Bristol-Meyers Squibb Co. v. Ben Venue Laboratories Inc.

Decision Date20 April 2001
Docket NumberPLAINTIFF-APPELLANT,BRISTOL-MYERS,DEFENDANT-APPELLEE,DEFENDANTS-APPELLEE,AND,No. 00-1304,00-1304
Parties(Fed. Cir. 2001) SQUIBB COMPANY,, v. BEN VENUE LABORATORIES, INC., BEDFORD LABORATORIES, AND BOEHRINGER INGELHEIM CORPORATION,IMMUNEX CORPORATION (ANDA NOW OWNED BY BAKER NORTON PHARMACEUTICALS, INC.), IVAX CORPORATION, AND ZENITH GOLDLINE PHARMACEUTICALS, INC.,MARSAM PHARMACEUTICALS, INC. AND SCHEIN PHARMACEUTICAL, INC.,MYLAN PHARMACEUTICALS, INC.,
CourtU.S. Court of Appeals — Federal Circuit

Robert L. Baechtold, Fitzpatrick, Cella, Harper & Scinto, of New York, New York, argued for plaintiff-appellant. With him on the brief were Nicholas M. Cannella, Bruce C. Haas, Jennifer A. Reda, and F. Christopher Mizzo. Of counsel on the brief were Evan R. Chesler, and Richard J. Stark, Cravath, Swaine & Moore, of New York, New York. Also of counsel on the brief was William J. O'Shaughnessy, McCarter & English, of Newark, New Jersey.

Martin B. Pavane, Cohen, Pontani, Lieberman & Pavane, of New York, New York, argued for defendants-appellees Ben Venue Laboratories, Inc. et al. With him on the brief were William A. Alper, and Mindy H. Chettih. Of counsel on the brief was Robert P. Raymond, Boehringer Ingelheim Corporation, of Ridgefield, Connecticut. Of counsel were Alfred H. Hemingway, Jr., and Yunling Ren.

William L. Mentlik, Lerner, David, Littenberg, Krumholz & Mentlik, Llp, of Westfield, New Jersey, argued for defendants-appellees Immunex Corporation, et al. With him on the brief were Arnold H. Krumholz Roy H. Wepner, and Michael H. Teschner. Of counsel on the brief was Jay B. Shapiro, Stearns Weaver Miller Weissler Alhadeff & Sitterson, P.A., of Miami, Florida. Also of counsel on the brief were Gerson A. Zweifach, and Sharon L. Davis, Williams & Connolly Llp, of Washington, Dc.

E. Anthony Figg, Rothwell, Figg, Ernst & Manbeck P.C., of Washington, Dc, for defendant-appellee Mylan Pharmaceuticals, Inc. With him on the brief were Steven Lieberman, and Glenn E. Karta. Of counsel on the brief was Charles Guttman, Proskauer Rose Llp, of New York, New York, for defendant-appellee Marsam Pharmaceutical, Inc., et al. Of counsel was Frank Holahan, Harwood & Lloyd, Llc, of Hackensack, New Jersey.

Before Lourie, Gajarsa, and Dyk, Circuit Judges.

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, "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 [t]axol treatment comprising parenterally administering to said patient an antineoplastically effective amount of about 135-175 mg/m2 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:

1. A method for treating a patient suffering from a taxol-sensitive tumor comprising

(i) premedicating said patient with a medicament that reduces or eliminates hypersensitivity reactions, and

(ii) parenterally administering to said patient about 135-175 mg/m2 taxol over about three hours.

5. A method for treating a cancer patient to effect regression of a taxol-sensitive tumor, said method being associated with reduced hematologic toxicity, said method comprising:

(i) premedicating said patient with a medicament that reduces or eliminates hypersensitivity reactions; and

(ii) parenterally administering to said patient about 135-175 mg/m2 taxol over about 3 hours.

'537 patent, col. 15, ll. 45-51; col. 16, ll. 21-27 (emphasis added).

Claims 2 and 8 of the '537 patent differ from claims 1 and 5, respectively, only in the dosage amount, which is "about 135 mg/m2 taxol." Id. at col. 16, ll. 5-6; ll. 41-42. Claims 6 and 9 of the '537 patent are directed to the same particular premedicants; claim 6 depends from claim 5 and claim 9 depends from claim 8. Claim 6 is reproduced below as representative of claims 6 and 9:

6. The method of claim 5 wherein the step of premedicating said patient comprises the administration of a medicament selected from the group consisting of steroids, antihistamines, H2 receptor antagonists, and combinations thereof.

'537 patent, col. 16, ll. 28-32 (emphasis added).

The defendants filed Abbreviated New Drug Applications ("ANDAs") seeking approval to market paclitaxel prior to the patents' expiration, alleging that the patents were invalid over, inter alia, an article by Kris in which Kris treated patients with three-hour infusions of paclitaxel within the claimed dosage ranges but observed no antitumor response. Mark G. Kris, et al., Phase I Trial of Taxol Given as a 3-Hour Infusion Every 21 Days, 70 Cancer Treatment Reports 605-07 (1986) ("Kris"). Patients treated with more than 190 mg/m2 of paclitaxel, an amount greater than the claimed range of 135-175 mg/m2, showed treatment-limiting hypersensitivity reactions. In his concluding remarks, Kris commented:

Hypersensitivity reactions constitute a severe and unpredictable treatment-limiting toxicity for the present cremophor-containing formulation of taxol given on this schedule. Further studies are needed to see if pretreatment regimens, alternative schedules . . . or a reformulated preparation will permit the safe administration of this compound.

Id. at 607. (emphasis added). Kris did not employ the suggested pretreatment regimens in that study.

Bristol sued for infringement based on the defendants' ANDAs under 35 U.S.C.A. §§ 271(e)(2) (West Supp. 2000); the defendants moved for summary judgment that the patents were invalid for anticipation under 35 U.S.C. §§ 102(b) (1994) and obviousness under 35 U.S.C. §§ 103 (Supp. IV 1998).

Following a Markman hearing, the district court construed the claims. Bristol-Myers Squibb Co. v. Immunex Corp., 86 F. Supp. 2d 447 (D.N.J. 2000) ("Bristol I"). The court first determined that the preamble expression in claim 5 of the '537 patent, "[a] method for treating a cancer patient to effect regression of a taxol-sensitive tumor, said method being associated with reduced hematologic toxicity," merely stated the intended use or purpose of the invention and did not limit the scope of the claim. Id. at 451. The court then held that the expression in the '803 claims, "an antineoplastically 2 effective amount," was inseparable from the specific concentrations described in the claims and only stated the purpose of the invention comprising the stated method steps. Id. at 454. Finally, the court held that the expression "reducing hematologic toxicity" meant a reduction in toxicity relative to that normally experienced in a twenty-four-hour paclitaxel infusion, which was the standard infusion time prior to Bristol's development of the three-hour infusion time. Id. at 455-456.

In Bristol II, the court granted the defendants' motion for summary judgment that the claims at issue were invalid, holding that Kris anticipated most of the claims in the '803 and '537 patents. Bristol II, 86 F. Supp. 2d at 442, 444. The court found that Kris disclosed all of the necessary steps to administer paclitaxel according to the claims, including dosage levels, duration of infusion, and premedication. Id. at 441. Although Kris did not actually premedicate the patients, the court determined "that one skilled in the art would have known exactly what Kris's premedication `suggestion' entailed and would have not have had to engage in further experimentation to gain possession of the patented invention." Id. The court relied on Bristol's statement during prosecution that the invention was drawn to "a novel method for administering taxol to patients that have been pretreated with conventional medication for minimizing hypersensitivity reactions" for its determination that Kris's suggestion of premedication would have enabled someone of skill in the art to pretreat patients according to the claims. Id.

Although the court did not consider the preamble language of reducing toxicity levels and tumor regression to be limiting, the court determined that even if these claim terms were limiting, the claims would have been inherently anticipated because reducing toxicity and tumor regression were necessary consequences of practicing the method steps of Kris. Id. at 442. However, the court denied the defendants' motion for summary judgment that the claims were obvious over Kris and other references because it found a genuine factual dispute as to...

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