Carnegie Mellon University v. Hoffman-La Roche (Fed. Cir. 2008)
Carnegie Mellon's patents cover recombinant plasmids used to enhance expression of an DNA polymerase. On appeal, the CAFC affirmed the lower court holding that the patent claims fail to meet the written description requirement under Lilly.
35 U.S.C. §112 requires that the patent document "contain a written description of the invention and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
The written description requirement is used to make sure that the patentee only claims what has been invented. The public gets a "meaningful disclosure in exchange for being excluded from practicing the invention for a limited period of time." Quoting Enzo Biochem (Fed. Cir. 2002).
A common written description argument is that the claims have not been disclosed to their full scope. In the Lilly case, for instance, the CAFC found that a generic claim directed to "any vertebrate and mammalian cDNA" were not supported by a specification that only discussed one species – rat cDNA.
To be clear, written description is not about enablement. Patent claims may well be enabled based on PHOSITA's knowledge of the art, but still fail the written description requirement because the patentee did not disclose the entire scope of its invention.
A representative claim from Carnegie's patents reads as follows:
1. A recombinant plasmid containing a cloned complete structural gene coding region isolated from a bacterial source for the expression of DNA polymerase I, under operable control of a conditionally controllable foreign promoter functionally linked to said structural gene coding region, said foreign promoter being functional to express said DNA polymerase I in a suitable bacterial or yeast host system.
In reviewing the claim, the CAFC noted that the DNA coding sequence is "broadly defined … only by its function of encoding DNA polymerase I" and that the claims are not limited to any particular bacterial or yeast species.
The specification only discloses one operative gene – the E. coli polA gene. And at the time of the patent, only three polA genes had been cloned (out of thousands of bacteria strains). "[W]ith regard to the 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."
"To satisfy the written description requirement in the case of a chemical or biotechnological genus, more than a statement of the genus is normally required. One must show that one has possession, as described in the application, of sufficient species to show that he or she invented and disclosed the totality of the genus. . . . [W]e conclude that that requirement was not met here.
Gentry Gallery: The district court also applied Gentry Gallery to invalidate other claims. In Gentry, the CAFC found a patent claim invalid because the claim failed to recite an "essential element" of the invention. Here, Roche argued that the patents were directed to avoiding the problem of lethality to host cells, but that the claims did not include that limitation. As it has done repeatedly, the CAFC rejected the idea that Gentry Gallery created an essential element test. (The claims remain invalid under the Lilly analysis.).