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United States Court of Appeals for the Federal Circuit
October 21, 2008, Decided
[***1164] [*1343] 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. 1 We 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.
This suit concerns two Abbott Laboratories patents on extended release formulations of the antibiotic drug clarithromycin, sold by Abbott with the brand name Biaxin(R)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 [**3] 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 [***1165] States Patent No. 6,010,718 (the '718 patent) and Patent No. 6,551,616 (the '616 patent). Abbott also charged infringement [*1344] of Patent No. 6,872,407, but has withdrawn this patent from suit.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 [**4] 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.
Full case includes Shepard's, Headnotes, Legal Analytics from Lex Machina, and more.
544 F.3d 1341 *; 2008 U.S. App. LEXIS 21880 **; 89 U.S.P.Q.2D (BNA) 1161 ***
ABBOTT LABORATORIES, Plaintiff-Appellee, v. SANDOZ, INC., Defendant-Appellant.
Prior History: [**1] Appeal from the United States District Court for the Northern District of Illinois in case no. 05-CV-5373, Judge David H. Coar.
Abbott Labs. v. Sandoz, Inc., 500 F. Supp. 2d 807, 2007 U.S. Dist. LEXIS 28185 (N.D. Ill., 2007)
district court, patent, preliminary injunction, merits, injunction, polymer, composition, clarithromycin, pharmaceutically, prior art, infringement, likelihood of success, substantial question, public interest, pharmacokinetic, inequitable conduct, azithromycin, erythromycin, derivative, immediate release, formulations, invalidity, factors, irreparable harm, limitations, disclose, patentee, movant, parameters, invention
Civil Procedure, Remedies, Injunctions, Preliminary & Temporary Injunctions, Appeals, Standards of Review, Abuse of Discretion, Patent Law, Anticipation & Novelty, General Overview, Defenses, Patent Invalidity, Fact & Law Issues, Equitable Relief, Temporary Restraining Orders, Nonobviousness, Elements & Tests, Prior Art, Ordinary Skill Standard, Inequitable Conduct, Burdens of Proof, Effect, Materiality & Scienter, Elements, Business & Corporate Compliance, Failure to Fulfill Duties, Infringement Actions, Claim Interpretation, Scope of Claim, Presumption of Validity, Grounds for Injunctions, Injunctions