Yesterday, in Centocor Ortho Biotech, Inc v Abbott Laboratories, the Federal Circuit held that the humanized antibody claims that Centocor had asserted against Abbott's Humira® product (claims 2, 3, 14 and 15 of U.S. 7,070,775) are invalid for failing to satisfy the written description requirement of 35 USC § 112. (This decision will negate a $1.67 billion damages award by the jury in the trial court proceeding). I will write more about this decision soon, but for now I want to highlight the court's discussion of the Written Description Guidelines for antibody claims.
Centocor's Written Description Guidelines Argument
One of Centocor's arguments was that the USPTO's Written Description Guidelines "support the view that fully disclosing the human TNF-α protein provides adequate written description for any antibody that binds to human TNF-α."
The Federal Circuit's Explanation of the Written Description Guidelines
One example in the USPTO's Written Description Guidelines relates to antibody claims. As summarized by the Federal Cricuit, the example indicates that a claim reciting "an isolated antibody capable of binding to [protein] X" is adequately described where the specification fully characterizes protein X—even if there are no working or detailed prophetic examples of actual antibodies that bind to protein X."
The Federal Circuit explained that this rule of thumb applies only when:
- the applicant fully discloses a novel protein and
- generating the claimed antibody is so routine that possessing the protein places the applicant in possession of an antibody
The court explained that the Guidelines do not support Centocor's position because the TNF-α protein was not novel.
The court also cautioned that when a claim recites "antibodies with specific properties" (such as Centocor's claims that recited "an antibody that binds to human TNF-α with A2 specificity"), a specific description of antibodies with those properties may be required to satisfy the written description requirement of 35 USC § 112. The court cited its decision in Noelle v. Lederman as an example of circumstances where antibody claims were not supported by an adequate written description. (In Noelle, the description of a murine protein and antibodies to that protein were insufficient to support claims encompassing antibodies to the human protein.)
Striking A Balance
The Federal Circuit's explanation of the limits of the "rule" reflected in the USPTO's Written Description Guidelines strikes a balance between scientific realities and the written description safeguard against overreaching claims. As noted in the Federal Circuit decision, the Guidelines base the antibody example on the understanding that generating an antibody against a "well-characterized protein" is a conventional undertaking. However, once the antibody at issue must have more specific properties, such as exhibiting specific binding properties or recognizing certain epitopes of the protein, other written description jurisprudence comes into play, such as the requirement that the specification "'convey with reasonable clarity . . . that . . . [the applicant] was in possession of the invention.'"