Baxalta, Inc. et al. v. Genentech, Inc. et al.
Docket No. 2019-1527MOORE, PLAGER, WALLACH
August 27, 2020
Brief Summary: DC non-infringement finding vacated and remanded due to erroneous construction of “antibody” and “antibody fragment”.
Summary: Baxalta appealed DC judgment based on its construction of “antibody” and “antibody fragment” for US 7,033,590. Baxalta alleged Genetech’s Helibra (emicizub-kxwh) bispecific antibody for treating hemolphilia infringed the ‘590 claims. Claim 1 of the ‘590 patent is directed to “[a]n isolated antibody or antibody fragment thereof that binds Factor IX or Factor IXa and increased the procoagulant activity of Factor IXa” while dependent claims 4 and 19 are directed antibodies or antibody fragments (monoclonal, chimeric, humanized (claims 4 and 19, single chain, bispecifici, diabody, di-/oligo-/multimers). The DC agreed with Genentech that the ‘590 patent requires an “antibody” to include “two identical heavy chains (H chains) and two identical light chains (L chains)” (e.g., “the patentee ‘chose [Genentech’s] narrower definition’ by expressly defining antibodies in column 5 of the patent”). The DC did “recognize that the ‘590 patent claims and discloses ‘bispecific antibodies, which do not have identical heavy and light chains’ and IgM and IgA antibodies, which ‘can have more than two heavy chains and more than two light chains,’ it determined that these claimed embodiments were ‘antibody derivatives’ rather than ‘antibodies’”, citing “an amendment Baxalta made during prosecution” changing the term “derivative” to “fragment” to overcome an enablement rejection (“a disclaimer of antibody derivatives ‘including bispecific antibodies, except antibody fragments”). The DC also agreed with Genentech that a “fragment” “partially or completely lacks the constant region” and that “the term ‘antibody fragment’ excludes bispecific antibodies.” The FC panel disagreed because, e.g. “[t]he dependent claims confirm that ‘antibody’ is not so limited” given that each of the chimeric, humanized and bispecific antibodies of dependent claim 4 (and humanized of claim 19) “fall outside the [DC’s] construction because each does not ‘only bind to the antigen that induced its synthesis or very similar antigens” (see FN3; DC construction…excludes these explicitly claimed embodiments” (Intel. Vent. I, FC 2018; Ortho, FC 2008 (“rejecting a construction that would ‘render several dependent claims meaningless’”); Budde, FC 2001 (“plausible reading of the excerpt in isolation” but “claim construction requires that we ‘consider the specification as a whole, and  read all portions of the written description, if possible, in a manner that renders the patent internally consistent”); “we read the excerpt in column 5 as a generalized introduction to antibodies rather than a definitional statement” (Luminara, FC 2016)). The FC panel also disagreed that the prosecution history “confirms the specification’s definition of antibody” because it rejected “the excerpt in column 5” as “definitional” (Phillips, FC 2005; Avid Tech., FC 2016 (no disclaimer “where the alleged disavowel is less than clear”); 3M (FC 2013 (“must be both clear and unmistakable”)). The FC panel also found that the DC misconstrued “antibody fragment” as the patentee did not “‘clearly express an intent’ to redefine” that term (Thorner, FC 2012). The DC decision was therefore vacated and remanded.