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Claimed Poxvirus Vaccine Was Enabled and Supported by Written Description Despite Lack of Examples and Recitation of Gene Sequence

May 26, 2006
Capron, Aaron J.

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Last Month at the Federal Circuit - June 2006

Judges: Gajarsa (author), Archer, Dyk

In Falkner v. Inglis, No. 05-1324 (Fed. Cir. May 26, 2006), the Federal Circuit affirmed the judgment of the Board holding that Falkner’s U.S. Patent No. 5,770,212 (“the Falkner ’212 patent”) could not antedate the priority date of Inglis’s U.S Application Serial No. 08/459,040 (“the Inglis ’040 application”). Accordingly, the Federal Circuit upheld the Board’s decision that Inglis was the senior party for the sole count of an interference proceeding.

Some vaccines against a virus (the “target virus”) incorporate harmless fragments of the target virus’s genetic material into a second virus, called a “viral vector.” The invention at issue relates to a way of making vaccines safer by deleting or inactivating an “essential” genefrom the viral vector’s genome, while growing the vaccines in cells that were modified to produce the absent essential viral gene product on behalf of the vector virus. The approach is applicable to many different kinds of vector viruses, but the subject matter of this interference is directed specifically to vaccines where the vector virus is a poxvirus.

The APJ accorded the Inglis ’040 application (filed June 2, 1995) the benefit of several earlier-filed applications, dating back to September 25, 1990. Likewise, the APJ accorded the Falkner ’212 patent (filed on February 21, 1997) the benefit of earlier-filed applications, but these dated back only to April 29, 1994. Consequently, the APJ designated Inglis as the senior party.

Although the specifications of all of Inglis’s earlier-filed applications focused on the herpesvirus vectors, they contained several passages relating to the poxvirus-based vaccines. Because Falkner believed that these passages did not adequately describe and enable the poxvirus invention, he filed motions before the Board arguing that Inglis had failed to meet the written description and enablement requirements under 35 U.S.C. § 112. After considering these issues, the Board denied Falkner’s motions and affirmed Inglis’s status as senior party.

On appeal, the Federal Circuit first determined that the Inglis applications were enabled. It supported the Board’s holding that while the Inglis applications provided extensive disclosure regarding the herpesvirus, the differences between the herpesvirus and the poxvirus were well known and, coupled with the high level of skill in the art, the lessons of the herpesvirus examples would have aided a person of ordinary skill in the art to construct the poxvirus vaccines. Moreover, the Court noted that the Board observed that the mere fact that the experimentation may have been difficult and time consuming does not mandate a conclusion that such experimentation would have been considered to be “undue” in this art. The Federal Circuit found no error in the Board’s conclusion, reasoning that a patent preferably omits what is well known in the art and that there was undisputed testimony, at the time of the earliest priority date, that professional journals had disclosed the DNA sequence of the poxvirus along with the locations of the essential regions.

The Federal Circuit then determined that the Inglis applications satisfied the written description requirement. The Court noted that the Board found several passages in the Inglis ’040 application (and in the benefit applications) were directed to poxvirus. Moreover, the Federal Circuit held that the absence of examples involving poxviruses in the Inglis applications did not render the written description inadequate.

The Court further held that the written description standard may be met even where actual reduction to practice of an invention is absent. It noted that while an actual reduction to practice ordinarily provides the best evidence for showing that an invention is complete, the written description requirement only requires a showing of a possession of the invention.

Lastly, the Court 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. Faulkner argued that the Inglis specifications did not adequately describe the poxvirus invention, in light of Regents of University of California v. Eli Lilly & Co., 119 F.3d 1559 (Fed. Cir. 1997), because they did not describe the “essential regions” of any poxvirus. The Federal Circuit rejected this argument, explaining that “Eli Lilly does not set forth a per se rule that whenever a claim limitation is directed to a macromolecular sequence, the specification must always recite the gene or sequence, regardless of whether it is known in the prior art.” Slip op. at 16. Instead,
the Court held that where accessible literature sources clearly provided, as of the relevant date, genes and their nucleotide sequences, satisfaction of the written description requirement does not require either the recitation or incorporation by reference of such genes and sequences. Accordingly, the Federal Circuit upheld the decision of the Board that the Inglis applications had satisfied the enablement and written description requirements.