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Court Reverses Ruling on Written Description

July 15, 2002

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Last Month at the Federal Circuit - August 2002

Judges: Lourie (author), Dyk, and Prost

In Enzo Biochem, Inc. v. Gen-Probe Inc., No. 01-1230 (Fed. Cir. July 15, 2002), the Federal Circuit, on petition for rehearing, vacated its prior ruling and held that a biological deposit may satisfy the written-description requirement of 35 U.S.C. § 112. As such, the Court reversed the district court’s grant of SJ that Enzo Biochem, Inc.’s (“Enzo”) claims of U.S. Patent No. 4,900,659 (“the ‘659 patent”) are invalid for failure to meet the writtendescription requirement and remanded on the issue.

The facts of the underlying decision are reported in our May 2002 edition of this Newsletter. In short, Enzo’s claims are directed to nucleic-acid probes that contain a high ratio of nucleotide sequence that hybridizes to N. gonorrhoeae compared to a sequence that hybridizes to N.  meningitidis. The specification contains information regarding how the probes are obtained and their approximate lengths, but not their sequences or the means by which the probes are identified. The probes were deposited with the American Type Culture Collection, a repository for biological material. In its prior decision, Enzo Biochem, Inc. v. Gen-Probe Inc., No. 01-1230 (Fed. Cir. Apr. 2, 2002), the Federal Circuit ruled that although a deposit for a microorganism may show enablement of an invention, to satisfy the written-description requirement, the invention must be described more than by stating that it exists in a depository.

On rehearing, the Federal Circuit noted that the practice of depositing biological material arose primarily to satisfy the enablement requirement of 35 U.S.C. § 112, ¶ 1. It ruled, however, that references with respect to such deposits can also satisfy the written-description requirement.

In this particular case, the Court found that the references in the specification to deposits of nucleotide sequences describe the sequences sufficiently in conjunction with the deposits specified. However, the Court remanded for further determinations as to whether the deposits drawn to certain species adequately describe the scope of certain genus claims. The Court instructed the district court to use the PTO guidelines concerning this issue to makes its determination.

Finally, the Court rejected Enzo’s additional argument that the written-description requirement for the generic claims was necessarily met as a matter of law because the claim language appears in ipsis verbis in the specification. The Court ruled that the specification must describe the claimed invention so that one skilled in the art can recognize what is claimed. The appearance of mere indistinct words in a specification or a claim, even an original claim, does not necessarily satisfy that requirement. If a purported description of an invention does not meet the requirements of the statute, the fact that it appears as an original claim or in the specification does not save it. The mere showing of possession of an invention does not cure a lack of written description in the specification.

In a related order, the Federal Circuit decided not to rehear the issue en banc. Judges Rader, Gajarsa, and Linn dissented from that decision, because, in their opinion, the written-description requirement is not separate from the enablement requirement and that issue should be addressed by the full Court.