Comparative Biologics

Yesterday, the U.S. Court of Appeals for the Federal Circuit issued its decision in Abbvie Deutschland Gmbh & Co. v. Janssen Biotech, Inc. relating to patents on directed to antibodies that bind to and neutralize the activity of human interleukin 12. The CAFC found there was sufficient evidence for the jury to find the patents invalid for lack of written description.

The decision (PDF) relates to similar patents as addressed in Justice Hughes’ decision from January 2014 in AbbVie Corporation et al. v. Janssen Inc., 2014 FC 55 (see earlier blog post) which found the patent at issue in the Canadian proceeding, CA2,365,281, valid and infringed.

The CAFC decision related to US6,914,128 and US7,504,485. From the decision:

It is true that 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 Biochem, Inc. v. Gen-Probe Inc., 323 F.3d 956, 964 (Fed. Cir. 2002). However, the record here does not indicate such an established correlation. Instead, AbbVie used a trial and error approach to modify individual amino acids in order to improve the IL-12 binding affinity. Moreover, the ’128 and ’485 patents do not describe any common structural features of the claimed antibodies. The asserted claims attempt to claim every fully human IL-12 antibody that would achieve a desired result, i.e., high binding affinity and neutralizing activity, and cover an antibody as different as Stelara, whereas the patents do not describe representative examples to support the full scope of the claims.

The appeal from Justice Hughes’ decision is pending before the Federal Court of Appeal (A-95-14) with a hearing scheduled for October 2014.