Prior Law for Written Description of Biologic Material Reinstated
 
August 20, 2002
 
Joshua Krumholz - Boston

On April 9, 2002, Holland & Knight issued an Alert reporting the Federal Circuit’s decision in Enzo Biochem, Inc., v. Gen-Probe, Inc., 285 F.3d 1013, 62 U.S.P.Q.2d 1289 (Fed. Cir. 2002) (“Enzo I”).¹ In Enzo I, the Federal Circuit affirmed the decision of the District Court in invalidating a patent claiming DNA probes for failure to comply with the written description requirement of 35 U.S.C. § 112.  The Court held that the description provided by the inventor should have disclosed the nucleotide sequence of the claimed material, and that this failing was not cured by the deposit of specific nucleic acid molecules with the American Type Culture Collection. 

 On July 15, 2002, after a rehearing of the appeal, the Federal Circuit reversed itself.  See Enzo Biochem, Inc., v. Gen-Probe, Inc., No. 01-1230, slip op. (Fed. Cir. July 15, 2002) (“Enzo II”).  Specifically, the Federal Circuit held that a patentee complied with the written description requirement by depositing biological material in a public depository. 

In addition, the Court also reversed itself concerning the requirements for the written description itself.  In Enzo I, the Court, in contradiction to earlier decisions, stated that the sequence of the genetic material must be disclosed for the written description requirement to be met.  That absolute rule, however, was rejected in Enzo II.  Rather, the opinion adopted provisions from the Guidelines issued by the PTO that state that the written description requirement can be met by a functional description of claimed materials, if coupled with a known or disclosed correlation between function and structure.  A disclosure of the sequence therefore was not always necessary.  Rather than an absolute rule, an analysis of the adequacy of a written description required a factual inquiry into the knowledge of those skilled in the relevant art.

What does this mean to you?

            Enzo II reflects a return to pre-Enzo I standards with respect to written descriptions.  Current and future applicants for patents on biological materials may wish to give increased consideration to placing samples in a depository, if unable to sequence the materials prior to filing, now that the Federal Circuit has endorsed consideration of such materials in connection with satisfaction of the written description requirement.  For current holders of patents for biological materials, the Enzo II standard may decrease the likelihood that their patents will be subject to invalidation in litigation based on a failure of the written description requirement. 

For further information, contact Patrea L. Pabst or Joshua C. Krumholz.  Each may be reached through our toll-free number, 888-688-8500.

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* The authors wish to thank Bruce F. Anderson, a summer associate, for his contributions to this Alert.

¹ See Federal Circuit Heightens Written Description Requirement for Patents on Genetic Material, available at http://hklaw.com/newsletters.asp?ID=268.