By Donald Zuhn --
In an appeal from a decision of the Board of Patent Appeals and Interferences, the
Federal Circuit affirmed judgment for Appellees (Inglis et al.) in an
interference involving vaccines comprising modified viral vectors. In particular, the subject matter of the
interference concerned vaccines comprising a poxvirus vector having a deleted
or inactivated essential gene, wherein the modified poxvirus is capable of
producing infectious viral particles when grown in a host cell modified to
produce the absent essential viral gene product. In contrast with the vaccines of the
invention, traditional vaccines had been prepared by deleting or inactivating
inessential genes in the viral vector, since the deletion or inactivation of
essential genes made it difficult to produce vaccines in commercial quantities.
On appeal, Appellants (Falkner et al.) reiterated several
arguments made before the Board, each concerning the common issue of whether
Appellees had adequately described and enabled a poxvirus-based vaccine. Specifically, Appellants argued that because
Appellees did not identify any essential poxvirus genes or the inactivation of
any such genes, Appellees had not sufficiently described and enabled vaccines
comprising a poxvirus vector having a deleted or inactivated essential gene.
With respect to the Board's determination that Appellees had sufficiently described vaccines comprising poxvirus vectors having modified essential genes, the Federal Circuit noted that there was undisputed testimony before the Board that at the time of filing of Appellees' earliest application, the DNA sequence of the poxvirus genome and the locations of essential poxvirus genes had been disclosed in the scientific literature. Adhering to the well-established rule that "[a] patent need not teach . . . what is well known in the art," the CAFC held that "there is no per se rule that an adequate written description of an invention that involves a biological macromolecule must contain a recitation of known structure." In affirming the Board's determination that Appellees adequately described the invention, the Federal Circuit concluded that because "accessible literature sources clearly provided, as of the relevant date, [poxvirus] genes and their nucleotide sequences (here "essential genes"), satisfaction of the written description requirement does not require either the recitation or incorporation by reference (where permitted) of such genes and sequences."
Falkner v. Inglis (Fed. Cir. 2006)
Panel: Circuit Judge Gajarsa, Senior Circuit Judge Archer, and Circuit Judge Dyk
Opinion by Circuit Judge Gajarsa
This article was originally published on Patently-O on June 1, 2006.
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