Opinion ID: 4560751
Heading Depth: 3
Heading Rank: 2

Heading: The Written Description of the ’590 Patent

Text: Under the heading “Antibodies and Antibody Derivatives,” the patentee explains: Antibodies are immunoglobulin molecules having a specific amino acid sequence which only bind to antigens that induce their synthesis (or its immunogen, respectively) or to antigens (or immunogens) which are very similar to the former. Each immu- noglobulin molecule consists of two types of polypeptide chains. Each molecule consists of large, identical heavy chains (H chains) and two light, also identical chains (L chains). ’590 patent at 5:56–65. The district court determined that this portion of the written description defined the term “antibody.” While this is a plausible reading of the excerpt in Case: 19-1527 Document: 59 Page: 10 Filed: 08/27/2020 10 BAXALTA INC. v. GENENTECH, INC. isolation, 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.” Budde v. Harley-Davidson, Inc., 250 F.3d 1369, 1379–80 (Fed. Cir. 2001). When considered in the context of the remainder of the written description and the claims, we read the excerpt in column 5 as a generalized introduction to antibodies rather than as a definitional statement. We also note that these general statements do not include terms we have held to be limiting in other contexts such as “the present invention includes . . .” or “the present invention is . . .” or “all embodiments of the present invention are . . . .” Luminara Worldwide, LLC v. Liown Elecs. Co., 814 F.3d 1343, 1353 (Fed. Cir. 2016). Beyond this general description in column 5, the written description provides specific disclosures regarding bispecific, chimeric, and humanized antibodies and methods of production thereof, all of which do not comport with the district court’s construction. For example, the written description explains that “[t]he inventive antibodies and antibody derivatives and organic compounds derived there from comprise . . . bispecific antibodies.” ’590 patent at 6:1–6. Both parties agree “bispecific antibodies” do not consist of two identical H chains and two identical L chains and thus fall outside the district court’s construction. See, e.g., Baxalta Op. Br. at 30 n.16; Genentech Resp. Br at 1. The written description further discloses that “antibodies and antibody derivatives may also include . . . ‘technically modified antibodies’ such as . . . chimeric or humanized antibodies . . . . In these technically modified antibodies, e.g., a part or parts of the light and/or heavy chain may be substituted.” ’590 patent at 6:15–24. And the written description explains that “[t]he antibodies of the present invention can be prepared by methods known from the prior art, e.g. by conventional hybridoma techniques, or by means of phage display gene libraries, immunoglobulin chain shuffling or humanizing techniques.” Id. at 7:65–8:3 (emphasis Case: 19-1527 Document: 59 Page: 11 Filed: 08/27/2020 BAXALTA INC. v. GENENTECH, INC. 11 added). The written description, therefore, discloses synthetic techniques for preparing antibodies such as humanized or chimeric antibodies, which are inconsistent with the district court’s claim construction requirement that the antibody “only binds to the antigen that induced its synthesis or very similar antigens.” Recognizing that these disclosed techniques for preparing the claimed antibodies would result in antibodies excluded by the district court’s construction, Genentech’s response was “I hesitate to say that that’s a typo.” Baxalta, No. 19-1527 Oral Arg. at 37:02–38:26. Genentech does not dispute that the written description discloses antibodies that fall outside the district court’s construction, but rather argues that “there is no legal problem with a claim construction that excludes certain disclosed embodiments, where the specification otherwise supports that construction.” Genentech Resp. Br. at 1, 60–61. To adopt Genentech’s construction, we would need to invalidate several dependent claims, which according to Genentech, the examiner overlooked in allowing, and to conclude that preparation techniques for the claimed antibodies included in the written description were disclosed in error. See Baxalta, No. 19-1527 Oral Arg. at 31:37–32:26 (counsel for Genentech conceding that “[claim 19] and claim 4 are inconsistent with the notion that column 5 is a definition of ‘antibody’”). As discussed, column 5 is not definitional, and the remainder of the written description and claims do not support the district court’s construction. The claim construction excluding these disclosed and claimed embodiments is therefore incorrect.