Centocor Ortho Biotech, Inc. v. Abbott Laboratories: Federal Circuit Throws out $1.67 Billion Jury Verdict for Lack of Written Description

Centocor Ortho Biotech, Inc. v. Abbott Lab., No. 2010-1144 (Fed. Cir. Feb. 23, 2011) Slip Opinion

The Federal Circuit recently ruled that a district court erred when it declined to grant the motion of defendant Abbott Laboratories (“Abbott”) for JMOL that the plaintiff’s asserted patent claims were invalid. In so holding, the court set aside a jury verdict of $1.67 billion in damages to plaintiff Centocor Ortho Biotech (“Centocor”) in the infringement suit concerning antibodies used to treat arthritis.

The Federal Circuit found that Centocor’s written description in its patent application was not adequate and conveyed merely a wish or plan to invent an antibody rather than constructive possession of that antibody. The court also held that Centocor’s disclosure of the TNF-α protein did not provide an adequate written description for all binding antibodies, since the protein was already known and the antibody claimed could not be routinely produced at the time of filing.

Patent Docs and Patently-O provide thorough overviews of the case.

Centocor and Abbott followed different paths to create a similar antibody to treat arthritis. Where Centocor started with a mouse antibody of the protein TNF-α and modified the constant regions of the antibody to decrease its immunogenic properties and to make it look more human, Abbott started from scratch to create an antibody with fully-human constant and variable regions. Centocor filed a continuation in part (“CIP”) application for its antibody in 1994, and Abbott filed a patent application for its antibody Humira(R) in 1996. After Abbott was granted regulatory approval to market Humira(R) in 2002, Centocor filed a patent application for fully-human antibodies to TNF-α, including a priority claim to its earlier CIP application. Centocor’s application issued as a ’775 patent in 2006. Centrocor filed suit against Abbott shortly thereafter, alleging Humira(R) infringed its ’775 patent.

Writing for the panel, Judge Prost explained that under 35 U.S.C. § 112, a patent specification must contain a written description that conveys more than a mere wish or plan for obtaining an invention, and instead should demonstrate that the inventor was in constructive possession of the invention. Embarking on “an objective inquiry into the four corners of the specification,” the court found that Centocor’s written description failed to describe “a single antibody that satisfies the claim limitations,” “disclose any relevant identifying characteristics for such fully-human antibodies,” or “disclose any relationship between the human TNF-α protein, the known mouse variable region that satisfies the critical claim limitations, and potential human variable regions.” Based on these failures, the court found that Centocor’s written description did not convey that it was in possession of a human antibody.

The court also considered the second issue of whether Centocor’s full disclosure of the TNF-α protein in its CIP application provided adequate written description for any antibody that binds to it (including Abbott’s Humira(R) antibody). The court held that “while our precedent suggests that written description for certain antibody claims can be satisfied by disclosing a well-characterized antigen, that reasoning applies to disclosure of newly-characterized antigens where creation of the claimed antibodies is routine.” Since at the time of Centocor’s patent filing TNF-α was already a known protein, and obtaining the human antigen claimed by Centocor was not possible using routine technology, Centocor did not have a claim to the human antibody. Centocor’s ’775 patent failed to demonstrate constructive possession rather than “‘merely recit[ing] a description to the problem to be solved while claiming all solutions to it.’” Prost concluded that Centocor should not be allowed to profit when “the actual inventive work of producing a human variable region was left for subsequent inventors to complete.”

Warren Woessner, in his blog patents4life, criticizes Prost’s holding regarding antibody descriptions, stating that he does not believe “the case law supports a requirement for structural characterization of the representative species,” and pointing out this ruling is problematic in cases involving the “therapeutic use of one of a genus of monoclonal antibodies that necessarily vary widely in structure.”

Katie Booth is a 1L at the Harvard Law School.