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

• Citation: 285 F.3d 1013
• Decision Date: 02 April 2002
• Docket Number: No. 01-1230.,01-1230.
• Parties: ENZO BIOCHEM, INC., Plaintiff-Appellant, v. GEN-PROBE INCORPORATED, and Chugai Pharma U.S.A., Inc. and Chugai Pharmaceutical Co., Ltd., and Biomerieux, Inc., and Becton Dickinson and Company, Defendants-Appellees, and Biomerieux SA, Defendant.
• Court: United States Courts of Appeals. United States Court of Appeals for the Federal Circuit

Page 1013

285 F.3d 1013

ENZO BIOCHEM, INC., Plaintiff-Appellant, v. GEN-PROBE INCORPORATED, and Chugai Pharma U.S.A., Inc. and Chugai Pharmaceutical Co., Ltd., and Biomerieux, Inc., and Becton Dickinson and Company, Defendants-Appellees, and

Biomerieux SA, Defendant.

No. 01-1230.

United States Court of Appeals, Federal Circuit.

DECIDED: April 2, 2002.

COPYRIGHT MATERIAL OMITTED

Richard L. DeLucia, Kenyon & Kenyon, of New York, NY, argued for plaintiff-appellant. With him on the brief were Charles A. Weiss, and Bradley S. Corsello.

William F. Lee, Hale and Dorr LLP, of Boston, MA, argued for defendants-appellees. With him on the brief was William G. McElwain. Of counsel on the brief were Robert J. Gunther, Jr., and Jeffrey A. Tochner, Latham & Watkins, of New York, NY, for Chugai Pharma U.S.A., Inc. and Chugai Pharmaceutical Co., Ltd. Of counsel was Kurt M. Rogers. Of counsel on the brief were Daniel A. Boehnen, and Joshua R. Rich, McDonnell Boehnen Hulbert & Berghoff, of Chicago, IL, for Biomerieux, Inc. Of counsel on the brief were Donald R. Ware and Barbara A. Fiacco, Foley Hoag & Eliot LLP, of Boston, MA, for Becton Dickinson and Company.

Before LOURIE, DYK and PROST, Circuit Judges.

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. gonorrhoeae reportedly has between eighty and ninety-three percent homology with Neisseria meningitidis. '659 patent, col. 2, ll. 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. gonorrhoeae, 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, l. 49 to col. 4, l. 14; col. 4, ll. 45-50. The inventors believed that if the preferential hybridization ratio of N. gonorrhoeae 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 meningitidis." Id. at col. 12, ll. 60-65. The three probes that the inventors actually derived had a selective hybridization ratio of greater than fifty. Id. at col. 13, ll. 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, ll. 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, ll. 29-36 (emphasis added). The method steps that follow are directed to obtaining the claimed ratio. Id. at col. 27, l. 37 to col. 28, l. 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, ll. 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, ll. 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 jurisdiction 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). "[C]ompliance with the written description requirement is a question of fact..." Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563, 19 USPQ2d 1111, 1116 (Fed. Cir.1991).

Enzo argues that its expert, Dr. Wetmer, raised a genuine factual issue that the disclosure inherently described the claimed nucleotide sequences, and that the court erred in bypassing the factual inquiry mandated by Vas-Cath and granting summary judgment solely on the basis of the patent's disclosure. Enzo also argues that its description of the binding affinity of the claimed nucleotide sequences satisfies the requirement set forth in the Guidelines for Examination of Patent Applications Under the 35 U.S.C. 112, ¶ 1 "Written Description" Requirement, 66 Fed. Reg. 1,099 (Jan. 5, 2001) ("Guidelines"). Enzo asserts that the court erred in not evaluating the patentability of the claims separately, pointing out that claims 4 and 6 are directed to the three deposited probes and variations and mixtures thereof. Enzo further asserts that the claims per se meet the written description requirement because they appear in ipsis verbis in the written description. Enzo also argues that this court's articulation of the written description requirement for genetic material in Eli Lilly should not apply to this case because Enzo reduced the invention to practice and deposited the derived biological materials, thereby demonstrating its "possession" of the invention.

The defendants respond that the district court properly granted summary judgment because the patent described the claimed nucleotide sequences only by their function, which is insufficient to meet the requirement of § 112, ¶ 1 as a matter of law under Eli Lilly, even for the narrower claims directed to the deposited materials. The defendants also assert that the expert's opinion that the deposited genetic materials could actually have been sequenced did not cure the actual failure of the inventors to identify them by some distinguishing characteristic such as their structure. The defendants argue that a description of the claimed genus of nucleotide sequences by its hybridization ratio does not satisfy § 112, ¶ 1 under this court's case law and the Guidelines. The defendants also urge that in ipsis verbis support for the claims in the specification does not per se establish compliance with the written description requirement. Finally, the defendants assert that the district court did not err in its determination that Enzo's "possession" of three nucleotide sequences that it reduced to practice and deposited nevertheless did not satisfy the written description requirement of § 112, ¶ 1.

The written description requirement of § 112, ¶ 1 is set forth as follows:

The specification shall contain a written description of the invention, and of the manner and process of making and...