Abbott Laboratories v. Sandoz, Inc.

• Decision Date: 21 October 2008
• Docket Number: No. 2007-1300.,2007-1300.
• Citation: 544 F.3d 1341
• Parties: ABBOTT LABORATORIES, Plaintiff-Appellee, v. SANDOZ, INC., Defendant-Appellant.
• Court: U.S. Court of Appeals — Federal Circuit

544 F.3d 1341

ABBOTT LABORATORIES, Plaintiff-Appellee, v.SANDOZ, INC., Defendant-Appellant.

No. 2007-1300.

United States Court of Appeals, Federal Circuit.

October 21, 2008.

Ted G. Dane, Munger, Tolles & Olson LLP, of Los Angeles, CA, argued for plaintiff-appellee.With him on the brief were Jeffrey I. Weinberger; and Jennifer L. Polse, Jason Rantanen, and Genevieve A. Cox, of San Francisco, California.Of counsel was Andrew W. Song, of Los Angeles, CA.

Scott B. Feder, Lord, Bissell & Brook LLP, of Chicago, IL, argued for defendant-appellant.With him on the brief were Keith D. Parr, Hugh S. Balsam, and Kevin M. Nelson.Of counsel on the brief was Shashank Upadhye, Sandoz, Inc., of Princeton, NJ.Of counsel were David B. Abramowitz, Myoka M. Kim, and James T. Peterka, of Lord, Bissell & Brook LLP, of Chicago, IL.

Jeffrey L. Light, Patients Not Patents, Inc., of Washington, DC, for amicus curiaePatients Not Patents, Inc.

Gregory A. Castanias, Jones Day, of Washington, DC, for amicus curiaeUnited Inventors Association.With him on the brief was Christopher S. Perry.

Before NEWMAN, Circuit Judge, ARCHER, Senior Circuit Judge, and GAJARSA, Circuit Judge.

Opinion for the court filed by Circuit Judge NEWMAN, in which Circuit Judge ARCHER concurs in the judgment and joins except as to Parts I and VI.Dissenting opinion filed by Circuit Judge GAJARSA.

NEWMAN, Circuit Judge.

This appeal is from the grant of a preliminary injunction, pending final resolution of the several challenges raised by Sandoz, Inc. to the validity, enforceability, and infringement of the Abbott Laboratories patents in suit.¹We conclude that abuse of discretion has not been shown in the district court's decision to grant the injunction pendente lite.That decision is affirmed.

BACKGROUND

This suit concerns two Abbott Laboratories patents on extended release formulations of the antibiotic drug clarithromycin, sold by Abbott with the brand name Biaxin®XL.The patent on clarithromycin itself expired in 2005; only extended release formulations are at issue.The purpose of the extended release formulation is to extend the period of drug effectiveness after ingestion and thereby to reduce the requisite frequency of dosage.Sandoz filed an Abbreviated New Drug Application (ANDA) for its extended release formulation of clarithromycin; the Food and Drug Administration approved the ANDA on August 25, 2005, and on September 16, 2005 Abbott filed suit in the United States District Court for the Northern District of Illinois, charging Sandoz with infringement of United States PatentNo. 6,010,718(the '718 patent) and PatentNo. 6,551,616(the '616 patent).Abbott also charged infringement of PatentNo. 6,872,407, but has withdrawn this patent from suit.

The '718 patent claims an extended release pharmaceutical composition comprising an erythromycin derivative and a pharmaceutically acceptable polymer, whereby after ingestion certain specified parameters of drug bioavailability are met.Claims 1, 4, and 6 of the '718 patent are in suit:

1.A pharmaceutical composition for extended release of an erythromycin derivative in the gastrointestinal environment, comprising an erythromycin derivative and from about 5 to about 50% by weight of a pharmaceutically acceptable polymer, so that when ingested orally, the composition induces statistically significantly lower mean fluctuation index in the plasma than an immediate release composition of the erythromycin derivative while maintaining bioavailability substantially equivalent to that of the immediate release composition of the erythromycin derivative.

4.A pharmaceutical composition for extended release of an erythromycin derivative in the gastrointestinal environment, comprising an erythromycin derivative and from about 5 to about 50% by weight of a pharmaceutically acceptable polymer, so that upon oral ingestion, maximum peak concentrations of the erythromycin derivative are lower than those produced by an immediate release pharmaceutical composition, and area under the concentration-time curve and the minimum plasma concentrations are substantially equivalent to that of the immediate release pharmaceutical composition.

6.An extended release pharmaceutical composition comprising an erythromycin derivative and a pharmaceutically acceptable polymer, the composition having an improved taste profile as compared to the immediate release formulation.

The '616 patent is a continuation-in-part of the '718 patent, with claims directed to the method of reducing gastrointestinal side effects.Claim 2 is in suit, shown with claim 1 from which it depends:

1.A method of reducing gastrointestinal adverse side effects comprising administering an effective amount of extended release pharmaceutical composition comprising an erythromycin derivative and a pharmaceutically acceptable polymer.

2.The method according to claim 1, wherein the erythromycin derivative is clarithromycin.

In response to the charge of infringement Sandoz presented the defenses of invalidity based on anticipation and obviousness, unenforceability based on inequitable conduct, and noninfringement.This appeal is from the district court's grant of Abbott's motion for a preliminary injunction, preserving the status quo during the pendency of this litigation.Sandoz challenges the district court's rulings on all issues.

IVALIDITY ISSUES

The district court reviewed the factors relevant to the grant or denial of a preliminary injunction, viz.,(1) likelihood of success on the merits of the underlying litigation, (2) whether irreparable harm is likely if the injunction is not granted, (3) the balance of hardships as between the litigants, and (4) factors of the public interest.SeeOakley, Inc. v. Sunglass Hut Int'l,316 F.3d 1331, 1338-39(Fed.Cir.2003);H.H. Robertson Co. v. United Steel Deck, Inc.,820 F.2d 384, 387-88(Fed.Cir.1987).At the stage of the preliminary injunction, before the issues of fact and law have been fully explored and finally resolved, "[t]he purpose of a preliminary injunction is merely to preserve the relative positions of the parties until a trial on the merits can be held."University of Texas v. Camenisch,451 U.S. 390, 395, 101 S.Ct. 1830, 68 L.Ed.2d 175(1981).

On appellate review of the grant of a preliminary injunction, the question "is simply whether the issuance of the injunction constituted an abuse of discretion."Doran v. Salem Inn,422 U.S. 922, 932, 95 S.Ct. 2561, 45 L.Ed.2d 648(1975)."It is well settled that the granting of a temporary injunction, pending final hearing, is within the sound discretion of the trial court; and that, upon appeal, an order granting such an injunction will not be disturbed unless contrary to some rule of equity, or the result of improvident exercise of judicial discretion."Deckert v. Independence Shares Corp.,311 U.S. 282, 290, 61 S.Ct. 229, 85 L.Ed. 189(1940).Abuse of discretion is established "by showing that the court made a clear error of judgment in weighing relevant factors or exercised its discretion based upon an error of law or clearly erroneous factual findings."Novo Nordisk of North America, Inc. v. Genentech, Inc.,77 F.3d 1364, 1367(Fed.Cir.1996).SeeCybor Corp. v. FAS Technologies, Inc.,138 F.3d 1448, 1460(Fed.Cir.1998)(en banc)("A district court abuses its discretion when its decision is based on clearly erroneous findings of fact, is based on erroneous interpretations of the law, or is clearly unreasonable, arbitrary or fanciful.").

Sandoz assigns legal error to the district court's rulings that Abbott is likely to prevail on the issues of validity, infringement, and inequitable conduct, and states that the district court abused its discretion in balancing the equities and granting the injunction.

Anticipation

"Anticipation" in patent usage means that the claimed invention was previously known and described in a printed publication, explicitly or inherently.Anticipation is established by documentary evidence, and requires that every claim element and limitation is set forth in a single prior art reference, in the same form and order as in the claim.SeeIn re Omeprazole Patent Litigation,483 F.3d 1364, 1373(Fed.Cir.2007);Continental Can Co. v. Monsanto Co.,948 F.2d 1264, 1267(Fed.Cir.1991).An anticipating reference must enable that which it is asserted to anticipate.Omeprazole,483 F.3d at 1378("To `anticipate,' the identical subject matter must not only be previously known, but the knowledge must be sufficiently enabling to place the information in the possession of the public.");Elan Pharmaceuticals, Inc. v. Mayo Found. for Medical Educ. & Research,346 F.3d 1051, 1054(Fed.Cir.2003)(same).

Sandoz argued that the '718 patent is anticipated by European Patent PublicationNo. 0,280,571 B1(the '571 Publication), which describes "a sustained release matrix formulation in tablet form comprising from 0.1% by weight to 90% by weight of an antimicrobial agent selected from ... erythromycin ... from 5% by weight to 29% by weight of a hydrophilic polymer, and from 0.5% by weight to 25% by weight of an acrylic polymer. ..."The '571 Publication states that hydrophilic polymers such as hydroxypropylmethyl cellulose (HPMC) can be used to form a hydrophilic matrix which "respond[s] to increases in pH with a corresponding increase in the permeability of the dosage form."Sandoz argued in the district court that although the '571 Publication does not mention clarithromycin or the specific pharmacokinetic limitations in the '718 patent claims, the '571 Publication anticipates the '718 claims because clarithromycin is an erythromycin derivative and the claimed pharmacokinetic limitations are inherent in the extended release compositions of the '571 Publication.Sandoz also argued that enablement of the compositions in the '571 Publication must be presumed, because the compositions in the '718 patent are presumed to be enabled and,...