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Bristol-Myers Squibb Co. v. Ben Venue Labs., Inc.

United States Court of Appeals for the Federal Circuit

April 20, 2001, Decided

00-1304

Opinion

 [***1510]   [*1371]  LOURIE, Circuit Judge.

Bristol-Myers Squibb Company appeals from the decision of the United States District Court for the District of New Jersey granting the motion by Ben Venue Laboratories, Inc., Bedford Laboratories, Boehringer Ingelheim Corporation, Immunex Corporation, IVAX Corporation, Zenith Goldline Pharmaceuticals, Inc., Marsam Pharmaceuticals, Inc., Schein Pharmaceutical, Inc., and Mylan Pharmaceuticals, Inc. (collectively,  [**3]  "the defendants") for summary judgment that claims 1-3 and 6 of U.S. Patent 5,641,803 and claims 1, 2, 5, 6, 8 and 9 of U.S. Patent 5,670,537 are invalid for anticipation. Bristol-Myers Squibb Co. v. Boehringer Ingelheim Corp., 86 F. Supp. 2d 433 (D.N.J. 2000) ("Bristol II").

Because the district court did not err in holding claims 1-3 and 6 of the '803 patent and claims 1, 2, 5 and 8 of the '537 patent invalid, we affirm the court's judgment as to those claims. The district court erred in holding claims 6 and 9 of the '537 patent invalid, however. We therefore vacate the court's grant of summary judgment with respect to those two claims.

BACKGROUND

Bristol-Myers Squibb Co. ("Bristol") is the assignee of the '803 and '537 patents, which relate to a three-hour administration of the antitumor drug paclitaxel. 1 The patents derive from the same parent application and share the same specification. Claim 1 of the '803 patent reads as follows:

1. A method for reducing hematologic toxicity in a cancer patient undergoing taxol treatment comprising parenterally administering to said patient an antineoplastically effective amount of about 135-175 mg/m2  [**4]   taxol over a period of about three hours.

 '803 patent, col. 16, ll. 13-18 (emphasis added). The '537 patent is also directed to three-hour paclitaxel administration and additionally requires premedication, as shown in representative claims 1 and 5 below:

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246 F.3d 1368 *; 2001 U.S. App. LEXIS 7262 **; 58 U.S.P.Q.2D (BNA) 1508 ***

BRISTOL-MYERS SQUIBB COMPANY, Plaintiff-Appellant, v. BEN VENUE LABORATORIES, INC., BEDFORD LABORATORIES, and BOEHRINGER INGELHEIM CORPORATION, Defendants-Appellees, and IMMUNEX CORPORATION (ANDA now owned by Baker Norton Pharmaceuticals, Inc.), IVAX CORPORATION, and ZENITH GOLDLINE PHARMACEUTICALS, INC., Defendants-Appellees, and MARSAM PHARMACEUTICALS, INC. and SCHEIN PHARMACEUTICAL, INC., Defendants-Appellees, and MYLAN PHARMACEUTICALS, INC., Defendant-Appellee.

Subsequent History:  [**1]  Rehearing and Rehearing En Banc Denied June 13, 2001, Reported at: 2001 U.S. App. LEXIS 14223.

Rehearing, en banc, denied by Bristol-Myers Squibb Co. v. Ben Venue Labs., Inc., 2001 U.S. App. LEXIS 14223 (Fed. Cir., June 13, 2001)

Prior History: Appealed from: United States District Court for the District of New Jersey. Judge William H. Walls.

Bristol-Myers Squibb Co. v. Boehringer Ingelheim Corp., 86 F. Supp. 2d 433, 2000 U.S. Dist. LEXIS 2153 (D.N.J., 2000)Bristol-Myers Squibb Co. v. Boehringer Ingelheim Corp., 86 F. Supp. 2d 433, 2000 U.S. Dist. LEXIS 2151 (D.N.J., 2000)Bristol-Myers Squibb Co. v. Immunex Corp., 86 F. Supp. 2d 447, 2000 U.S. Dist. LEXIS 2150 (D.N.J., 2000)

Disposition: AFFIRMED-IN-PART, VACATED-IN-PART, and REMANDED.

CORE TERMS

anticipation, patients, toxicity, premedication, invention, patent, district court, paclitaxel, summary judgment, hematologic, effective, infusions, pretreatment, steps, taxol, antineoplastically, hypersensitivity, invalid, disclosure, reactions, prior art, premedicants, three-hour, preamble, treating, skill, administering, references, tumor, new use

Civil Procedure, Appeals, Standards of Review, De Novo Review, Patent Law, Infringement Actions, Claim Interpretation, General Overview, Claims, Claim Parts, Preambles, Summary Judgment, Motions for Summary Judgment, Opposing Materials, Entitlement as Matter of Law, Appropriateness, Genuine Disputes, Legal Entitlement, Materiality of Facts, Anticipation & Novelty, Elements, Defenses, Patent Invalidity, Presumption of Validity, Claim Differentiation, Utility Patents, Process Patents