Enzo Biochem, Inc. v. Gen-Probe Inc.

285 F.3d 1013, 2002 WL 487156
CourtCourt of Appeals for the Federal Circuit
DecidedApril 2, 2002
DocketNo. 01-1230
StatusPublished
Cited by21 cases

This text of 285 F.3d 1013 (Enzo Biochem, Inc. v. Gen-Probe Inc.) is published on Counsel Stack Legal Research, covering Court of Appeals for the Federal Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Enzo Biochem, Inc. v. Gen-Probe Inc., 285 F.3d 1013, 2002 WL 487156 (Fed. Cir. 2002).

Opinions

Opinion for the court filed by LOURIE, Circuit Judge. Dissenting opinion filed by Circuit Judge DYK.

LOURIE, Circuit Judge.

Enzo Biochem, Inc. appeals from the decision of the United States District Court for the Southern District of New York granting Gen-Probe Incorporated, Chugai Pharma U.S.A., Inc., Chugai Pharmaceutical Co., Ltd., Biomerieux, Inc., Biomerieux SA, and Becton Dickinson and Company’s (collectively, “the defendants”) motion for summary judgment that claims 1-6 of U.S. Patent 4,900,659 are invalid for failure to meet the written description requirement of 35 U.S.C. § 112, ¶ 1. Enzo Biochem, Inc. v. Gen-Probe Inc., No. 99 Civ. 4548 (S.D.N.Y. Apr. 4, 2001) (final order). Because the district court did not err in its conclusion that there were no genuine issues of material fact and that the defendants were entitled to judgment as a matter of law, we affirm.

BACKGROUND

Enzo is the assignee of the '659 patent, which is directed to nucleic acid probes that selectively hybridize to the genetic material of the bacteria that cause gonorrhea, Neisseria gonorrhoeae. N. gonor-rhoeae reportedly has between eighty and ninety-three percent homology with Neisseria meningitidis. '659 patent, col. 2,11. 61-64. Such a high degree of homology has made detection of N. gonorrhoeae difficult, as any probe capable of detecting N. gonorrhoeae may also show a positive result when only N. meningitidis is present. Enzo recognized the need for a chromosomal DNA probe specific for N. gonor-[1016]*1016rhoeae, and it derived three such probes that preferentially hybridized to six common strains of N. gonorrhoeae over six common strains of N. meningitidis. Id. at col. 3, 1. 49 to col. 4, 1. 14; col. 4, 11. 45-50. The inventors believed that if the preferential hybridization ratio of N. gonor-rhoeae to N. meningitidis were greater than about five to one, then the “discrete nucleotide sequence will hybridize to virtually all strains of Neisseria gonorrhoeae and to no strain of Neisseria meningitid-is.” Id. at col. 12, 11. 60-65. The three probes that the inventors actually derived had a selective hybridization ratio of greater than fifty. Id. at col. 13,11. 9-15. Enzo deposited those probes in the form of a recombinant DNA molecule within an E. coli bacterial host at the American Type Culture Collection. Id. at col. 13,11. 27-31.

Claim 1, in relevant part, is as follows:

1. A composition of matter that is specific for Neisseria gonorrhoeae comprising at least one nucleotide sequence for which the ratio of the amount of said sequence which hybridizes to chromosomal DNA of Neisseria gonorrhoeae to the amount of said sequence which hybridizes to chromosomal DNA of Neisseria meningitidis is greater than about five, said ratio being obtained by a method comprising the following [sic] steps;

Id. at col. 27, 11. 29-36 (emphasis added). The method steps that follow are directed to obtaining the claimed ratio. Id. at col. 27, 1. 37 to col. 28, 1. 26. Claim 4 is directed to the deposited probes (referenced by their accession numbers) and variations thereof as follows:

4. The composition of claim 1 wherein said nucleotide sequences are selected from the group consisting of:
a.the Neisseria gonorroheae [sic] DNA insert of ATCC 53409, ATCC 53410 and ATCC 53411, and discrete nucleotide subsequences thereof,
b. mutated discrete nucleotide sequences of any of the foregoing inserts that are within said hybridization ratio and subsequences thereof; and
c. mixtures thereof.

Id. at col. 28,11. 31-39. Claim 6 is directed to a method of conducting a hybridization assay with the deposited probes and variations thereof. Id. at col. 28, 11. 47-56.

Enzo sued the defendants for infringement of the '659 patent, and the defendants moved for summary judgment that the claims were invalid for failure to meet the written description requirement of 35 U.S.C. § 112, ¶ 1. The district court, in oral remarks from the bench, granted that motion. Tr. of Hr’g at 42, Enzo Biochem, Inc. v. Gen-Probe, Inc., No. 99-CV-4548 (S.D.N.Y. Jan. 24, 2001) (“Enzo Hearing”). It concluded that the claimed composition of matter was defined only by its biological activity or function, viz., the ability to hybridize to N. gonorrhoeae in a ratio of better than about five with respect to N. meningitidis, which was insufficient to satisfy the § 112, ¶ 1 requirement set forth in this court’s holdings in Regents of the University of California v. Eli Lilly & Co., 119 F.3d 1559, 43 USPQ2d 1398 (Fed.Cir.1997), Fiers v. Revel, 984 F.2d 1164, 25 USPQ2d 1601 (Fed.Cir.1993), and Amgen, Inc. v. Chugai Pharmaceutical Co., 927 F.2d 1200, 18 USPQ2d 1016 (Fed.Cir.1991). Id. at 28. The court rejected Enzo’s argument that the reference in the specification to the deposits of biological materials in a public depository inherently disclosed that the inventors were in possession of the claimed sequences. Id. at 35. It distinguished this court’s cases concerning deposits as relating to the enablement requirement of § 112, ¶ 1. Id. at 38-40. Enzo appealed to this court; we have [1017]*1017jurisdiction pursuant to 28 U.S.C. § 1295(a)(1).

DISCUSSION

Summary judgment is appropriate when there is no genuine issue of material fact and the moving party is entitled to judgment as a matter of law. Fed. R.Civ.P. 56(c); Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 247-48, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986). On motion for summary judgment, the court views the evidence and any disputed factual issues in the light most favorable to the party opposing the motion. Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 587, 106 S.Ct. 1348, 89 L.Ed.2d 538 (1986). A patent is presumed to be valid, 35 U.S.C. § 282 (1994), and this presumption can only be overcome by facts supported by clear and convincing evidence to the contrary, see, e.g., WMS Gaming, Inc. v. Int’l Game Tech., 184 F.3d 1339, 1355, 51 USPQ2d 1385, 1396-97 (Fed.Cir.1999).

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285 F.3d 1013, 2002 WL 487156, Counsel Stack Legal Research, https://law.counselstack.com/opinion/enzo-biochem-inc-v-gen-probe-inc-cafc-2002.