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

United States Court of Appeals for the Federal Circuit

July 15, 2002, Decided

01-1230

Opinion

 [*960]  ON PETITION FOR REHEARING

LOURIE,  [**3]  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, P 1. Enzo Biochem, Inc. v. Gen-Probe Inc., 2001 U.S. Dist. LEXIS 23791, 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 [**4]  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.  [*961]  gonorrhoeae, and it derived three such sequences that preferentially hybridized to six common strains of N. gonorrhoeae over six common [**5]  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:

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323 F.3d 956 *; 2002 U.S. App. LEXIS 28124 **

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.

Prior History:  [**1]  Appealed from: United States District Court for the Southern District of New York. Judge Alvin K. Hellerstein.

Enzo Biochem, Inc. v. Gen-Probe Inc., 2001 U.S. Dist. LEXIS 23791 (S.D.N.Y., Apr. 4, 2001)Enzo Biochem, Inc. v. Gen-Probe Inc., 285 F.3d 1013, 2002 U.S. App. LEXIS 5642 (Fed. Cir., 2002)

Disposition: REVERSED and REMANDED.

CORE TERMS

written description, invention, patent, disclosure, sequences, specification, deposited, inventor, filing date, subject matter, new matter, skill, nucleotide, hybridization, original claim, en banc, gonorrhoeae, cases, strains, cDNA, biological, conveys, insulin, genus, district court, biotechnology, meningitidis, enabled, terms, first paragraph

Civil Procedure, Summary Judgment, Opposing Materials, General Overview, Motions for Summary Judgment, Entitlement as Matter of Law, Appropriateness, Genuine Disputes, Legal Entitlement, Materiality of Facts, Patent Law, Defenses, Patent Invalidity, Presumption of Validity, Specifications, Description Requirement, Standards & Tests, Definiteness, Written Description Versus Enablement, Evidence, Judicial Notice, US Patent & Trademark Office Proceedings, Inequitable Conduct, Enablement Requirement, Invention Date & Priority, Reduction to Practice