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Few areas of patent law have engendered as much debate and commentary as the written-description requirement, a requirement that weighs disproportionately on biotechnology patents. Judges on the U.S. Court of Appeals for the Federal Circuit, the appellate court for all patent cases, fuel the debate by falling into three groups with divergent views. Therefore, when procuring or evaluating patents for biotech clients, understanding these divergent views may provide guidance, particularly on the future of this crucial issue. Moreover, when arguing a written-description issue in an appeal, knowing the group to which each of the judges on a panel belongs may help shape a winning argument. The level of disclosure required in U.S. patent applications is governed by �112 of the Patent Statute, 35 U.S.C. 112. The first sentence of this section provides: “The specification shall 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.” THREE CATEGORIES Chief Judge Paul R. Michel and judges Haldane Robert Mayer, Alan D. Lourie, Raymond C. Clevenger, Alvin A. Schall and Sharon Prost, the “separatists,” believe that this sentence of �112 sets forth two distinct requirements for patentability. In contrast, the “fusionists,” judges Randall R. Rader, Arthur S. Gajarsa and Richard Linn, believe the section provides just one requirement, while the “clarificationists,” judges Pauline Newman, William C. Bryson and Timothy B. Dyk, simply want the issue clarified. Separatists, and some clarificationists, read this sentence of �112 as requiring the specification of a patent application to set forth both a “written description of the invention” (written description) and a description with enough detail to “enable” a person of skill in the art to practice the invention (enablement). The separatists currently form the majority and have precedent on their side. This precedent mandates separate analyses for determining whether each requirement is satisfied. Hence, it is possible to enable an invention but not describe it, and vice versa. See, e.g., In re DeLione, 436 F.2d 1404, 1405 (CCPA 1971) (a specification that discusses only compound A and does not contain any broadening language might enable one skilled in the art to make and use compounds B and C; yet the genus consisting of A, B and C is not described). Fusionists, on the other hand, interpret this same sentence of �112 to include a single requirement. These judges believe that the words “written description” are used merely to explain how one should provide the enabling disclosure: “The specification shall contain a written description of the invention in such … terms as to enable.” Under this interpretation, if the specification is enabling, the written description is necessarily adequate. See, e.g., Enzo Biochem v. Gen-Probe Inc., 323 F.3d 956, 976 (Fed. Cir. 2003) (Rader, J., dissenting from denial of rehearing en banc). Finally, clarificationists, the third and growing group of judges, believe the Federal Circuit should clarify the proper interpretation of the written-description requirement. SIGNIFICANCE OF ‘LILLY’ The judges’ diverging views became evident, especially for biotech companies, after the 1997 Federal Circuit decision in Regents of the Univ. of Calif. v. Eli Lilly & Co., 119 F.3d 1559 (Fed. Cir. 1997). In Lilly, Newman, Lourie and Bryson held claims directed to cDNAs encoding human insulin together with claims directed to cDNAs encoding mammalian insulin invalid because the specification provided the sequence for rat insulin only. Id. at 1567-68. Thus, even though the specification described procedures that would have enabled someone to obtain the cDNA for human insulin, there was no written description of that actual cDNA. As such, the court held the claims to cDNAs for human and mammalian insulin invalid for failure to meet the written-description requirement. While separatists believe Lilly is consistent with earlier cases, fusionists disagree. In particular, fusionists point out that all of the earlier cases dealt with priority issues, i.e., when a party seeks to rely on an earlier-filed application that may not include all of the disclosure found in a later-filed application. See 35 U.S.C. 120. In these earlier cases, the court decided whether the earlier-filed application set forth a “written description” of the invention subsequently claimed in the later-filed application. Because patent priority was not at issue in Lilly, commentators criticize it for expanding written description beyond the original scope. Enzo, 323 F.3d at 979-81 (Rader, J., dissenting from the denial of rehearing en banc). THE PRIORITY DISTINCTION Fusionists argue that this priority distinction is crucial because the separate written-description requirement is designed to prevent a patentee from later claiming that which he had not invented when he filed the earlier application. See, e.g. Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555,1561 (Fed. Cir. 1991). Indeed, Linn maintains that this function of the separate written-description requirement is irrelevant when priority is not at issue because “the claim itself evidence(s) possession of the invention as of the filing date.” Enzo, 323 F.3d at 988 (Linn, J., dissenting from denial of rehearing en banc). Moreover, fusionists argue that, in a priority context, the separate written-description requirement is indistinguishable from the prohibition against new matter in 35 U.S.C. 132. Rader notes that rejection of a claim under �132 “is equivalent to a rejection under �112, first paragraph.” Id. at 978, quoting In re Rasmussen, 650 F.2d 1212, 1214 (CCPA 1981). Hence, fusionists conclude that a separate written-description requirement is of little practical consequence so long as it applies only in priority cases. Enzo, 323 F.3d at 977-79. Based on this logic, application of a written-description requirement when priority is not at issue adds an additional patentability requirement and hence raises the bar for patentability. Thus, the fusionists contend that, under current precedent, biotech patents, which often involve subject matter that is difficult to describe, are more susceptible to validity challenges. Id. at 983. At least Bryson disagrees with this logic. For example, in defense of Lilly, Bryson argues that “it is difficult to find a principled basis for restricting [the separate written-description] requirement to cases involving priority disputes … [because] there is no language in Section 112 that would support such a restriction.” See Moba B.V. v. Diamond Automation Inc., 325 F.3d 1306, 1327-28 (Fed. Cir.), cert. denied, 124 S. Ct. 464 (2003) (Bryson, J., concurring). Yet, although he disagrees with the priority distinction, Bryson also has commented that precedent may incorrectly interpret �112. Id. Thus, with his recent vote in favor of en banc resolution of written description, Bryson became a clarificationist. See University of Rochester v. G.D. Searle & Co., 358 F.3d 916 (Fed. Cir.), reh’g en banc denied, 375 F.3d 1303 (Fed. Cir. 2004), cert. denied, 73 U.S.L.W. 3247 (U.S. Nov. 29, 2004). Another clarificationist, Newman, vigorously defends the separate written-description requirement. In her view, the public purpose of patents would be “seriously disserved by eliminating the description requirement entirely.” 375 F.3d at 1307 (Newman, J., dissenting). Newman believes that critics of Lilly mischaracterize that decision. Thus, she argues for en banc resolution of written description because the court has “promoted [this analysis] from simple semantics into a fundamental conflict concerning patent scope and the support needed to claim biological products.” Id. POSSIBLE EN BANC RESOLUTION Although the fusionists have twice voted in favor of taking a written-description case en banc, see Enzo, 323 F.3d at 970, and Rochester, 375 F.3d at 1307, n.1, they alone cannot provoke an en banc hearing of a written-description appeal. Still, there has been a recent shift toward en banc resolution. Specifically, Newman and Bryson, who voted against en banc resolution in Enzo, voted for en banc resolution two years later in Rochester. See id; Enzo, 323 F.3d at 970. Thus, the fusionists and clarificationists would both take the right biotech written-description case en banc, but for different reasons. Significantly, Dyk, also a clarificationist, ultimately may hold a pivotal vote. He agrees with Newman that “it is clear that the statute contains” a written-description requirement. Rochester, 375 F.3d at 1307 (Dyk, J., concurring). However, he does not endorse the court’s precedent, believing that the court has yet to articulate a satisfactory standard for written description that would be applicable to all technologies. Id. Currently, though, Dyk is not in favor of en banc review because he believes that the court will benefit from further percolation. Id; see also Enzo, 323 F.3d at 976 (Dyk, J., concurring in denial of rehearing en banc). Hence, combining fusionists with clarificationists currently yields five judges favoring en banc review of written description, with Dyk as a potential sixth. Although this growing number indicates the court’s awareness of the confusion caused by its divergent positions, it does not indicate that the written-description requirement is likely to change significantly. Separatists currently hold the majority, and although Newman and Dyk are clarificationists, they nevertheless believe that written description is distinct from enablement. See Rochester, 375 F.3d at 1304, 1327. None of the other separatist judges has yet voted in favor of addressing written description en banc, and only Lourie has written opinions concurring in the denials of rehearing en banc in Enzo and Rochester. Lourie embraces the view that �112 plainly requires satisfaction of both written-description and enablement requirements for patentability. Rochester, 375 F.3d at 1305 (Lourie, J., concurring); Enzo, 323 F.3d at 971 (Lourie, J., concurring in denial of rehearing en banc). Indeed, Lourie argues that it “is basic patent law, the quid pro quo for the grant of a patent,” that each patent specification must set forth a written description of an invention in addition to an enabling description. Id. Like Bryson, Lourie maintains that there is no language in �112 restricting the written-description requirement to priority cases. Rochester, 375 F.3d at 1305 (Lourie, J., concurring). Further, in contrast to Rader, Lourie does not believe that all written-description issues can be adequately resolved under the new-matter doctrine in 35 U.S.C. 132. Id. Indeed, Lourie argues that �132 is neither a substitute nor an equivalent of the written-description requirement under �112. Id. Lourie disagrees with Linn that original claims are enough to satisfy written description. For example, if an original claim is to a genus, the specification might not describe a representative number and variety of species within that claimed genus. Thus, although the genus claim is part of the original disclosure, the written-description requirement would not be satisfied. See e.g., “Guidelines for Examination of Patent Applications Under the 35 U.S.C. �112, 1 ‘Written Description’ Requirement,” 66 Fed. Reg. 1099 (Jan. 5, 2001). Hence, Lourie argues that the court has “evolved a consistent body of law over a number of years, based on [�112] and basic principles of patent law. … [And there is] no reason to … rewrite the statute.” Enzo, 323 F.3d at 975 (Lourie, J., concurring in denial of rehearing en banc). While proponents of addressing the written-description requirement en banc currently lack a majority, after further percolation of the issue, a majority of Federal Circuit judges may join the call for en banc resolution. Until then, however, when faced with a written-description question in a biotechnology case, practitioners should be aware of the various views of Federal Circuit judges. If priority is an issue, a patent may be challenged for lack of written description under either �112 or �132. If priority is not an issue, the patentee may be able to provoke en banc consideration by arguing, as do the fusionists, that Lilly, Enzo, Rochester and their progeny are inapplicable as applying an improper interpretation of �112. See Enzo, 323 F.3d at 983 (Rader, J., dissenting from denial of rehearing en banc). Meredith Martin Addy and Jeffery M. Duncan are shareholders, and C. Noel Kaman is an associate, in the biotech practice group at Chicago-based Brinks Hofer Gilson & Lione. Addy, a former law clerk to Chief Judge Paul R. Michel of the Federal Circuit, concentrates on appellate practice and can be reached at [email protected]. Duncan, the chairman of the biotech practice group, focuses on counseling and patent prosecution and can be reached at [email protected]. Kaman’s practice focuses on biotech litigation and patent prosecution. She can be reached at [email protected].

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