Centocor human antibody claims invalidated for lack of written description


03.06.11 Posted in Federal Circuit Opinions by

Centocor Ortho Biotech Inc. v. Abbott Labs., No. 2010-1144 (Fed. Cir. 2/23/2011) (opinion by Prost).

Centocor sued Abbott for patent infringement alleging that Abbott’s Humira® antibody infringes US Patent No. 7,070,775. The jury rejected Abbott’s  defense that the asserted claims were invalid, and found Abbott liable for willful infringement and awarded Centocor $1.67 B. Abbott moved for JMOL on invalidity, noninfringement, and willfulness. The district court granted Abbott’s motion on willful infringement only.  But on appeal, the Federal Circuit panel reversed, granting Abbott’s motion for JMOL that that the asserted claims were invalid for lack of written description.

This case involved antibodies to human tumor necrosis factor alpha (“TNF-alpha”).  The specific issue was the disclosure of antibodies with a human variable region to TNF-alpha.  Centocor identified a mouse antibody to human TNF-alpha and later humanized their antibody. Centocor filed its first patent application for which the ‘775 patent claims priority in 1991, and filed a number of continuations, including CIP’s in 1994 and 2002. The ‘775 patent was finally granted in 2006. Abbott took a different approach, constructing a fully human antibody to TNF-alpha from scratch. Abbott filed a patent on its antibody in 1996 that was granted in 2000. Meanwhile, Centocor did not file a claim to a human variable region until the 2002 CIP, i.e., after the Abbott patent was granted. Thus, for Centocor to prevail in its challenge against Abbott, it had to show that there was support in the 1994 CIP application for the human variable region. Slip op. at 17.

The federal circuit panel held there was no such support.  The opinion states that “very little” in the ‘775 patent supports an antibody with a human variable region. Slip op. at 13.  Abbott’s expert testified that “a person of ordinary skill would not have understood that Centocor had possession of a fully human antibody.” Slip op. at 12.  Abbott emphasized that this was the only expert testimony on written description. Abbott argued that there was no disclosure in the specification of a human variable region, and that Centocor “merely disclosed tools that might be used in an attempt to make the claimed invention—essentially, that Centocor’s disclosure is no more than a mere wish or plan for how one might search for a fully-human antibody that satisfies the claims.”  Id.  

Centocor presented no evidence on written description at trial, relying instead in the 1994 CIP, PTO guidelines, and Noelle v. Lederman, a 2004 Federal Circuit decision.  Centocor also argued that “that the written description requirement demands neither actual reduction to practice nor working examples to claim an invention.” Slip op. at 13.

The opinion then asserts that there was a substantial disclosure of chimeric antibodies not relevant to the claim of infringement against Abbott. Slip op. at 14–15. Centocor “was able to point to only a few sentences sprinkled throughout the ‘775 patent that mention human antibodies or human variable regions.”  Slip op. at 15.  The opinion approvingly quotes Abbott’s expert as saying “the mere fact that ‘the words appear’ does not reasonably suggest to one of skill in the art that Centocor was in possession of such antibodies.” Id.

The opinion concludes “while the patent broadly claims a class of antibodies that contain human variable regions, the specification does not describe a single antibody that satisfies the claim limitations.”  Further, the asserted claims were “a wish list of properties,” slip op. at 17, and the “specification at best describes a plan for making fully-human antibodies and then identifying those that satisfy the claim limitations. But a “mere wish or plan” for obtaining the claimed invention is not sufficient” to satisfy the written description requirement.  Id.

The opinion further concludes, slip op. at 20–21, “we have repeatedly indicated that the written description requirement does not demand either examples or an actual reduction to practice. Ariad, 598 F.3d at 1352. What it does demand is that one of skill in the art can “visualize or recognize” the claimed antibodies [i.e., invention] based on the specification’s disclosure. Eli Lilly, 119 F.3d at 1568. In other words, the specification must demonstrate constructive possession, and the ’775 patent’s specification fails to do so. Ariad, 598 F.3d at 1352.”



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