“Functional Defined Antibody Claims Invalid for Lack of Written Description”

July 2, 2014
Marshall Gerstein Alert

The Federal Circuit decided AbbVie Deutschland GmBH & Co. v. Janssen Biotech, Inc., Docket No. 2013-1338 & -1346 (Fed. Cir. 2014) (Lourie, J.) on July 1, affirming a jury verdict of invalidity based on lack of written description.

AbbVie had asserted two patents against Janssen and Centocor’s anti-IL-12 antibody product Stelara®; after a validity trial, the jury determined that all asserted claims were invalid on the grounds of written description, enablement, and obviousness. The consolidated appeal also included review of a patent interference action in which priority of invention and obviousness were at issue. The Federal Circuit affirmed invalidity in both the infringement and the interference actions on the basis of lack of adequate written description, stating that the AbbVie patents did not describe species of antibodies that were representative of the full scope of the genus claimed.

AbbVie’s claims were to a "human antibody, or antigen-binding portion thereof that binds to human IL-12 and disassociates from human IL-12 with [an off rate constant indicating high affinity]." AbbVie argued that the claims were to a small genus of antibodies that are rare and difficult to obtain, and that its patents described a representative number of antibodies commensurate with the scope of the claims. The Federal Circuit disagreed, noting that the claims were defined by functional limitations, not structural limitations, that all of AbbVie’s representative species were derived from a single antibody, and that all of AbbVie’s disclosed species were significantly structurally different from Stelara® (50% identity over the variable region).

Having decided validity based on written description, the Federal Circuit declined to address enablement. Judge O’Malley’s concurring opinion would have affirmed invalidity on the obviousness finding, which AbbVie did not appeal, and suggested that the written description analysis might be dicta.

This decision is another in a long line of cases that Judge Lourie has authored in which the written description requirement has been used to invalidate biotechnology patent claims. Practitioners in the biotech and chemical fields should carefully consider the written support for genus claims when drafting and enforcing claims.

If you have any questions, please contact an attorney in our biotechnology group.

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