotechnology companies are left with the option of proposing claims with narrow functional limitations or claims with structural limitations. The breadth of structural limitations in claims to antibodies or other biologics however are by nature limiting because such claims often mean reciting specific amino acid or nucleic acid sequences. Thus, the Federal Circuit’s continuing reliance on full scope enablement has far reaching consequences for patent protection for biologics.

Footnotes