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In its most recent treatments of the first paragraph of 35U.S.C. 112, the U.S. Court of Appeals for the Federal Circuit has edged awayfrom the heightened written description requirement for biotechnology patentsarticulated in Regents of the Univ. of Calif. v. Eli Lilly & Co.,119 F.3d 1559 (Fed. Cir. 1997). This process has revealed dissenting opinionsamong the Federal Circuit judges, which may only be resolved by en banc reviewof the written description requirement as a whole. As a result, the standardfor satisfying the written description requirement remains elusive, leavingpractitioners struggling to determine the level of written description thatwill be deemed “adequate” to support biotechnology patent claims. The first paragraph of 35 U.S.C. 112 provides: “Thespecification shall contain a written description of the invention, and of themanner and process of making and using it, in such full, clear, concise, andexact terms as to enable any person skilled in the art to which it pertains, orwith which it is most nearly connected, to make and use the same, and shall setforth the best mode contemplated by the inventor of carrying out hisinvention.” In Lilly, the Federal Circuit invalidatedclaims to human and vertebrate insulin-encoding DNAs for lack of adequatewritten description under 35 U.S.C. 112, even though the patent’s specificationdescribed the related rat DNA sequence and methods for obtaining the human DNAsequence. The court held that a claim to a DNA will not meet the writtendescription requirement absent a description of the DNA’s structural or physicalcharacteristics, as would be accomplished by a recitation of its nucleotidesequence. 119 F.3d at 1566-67. The Lilly rule has been criticizedas establishing a uniquely rigorous, technology-specific written descriptionrequirement for inventions related to new genes and, indeed, to biotechnologypatents generally. The Federal Circuit appeared to reach high tide on the Lillyrule in Enzo Biochem Inc. v. Gen-Probe Inc., 285 F.3d 1013 (Fed.Cir. 2002) ( Enzo I). There the court held that a biological depositof nucleic acid probes having a known functionality, but whose sequences werenot disclosed, may not satisfy the written description requirement for claimsdirected to the deposited probes. The tide began to turn in Enzo Biochem Inc. v.Gen-Probe Inc., 296 F.3d 1316 (Fed. Cir. 2002) ( Enzo II),when the same three-judge panel that decided Enzo I vacated itsearlier decision and specifically acknowledged that not all functionaldescriptions of genetic material necessarily fail to satisfy the written descriptionrequirement. Id. at 1324. The court remanded the case to the district court forfurther consideration consistent with its revised opinion. Of significance to patent practitioners, the court’sdecision in Enzo II was based in part on deference to theGuidelines for Examination of Patent Applications Under the 35 U.S.C. 112, � 1″Written Description” Requirement (66 Fed. Reg. 1099 (Jan. 5, 2001)),in which the U.S. Patent and Trademark Office (PTO) has determined that awritten description requirement can be met by disclosing functionalcharacteristics when coupled with a known or disclosed correlation betweenfunction and structure. Concurrently with its revised decision in Enzo II,the Federal Circuit denied Enzo’s petition for rehearing en banc of EnzoI. 42 Fed. Appx. 439 (Fed. Cir. 2002). Judges Alan D. Lourie andPauline Newman concurred in the denial, defending a robust written descriptionrequirement. In a dissent joined by Judges Richard Linn and Arthur J. Gajarsa,Judge Randall R. Rader asserted that, outside the context of resolvingpriority, there is no statute or precedent supporting a heightened writtendescription requirement. Though agreeing that en banc review was not warrantedin the case at bar, Judge Timothy B. Dyk in his concurrence recognized thatquestions raised in the Rader dissent regarding Lilly mightmerit future en banc review. In the biotechnology field, Amgen Inc. v. HoechstMarion Roussel Inc., 314 F.3d 1313 (Fed. Cir. 2003), marked a furtherdeparture by the Federal Circuit from rigorous application of the Lillyrule. The claims at issue in Amgen were directed to expression ofexogenous erythropoietin (EPO) — a hormonal substance that stimulates red bloodcell formation — in vertebrate and mammalian cells, but the specificationdisclosed methods of producing EPO only in hamster and monkey cells. Thedefendants in Amgen relied upon Lilly and EnzoII to support their position that Amgen’s patents lacked adequatewritten description for the generic claims covering vertebrate and mammalianEPO-producing cells. However, the court emphatically found both Lilly and Enzo II inapposite to the case at bar “because the claimterms at issue here are not new or unknown biological materials that ordinarilyskilled artisans would easily miscomprehend” but instead “refer totypes of cells that can be used to produce recombinant human EPO.” Id. at1332. The court thus distinguished Lilly, notingthat, in contrast to the relative lack of description of an actual DNA sequenceby the term “cDNA,” the words “mammalian cells” and”vertebrate cells” “readily ‘convey distinguishing informationconcerning [their] identity’ such that one of ordinary skill in the art could’visualize or recognize the identity of those members of the genus.’” Id.(quoting Lilly, 119 F.3d at 1567, 1568). Accordingly, the courtaffirmed the finding that the specification’s description of producing theclaimed EPO in two species of vertebrate and mammalian cells adequatelysupported claims covering EPO made using the entire genus of vertebrate ormammalian cells. Id. ‘MOBA’ POINTS TO EN BANC REVIEW The Federal Circuit most recently opted to review itswritten description jurisprudence in a case involving mechanical arts. MobaB.V. v. Diamond Automation Inc., 325 F.3d 1306 (Fed. Cir. 2003).Although the written description challenge in Moba concernedautomated egg-processing equipment, the court applied a Lillyanalysis, with possible consequences for biotech patents. Moba challenged thewritten description for failure to describe adequately a claimed mechanism forlifting eggs. Id. at 1319. The court noted that Federal Circuit case law reflects twoapplications of 35 U.S.C. 112, � 1. The first relates to policing priority,that is, preventing the addition of new matter to claims. 325 F.3d at 1319. Thecourt observed that use of the written description requirement of � 112 toassess new matter has been viewed as synonymous with proscription of new matterunder 35 U.S.C. 132. Id. Reiterating Amgen‘s discussion, thecourt stated that the written description requirement serves to preventapplicants from later claiming subject matter not within the scope of theiroriginal disclosures. Thus, written description serves to measure whether aclaim should be accorded an earlier priority date. Id. The court then turned to the second application of 35U.S.C. 112, � 1, that was reflected in the Lilly decision, wherethe written description requirement was invoked in a case without priorityissues. Moba, 325 F.3d at 1320. According to the court,compliance with 35 U.S.C. 112, � 1, has always required sufficient informationin the original disclosure to convince an ordinarily skilled artisan that the inventorpossessed the invention at the time of filing. The court distinguished the holdingsin Enzo II and Amgen from Lilly inthat the specifications in Enzo II and Amgen notonly enabled a skilled artisan to make and use the invention, but alsoconvinced that artisan the inventors had possession of the claimed invention.The court resolved the Moba case on the same basis, holding thatno particular form of disclosure was required under the Lillyrule because possession by the inventors, at the time of filing, would havebeen apparent to the skilled artisan. RADER CRITICIZES ‘LILLY’ In his concurrence in Moba, Rader took theopportunity to criticize sharply the Lilly holding. He assertedthat Lilly contravened established statutory interpretation andpublic policy by extending the writtendescription requirement beyond its rolein policing priority. 325 F.3d at 1322. According to Rader, a patent disclosurepossesses adequate written description under 35 U.S.C. 112, � 1, if it enablesskilled artisans to make and use the invention. Under this interpretation,enabling disclosures necessarily show that the inventor was in possession ofthe invention. Thus, Rader ascribed the source of the “mischief”created by Lilly to a failure to recognize that the modernwritten description requirement evolved in the context of priority disputes(i.e., prohibition of new matter). Rader contended that, outside of thiscontext, the writtendescription requirement is illogical because � 112 alreadyprovides the enablement requirement to determine the adequacy ofspecifications. Id. The Lilly rule, in Rader’s view, constitutesa new doctrine that has no basis in the patent statutes, stands on no precedentand, thus far, has been applied solely to biotechnology cases. Id. at 1324-25.Rader commented that the Lilly rule is difficult to distinguishfrom the enablement requirement and deemed it, in essence, abiotechnology-specific “super-enablement requirement.” Id. In Rader’sview, the harm done by the Lilly rule to the biotechnologyindustry is manifold. The validity of many issued biotechnology patents is atrisk for “serious and unavoidable” challenges. Id. at 1325. Forcurrent applications, the problem may be worse because, “[e]ven if adrafter of biotechnology patents now knows the new law, compliance may tax adrafter beyond reasonable limits.” Id. For example, adequate disclosureof a claimed protein would require disclosure of potentially thousands ofsequences to satisfy the Lilly rule due to conservativesubstitutions of amino acids in the protein sequence. Id. Rader likened the Lilly rule forbiotechnology to a rule for new software patents requiring “the entiresource code, symbol by symbol, including all source code permutations thatwould not alter the function.” Id. at 1325. Such a rule was flatlyrejected in the context of enablement for a software patent. See id. (citing N.Telecom Inc. v. Datapoint Corp., 908 F.2d 931, 941-2 (Fed. Cir. 1990)). Rader noted that the Federal Circuit”fortunately” is retreating from the Lilly rule.However, he urged en banc correction rather than continuation of what he characterizedas a mistake that burdens courts, confuses juries, “complicates biotechnologypatent drafting to the point of near impossibility,” and prices some noncorporateinventors out of biotechnology invention markets. Id. at 1326-27. In his concurrence, Judge William C. Bryson addressedRader’s opinion with a query as to whether any fundamental flaw with thewritten description requirement as perceived by Rader lies not with the Lillyrule itself but with an erroneous underlying statutory interpretation thatcalls for a written description requirement separate from the enablementrequirement. Id. at 1327-28. Bryson concluded that the appropriateness, or lackthereof, of a separate written description requirement would be suitable for enbanc review. Id. at 1328. Thus, viability of the Lilly rule, andperhaps of the separate written description requirement altogether, is cominginto question. The opinions in Enzo II, Amgen andnow Moba suggest that the Federal Circuit may consider en bancreview of the written description requirement of � 112 in an appropriate case. HOW THE VOTES MAY GO A rigorous written description requirement as applied in EliLilly would likely be defended by Lourie and Newman in view of the Lillyand Enzo opinions. In contrast, Rader appears to favorlimitation of the written description requirement to the priority context.Gajarsa also may favor limited application of the written descriptionrequirement given his agreement with Rader’s and Linn’s dissents in thedecision on Enzo’s petition for rehearing en banc. Linn, who joined Rader’sopinion and also wrote his own dissent in the denial of en banc review of EnzoI, characterized the issue as ripe for en banc review. Although Dykconcurred in denial of Enzo’s petition for rehearing en banc, he apparentlywould favor en banc review of the written description requirement in the properappellate case. Though en banc review of the written descriptionrequirement seems timely, the disparate perspectives of the Federal Circuitjudges make the outcome difficult to predict. It is uncertain whether a majoroverhaul of statutory interpretation is in the works, or whether the current interpretationwill remain substantially intact. The patent bar and the biotechnology industrywill no doubt eagerly await resolution of the current ambiguity, accompanied,it is to be hoped, by pronouncement of a clear standard for writtendescription to be applied by the PTO during patent prosecution and by thecourts in patent litigation. In the meantime, practitioners should expect the courts tolook upon validity challenges based on the written description requirement withgreater scrutiny and less favor than they have in recent years. Accordingly,parties seeking to invalidate patents would be advised to use caution inasserting challenges on the basis of written description. Likewise, patenteesmay now find a greater sense of security in the validity of their patentclaims, knowing that the Lilly rule appears to be on the waneand, if nothing else, is certainly open to interpretation. Janet E. Reed, Felicity E. Groth and Scott E. Scioli arepartner, associate and patent agent, respectively, and members of thebiotechnology-patent practice group of Philadelphia’s Woodcock Washburn. (www.woodcock.com) If you are interested in submitting an article to law.com, please click here for our submission guidelines.

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