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Possessing a claimed invention when filing a patent application — and disclosing it there — may no longer meet the written-description requirement, particularly if the invention is a nucleic acid. In Enzo Biochem Inc. v. Gen-Probe Inc., No. 01-1230, 2002 WL 487156 (Fed. Cir. April 2, 2002), the U.S. Court of Appeals for the Federal Circuit, in a 2-1 decision by Judge Alan D. Lourie (Judge Timothy B. Dyk dissenting), invalidated claims to nucleic acid probes deposited as of the filing date and disclosed in the same terms as the claims. Lourie’s previous opinions foreshadowed Enzo, but its announcement of a heightened written-description requirement is nonetheless surprising in light of long-standing precedent. Title 35 U.S.C. 112, � 1 requires that the specification, the descriptive part of the application and claims as filed, “contain a written description of the invention.” This mandates demonstration of “possession of the invention,” which is whatever is ultimately claimed, in the original application. Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1564 (Fed. Cir. 1991). Since knowledge about modern biochemical inventions can be limited when contemplating a patent, the written-description requirement imposes real limitations on when a patent can be sought and on the subject matter that can be claimed. Lourie first signaled a possible elevation of the written-description bar in Fiers v. Revel, 984 F.2d 1164 (Fed. Cir. 1993). Fiersinvolved a three-party contest over the right to claim DNA that coded for human fibroblast beta-interferon, a molecule produced in defense of viral infection. Dr. Michel Revel asserted entitlement to this right in his U.S. application based on disclosure in his earlier Israeli application. Finding that the Israeli application failed to provide a written description of the subject matter sought, the court explained that “bare reference to a DNA with a statement that it can be obtained by reverse transcription is not a description; it does not indicate that Revel was in possession of the DNA.” Id. at 1171. Thus, since Revel had only “a wish, or arguably a plan, for obtaining the DNA,” he could not obtain the right to the invention because he was not first to communicate possession of it. Id. In Regents of the University of California v. Eli Lilly & Co., 119 F.3d 1559 (Fed. Cir. 1997), Lourie took the written-description requirement a step further. The University of California sued Eli Lilly, asserting infringement of claims to a recombinant plasmid, a ring of DNA found in bacteria, containing cDNA for producing insulin of a vertebrate. The specification disclosed a nucleotide sequence for rat insulin but only a general method for obtaining insulin of other vertebrates. Invalidating the claims, the court held that general statements about vertebrate cDNA, coupled with a nucleotide sequence for one vertebrate cDNA, was insufficient to describe the genus of cDNA for insulin of vertebrates. Here the inventors demonstrated more possession than in Fiersby disclosing one example and providing some general statements, but the court concluded that this did not describe the claimed invention. LONG-HELD VIEWS ARE IN DOUBT Although Fiersand Eli Lillyhinted that Lourie’s decision in Enzomight lie ahead, Enzo’s major extension of them calls into question long-held views of the written-description requirement. Enzoinvolved both broad and specific claims to nucleic acids. The broad claims covered nucleic acid probes that hybridize — or bind to — the genetic material of bacteria that cause gonorrhea “greater than about five” times more than to that which causes meningitis. The specific claims involved variations of three probes placed in a biological deposit before the application was filed. Fiersand Eli Lillyquestioned whether the inventors actually possessed their claimed inventions, let alone communicated that possession in their original applications. However, there was no dispute that the original application in Enzocommunicated possession of the invention in the same terms as the issued claims, including reference to the deposit numbers of the specific probes. Before Enzo, more than 30 cases considered possession to be the touchstone of written-description analysis. See, e.g., Vas-Cath, 935 F.2d at 1563-64. Communication of that possession in the same terms as the issued claims ended the inquiry; a written-description challenge was “fully defeated by a specification which describe[d] the invention in the same terms as the claims.” In re Bowen, 492 F.2d 859, 864 (CCPA 1974). Nevertheless, in Enzothe court invalidated all the claims because it believed the specification failed to communicate that possession adequately. Enzoestablishes that, even when the original application discloses possession of inventions as claimed, more “description” is needed. FFECTS ON ISSUED PATENTS If Lourie’s decision in Enzostands, more than communication of possession in the same terms as the issued claims will be required to comply with the written-description requirement. Fiers, Eli Lillyand Enzomake the expectations clear for claims to DNA: “adequate written description of genetic material requires a precise definition, such as by structure, formula, chemical name, or physical properties.” Enzo, 2002 WL 487156, at *4. One approved approach is disclosure of nucleotide sequences. See Fiers, 984 F.2d at 1172. Armed with this knowledge, applicants seeking claims to DNA can ensure compliance. If, as in Eli Lilly, the claim encompasses a class of DNAs, then the applicant need not provide a nucleotide sequence for every DNA but must offer sequences for a number of representative members or a description of structural features common to the class. See119 F.3d at 1569. However, while providing sequences may offer a safe harbor from written-description challenge, Enzocautions that solely describing DNA in other terms could be risky. The court’s finding that the description in Enzo, which involved hybridization ratios, was “purely functional” admonishes that applicants should be explicit in describing DNA structure. Enzo, 2002 WL 487156, at *4. Hybridization involves binding of complementary strands of DNA, and, accordingly, description of genetic targets necessarily provides some insight into the structure of complements that will bind to them. Under Enzo, such indirect description based on hybridization targets or translation from a nucleic acid to a protein is clearly defective. Moreover, Enzo‘s higher bar may sometimes be insurmountable. While Enzoand its precursors all arose in the context of claims to DNA, � 112 does not discriminate based on technologies and provides no basis for limiting Enzo’s reach to biotechnology. Patentees whose issued patents in any technological discipline have claims that fail to satisfy Enzo‘s elevated standard have no recourse; those claims are invalid. Meeting this standard may also postpone filing of applications to allow applicants to gather the requisite information. While Lourie’s decisions suggest that he embraces this consequence, waiting to file may be fatal to certain applicants. If a 35 U.S.C. 102(b) statutory bar has been activated by patent issuance, disclosure, public use or placing the invention on sale, � 102(b) could preclude applicants from patenting their inventions if they do not obtain the needed information before the one-year grace period expires. Given these harsh consequences, it would be comforting to point to some valuable policy objective fulfilled by Enzo. However, identifying an underlying policy is challenging. ENABLEMENT AND DEFINITENESS The written-description requirement does not stand alone in � 112 to ensure the adequacy of the patent document. Section 112 also requires that an application enable those familiar with the field of the invention to make and use it. The claims must also specify the subject matter intended to be covered with definiteness. These enablement and definiteness requirements complement the written-description requirement. Each requirement serves an independent goal. As identified earlier, before Enzo, the Federal Circuit’s view was that the written-description requirement demands that the applicant demonstrate possession of the invention ultimately claimed in the original application. Importantly, this “guards against the inventor’s overreaching” by ensuring he or she originally possessed the subject matter to which he or she obtains legal exclusivity. Vas-Cath, 935 F.2d at 1561. The enablement requirement perhaps goes to the heart of the quid pro quo of the patent system’s exchange of exclusivity for disclosure. By demanding disclosure of how to make and use the invention, the enablement requirement ensures that others can enjoy its full benefit after patent expiration. On the other hand, the definiteness requirement benefits others during the term of the patent by “insisting that they receive notice of the scope of the patented device.” Id. Enzo‘s explanations for elevating the written-description requirement express concerns traditionally associated with enablement and definiteness. Enzodeclares “the language of the claim must describe the invention so that one skilled in the art can recognize what is claimed.” 2002 WL 487156, at *6. This is precisely what the definiteness requirement demands. See Miles Laboratories Inc. v. Shandon Inc., 997 F.2d 870, 875 (Fed. Cir. 1993). Further, Enzo‘s statement of the fundamental policy behind the written-description requirement is actually an explanation of the rationale for the definiteness requirement. Enzoasserts, “The written description requirement is the most basic requirement of the patent law — to adequately identify what one has invented.” 2002 WL 487156, at *8. But this is exactly the function served by the claims; the “claims particularly point … out and distinctly claim … the subject matter which the applicant regards as his invention.” 35 U.S.C. 112, � 2. Portions of Enzoalso suggest enablement concerns. Enzofound the broad claims objectionable under the written-description requirement because only three probes were deposited, but this is really a scope of enablement objection. In Amgen v. Chugai Pharmaceutical Co., 927 F.2d 1200, 1213 (Fed. Cir. 1991), Lourie explained that an applicant must “enable one skilled in the art to carry out the invention commensurate with the scope of his claims. For DNA sequences, that means disclosing how to make and use enough sequences to justify grant of the claims sought.” Apart from the rationales for enablement and definiteness, it is difficult to identify an independent justification for Enzo’s invalidation of claims on written-description grounds when it is undisputed that the inventors communicated possession of the invention as of the filing date in the same terms as the issued claims. Enzodoes not propose a new policy for its holding, but, by finding that deposits do not satisfy the written-description requirement, it raises for the first time an intriguing issue about what it means to have a written description. Previous cases explained that written description is not limited to written words but also includes drawings in the specification. See Vas-Cath, 935 F.2d at 1565. Yet, while the reference to a deposit of the three claimed probes in Enzowas perhaps superior evidence of possession, it was a meager written communication. There is special significance to a writing — it is self-contained and immediately conveys information without the need for equipment to manipulate and time to evaluate a physical embodiment. Nevertheless, given that the written-description requirement has been virtually synonymous with a possession requirement and that deposits can be used to show enablement, it is arguable whether the adjective “written” deserves particular force. While this point is open to debate, Enzounquestionably infuses the written-description requirement with greater might to strike down claims. Patent applicants will need to consider its heightened standard in filing applications, particularly in the biotechnology arena. Frank P. Porcelli is a principal, and Charles H. Sanders is an associate, in the Boston office of Fish & Richardson, . Porcelli has taught patent law at Harvard Law School. The authors contributed to an amicus curiae brief for en banc rehearing inEnzo . They may be contacted at [email protected] , and [email protected], respectively.

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