Novartis Pharmaceuticals v. Abbott Laboratories

• Decision Date: 27 March 2003
• Docket Number: No. CIV.A.00-784 JJF.,CIV.A.00-784 JJF.
• Citation: 294 F.Supp.2d 557
• Parties: NOVARTIS PHARMACEUTICALS CORPORATION, Novartis AG, Novartis Pharma AG, and Novartis International Pharmaceutical Ltd., Plaintiffs, v. ABBOTT LABORATORIES, INC., Defendant.
• Court: U.S. District Court — District of Delaware

294 F.Supp.2d 557

NOVARTIS PHARMACEUTICALS CORPORATION, Novartis AG, Novartis Pharma AG, and Novartis International Pharmaceutical Ltd., Plaintiffs, v. ABBOTT LABORATORIES, INC., Defendant.

No. CIV.A.00-784 JJF.

United States District Court, D. Delaware.

March 27, 2003.

COPYRIGHT MATERIAL OMITTED

Stuart B. Young, Esquire, Josy W. Ingersoll, Esquire, John W. Shaw, Esquire of Young, Conaway, Stargatt & Taylor, Wilmington, DE, Of Counsel: Robert L. Baechtold, Esquire, Nicholas N. Kallas, Esquire and Diego Scambia, Esquire of Fitzpatrick, Cella, Harper & Scinto, New York, New York, for Plaintiffs.

Allen M. Terrell, Jr., Esquire, Jeffrey L. Moyer, Esquire, Peter B. Ladig, Esquire of Richards, Layton & Finger, Wilmington, DE, Of Counsel: Jeffrey I. Weinberger, Esquire, Ted Dane, Esquire, Andrea J. Weiss, Esquire and Sean P. Gates, Esquire of Munger, Tolles & Olson LLP, Los Angeles, CA, for Defendant.

MEMORANDUM OPINION

FARNAN, District Judge.

Pending before the Court is a Renewed Motion For Judgment As A Matter Of Law And Alternative Motion For A New Trial (D.I.434) filed by Defendant, Abbott Laboratories, Inc. By its Motion, Abbott Laboratories, Inc. requests the Court to enter judgment as a matter of law in its favor on Claim 81 of United States Patent No. 6,007,840. In the alternative, Abbott Laboratories, Inc. requests the Court to grant a new trial on the grounds that the Court erroneously excluded relevant evidence and the jury's verdict is facially inconsistent and against the clear weight of the evidence. For the reasons discussed, the Court will grant Abbott Laboratories, Inc.'s Motion For Judgment As A Matter Of Law and deny as moot its Alternative Motion For A New Trial.

BACKGROUND

I. Procedural Background

This action was brought by Plaintiffs, Novartis Pharmaceuticals Corporation, Novartis AG, Novartis Pharma AG, and Novartis International Pharmaceutical Ltd. (collectively, "Novartis") against Defendant, Abbott Laboratories, Inc. ("Abbott") alleging infringement of Claims 1, 3, 7 and 11 of United States Patent No. 5,342,625 (the "'625 Patent"), Claims 17-19, 25, 81-83 of United States Patent No. 6,007,840 (the "'840 Patent"), and Claims 13-15 and 19 of United States Patent No. 5,963,017 (the "'017 Patent"). After conducting a Markman hearing and construing the disputed terms of the patents, the Court held a jury trial. During trial, Novartis withdrew its claims based on the '017 Patent. In addition, Novartis withdrew several of its claims related to the '625 and '840 Patents, leaving the jury to consider only its claim of infringement pertaining to Claim 1 of the '625 Patent and Claim 81 of the '840 Patent. After deliberating, the jury returned a verdict in favor of Abbott on Novartis' claim that Abbott infringed Claim 1 of the '625 Patent. With regard to the '840 Patent, the jury returned a verdict in favor of Novartis on its claim that Abbott infringed Claim 81 of the '840 Patent.

II. Factual Background

A. The Patents Generally

Both the '625 Patent and the '840 Patent relate to pharmaceutical compositions of the drug cyclosporin, which is used to prevent organ rejection in transplant patients. Specifically, the '625 and '840 Patents disclose cyclosporin compositions in microemulsion pre-concentrate and microemulsion form, and oral methods for the administration of these compositions. Both patents claim priority from the same patent application, i.e. the predecessor application to the '625 Patent. In addition, both patents have nearly identical specifications.

Claim 1 of the '625 Patent defines compositions comprised of cyclosporin as the active ingredient and containing a hydrophilic phase component, a lipophilic phase component and a surfactant. In full, Claim 1 of the '625 Patent provides:

1. A pharmaceutical composition comprising a cyclosporin as active ingredient,

1) a hydrophilic phase component comprising

1.1) a pharmaceutically acceptable di-or partial-ether of the formula

R₁[O(CH₂)₂]_x-OR₂

wherein R₁ is C_1-5alkyl or tetrahydrofurfuryl, R₂ is hydrogen, C₁-alkyl or tetrahydrofurfuryl, and X is an integer from 1 to 6, or

1.2) 1, 2-propylene glycol;

2) a lipophilic phase component; and

3) a surfactant;

wherein said composition is a microemulsion pre-concentrate, which upon dilution with water to a ratio of 1:1 parts by weight pre-concentrate to water or more of said water, is capable of providing an oil-in-water microemulsion having average particle size of less than about 1,000 E.

(D.I. 412, Ex. A, '625 Patent, col. 33, ll. 15-35).

Claim 81 of the '840 Patent is narrower than Claim 1 of the '625 Patent and sets forth the weights and proportions of the various components comprising a pharmaceutical cyclosporin composition. In full, Claim 81 of the '840 Patent provides:

An oral pharmaceutical composition comprising about 5 to about 25% by weight of cyclosporin A, about 0.5 to about 90% by weight of a lipophilic component, about 0.5 to about 90% by weight of a hydrophilic surfactant, all weight percents being based on the total weight of the composition, the relative proportion of said cyclosporin A, hydrophilic component, lipophilic component and hydrophilic surfactant being such that upon dilution of said composition with adequate water, an oil-in-water microemulsion having an average particle size of less than about 1,500 E is spontaneously formed.

(D.I. 412, Ex. A, '840 Patent, col. 38, ll. 58-67 — col. 39, ll. 1-2).

B. The Court's Claim Construction

Both the asserted claims of the '625 and '840 Patents require that the formulation contain a lipophilic component. ('625 Patent at col. 33-34; '840 Patent at col. 34-39). Specifically, Claim 1 of the '625 Patent requires a "lipophilic phase component" and Claim 81 of the '840 Patent requires a "lipophilic component."

In its claim construction, the Court construed the phrase "lipophilic phase component" to require:

at least one excipient meeting the following criteria: (1) a pharmaceutically acceptable lipophilic solvent in which cyclosporin is soluble, which is (2) immiscible with both water and the hydrophilic phase component(s) (in the absence of a surfactant), and which (3) lacks the amphiphilic function characteristic of a surfactant (i.e. it must not be a surfactant).

(D.I.341). The parties agreed and the Court recognized in its claim construction decision that the term "lipophilic component" as used in the Claim 81 of the '840 Patent has the same meaning as the term "lipophilic phase component" in Claim 1 of the '625 Patent. (D.I. 342 at 3, n. 1).

In addition to this common element, both claims require the spontaneous formation of an oil-in-water microemulsion upon addition to water. Addressing the parties dispute with respect to the phrase "oil-in-water microemulsion," the Court concluded that the specification provided sufficient detail regarding the meaning of the phrase, such that additional claim construction by the Court was unnecessary. (D.I. 342 at 8-9) (citing '625 Patent, col. 5, ll. 61-col.6, ll. 18; col. 6, ll. 63-68).

C. The Accused Product

By its Complaint, Novartis contends that Abbott's product, Gengraf, infringes Claim 1 of the '625 Patent and Claim 81 of the '840 Patent. Gengraf is a generic cyclosporin capsule containing an ingredient known as Span 80.

DISCUSSION

I. Standard of Review

A. Legal Standard For Judgment As A Matter Of Law

To prevail on a renewed motion for judgment as a matter of law following a jury trial, the moving party "`must show that the jury's findings, presumed or express are not supported by substantial evidence or, if they were, that the legal conclusions implied [by] the jury's verdict cannot in law be supported by those findings.'" Pannu v. Iolab Corp., 155 F.3d 1344, 1348 (Fed.Cir.1998) (quoting Perkin-Elmer Corp. v. Computervision Corp., 732 F.2d 888, 893 (Fed.Cir.1984)). In assessing the sufficiency of the evidence, the court must give the non-moving party, "as [the] verdict winner, the benefit of all logical inferences that could be drawn from the evidence presented, resolve all conflicts in the evidence in his favor, and in general, view the record in the light most favorable to him." Williamson v. Consolidated Rail Corp., 926 F.2d 1344, 1348 (3d Cir.), reh'g en banc denied, (3d Cir. Mar. 29, 1991); Perkin-Elmer Corp., 732 F.2d at 893. In sum, the court must determine whether the evidence reasonably supports the jury's verdict. See Dawn Equip. Co. v. Kentucky Farms, Inc., 140 F.3d 1009, 1014 (Fed.Cir.1998); 9A Wright & Miller, Federal Practice & Procedure § 2524 at 249-266 (3d ed. 1995) ("The question is not whether there is literally no evidence supporting the party against whom the motion is directed, but whether there is evidence upon which the jury properly could find a verdict for that party.")

B. Legal Standard For The Grant Of A New Trial

In pertinent part, Federal Rule of Civil Procedure 59(a) provides:

A new trial may be granted to all or any of the parties and on all or part of the issues in an action in which there has been a trial by jury, for any of the reasons for which new trials have heretofore been granted in actions at law in the courts of the United States.

Fed.R.Civ.P. 59(a). Among the most common reasons for granting a new trial are the following: (1) the jury's verdict is against the clear weight of the evidence, and a new trial must be granted to prevent a miscarriage of justice; (2) newly discovered evidence exists that would likely alter the outcome of the trial; (3) improper conduct by an attorney or the court unfairly influenced the verdict; or (4) the jury's verdict was facially inconsistent. Zarow-Smith v. New Jersey Transit Rail Operations, 953 F.Supp. 581, 584 (D.N.J.1997) (citations omitted).

The decision to grant or deny a new trial is committed to the sound discretion of the district court. Allied Chemical Corp. v. Daiflon, Inc., 449 U.S. 33, 36, 101 S.Ct. 188, 66 L.Ed.2d 193 (1980); Olefins Trading, Inc. v. Han...