United States Court of Appeals for the Federal Circuit

01-1230

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.

Richard L. Delucia, Kenyon & Kenyon, of New York, New York, filed a petition for rehearing en banc for plaintiff-appellant. With him on the petition were Charles A. Weiss and Bradley S. Corsello.

The appellees filed a consolidated response to the petition for rehearing en banc. William F. Lee, Hale and Dorr LLP, of Boston, Massachusetts, for defendant-appellee Gen-Probe Incorporated. With him on the response was William G. McElwain.

Robert J. Gunther, Jr., Latham & Watkins, of New York, New York, for defendants-appellees Chugai Pharma U.S.A., Inc. and Chugai Pharmaceutical Co., Ltd. With him on the response was Jeffrey A. Tochner. Of counsel was Kurt M. Rogers.

Daniel A. Boehnen, McDonnell Boehnen Hulbert & Berghoff, of Chicago, Illinois, for defendant-appellee Biomerieux, Inc. With him on the response was Joshua R. Rich.

Donald R. Ware, Foley Hoag & Eliot LLP, of Boston, Massachusetts, for defendant-appellee Becton Dickinson and Company. With him on the response was

Barbara A. Fiacco.

Frank P. Porcelli, Fish & Richardson P.C., of Boston, Massachusetts, filed a brief for amicus curiae Fish & Richardson P.C. Of counsel on the brief were Robert E. Hillman and Charles H. Sanders.

Mark S. Davies, Attorney, Appellate Staff, Civil Division, Department of Justice, of Washington, DC, filed an amicus curiae brief for the United States in support of rehearing en banc. With him on the brief were Robert D. McCallum, Jr., Assistant Attorney General, and Scott R. McIntosh, Attorney. Of counsel on the brief was John M. Whealan, Solicitor, U.S. Patent and Trademark Office, of Arlington, Virginia.

Appealed from: United States District Court for the Southern District of New York

Judge Alvin K. Hellerstein

United States Court of Appeals for the Federal Circuit

01-1230

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.

_________________________

DECIDED: July 15, 2002

_________________________

Before LOURIE, DYK, and PROST, Circuit Judges.

ON PETITION FOR REHEARING

LOURIE, Circuit Judge.

Enzo Biochem, Inc. petitions for rehearing of this appeal following our prior decision, reported at 285 F.3d 1013, 62 USPQ2d 1289 (Fed. Cir. 2002), in which we affirmed the decision of the United States District Court for the Southern District of New York. The district court had granted 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). Having considered Enzo’s petition for rehearing and the defendants’ response,[1] we have determined that our prior decision that a deposit may not satisfy the written description requirement was incorrect. We therefore grant Enzo’s petition for rehearing, vacate the prior decision, and reverse the district court’s grant of summary judgment that Enzo’s claims are invalid for failure to meet the written description requirement. Because genuine issues of material fact exist regarding satisfaction of the written description requirement, we remand.

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 sequences 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 [would] hybridize to virtually all strains of Neisseria gonorrhoeae and to no strain of Neisseria meningitidis.” Id. at col. 12, ll. 60-65. The three sequences that the inventors actually derived had a selective hybridization ratio of greater than fifty. Id. at col. 13, ll. 9-15. Enzo deposited those sequences 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 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 steps;

(a) providing a radioactively labeled form of said nucleotide sequence;

(b) providing a serial dilution series of purified chromosomal DNA from each of the N. gonorrhoeae strains; (1) ATCC 53420, (2) ATCC 53421, (3) ATCC 53422, (4) ATCC 53423, (5) ATCC 53424, (6) ATCC 53425, and forming test dots from each of said dilution series on a matrix;

(c) providing a serial dilution series of purified nucleotide sequences from each of the N. meningitidis strains: (1) ATCC 53414, (2) ATCC 53415, (3) ATCC 53416, (4) ATCC 53417, (5) ATCC 53418, (6) ATCC 53419, and forming test dots from each of said dilution series on a matrix;

(d) hybridizing equal portions of the labeled nucleotide sequences to the matrix provided in step (b) and (c), respectively; wherein the hybridization is conducted in a solution having a salt concentration of 2X SSC at (i) 65°C. in cases in which the sequence has greater than 50 base pairs or (ii) at Tm (°C.) minus 30°C. in cases in which the sequence has less than 50 base pairs, wherein Tm is the denaturation temperature of the sequence;

(e) quantifying the labeled nucleotide sequence hybridized in step (d) to each test dot;

(f) subtracting from the data of step (e) an averaged amount of radioactivity attributable to background to obtain a corrected amount of hybridized radioactivity at each test dot;

(g) normalizing the data of step (f) by multiplying the amount of corrected radioactivity at each test dot by a factor which adjusts the amount of radioactivity to equal amounts of chromosomal DNA at each test dot;

(h) selecting two normalized values that are most nearly the same and that correspond to adjacent members of the dilution series for each of the above strains of N. gonorrhoeae and obtaining the average of the selected values;

(i) selecting two normalized values that are most nearly the same and that correspond to adjacent members of the dilution series for each of the above strains of N. meningitidis and obtaining the average of the selected values;

(j) dividing the lowest average obtained in step (h) by the highest average obtained in step (i) to obtain said ratio.

Id. at col. 27, l. 29 to col. 28, l. 27 (emphasis added). Claims 2 and 3 depend from claim 1 and further limit the hybridization ratio to greater than about twenty-five and fifty, respectively. Id. at col. 2, ll. 27-30. Claim 4 is directed to the three deposited sequences (referenced by their accession numbers) and variants 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 5 is directed to an assay for detection of N. gonorrhoeae using the composition of claim 1. Id. at ll. 40-46. Claim 6 further limits the method of claim 5 to the nucleotide sequences that Enzo deposited (i.e., those in claim 4) and variants thereof. Id. at 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). 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 it was held 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). Tr. of Hr’g 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 precedents 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 (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 (1986). A patent is presumed to be valid, 35 U.S.C. § 282 (1994), and this presumption can be overcome only 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). Compliance 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).