Novartis Pharmaceuticals Corp. v. Abbott Labs.

• Decision Date: 08 July 2004
• Docket Number: No. 03-1367.,No. 03-1393.,03-1367.,03-1393.
• Citation: 375 F.3d 1328
• Parties: NOVARTIS PHARMACEUTICALS CORPORATION, Novartis AG, Novartis Pharma AG, and Novartis International Pharmaceutical Ltd., Plaintiffs-Appellants, v. ABBOTT LABORATORIES, Defendant-Cross Appellant.
• Court: U.S. Court of Appeals — Federal Circuit

Page 1328

375 F.3d 1328

NOVARTIS PHARMACEUTICALS CORPORATION, Novartis AG, Novartis Pharma AG, and Novartis International Pharmaceutical Ltd., Plaintiffs-Appellants, v. ABBOTT LABORATORIES, Defendant-Cross Appellant.

No. 03-1367.

No. 03-1393.

United States Court of Appeals, Federal Circuit.

July 8, 2004.

Rehearing and Rehearing En Banc Denied August 31, 2004.

Robert L. Baechtold, Fitzpatrick, Cella, Harper & Scinto, of New York, NY, argued for plaintiffs-appellants. With him on the brief were Nicholas N. Kallas, Stevan J. Bosses, and Diego Scambia.

Jeffrey I. Weinberger, Munger, Tolles & Olson LLP, of Los Angeles, CA, argued for defendant-cross appellant. With him on the brief were Ted G. Dane and Andrea Weiss Jeffries.

Before BRYSON, GAJARSA, and PROST, Circuit Judges.

Opinion of the Court filed by Circuit Judge PROST. Dissenting opinion filed by Circuit Judge BRYSON.

PROST, Circuit Judge.

Appellants Novartis Pharmaceuticals Corporation, Novartis AG, Novartis Pharma AG, and Novartis International Pharmaceutical Ltd. (collectively "Novartis") appeal the claim construction and entry by the United States District Court for the District of Delaware of a judgment as a matter of law ("JMOL") for noninfringement of United States Patent No. 6,007,840 ("the '840 patent") in favor of Abbott Laboratories ("Abbott"). Novartis Pharms. Corp. v. Abbott Labs., Inc., 294 F.Supp.2d 557 (D.Del.2003). While we reverse the claim construction of "lipophilic component," we perceive no error in the district court's finding that no reasonable juror could conclude that an equivalent to a pharmaceutically acceptable non-surfactant lipophilic excipient, which is capable of dissolving cyclosporin, is present in Abbott's accused product. Accordingly, we affirm the grant of JMOL for noninfringement.

BACKGROUND

Novartis commenced a lawsuit against Abbott for allegedly infringing United States Patent No. 5,342,625 ("the '625 patent") and the '840 patent. The '625 and '840 patents relate to pharmaceutical compositions of the drug cyclosporin, which help prevent organ rejection in transplant patients. Cyclosporin is highly hydrophobic, and as a consequence, has been difficult to administer in a convenient form that provides the desired bioavailability to a patient. '840 patent, col. 3, l. 32, col. 4, ll. 32-40. The two patents asserted by Novartis are directed to compositions that facilitate human absorption of cyclosporin by use of a microemulsion. '625 patent, col. 5, ll. 1-5; '840 patent, col. 4, l. 64-col. 5, l. 1.

After the district court conducted a Markman hearing and construed the disputed terms in the '625 and the '840 patents, Novartis narrowed its allegation of infringement in its complaint to claim 1 of the '625 patent¹ and claim 81 of the '840 patent². Each of the remaining asserted claims calls for a microemulsion pre-concentrate composition that, upon addition of water, forms an oil-in-water ("o/w") microemulsion. The parties disputed, among other things, whether Abbott's product includes a "lipophilic phase component" in the '625 patent or a "lipophilic component" in the '840 patent. In addition, the parties disputed whether "surfactant," as it is used in each of the asserted patents, encompasses both hydrophilic and lipophilic surfactants.

In its claim construction of the phrase "lipophilic phase component," the district court held that the term requires:

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).

Novartis, 294 F.Supp.2d at 561 (emphasis added). The district court construed "surfactant" to encompass both hydrophilic and lipophilic surfactants. While Novartis disputes whether the claim construction of "lipophilic phase component" is correct, the parties agree that this term bears the same meaning as the term "lipophilic component," as used in the '840 patent.³

According to Abbott, its accused product, Gengraf, is a cyclosporin formulation that contains only hydrophilic excipients and surfactants. The accused product contains an ingredient called Span 80, which Abbott contends is a surfactant and not a "lipophilic component." After the parties put on their evidence, the district court permitted Novartis to submit to the jury the question of whether Abbott infringes either of the asserted patents under the doctrine of equivalents. The jury returned a verdict finding that Abbott did not infringe claim 1 of the '625 patent, but did infringe claim 81 of the '840 patent. Abbott moved for a judgment as a matter of law ("JMOL") in its favor on claim 81, or in the alternative, a new trial because the district court had erroneously excluded relevant evidence and because the '840 verdict is facially inconsistent with the '625 verdict and against the clear weight of evidence.

The district court granted Abbott's motion for a JMOL. Id. at 567. The court noted that under its claim construction, "the `lipophilic phase component' cannot be a surfactant." Id. at 565; see also id. at 566 ("Under the Court's claim construction, Novartis is precluded from claiming that surfactants are the equivalent of the `lipophilic phase component.'"). In construing the claims and concluding that surfactants cannot be a component of the lipophilic phase, the district court relied on a passage from the '625 specification, which states:

Suitable components for use as lipophilic phase include any pharmaceutically acceptable solvent which is non-miscible with the selected hydrophilic phase, e.g. as defined under (1.1.) or (1.2.). Such solvents will appropriately be devoid or substantially devoid of surfactant function.

'625 patent, col. 8, ll. 58-63. The court effectively read this language as a disavowal of any lipophilic component having surfactant function. In addition, the district court noted that the enumeration of three excipient components in the claim language gave support to viewing each component as separate and distinct. Lastly, the district court observed that the patentee had acknowledged during the prosecution of the application that led to the '840 patent that distinctions exist between surfactant and lipophilic compounds that differentiate the chemical entity of each class of compound. According to the district court, "[b]ecause surfactants are expressly excluded from coverage, a surfactant acting as the `lipophilic phase component' is inconsistent with the language of the claim, as construed by the Court." Novartis, 294 F.Supp.2d at 567. Because Span 80 is a surfactant, the district court reasoned that Novartis could not, as a matter of law under the specific exclusion principle, establish that the substance is an equivalent to the "lipophilic component." Id. Accordingly, the district court concluded that Novartis could not demonstrate that Abbott infringes under the doctrine of equivalents. Id.

STANDARD OF REVIEW

In a determination of infringement, the claims must be first construed by the court, and then the properly construed claims must be compared to the accused product by the fact finder. Cybor Corp. v. FAS Techs. Inc., 138 F.3d 1448, 1454 (Fed.Cir.1998) (en banc). If challenged, we review claim construction de novo. Golight, Inc. v. Wal-Mart Stores, Inc., 355 F.3d 1327, 1330 (Fed.Cir.2004); Markman v. Westview Instruments, Inc., 52 F.3d 967, 970 (Fed.Cir.1995) (en banc), aff'd, 517 U.S. 370, 116 S.Ct. 1384, 134 L.Ed.2d 577 (1996). We likewise review the grant of a JMOL for noninfringement de novo, reapplying the JMOL standard used by the district court. Ericsson, Inc. v. Harris Corp., 352 F.3d 1369, 1373 (Fed. Cir.2003); Markman, 52 F.3d at 975. "To prevail on a renewed motion for JMOL following a jury trial, a party `must show that the jury's findings, presumed or express, are not supported by substantial evidence or, if they were, that the legal conclusion(s) 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) (citing Perkin-Elmer Corp. v. Computervision Corp., 732 F.2d 888, 893 (Fed.Cir.1984)); Fed. R.Civ.P. 50(b). If the former situation applies, "we must view the evidence in the light most favorable to the non-moving party, and determine whether the record contains the `minimum quantum of evidence from which a jury might reasonably afford relief.'" Glenn Distribs. Corp. v. Carlisle Plastics, Inc., 297 F.3d 294, 299 (3d Cir.2002) (quoting Parkway Garage, Inc. v. City of Philadelphia, 5 F.3d 685, 691 (3d Cir.1993)).

DISCUSSION

I. Collateral Estoppel

As a threshold issue, Abbott asserts that Novartis is barred in this appeal from challenging the jury verdict on the '625 patent or the JMOL on the '840 patent. Because the parties agree that the terms "lipophilic component" and "surfactant" are common to the '625 and '840 patents, Abbott argues that Novartis' failure to challenge the construction of these terms in connection with the '625 patent estops Novartis from challenging their meaning in the related '840 patent. According to Abbott, "any legal determinations or factual findings necessary to the jury's verdict as to claim 1 of the '625 patent, the parent of the '840 patent, must be accorded preclusive effect." (Citing Mycogen Plant Science, Inc. v. Monsanto Co., 252 F.3d 1306, 1311 (Fed.Cir.2001)).

Novartis claims that it preserved its right to challenge the jury verdict on the '625 patent, and that collateral estoppel does not apply to preclude its challenge to the JMOL on the '840 patent. As evidence, Novartis notes that when discussing the construction of the term "surfactant," it pointed out that the correct construction of this term is relevant only to the '625 patent. Novartis further observes that it...