Absent any structural features common to the members of a claimed genus, the specification must disclose representative species that are diverse across the breadth of the claimed genus in order to satisfy the written description requirement. “[A]nalogizing the genus to a plot of land, if the disclosed species only abide in a corner of the genus, one has not described the genus sufficiently to show that the inventor invented, or had possession of, the genus.”
Background / Facts: The patents being asserted here are directed to a class of fully human antibodies that are defined by their high affinity and neutralizing activity to human interleukin 12 (“IL-12”), a known antigen. The claims cover a broad genus of such antibodies and the specification gives several example species, but the specification does not disclose any structural features common to the members of the claimed genus.
Issue(s): Whether the patents sufficiently otherwise describe representative species to support the entire genus of the claims.
Holding(s): No. “Although the number of the described species appears high quantitatively, the described species are all of the similar type and do not qualitatively represent other types of antibodies encompassed by the genus.” In particular, “the patents do not describe any example, or even the possibility, of fully human IL-12 antibodies having heavy and light chains other than the VH3 and Lambda types.” To the contrary, the patentee “used a trial and error approach to modify individual amino acids in order to improve the IL- 12 binding affinity” and then “attempt[ed] to claim every fully human IL-12 antibody that would achieve a desired result, i.e., high binding affinity and neutralizing activity, and cover an antibody as different as [the accused product].”