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In recent years, cases such as Enzo Biochem, Inc. v. Gen-Probe, Inc., 323 F.3d 956 (Fed. Cir. 2002) ('Enzo') and University of Rochester v. G.D. Searle and Co., Inc., 375 F.3d 1303 (Fed. Cir. 2004) ('Rochester') have fueled an ongoing debate over whether the first paragraph of 35 U.S.C. '112 includes a written description requirement, separate and distinct from enablement and best mode. According to Judge Randall Ray Rader, Univ. of Cal. v. Eli Lilly & Co., 119 F.3d 1559 (Fed. Cir. 1997) ('Eli Lilly') brought the written description requirement squarely to light. Rochester, 375 F.3d at 1307 (Circuit Judge Rader dissenting). This 'new' requirement creates 'enormous confusion,' not only for the courts, but also for patent drafters. Id. Because the requirement is in flux, patent practitioners should avoid overlooking the requirement or taking it too lightly.
In Rochester, a sharply divided Federal Circuit declined to rehear the district court's decision that invalidated a patent previously held by the University for failing to meet the separate written description requirement. Judge Alan David Lourie, in his concurring opinion, wrote that 'there is and always has been a separate written description requirement in the patent law.' Id. at 1305. Both Judges Richard Linn and Rader disagreed. First, '[r]eading into paragraph 1 of section 112 an independent written description requirement, divorced from enablement, sets up an inevitable clash between the claims and the written description as the focus of the scope of coverage. This is ill-advised.' Id. at 1307. Second, the Federal Circuit's issuance, withdrawal and re-issuance of the decision in the Enzo case indicated that a controversy existed over whether the written description requirement, as a separate and distinct requirement, is indeed valid. In Enzo, the Federal Circuit initially held that 'a deposit is not a substitute for a written description of the claimed invention.' Id. at 1308 (citation omitted). In so holding, the Federal Circuit applied the recently adopted requirement from Eli Lilly that a biotechnological invention must include a nucleotide-by-nucleotide recitation of its structure. Accordingly, the Enzo court invalidated the claims to a polypeptide detector, even though the patent described the polypeptides and three samples of the specifically claimed material were deposited at the American Type Culture Collection. Rochester, 375 F.3d at 1308. The Federal Circuit hastened to withdraw the initial Enzo decision following a firestorm of controversy and reversed the result. Id.
Despite the majority's decision not to rehear the Rochester case en banc, it still called for the confusion surrounding the written description requirement to be settled. Judge Timothy B. Dyk, in a concurring opinion, stated, 'In my view we have yet to articulate satisfactory standards that can be applied to all technologies.' Id. at 1308. Judge Pauline Newman, in her dissent, stated, 'This question has percolated enough; it is ripe for en banc resolution.' Id. at 1307. Whether the Federal Circuit will continue to invalidate patents for failing to comply with the separate written description requirement, revert to a more traditional role 'to prevent applicants from adding new inventions to an older disclosure,' or even limit the scope of the requirement to fields such as biotechnology, the lesson for the practitioner becomes one of exhibiting an abundance of caution in complying with the written description requirement.
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