United States: Priority And Two-Way Interference-in-Fact Test Not Satisfied Where Claimed Invention Relied on Functional Characteristics

In a case turning on priority of invention, the U.S. Court of Appeals for the Federal Circuit affirmed that the disclosure of a murine antibody or its activity and antigen failed to adequately describe additional species or genus claims. Competing claims to murine and human forms were further found to fail the two-way interference-in-fact test. Noelle v. Lederman, Case No. 02-1187 (Fed. Cir. Jan. 20, 2004).

The application No. 08/742,480 to Noelle (the `480 application) claims antibodies to the genus, murine and human forms of CD40CR antigen. The patent No. 5,474,771 to Lederman (the `771 patent) claims a CD40CR antibody to the human antigen. The interference count encompassed all three forms of CD40CR antibody, which inhibits immune signaling and is clinically useful for treating allergic reactions and autoimmune diseases. Analogizing antibody claims to DNA claims, the Board of Patent Appeals and Interferences (the Board) determined that the priority disclosure of the murine antibody form or its antigen failed to adequately describe the human and genus antibody claims of the `480 application and were anticipated by the `771 patent. The Board also concluded that there was no interference-in-fact between the remaining murine and human claims because the latter was unobvious.

The Court approved of the analogy to genetic material and embraced its previous holdings that a biotechnology invention cannot necessarily claim a genus after describing only a limited number of species. However, the written description requirement for antibodies relying on functional characteristics can only be met if the function is coupled with a disclosed correlation to a known structure. Finding a lack of written description and, therefore, no entitlement to priority, the Court found that the `480 priority application failed to adequately describe the human and genus antibody forms because it only disclosed antibody activity and structure to the murine antigen.

The Court also found that substantial evidence supported the Board’s determination of no interference-in-fact between the remaining murine antibody claim in the `480 application and the human claim in the `771 patent. Satisfaction of the two-way test requires that invention A must anticipate or make obvious invention B (step 1), and invention B must anticipate or make obvious invention A (step 2). The parties conceded that neither anticipation was not in issue the parties also conclude the motivation prong of the obviousness inquiry was not in issue. As to the remaining obviousness issue, the Court rejected the argument that the human claims were obvious in light of disclosed methods of isolating CD40CR antibodies, noting that the same patentable invention is being claimed is determined through a comparison of the competing claims. Because the `480 application did not claim a method of isolating either the human antibody form or antigen, the Court held that one of ordinary skill in the art would not have had a reasonable expectation of success in obtaining the human form given the murine disclosure in the `480 claims.