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BRISTOL-MYERS SQUIBB CO. v. IMMUNEX CORP

March 2, 2000

BRISTOL-MYERS SQUIBB COMPANY, PLAINTIFF,
V.
IMMUNEX CORPORATION, ZENITH GOLDLINE PHARMACEUTICALS, INC. AND IVAX CORPORATION, BOEHRINGER INGELHEIM CORP., BEN VENUE LABORATORIES AND BEDFORD LABORATORIES, DEFENDANTS.



The opinion of the court was delivered by: Walls, District Judge.

OPINION

Defendant-counterclaimants Immunex Corporation, Zenith Goldline, and IVAX Corporation (collectively "IVAX defendants") move for a Markman claim interpretation ruling and for partial summary judgment of noninfringement of U.S. Patent No. 5,641,803 ("the '803 patent"), owned by plaintiff Bristol-Myers Squibb Co. ("Bristol") and asserted in these infringement actions. Patentee Bristol opposes the motion. This Opinion sets out the construction of the two patents in suit. The IVAX defendants' motion for partial summary judgment of noninfringement of the '803 patent is denied.

ANALYSIS

1. "Markman" Rulings: Standards for Claim Construction

The construction of patent claims is a matter of law exclusively for the court. Markman v. Westview Instruments, 52 F.3d 967 (Fed.Cir. 1995).

The court must look first to the "intrinsic evidence," which consists of the patent claims, the specification, and the prosecution history if in evidence. "Such intrinsic evidence is the most significant source of the legally operative meaning of disputed claim language." Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576, 1582 (Fed.Cir. 1996). The court should presume that the terms in the claim mean what they say, and, unless otherwise compelled, give full effect to the ordinary and accustomed meaning of claim terms. See Johnson Worldwide Associates, Inc. v. Zebco Corp., 175 F.3d 985, 989 (Fed.Cir. 1999). Of course, "claim construction is not philosophy . . . [it] is firmly anchored in reality by the understanding of those of ordinary skill in the art." K-2 Corp. v. Salomon S.A., 191 F.3d 1356 (Fed.Cir. 1999). And though the prosecution history can and should be used to understand the language used in the claims, it may not be used to "enlarge, diminish, or vary" the limitations in the claims. Markman, 52 F.3d at 979 (citation omitted).

2. Construction of the '537 Patent Claims

United States Patent No. 5,670,537 ("'537 patent") issued from a chain of applications prosecuted by Bristol over a period of five years beginning in 1992. The first, "grandparent application," serial number 923,628 ("the '628 application"), was filed in August 1992 to provide Bristol with patent coverage of certain inventions resulting from a multinational study of taxol to treat refractory ovarian cancer known as the "OV.9 study." Later, "parent application" number 109,331 ("the '331 application") was filed as a division of the grandparent in June 1993 pursuant to 35 U.S.C. § 121. In January 1995, the patent examiner entered a restriction requirement directed to claims which mentioned premedication to prevent hypersensitivity reactions ("HSRs"). "Child application" number 544,594 ("the '594 application") was filed in October 1995.*fn1 Finally, for lack of a better description, "grandchild" application number 08/715,914 ("the '914 application") was filed on September 19, 1996 as a continuation of the '594 application. The '537 patent issued from the '914 application on September 23, 1997. The specifications submitted in support of each application and the issued patent were identical. However, throughout this period, Bristol amended, added and deleted various claims submitted to the United States Patent and Trademark Office (PTO).

The '537 patent contains ten claims, divided between independent and dependent claims. Claims 1 and 5 are representative of claims 2-4 and 6-10, respectively, and read:

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 three hours.

The element common to each claim is premedication to reduce or eliminate hypersensitivity reactions ("HSRs"), an element missing from claims of the '803 patent.

The construction of claims 1-4 of the '537 patent is not disputed. See BMS Opp. Brf. to Ben Venue's Motion for Summary Judgment of Invalidity at 11 (stating that the parties largely agree on the limitations of the '537 Patent).*fn2 The import of the phrase "[a] method for treating a cancer patient to effect regression of a taxol-sensitive tumor, said method being associated with reduced hematologic toxicity," in claims 5-10, however, is contested. Id.

Whether the phrase, "[a] method for treating a cancer patient to effect regression of a taxol-sensitive tumor, said method being associated with reduced hematologic toxicity," in claims 5-10, is properly understood as a claim limitation.

Ben Venue argues that the phrase, "[a] method for treating a cancer patient to effect regression of a taxol-sensitive tumor, said method being associated with reduced hematologic toxicity," in claims 5-10 of the '537 patent, is not a claim limitation "but rather a statement of the object of practicing the method set forth" in the claims. Ben Venue '537 Brf. at 17. Bristol responds that a review of the patents,*fn3 their prosecution history and specifications, makes clear that "reducing hematologic toxicity while achieving [antitumor] efficacy is a key element of the invention." BMS Opp. Brf. at 17; see also '537 Patent, cols. 8-10 (Efficacy & Safety; Hematologic Toxicity). Thus, the references to reducing toxicity and shrinking tumors are "necessary to give life and meaning" to Bristol's inventions. Brf. at 17. Bristol also relies on the presumption of claim differentiation to buttress its argument — if the Court ignores the preamble of the '537 patent (claims 5-10) as a limitation, claim 5 is identical to claim 1. Claim differentiation teaches that "each claim of a patent constitutes a separate invention." See P.A.T. Co. v. Ultrak, Inc., 948 F. Supp. 1506, 1511 (D.Kan. 1996).

A patent claim is normally divided into three sections: (1) the preamble; (2) the transition; and, (3) the body. See STX, Inc. v. Brine, Inc., 37 F. Supp.2d 740, 752 (D.Md. 1999). "The preamble is that portion of the claim preceding the word `comprising.'" Boehringer Ingelheim Animal Health, Inc. v. Schering-Plough Corp., 984 F. Supp. 239, 247 (D.N.J. 1997). "The preamble is an introductory phrase that may summarize the invention, its relation to the prior art, or its intended use or properties . . . . [i]t may also constitute a limitation." See Donald A. Chisum, Patents § 8.06 (1994). "[A] claim preamble has the import that the claim as a whole suggests for it." Bell Communications Research, Inc. v. Vitalink Communications Corp., 55 F.3d 615, 620 (Fed.Cir. 1995). On the other hand, claim limitations serve to "point out distinctly the process, machine, manufacture or composition of matter which is patented . . . not its advantages." See Preemption Devices, Inc. v. Minnesota Mining & Manuf. Co., 732 F.2d 903, 907 (Fed.Cir. 1984); 35 U.S.C. § 101. Thus, whether a preamble contains a limitation or merely a statement of purpose can only be decided "on review of the entirety of the patent to gain an understanding of what the inventors actually invented." Rowe v. Dror, 112 F.3d 473, 477 (Fed.Cir. 1997); see also General Electric Co. v. Nintendo Co., 179 F.3d 1350, 1361 (Fed.Cir. 1999).

Though still somewhat "opaque," certain rules for analyzing preambles have developed. See Patrick J. Flimm, Claim Construction Trends in the Federal Circuit, 572 PLI/PAT 317, 335-36 (1999) (characterizing the preamble/limitations test as "opaque" and without a set framework). However, "[t]he Federal Circuit has made it reasonably clear that the mere fact that a patentee finds something useful in a claim preamble in the [patent] litigation does not alone justify treatment of a claim preamble as a limitation." See STX, 37 F. Supp.2d at 752. If the body of the claim sets out a "structurally complete" invention, it is not a limitation. See Rowe, 112 F.3d at 478. Thus, where:

the body of the claim fully and intrinsically sets forth the complete invention, including all of its limitations, and the preamble offers no distinct definition of any of the defined claims limitations, but rather merely states, for example, the purpose or intended use of the invention, then the preamble is of no significance to claim ...

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