To Satisfy the Written Description Requirement for a Genus, Sufficient Species Must Be Shown

The Federal Circuit, in Carnegie Mellon University v. Hoffman-La Roche Inc. (No. 2007-1266, -1267; Sept. 8, 2008), affirms the District Court for the Northern District of California's finding of invalidity, holding that the asserted claims of U.S. Patent Nos. 4,767,708 (the '708 patent) and 5,126,270 (the '270 patent) and certain asserted claims of U.S. Patent No. 6,017,745 (the '745 patent) lack a proper written description.

Plaintiffs-Appellants Carnegie Mellon University and Three Rivers Biologicals, Inc. (Carnegie Mellon) brought suit against Roche for patent infringement, asserting that Roche's recombinant plasmid pLSG5 -- which can be used to express Thermus aquaticus (Taq) DNA polymerase -- infringes their patents. In response, Roche filed separate motions for summary judgment of, inter alia, invalidity for lack of written description, which the district court granted. The district court concluded that the patents lacked an adequate written description under Regents of University of California v. Eli Lilly & Co., 119 F.3d 1559 (Fed. Cir. 1997), since the claims encompass a cloned polA gene from any bacterial source, but the specification only describes plasmids containing the polA gene from Escherichia coli. On appeal, Carnegie Mellon argued that the district court had erred in granting Roche's motions for summary judgment of invalidity of the '708, '270, and '745 patents because their invention involves the combination of well known elements to create a general biotechnological tool.

With respect to the issue of invalidity of the patents, the Federal Circuit notes that the appealed claims of the patents "are directed to recombinant plasmids that contain a DNA coding sequence that is broadly defined, and only by its function, viz., encoding DNA polymerase I," and further, that "the generic claims are not limited to a single bacterial species, but broadly encompass coding sequences originating from any bacterial species." In addition, the Federal Circuit observes that at the time of invention, out of thousands of bacterial species, only three bacterial polA genes had been cloned, and only one of these genes had been described in the patents at issue. Moreover, despite the description in the patents that "an important feature of this invention [is] that the cloned polA gene fragment contains essentially none of or at the most only a portion of the activity of its natural promoter," the patents "fail to disclose the nucleotide sequence or other descriptive features for a polA gene (including the promoter sequence) from any bacterial source other than E. coli." As a result, the Federal Circuit concludes that no genuine issues of material fact existed as to whether the written descriptions of the patents at issue adequately support the appealed claims, and therefore, the Court affirms the district court's grant of summary judgment of invalidity.