By Jason Rantanen
Centocor Ortho Biotech, Inc. v. Abbott Laboratories (Fed. Cir. 2011) Download 10-1144
Panel: Bryson, Clevenger, Prost (author)
Centocor, the holder of Patent No. 7,070,775, which claims fully human antibodies to human necrosis factor α ("TNF-α"), sued Abbott for infringement by the therapeutic antibody Humira®. A jury rejected Abbott's defenses and awarded Centocor $1.67 billion in damages. After the district court granted Abbott's JMOL of no willful infringement, but denied JMOL on invalidity, noninfringement and damages, Abbott appealed.
Later Added Claims Lacked Written Description
On appeal, the CAFC reversed, focusing solely on the issue of written description. In many ways this is a prototypical written description case. Centocor's approach to developing a TNF-α antibody involved first identifying a mouse antibody to human TNF-α, then changing the less critical portions of the antibody to make it more human – thus producing a chimeric antibody. Abbott followed a different path, setting out from the start to develop a fully human antibody, a process that ultimately led to Humira®. Both Centocor and Abbott obtained patents on their antibodies.
In 2002, after Abbott obtained regulatory approval to market Humira®, Centocor filed claims to fully human antibodies as part of an ongoing continuation of the chimeric antibody patent family. These claims later issued as part of the '775 patent. In responding to Abbott's argument that the fully human antibody claims lacked adequate written description, Centocor relied on a 1994 CIP in the chain that predated the 1996 filing date of Abbott's patent application.
In its opinion, the CAFC honed in on the lack of disclosure of any human variable regions (the portion of the antibody that binds to TNF-α) in the 1994 CIP. Examining the "four corners" of the 1994 CIP application, the court concluded that "[t]here is nothing in the specification that conveys to one of skillin the art that Centocor possessed fully-human antibodies or human variable regions that fall within the boundaries of the asserted claims."
"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. See Eli Lilly, 119 F.3d at 1566-69. It does not disclose any relevant identifying characteristics for such fully-human antibodies or even a single human variable region. See id. Nor does it 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 that will satisfy the claim limitations."
Slip Op. at 16-17. Essentially, the claims constituted a wish list of properties for a fully-human, therapeutic TNF-α antibody would possess – but a mere wish or plan for obtaining the invention is not sufficient to satisfy the written description requirement.
Disclosure of a Protein Does Not Necessarily Suffice to Support Claims to All Associated Antibodies
Centocor also suggested that it satisfied the written description requirement by fully disclosing the human TNF-α protein. It based that suggestion on the current PTO written description guidelines, together with Noelle v. Lederman, 355 F.3d 1343 (Fed. Cir. 2004). One example in the PTO guidelines indicates that "'an isolated antibody capable of bding 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." Slip Op. at 17-18. In other words, simply disclosing the "lock" is suffient to support a claim to the key fitting into that lock. This view was reinforced by Noelle, in which the CAFC held that:
"as long as an applicant has disclosed a “ fully characterized antigen,” either by its structure, formula, chemical name, or physical properties, or by depositing the protein in a public depository, the applicant can then claim an antibody by its binding affinity to that described antigen."
Noelle, 355 F.3d at 1349.
Accepting that while this may be true in some cases, the CAFC rejected its application to the multi-part claims at issue. "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." Slip Op. at 19. Here, the creation of the claimed antibodies – which possessed a number of characteristics beyond their relationship with the antigen – was anything but routine. "Claiming antibodies with specific properties, e.g., an antibody that binds to human TNF-α with A2 specificity, can result in a claim that does not meet written description even if the human TNF-α protein is disclosed because antibodies with those properties have not been adequately described." Id. at 20. As Centocor "failed to support its contention that generating fully-human antibodies with he claimed properties would be straightforward for a person of ordianry skill in the art" at the time, possession of the known antigen did not place it in possession of the claimed antibodies.
For those who are interested in reading further, PatentDocs has a detailed write-up of the decision.