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BRISTOL-MYERS SQUIBB CO. v. BOEHRINGER INGELHEIM

March 2, 2000

BRISTOL-MYERS SQUIBB CO., PLAINTIFF,
V.
BOEHRINGER INGELHEIM CORP., BEN VENUE LABORATORIES, INC., AND BEDFORD LABORATORIES, AND IMMUNEX CORPORATION, AND ZENITH GOLDLINE PHARMACEUTICALS, INC. AND IVAX CORPORATION, AND MYLAN PHARMACEUTICALS, INC., AND MARSAM PHARMACEUTICALS, INC. AND SCHIEN PHARMACEUTICALS, INC., DEFENDANTS. ZENITH GOLDLINE PHARMACEUTICALS, INC., IVAX CORPORATION, AND BAKER NORTON PHARMACEUTICALS, COUNTERCLAIM PLAINTIFFS, V. BRISTOL-MYERS SQUIBB COMPANY, COUNTERCLAIM DEFENDANT.



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

  OPINION

Defendants and counterclaimants Zenith Goldline Pharmaceuticals, IVAX Corporation, Baker Norton Pharmaceuticals, Immunex Corporation (collectively the "IVAX defendants") and Ben Venue Laboratories ("Ben Venue") move for summary judgment of invalidity of United States Patents Nos. 5,670,537 ("'537 patent") and 5,641,803 ("'803 patent") on the grounds of anticipation, 35 U.S.C. § 102(b), and obviousness, 35 U.S.C. § 103. Plaintiff Bristol-Myers Squibb ("Bristol") opposes the motions. The motions are granted in part.

Ben Venue's first motion for summary judgment of invalidity asserts that claims 1, 2, 5, 6, 8 and 9 of the '537 patent are invalid as anticipated or obvious by Mark Kris, et al., Phase I of Taxol Given as a 3-Hour Infusion Every 21 Days, 70 Cancer Treatment Reports 605-07 (1986) (the "Kris article"). Ben Venue further asserts that all claims of this patent are invalid as obvious from a written abstract ("OV.9 abstract") and oral presentation at an April 1991 meeting of the Clinical Trials Group of the National Cancer Institute of Canada ("NCIC"). Ben Venue's second motion for summary judgment of invalidity asserts that claims 1-3 and 6 of the '803 patent are anticipated by the Kris article and all claims of the '803 patent are anticipated by the OV.9 abstract. Zenith Goldline Pharmaceuticals, IVAX Corporation, Baker Norton Pharmaceuticals, and Immunex Corporation, in their motion, contend that claims 1-3 and 6 of the '803 patent and claims 1, 2, 5, and 8 of the '537 patent are anticipated by the Kris article; all claims of both patents are anticipated by the OV.9 abstract; and, all claims of both patents are invalid as obvious when the prior art, including but not limited to the Kris article and the OV.9 abstract, is considered in its entirety. Bristol responds that summary judgment is inappropriate and further argues that the prior art neither anticipates nor renders obvious the patents at issue.

Summary Judgment Standard

Patent cases are not immune to summary judgment motions. The Federal Circuit has "repeatedly emphasized that `summary judgment is as appropriate in a patent case as any other.'" Avia Group Int'l, Inc. v. L.A. Gear California, 853 F.2d 1557, 1561 (Fed.Cir. 1988). Summary judgment is appropriate where the moving party establishes that "there is no genuine issue of fact and that [it] is entitled to a judgment as a matter of law." Fed. R.Civ.P. 56. A factual dispute between the parties will not defeat a motion for summary judgment unless it is both genuine and material. See Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 247-48, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986). A factual dispute is genuine if a reasonable jury could return a verdict for the non-movant and it is material if, under the substantive law, it would affect the outcome of the suit. See id. at 248, 106 S.Ct. 2505. The moving party must show that if the evidentiary material of record were reduced to admissible evidence in court, it would be insufficient to permit the non-moving party to carry its burden of proof. See Celotex v. Catrett, 477 U.S. 317, 318, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986).

The party opposing a motion for summary judgment must set forth specific facts showing a genuine issue for trial and may not rest upon the mere allegations or denials of its pleadings. See Sound Ship Bldg. Co. v. Bethlehem Steel Co., 533 F.2d 96, 99 (3d Cir. 1976), cert. denied, 429 U.S. 860, 97 S.Ct. 161, 50 L.Ed.2d 137 (1976). At the summary judgment stage the court's function is not to weigh the evidence and determine the truth of the matter, but rather to determine whether there is a genuine issue for trial. See Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 249, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986). And, the court must construe the facts and inferences in the light most favorable to the non-moving party. See Wahl v. Rexnord, Inc. 624 F.2d 1169, 1181 (3d Cir. 1980).

Defendants, here, contend that certain claims of both patents in suit are invalid because they were anticipated or rendered obvious by prior art. 35 U.S.C. § 102(b) & 103. Since patent claims are presumptively valid, 35 U.S.C. § 282, defendants must advance clear and convincing evidence of invalidity in order to succeed. See generally Intel Corp. v. United States Int'l Trade Comm'n, 946 F.2d 821, 829 (Fed.Cir. 1991); Tyler Refrigeration v. Kysor Indus. Corp., 777 F.2d 687, 690 (Fed. Cir. 1985).

Law of Anticipation

A patent is invalid as anticipated if:

the invention . . . was described in a printed publication in this or a foreign country . . . more than one year prior to the date of the application for the patent in the United States.

35 U.S.C. § 102(b). Under Section 102(b), inventions described in a "printed publication" distributed over one year before the initial patent application cannot be patented. The question of whether a document is a printed publication is "a legal determination based on underlying fact issues and, therefore, must be approached on a case-by-case basis." In re Hall, 781 F.2d 897, 899 (Fed.Cir. 1986). A document "disseminated or otherwise made available" "to persons concerned with the art to which the document relates" is a "printed publication." Massachusetts Inst. of Tech. v. AB Fortia, 774 F.2d 1104, 1109 (Fed. Cir. 1985); Carella v. Starlight Archery, 804 F.2d 135, 139 (Fed.Cir. 1986).

To invalidate an existing patent, a single prior publication must contain all of the essential limitations of each claim; there must be identity between the claimed process and a process described in a prior art reference. See Glaverbel Societe Anonyme v. Northlake Mktg. & Supply, Inc., 45 F.3d 1550, 1554 (Fed.Cir. 1995); Hybritech, Inc. v. Monoclonal Antibodies, Inc., 802 F.2d 1367, 1379 (Fed. Cir. 1986). Defendants must show that "each element of the claim in issue is found in a prior patent or publication, either expressly or under principles of inherency." Tyler Refrigeration v. Kysor Indus. Corp., 777 F.2d 687, 689 (Fed.Cir. 1985); see also Celeritas Tech. Ltd. v. Rockwell Int'l Corp., 150 F.3d 1354, 1360 (Fed.Cir. 1998); Verdegaal Bros., Inc. v. Union Oil Co., 814 F.2d 628, 631-32 (Fed.Cir. 1987). Inherency occurs when the invention described by the prior art necessarily functions in accordance with a claim limitation, even if the limitation is not expressly mentioned in the art. See generally Robert Harmon, Patents and the Federal Circuit § 3.2 (4th ed. 1999).

Claim anticipation in prior art is a finding of fact. See Titanium Metals Corp. v. Banner, 778 F.2d 775, 780-782 (Fed.Cir. 1985); Ecolochem, Inc. v. Southern California Edison Co., 863 F. Supp. 1165, 1179 (C.D.Cal. 1994), aff'd in part, rev'd in part, 91 F.3d 169 (Fed.Cir. 1996) ("Whether a [prior art] reference discloses each element of the claim is a question of fact."). Defendants' motions, then, can only be granted if there are no genuine disputes of material fact whether the processes described in any one of the articles submitted anticipate the patents' claims.

The prior art need not present the invention in a positive light, so long as all claims are explicitly or inherently contained in the publication. See Celeritas, 150 F.3d at 1361 ("A reference is no less anticipatory if, after disclosing the invention, the reference then disparages it . . . . the question of whether a reference `teaches away' from the invention is inapplicable to an anticipation analysis."); see also Kalman v. Kimberly-Clark Corp., 713 F.2d 760, 772 (Fed.Cir. 1983), overruled on other grounds, SRI Intern. v. Matsushita Elec. Corp., 775 F.2d 1107 (Fed.Cir. 1985) ("The law of anticipation does not require that the reference `teach' what the subject patent teaches."); Merck & Co. v. Mylan Pharm., Inc., 19 F. Supp.2d 334, 345-46 (E.D.Pa. 1998); see generally Lance L. Barry, Teaching A Way Is Not Teaching Away, 79 J. Pat. & Trade. Off. Soc'y 867, 869 (1997) (a reference teaches away when "it suggests that the line of development flowing from the reference's disclosure is unlikely to be productive of the result sought by the applicant."). The invention as disclosed by the prior art, however, must be described so as to "enable" one skilled in the art to (1) identify all claim limitations and (2) create the invention.*fn1

Thus, anticipation analysis is a three-step process. The first step is claim construction. The claims of the two patents in suit are constructed in a companion opinion (the "Markman Opinion"). The second step requires the Court to compare the properly constructed claims with the subject matter described in the prior art reference and identify the elements disclosed in the allegedly anticipating reference. The final step requires the Court to determine whether the prior art placed the allegedly disclosed matter in the possession of the public; the art must enable one skilled in the art to produce the claimed invention.*fn2 See, e.g., PPG Indus., Inc. v. Guardian Indus. Corp., 75 F.3d 1558, 1566 (Fed.Cir. 1996).

Law of Obviousness

Under 35 U.S.C. § 103, a patent is invalid:

though the invention is not identically disclosed or described as set forth in section 102of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains.

Obviousness of a patent is a mixed question of law and fact. The ultimate question of obviousness is one of law, based on certain factual determinations. See In re Dance, 160 F.3d 1339, 1342 (Fed.Cir. 1998); Richardson-Vicks, Inc. v. Upjohn Co., 122 F.3d 1476, 1479 (Fed.Cir. 1997). The primary underlying factual determinations include: (1) the scope and content of the prior art; (2) the level of ordinary skill in the art; (3) the difference between the claimed invention and the prior art; and (4) the extent of any proffered objective indicia of nonobviousness. See Graham v. John Deere Co., 383 U.S. 1, 17-18, 86 S.Ct. 684, 15 L.Ed.2d 545 (1966). Objective indicia of nonobviousness, called "secondary considerations" of obviousness, include: (a) the invention's commercial success; (b) copying of the invention; (c) a long felt need for the invention; (d) failure of others to create the invention; and (e) unexpected results. See In re Rouffet, 149 F.3d 1350, 1355 (Fed.Cir. 1998).

In this analysis, then, the Court must "look at the whole invention rather than merely its different elements," and must "step backward in time and into the shoes worn by a person of ordinary skill in the art when the invention was unknown and just before it was made." Boehringer Ingelheim Vetmedica, Inc. v. Schering-Plough Corp., 68 F. Supp.2d 508, 530-31 (D.N.J. 1999). The issue of whether the prior art "teaches away" from the invention, then, is relevant. See generally Bausch & Lomb, Inc. v. Barnes-Hind/Hydrocurve, Inc., 796 F.2d 443, 448 (Fed.Cir. 1986) (portions of a reference teaching away from claimed invention should be considered when determining obviousness). In addition, multiple references may be combined to render a patent obvious where an artisan of ordinary skill would have known to combine the various references. See In re Dance, 160 F.3d at 1342-43 (there must be "some suggestion, teaching, or motivation [to combine] the prior art, arising from what the prior art would have taught a person of ordinary skill in the field of the invention").

A finding, however, that the patented invention may have been "obvious to try" from the prior art will not invalidate it. Prior art that makes the invention only "obvious to try" rather than "obvious" "gives either no indication of which parameters are critical or no direction as to which of many possible choices is likely to be successful." Merck & Co. v. Biocraft Labs., 874 F.2d 804, 807 (Fed.Cir. 1989). The correct standard is not whether the invention would have been "obvious to try" but whether one skilled in the art would have "a reasonable expectation that the beneficial result will be achieved." In re Merck & Co., 800 F.2d 1091, 1097 (Fed.Cir. 1986); see also James Ruland, Chapter 2100 of the Manual of Patent Examining Procedure — A Means For Persuasion, 6 Tex. Intell. Prop. L.J. 49, 54 (1997) ("the standard with which obviousness is determined must be a reasonable expectation of success"). Thus, "absolute predictability" is not required. Merck, 800 F.2d at 1097.

Prior Art References

Kris Article

In 1986, an article by Mark G. Kris, et al. ("Kris article") was published in a cancer journal. See Kris, et al., Phase I of Taxol Given as a 3-Hour Infusion Every 21 Days, 70 Cancer Treatment Reports 605-07 (1986). The seventeen patients in the study described in the article were suffering from various solid tumors. The trial was initiated at a dose of 15 mg/m² for three hours, "[e]scalation proceeded using doses of 30, 45, 75, 100, 135, 160 and 230 mg/m² . . . . [p]atients who experienced no drug-related toxicity were eligible to reenter the study at a higher dosage level." Kris article at 606. Three patients, two who received 190 mg/m² and one who received 230 mg/m², suffered from "treatment-limiting hypersensitivity reactions" ("HSRs"). Id. None of the patients was premedicated to reduce HSRs. The article noted that for those who received doses up to 190 mg/m², "leukopenia, thrombocytopenia, nausea and vomiting, alopecia, stomatitis, transient rashes and hypersensitivity reactions were observed. No anticancer effects were noted in this trial." Id. at 607. The first paragraph of the article — essentially a summary of the findings of the study — warned "[w]ith the severity and unpredictability of the hypersensitivity reactions, further usage of taxol is not indicated with this drug formulation on this administration schedule." The final paragraph, however, stated:

Hypersensitivity reactions constitute a severe and unpredictable treatment-limitingtoxicity for the present cremaphorcontaining formulation of taxolgiven on this schedule. Further studies are needed to see if pretreatment regimens, alternative schedules [footnote to an article conducting a 24-hr. infusion schedule], or a reformulated preparation will permit the safe administration of this compound.

Id. at 607 (emphasis added). Bristol brought this article to the attention of the United States Patent and Trademark Office ("USPTO") during prosecution.

O'Connell

An interim abstract of the Phase I study discussed in the Kris article appeared in March 1985. See O'Connell, et al., Phase I Trial of Taxol Given as a Three Hour Infusion Every Three Weeks, 26 Proceedings of the AACR 169 (No. 671) (March 1985). This abstract ("O'Connell abstract") described the Kris article's three-hour infusion/escalating dose schedule. The article stated that "no antitumor effects were observed" but concluded "that for doses up to 160 mg/m²: 1) Taxol can be safely given as a 3 ...


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