By Kevin E. Noonan --
Today the Federal Circuit reversed a priority determination in an interference over claims to human beta-interferon, in an opinion teeming with irony, déjà vu, anachronism, and the peculiar effects on outcome caused by the form of interference counts.
Two interferences, Nos. 105,334 and 105,337 between Junior Party David Goeddel and Robert Crea and Senior Party Haruo Sugano, Masami Muramatsu, and Tadatsigi Tanaguchi, were directed towards claims to isolated human DNA encoding beta-interferon (also termed "human fibroblast interferon" or hFIF in the opinion) as well as the isolated interferon protein itself. The "DNA Interference" was declared between Goeddel patent application No. 07/374,311 and Sugano patent Nos. 5,326,859 and 5,514,567 and contained one count:
A DNA encoding a mature human fibroblast interferon having a total of 166 amino acids of the sequence
Met Ser Tyr Asn Leu Leu Gly Phe Leu Gln Arg Ser Ser Asn Phe Gln Cys Gln Lys Leu Leu Trp Gln Leu Asn Gly Arg Leu Glu Tyr Cys Leu Lys Asp Arg Met Asn Phe Asp Ile Pro Glu Glu Ile Lys Gln Leu Gln Gln Phe Gln Lys Glu Asp Ala Ala Leu Thr Ile Tyr Glu Met Leu Gln Asn Ile Phe Ala Ile Phe Arg Gln Asp Ser Ser Ser Thr Gly Trp Asn Glu Thr Ile Val Glu Asn Leu Leu Ala Asn Val Tyr His Gln Ile Asn His Leu Lys Thr Val Leu Glu Glu Lys Leu Glu Lys Glu Asp Phe Thr Arg Gly Lys Leu Met Ser Ser Leu His Leu Lys Arg Tyr Tyr Gly Arg Ile Leu His Tyr Leu Lys Ala Lys Glu Tyr Ser His Cys Ala Trp Thr Ile Val Arg Val Glu Ile Leu Arg Asn Phe Tyr Phe Ile Asn Arg Leu Thr Gly Tyr Leu Arg Asn
and unaccompanied by a human fibroblast interferon presequence.
The "Protein Interference" was declared between Sugano's application No. 08/463,757 and Goeddel's patent No. 5,460,811. The sole count of the "Protein Interference" is:
A composition comprising water and a nonglycosylated mature human fibroblast interferon polypeptide having a total of 166 amino acids and the following amino acid sequence
Met Ser Tyr Asn Leu Leu Gly Phe Leu Gln Arg Ser Ser Asn Phe Gln Cys Gln Lys Leu Leu Trp Gln Leu Asn Gly Arg Leu Glu Tyr Cys Leu Lys Asp Arg Met Asn Phe Asp Ile Pro Glu Glu Ile Lys Gln Leu Gln Gln Phe Gln Lys Glu Asp Ala Ala Leu Thr Ile Tyr Glu Met Leu Gln Asn Ile Phe Ala Ile Phe Arg Gln Asp Ser Ser Ser Thr Gly Trp Asn Glu Thr Ile Val Glu Asn Leu Leu Ala Asn Val Tyr His Gln Ile Asn His Leu Lys Thr Val Leu Glu Glu Lys Leu Glu Lys Glu Asp Phe Thr Arg Gly Lys Leu Met Ser Ser Leu His Leu Lys Arg Tyr Tyr Gly Arg Ile Leu His Tyr Leu Lys Ala Lys Glu Tyr Ser His Cys Ala Trp Thr Ile Val Arg Val Glu Ile Leu Arg Asn Phe Tyr Phe Ile Asn Arg Leu Thr Gly Tyr Leu Arg Asn
said composition being free of any glycosylated human fibroblast interferon.
In each interference, Junior Party Goeddel was given the benefit of priority to U.S. patent application Serial No. 06/190,799, filed September 25, 1980. Senior Party Sugano was given priority to a Japanese application, No. 33931/80, filed March 19, 1980. The Board of Patent Appeals and Interferences decided the priority question in favor of Sugano in each interference, based on its determination that the Japanese application constituted a constructive reduction to practice of an invention within the scope of each interference count.
On appeal, Goeddel argued that Sugano's Japanese priority application did not satisfy the enablement or written description requirements of 35 U.S.C. § 112, first paragraph; interference practice permits a party to rely on a prior, foreign filed application only if that application satisfies the requirement of § 112, first paragraph (Hyatt v. Boone, 146 F.3d 1348, 1351 (Fed. Cir. 1998)). The basis of Goeddel's argument is that both counts were directed to nucleic acids encoding or an isolated protein having the amino acid sequence of the "mature" (active) form of human beta-interferon. The mature form has the 166 amino acid sequence set forth in each of the interference counts, but beta-interferon DNA encodes a 187 amino acid (inactive) form that is produced in human cells and then specifically cleaved to produce the mature, active, 166 amino acid form (i.e., the first 21 amino acids of the immature form are removed from the protein to produce the mature form). The Sugano priority Japanese application disclosed this immature, 187 amino acid form (both the nucleic acid and protein) but did not disclose the mature, 166 amino acid form. Instead, the application referenced a scientific publication by Knight, entitled "Human Fibroblast Interferon: Amino Acid Sequence Analysis and Amino Terminal Amino Acid Sequence," which disclosed amino terminal protein sequencing that identified the first 13 amino acids of the mature form. The Sugano Japanese priority application disclosed production of human beta-interferon in bacteria, which do not specifically cleave the immature, 187 amino acid form into the mature, 166 amino acid form, and also does not disclose either the mature form nor the specific cleavage site that could be used to produce the mature form of human beta-interferon. (As quoted in the Federal Circuit's opinion, the Board found that "[t]he sequences of mature hFIF DNA or polypeptide are not explicitly disclosed.") Because of these deficiencies, Goeddel argued that Sugano's Japanese priority application did not satisfy the requirements of 35 U.S.C. § 112, first paragraph, was not a competent priority document, did not provide Sugano with an earlier priority date for either of the interference counts and thus that Goeddel should be awarded priority in both interferences.
The Board found (correctly, Sugano argued on appeal) that its disclosure in the Japanese priority application satisfied the enablement and written description requirements. For enablement, Sugano argued that the determination of whether a priority document satisfied the statutory requirements must take into consideration the knowledge of the person of ordinary skill in the art. ("[P]atent applications are 'written for a person of skill in the art, and such a person comes to the patent with the knowledge of what has come before,' [argued Sugano], and thus 'it is unnecessary to spell out every detail of the invention in the specification,'" citing Lizard Tech, Inc. v. Earth). Supplementing the express disclosure of the Japanese priority application with the knowledge from the art, including the disclosure of the Knight reference, would have been sufficient to enable the skilled worker to produce the mature form of beta-interferon, according to Sugano. The Board relied on testimony from a Goeddel expert, to the effect that "no new technology" would have been required for the skilled worker to produce the mature form in view of the disclosure of the Japanese priority application disclosing the immature, 187 amino acid form and the identification in the Knight reference of the "line of demarcation" between the 21 amino-terminal presequence and the amino terminus of the mature, 166 amino acid form. Regarding the written description requirement, the Board found, and Sugano argued, that the combination of the complete 187 amino acid immature sequence expressly disclosed in the Japanese priority application, and the disclosure by Knight of the amino terminal amino acids of the mature, 166 amino acid form of beta-interferon would permit the skilled worker to "envision" the mature form and thus satisfy the written description requirement. The Board stated that "although not explicitly described in the Japanese Application, 'the amino acid of, and DNA sequence encoding, mature hFIF would be readily apparent,'" and that "a person of skill in the field of the invention, reading the Japanese Application, would conclude that Sugano was in possession of the invention of the interference counts" (despite an admission by Sugano's expert that the Japanese priority application "does not state where the presequence ends and where the mature hFIF sequence begins").
The Federal Circuit disagreed with the Board and Sugano, in an opinion written by Judge Newman and joined by Judge Lourie and Judge Bryson. The Court rejected the standard that an application merely enable the skilled worker to "envision" the claimed invention to satisfy the requirement for constructive reduction to practice in an interference proceeding. "[C]onstructive reduction to practice 'is "not a question of whether one skilled in the art might be able to construct the patentee's device from the teachings of the disclosure. . . . Rather, it is a question whether the application necessarily discloses that particular device," according to the Federal Circuit opinion, citing Purdue Pharma L.P. v. Faulding Inc., 230 F.3d 1320, 1326-27 (Fed. Cir. 2000) (quoting Jepson v. Coleman, 314 F.2d 533, 536 (CCPA 1963). "[I]n the context of interference priority, [Section 112] requires that the subject matter of the counts be described sufficiently to show that the applicant was in possession of the invention," said the Court, which in this case meant possession of the 166 amino acid, mature and active form of beta-interferon.
That a modified gene encoding the 166 amino acid protein could have been "envisioned" does not establish constructive reduction to practice of the modified gene. The question is not whether one skilled in this field of science might have been able to produce mature hFIF by building upon the teachings of the Japanese Application, but rather whether that application "convey[ed] to those skilled in the art that the inventor had possession of the claimed subject matter as of the filing date." Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en banc) . . . The Japanese application does not describe a bacterial expression vector that directly produces the mature hFIF, nor does it suggest producing a modified gene to directly encode the 166 amino acid mature hFIF.
And thus, the Board erred in granting priority to Party Sugano, the Federal Circuit concluded. Sugano's attempts to support its claims with reference to the Court's decisions in Enzo Biochem, Inc. v. Gen-Probe Inc., 323 F.3d 956, 968 (Fed. Cir. 2002), and University of Rochester v. G.D. Searle & Co., 358 F.3d 916, 923 (Fed. Cir. 2004), were similarly unavailing, the Court stating that "these cases do not hold that envisioning an invention not yet made is a constructive reduction to practice of that invention." The panel aded that "[p]recedent in evolving science is attuned to the state of the science, but remains bound by the requirement of showing 'that the inventor actually invented the invention claimed,'" citing Bradford Co. v. Conteyor North Am., Inc., 603 F.3d 1262, 1269 (Fed. Cir. 2010), and Fiers v. Revel, 984 F.2d 1164, 1170 (Fed. Cir. 1993).
Hence the irony, since "Fiers v. Revel" is the caption of an interference decision that is more properly styled "Fiers v. Revel v. Sugano," also involving an interference between Sugano and different parties almost twenty years ago. The Fiers v. Revel case is arguably the first case in the line of written description jurisprudence that goes through University of California v. Eli Lilly, Enzo Biochem., Rochester, and Ariad. Sugano prevailed in that interference, precisely because its priority document contained the nucleotide sequence of human beta-interferon where the other two parties' applications did not. Perhaps fittingly. Sugano lost this interference because its priority application could not satisfy the standards that its earlier interference helped to establish.
Goeddel v. Sugano (Fed. Cir. 2010)
Panel: Circuit Judges Newman, Lourie, and Bryson
Opinion by Circuit Judge Newman
Image of beta-interferon (above) by AJC1, from flickr under the Creative Commons license.
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