Case Study: Are the Terms ‘Antibody Derivative’ and ‘Bispecific Antibody’ Described in Dependent Claims or Specification of Antibody Patents?

An antibody can take various forms, including the following: a monoclonal, polyclonal, mouse, human, humanized, monospecific, bispecific, glycosylated (sugar chain-modified), Fc-modified, or ADC (antibody-drug conjugate) antibody; an antibody fragment (e.g., Fab, scFv, diabody, sdAb, tandem scFv); or an antibody of different class or subclass (e.g., IgG (e.g., IgG1, IgG2, IgG3, IgG4), IgM, IgE, IgA). If claim 1 recites an “antibody”, whether or not the antibody includes each of the above forms can be an issue in an infringement lawsuit. In Baxalta Inc. v. Genentech, Inc. (Fed. Cir. 2020), Baxalta alleged that Genentech’s Hemlibra® (emicizumb-kxwh) product infringed its U.S. Patent No. 7,033,590 (’590 patent). In this lawsuit, the issue was whether or not the “antibody or antibody fragment thereof” in claim 1 of the ‘590 patent should comprise a bispecific antibody (the form of Hemlibra).

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