Baxalta Inc. et al. v. Genentech, Inc.
Docket No. 2022-1461 (https://cafc.uscourts.gov/opinions-orders/22-1461.OPINION.9-20-2023_2193254.pdf)
MOORE, CLEVENGER, CHEN
September 20, 2023
Brief Summary: DC grant of SJ finding Baxalta’s antibody claims invalid under Amgen (US 2023) affirmed.
Summary: Baxalta appealed DC grant of summary judgment (SJ) to Genentech that claims 1-4, 19 and 20 of US 7,033,590 directed to “[a]n isolated antibody or antibody fragment thereof that binds Factor IX or Factor IXa and increases the procoagulant activity of Factor IXa” (representative claim 1) are invalid for lack of enablement. The FC panel opinion explains that during development of candidate antibodies “[t]he inventors discovered that only 1.6% of the thousands of screened antibodies increased the procoagulant activity of Factor IXa”, the ‘590 patent “discloses the amino acid sequences of eleven antibodies” that meet the claim requirements, and “[t]he written description of the ’590 patent explains that a skilled artisan may use well-known antibody engineering techniques to transform the resulting antibody into different structural formats.” Baxalta alleged Genentech’s humanized bispecific antibody “Hemlibra® (emicizumab) product infringes the ’590 patent”. Emicizumab “binds to Factor IXa with one arm and Factor X with the other arm, thereby mimicking the function of Factor VIIIa”. The DC’s claim construction determined that “‘antibody’ and ‘antibody fragment’ to exclude bispecific antibodies, the parties stipulated to non-infringement subject to appeal.” The FC panel explained that in a previous decision, it “held the proper construction of ‘antibody’ was ‘an immunoglobulin molecule having a specific amino acid sequence comprising two heavy chains (H chains) and two light chains (L chains),’ and the proper construction of ‘antibody fragment’ was ‘a portion of an antibody’” (Baxalta, FC 2020). In that decision, the FC panel found the DC’s claim construction “erroneously excluded bispecific antibodies, we vacated the judgment of non-infringement and remanded for further proceedings”, after which the DC granted the SJ that is the subject of this appeal. In this appeal, Baxalta argued “skilled artisans can obtain the full scope of claimed antibodies without undue experimentation”, but the FC panel disagreed based on SCOTUS’ Amgen decision (US 2023; see also Sil (FC 2012) and Alza (FC 2010)). The FC panel explained that in Amgen “[t]he full scope of the claims covered potentially millions of antibodies, but the specification only disclosed the amino acid sequences of twenty-six antibodies that performed the two claimed functions” and SCOTUS determined that the “roadmap” provided was inadequate (e.g., ““merely describes step-by-step Amgen’s own trial-and-error method for finding functional antibodies”, “an uncertain prospect given the state of the art”, “painstaking experimentation’ to see what works…is not enablement”, “might be sufficient…where the patent discloses ‘a quality common to every functional embodiment’”). The FC panel found “[t]he facts of this case are materially indistinguishable from those in Amgen” (e.g., “millions of potential candidate antibodies” and disclosure of “only eleven”, no “quality common to every functional embodiment”). It therefore affirmed the DC grant of SJ.