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Bristol-Myers Squibb Co. v. Ben Venue Laboratories

March 24, 2000

BRISTOL-MYERS SQUIBB COMPANY,
PLAINTIFF,
V.
BEN VENUE LABORATORIES AND BEDFORD LABORATORIES,
IMMUNEX CORPORATION,
ZENITH GOLDLINE PHARMACEUTICALS, INC. AND IVAX CORPORATION,
MYLAN PHARMACEUTICALS,
SCHEIN PHARMACEUTICALS AND MARSAM PHARMACEUTICALS,
DEFENDANTS.



The opinion of the court was delivered by: William H. Walls, U.S.D.J.

OPINION

William H. Walls, U.S.D.J.

INTRODUCTION and BACKGROUND

Plaintiff Bristol-Myers Squibb Company ("Bristol") moves for summary judgment that U.S. Patent Nos. 5,641,803 ("the `803 patent") and 5,670,537 ("the `537 patent") are not unenforceable due to inequitable conduct. Defendants and counterclaimants, Zenith Goldline Pharmaceuticals, Inc., IVAX Corporation, Baker Norton Pharmaceuticals, Inc., and Immunex Corporation (collectively "IVAX") oppose this motion. Defendants Mylan, Schein and Marsam join and adopt IVAX's arguments. So too defendants Ben Venue Laboratories, Inc. and Bedford Laboratories (together "Ben Venue"), who also separately oppose the motion.

Bristol has asserted its `803 and `537 patents against each defendant. Although U.S. Patent No. 5,621,001 ("the `001 patent"), has not been asserted against any defendant, its prosecution history is relevant. Each of these three patents descended from the same "grandparent," U.S. Patent application Serial No. 07/923,628 ("the `628 application"), filed August 3, 1992. During the five-year prosecution history, Bristol filed numerous divisional applications, amended and deleted claims, sometimes pursuant to restriction requirements mandated by the patent examiner. See chart, Bristol Motion I, Exh. C. Ultimately, the `803 and `537 patents issued from continuation applications descended from "parent" application 08/109,331 ("the `331 application"). In contrast, the `001 patent issued from continuation applications of the `404 application, located in a separate chain from the `331 application.

The Ben Venue defendants allege the following: Pursuant to a 1991 Cooperative Research and Development Agreement ("CRADA") between Bristol and the National Cancer Institute ("NCI"), Bristol obtained exclusive rights to all of NCI's development work with taxol. Using that work, in July 1992, Bristol filed a New Drug Application ("NDA") with the FDA for approval to market taxol in the United States. In December 1992, the FDA approved Bristol's NDA, and pursuant to the Hatch-Waxman Act, Bristol received five years of marketing exclusivity.

These defendants allege that in order to maintain its monopoly, despite representations to Congress that taxol was not patentable, Bristol filed its first patent application in August 1992. They describe the financial incentives: "A Bristol patent could be listed in the FDA's Orange Book, with the consequence that potential generic competitors would have to challenge Bristol's patents before they could obtain approval from FDA to market their generic drugs. Under the Hatch-Waxman Act, any such patent challenge results in an automatic 30 month delay of generic approvals, unless the litigation is terminated earlier." Ben Venue Br. at 2-3; 21 U.S.C. § 355(j)(5)(B)(iii). Over the ensuing years, defendants assert, various patent claims submitted by Bristol were rejected as anticipated or rendered obvious by prior art references. Finally, between April and September 1997, immediately before Bristol's Hatch-Waxman exclusivity was to expire, the patent examiner allowed four separate patents concerning taxol to Bristol as assignee.

The defendants accuse Bristol of inequitable conduct at two stages: during the prosecution of the `803 and `537 patents; and during the prosecution of the non-asserted `001 patent, under a theory of "infectious unenforceability."

Bristol has filed two pending motions. In the present motion, which Bristol calls "Bristol Motion II," the plaintiff moves for summary judgment of no inequitable conduct. And by "Bristol Motion I," Bristol moves for summary judgment on defendants' remaining Walker Process counterclaims. Arguments and exhibits from that motion are incorporated herein by reference.

DISCUSSION

1. Summary Judgment Standard

Summary judgment is appropriate where the moving parties establish that "there is no genuine issue as to any material fact and that [they are] entitled to a judgment as a matter of law." Fed. R. Civ. P. 56(c). 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 (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 Anderson, 477 U.S. at 248. 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 (1986).

Once the moving party has carried its burden under Rule 56, the opposing parties "must do more than simply show that there is some metaphysical doubt as to the material facts in question." Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 586 (1986). They must set forth specific facts showing a genuine issue for trial and may not rest upon the mere allegations or denials of their pleadings. See Sound Ship Building Co. v. Bethlehem Steel Co., 533 F.2d 96, 99 (3rd Cir. 1976), cert. denied, 429 U.S. 860 (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, 477 U.S. at 249. In doing so, the court must construe the facts and inferences in the light most favorable to the non-moving parties. See Wahl v. Rexnord, Inc. 624 F.2d 1169, 1181 (3rd Cir. 1980). Summary judgment is as appropriate in a patent case as in any other. See, e.g., Desper Products, Inc. v. QSound Labs, Inc., 157 F.3d 1325, 1332 (Fed. Cir. 1998).

Thus, the "proper inquiry . . . is `whether the evidence presents a sufficient disagreement to require submission to a jury or whether it is so one-sided that one party must prevail as a matter of law.'" Paragon Podiatry Laboratory, Inc. v. KLM Laboratories, Inc., 984 F.2d 1182, 1185 (Fed. Cir. 1993) (citation omitted). "[S]ummary judgment is authorized when it is quite clear what the truth is." Id.

2. Inequitable Conduct Standard

A patent applicant has a duty to prosecute applications before the Patent and Trademark Office (PTO) with candor, good faith and honesty. Molins PLC v. Textron, Inc., 48 F.3d 1172, 1178 (Fed. Cir. 1995). Inequitable conduct includes affirmative misrepresentation of a material fact, failure to disclose material information or submission of false material information, coupled with an intent to deceive. Id. In this regard, the knowledge and actions of an applicant's representatives are chargeable to the applicant. FMC Corp. v. Manitowoc Co., 835 F.2d 1411, 1415 n.8 (Fed. Cir. 1987).

The determination of inequitable conduct is committed to the court's discretion. Critikon, Inc. v. Becton Dickinson Vascular Access, Inc., 120 F.3d 1253, 1255 (Fed. Cir. 1997). To prevail, a defendant must produce clear and convincing evidence of both materiality and intent to deceive. Kingsdown Med. Cons., Ltd. v. Hollister, 863 F.2d 867, 872 (Fed. Cir. 1988). Once threshold findings of materiality and intent are made, the court must weigh them together to determine whether a conclusion of inequitable conduct is warranted. Halliburton Co. v. Schlumberger Tech. Corp., 925 F.2d 1435, 1439 n.3 (Fed. Cir. 1991). The more material the omission or misrepresentation, the less intent that must be shown to reach a conclusion of inequitable conduct, and vice versa. Akzo N.V. v. U.S. Int'l Trade Comm'n, 808 F.2d 1471, 1481-82 (Fed. Cir. 1986). Close cases should not be resolved unilaterally by the applicant, but rather through disclosure to the PTO. LaBounty Mfg., Inc. v. U.S. Int'l Trade Comm'n, 958 F.2d 1066, 1076 (Fed. Cir. 1992).

"The starting point in determining materiality is the definition of the PTO." Critikon, 120 F.3d at 1257. PTO Rule 56 provides that "information is material to patentability when it is not cumulative to information already of record or being made of record in the application, and . . . [i]t establishes, by itself or in combination with other information, a prima facie case of unpatentability of a claim; or . . . [i]t refutes, or is inconsistent with, a position the applicant takes in: . . . [o]pposing an argument of unpatentability relied on by the Office, or [a]sserting an argument of patentability." 37 C.F.R. § 1.56 (1999). The standard is not whether the particular examiner of the application at issue considered a reference important; rather, the appropriate inquiry focuses on a "reasonable examiner." Molins, 48 F.3d at 1179. Finally, a reference is not immaterial simply because claims are ultimately patented thereover. Id.

In turn, because direct evidence of intent to deceive is rarely available, the intent element may be inferred from the surrounding circumstances. J.P. Stevens & Co. v. Lex Tex, Ltd., 747 F.2d 1553, 1559 (Fed. Cir. 1984). Thus, "smoking gun" evidence is not required in order to establish an intent to deceive. Paragon, 984 F.2d at 1189-90. An inference of intent is warranted where a patent applicant knew or should have known that the withheld information would be material to the PTO's consideration of the patent application. Critikon, 120 F.3d at 1256. "In a case involving nondisclosure of information, clear and convincing evidence must show that the applicant made a deliberate decision to withhold a known material reference." Molins, 48 F.3d at 1181. 3. Whether A Triable Issue Exists As To Bristol's Inequitable Conduct in

Prosecuting the `537 and `803 Patents

Bristol claims that the record evidence shows that its representatives, particularly patent counsel, provided "the most pertinent prior art" to the patent examiner during prosecution of the two patents at issue. For this motion, the plaintiff considers only the 14 material misrepresentations alleged by defendants in their Expert Reports of December 2, 1999. See Bristol Br. at 18. Bristol claims that thirteen of these alleged misrepresentations relate to characterizations by patent counsel or inventor Renzo Canetta of five prior art references authored by Longnecker et al., Donehower et al., Kris et al., Wiernik et al., and Weiss et al. Id. The patentee further claims that counsel provided these five references to the patent examiner, who acknowledged that he read and considered each document. See Bristol Statement of Material Facts ¶¶ 14, 23, 27, 44, 52, 57 (asserting that Kris et al. and other unspecified references were disclosed on various Information Disclosure Statements ("IDS")). Absent proof to the contrary, the court presumes that the examiner did consider the cited references. Molins, 48 F.3d at 1184.

The crux of Bristol's argument is that it delivered all material prior art as required to the patent examiner. And that, under Federal Circuit precedent, it was then free to advocate for the patentability of its inventions over the disclosed references. See Akzo N.V. v. U.S. Int'l Trade Comm'n, 808 F.2d 1471, 1482 (Fed. Cir. 1986).

The defendants, both IVAX and Ben Venue, challenge that conclusion.

A. References Withheld from the PTO

i. The O'Connell Abstract

Initially, the IVAX defendants claim that Bristol acted inequitably by failing to disclose the O'Connell reference, which reported the results of a Phase I study where taxol had been administered over a 2-3 hour infusion period every three weeks. The reported dosage range began at 15 mg/m2 and rose to 230 mg/m2. O'Connell concluded: "[F]or doses up to 160 mg/m2 . . . Taxol can be safely given as a 3 hour infusion every 3 weeks." See O'Connell et al., "Phase I Trial of Taxol Given as a Three Hour Infusion Every Three Weeks," 26 Proceedings of AACR, 169 (671) (1985), Holland Decl. Exh. C. IVAX charges that this reference is significant because it reported administration of doses of 135 and 160 mg/m2, which fall within the range of doses claimed in the patents at issue, to be safe.

Bristol, in its other motion for summary judgment ("Bristol Motion I"), claims that the O'Connell reference is not material because it is cumulative to the Kris et al. study. Id. at 30. The Kris study was cited as prior art in the `537 patent and referenced in the `803 patent. See Bristol Statement of Material Facts in Supp. of Bristol Motion I ¶ 127; Haas Decl. Exh. 3 (`537 patent); Exh. 2, cols. 1-2 (`803 patent). The plaintiff characterizes O'Connell as a "preliminary summary" of the Kris study, which IVAX does not dispute.

Bristol relies upon the Federal Circuit's affirmance of a district court's grant of partial summary judgment of no inequitable conduct where an applicant failed to submit a brief abstract of a study, but disclosed both the "complete" study itself and submitted several other references which cited the abstract. See Scripps Clinic & Research Found. v. Genentech, Inc., 927 F.2d 1565 (Fed. Cir. 1991). And, the Federal Circuit again in Regents of the University of California v. Eli Lilly & Co., 119 F.3d 1559, 1575 (Fed. Cir. 1997), held that the withholding of a prior art reference which described "essentially the same" work as that described in two disclosed articles could not support a finding of inequitable conduct. "[A] patentee has no obligation to disclose an otherwise material reference if the reference is cumulative or less material than those already before the examiner." Halliburton Co. v. Schlumberger Technology Corp., 925 F.2d 1435, 1440 (Fed. Cir. 1991).

Nonetheless, IVAX argues that Bristol should have disclosed the O'Connell reference for two reasons. First, these defendants allege that Bristol "mercilessly attacked" the Kris et al. study during prosecution of the patents-in-suit, and characterized the 3-hour dosing regimen taught by Kris as "unduly hazardous." See Declaration of Renzo Canetta Pursuant to 37 CFR § 1.132 in Support of `594 Application, Mentlik Sec. Suppl. Decl. Exh. J at 469 ("In my opinion, one of ordinary skill in the art would conclude, based upon the Kris et al. reference, that a 3-hour duration of infusion for the administration of paclitaxel would be unduly hazardous. Moreover, since Kris et al. observed no antitumor activity, virtually any toxicity manifestation would invalidate the treatment regimen used by Kris et al."). To the contrary, according to IVAX, the O'Connell reference by reporting that the regimen was safe refuted Bristol's argument to PTO.

The court takes the defendants' point. The decisions relied upon by Bristol relieve a patent applicant of the need to disclose an abstract or summary which reaches the same conclusions as a more complete study, when the latter is disclosed to the PTO. They should not be read to extend to circumstances, as here, where the author of an abstract had reached conclusions antinomic to those of the patent applicant. The IVAX defendants have made a colorable showing that the O'Connell abstract "refutes," or is at least "inconsistent with," Bristol's position before the PTO, and should have been disclosed. See 37 C.F.R. § 1.56 (1999).

Further, a fact finder may infer deceptive intent when a patent applicant withholds potentially pertinent information and makes arguments for patentability which could not have been made had the information been disclosed. LaBounty, 958 F.2d at 1076. At best, Bristol's argument that Dr. O'Connell's conclusions were "undermined" by later events in connection with the Kris study raises an issue of material fact whether the O'Connell reference was still material by 1992. Bristol was not free to unilaterally decide that the reference was immaterial. Id. at 1076.

The court concludes that the IVAX defendants have raised a genuine, triable issue concerning the materiality of this reference. To the extent the defendants' allegations of inequitable conduct rest on nondisclosure of the O'Connell abstract, Bristol's motion for summary judgment is denied.

Because of this disposition, the court does not now need to consider IVAX's argument that Bristol was additionally required to disclose the citation of the O'Connell article as prior art in a 1994 proceeding against Bristol's corresponding Australian patent. See Mentlik Third Suppl. Decl. Exh. W (Statement of Claim and Particulars of Grounds of ...


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