Abbvie Deutschland GmbH & Co., KG, et al. v. Janssen Biotech, Inc. and Centocor Biologics, LLC Janssen Biotech, Inc. v. Abvie Deutschland GmbH & Co., KG


Docket Nos. 2013-1338, -1346

LOURIE, O’MALLEY(c), CHEN
July 1, 2014

Brief Summary: DC decision invalidating AbbVie’s patents regarding human antibodies for neutralizing human IL-12 affirmed for lack of written description (functional genus claims not supported by representative species).

Summary: AbbVie sued Janssen and Centocor (“Centocor”) for infringement of US Pat. Nos. 6,914,128 and 7,504,485 relating to human antibodies for neutralizing human IL-12. AbbVie appealed the DC denial of its motions for SJ that Centocor was not collaterally estopped from raising invalidity defenses not raised during the interference proceeding in front of the BPAI (§146, pre-AIA) and for JMOL regarding written description and enablement (jury determined that all asserted claims were invalid on WD, enablement and obviousness grounds), as well as its motion for a new trial. The FC panel concluded Centocor was not collaterally estopped because the Board decision was not a final judgment as the interference action was still pending at the DC (Agilent Techs., FC 2009 (a party seeking review of a decision of the Board under §146 may ‘shore up evidentiary gaps’…which could not be presented to the PTO”)). Regarding WD, AbbVie argued “that each of the asserted claims is limited to a small genus of antibodies that are rare and difficult to obtain and that its patents describe a representative number of antibodies commensurate with the scope of the claims.” Centocor argued the claims are functional (e.g., “dissociates from human IL-12 with a koff rate constant of 1×10-2s-1 or less, as determined by surface plasmon resonance”) and “cover widely varying structures” (including its Stelara product). The FC panel agreed with Centocor because, as in Regents (FC 1997 (rat insulin DNA not representative of “mammalian” insulin DNA)), the common specification does “not disclose structure features common to the members of the claimed genus” or “otherwise describe representative species to support the entire genus.” Analogizing the situation to drawing a line around a plot of land, the opinion explained that one cannot show the genus has been invented by “drawing a fence around a perceived genus” (e.g., where “one only has a research plan, leaving it to others to explore the unknown contours of the claimed genus”). The patents are summarized as only describing antibodies derived from one parent antibody (“Joe-9”), having VH3 heavy chains and Lambda light chains, sharing 90% or more similarity in the variable regions, and over 200 that differ from one particular antibody by one one amino acid, but not describing “any example, or even the possibility, of fully human IL-12 antibodies having” other heavy and light chains (Centocor’s Stelara has VH5/kappa heavy/ligh chains). While “functionally defined claims can meet the written description requirement if a reasonable structure-function correlation is established, whether by the inventor as described in the specification or known in the art at the time of the filing date” (Enzo, FC 2002), the opinion explained that “the record here does not indicate such as established correlation.” The panel also concluded the DC did not abuse its discretion in denying a new trial. AbbVie did not contest the DC conclusion of obviousness and those were therefore not discussed in the opinion. However, Judge O’Malley’s concurring opinion explained that the DC invalidation decision should have been affirmed on obviousness grounds.

This entry was posted in Appeal, Functional limitations, Written description. Bookmark the permalink.

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