Centocor v. Abbott Labs: Must You Only Preach What You Practice?

Specifically, Centocor held that the written description of U.S. Patent No. 7,070,775 (“the '775 patent”) describing a mouse antibody and chimeric antibody having a mouse variable region was inadequate to show possession of an invention relating to human antibodies that could neutralize human TNF-a for use as a drug. The court also found that generating human antibodies with the properties claimed would not have been within the skill of one of ordinary skill in the art at the time of the original invention. Rather, the court held that the claimed antibody was merely a “wish list” of desired properties.

Centocor highlights the current disparity between the viewpoint of some Federal Circuit judges and the USPTO's ' 112 guidelines, which suggest an “antibody exception.” This “exception” allows an applicant to claim an antibody capable of binding to a protein when the specification characterizes the protein but lacks any actual or prophetic examples of actual antibodies binding to the protein. Such an exception allows inventors to claim outside the boundaries of the invention they actually reduced to practice, which is permitted in other areas. Previously, cases such as Noelle v. Lederman, 355 F.3d 1343 (Fed. Cir. 2004) have reinforced the guidelines. In Noelle, the Federal Circuit stated, “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.” Id. at 1349.