Abbott Laboratories v. Andrx Pharmaceuticals, Inc.
| Decision Date | 05 January 2007 |
| Docket Number | No. 06-1101.,06-1101. |
| Citation | 473 F.3d 1196 |
| Parties | ABBOTT LABORATORIES, Plaintiff-Appellee, v. ANDRX PHARMACEUTICALS, INC., Defendant-Appellant, and Roxane Laboratories, Inc. and Teva Pharmaceuticals USA, Inc., Defendants. |
| Court | U.S. Court of Appeals — Federal Circuit |
Jeffrey I. Weinberger, Munger, Tolles & Olson, LLP, of Los Angeles, CA, argued for plaintiff-appellee. With him on the brief was Ted G. Dane. Of Counsel on the brief were Jason Rantanen and Genevieve A. Cox, of San Francisco, CA.
Eric D. Isicoff, Isicoff, Ragatz & Koenigsberg, of Miami, FL, argued for defendant-appellant. With him on the brief was Teresa Ragatz. Of counsel on the brief were Alan B. Clement, Martin P. Endres, and Katharine G. Loving, Hedman & Costigan, P.C., of New York, NY; and Steven H. Sklar, Leydig, Voit & Mayer, Ltd., of Chicago, IL.
Before MICHEL, Chief Judge, PROST, Circuit Judge, ELLIS,* District Judge.
Abbott Laboratories ("Abbott") brought suit against Andrx Pharmaceuticals, Inc. ("Andrx") alleging infringement of its patents relating to extended release formulations of clarithromycin. Abbott moved for a preliminary injunction based on Andrx's alleged infringement of claims 1, 4, and 6 of U.S. Patent No. 6,010,718 ("'718 patent"); claim 2 of U.S. Patent No. 6,551,616 ("'616 patent"); and claims 8 and 16 of U.S. Patent No. 6,872,407 ("'407 patent"). The district court granted the injunction with respect to all the asserted claims. The court concluded that Abbott had shown a likelihood of proving infringement of the '616 and '718 patents under the doctrine of equivalents and infringement of the '407 patent under literal infringement, and that Andrx had not shown a likelihood of proving that any of the patents are invalid. Ranbaxy Labs. Ltd. v. Abbott Labs., Abbott Labs. v. Andrx Pharms. Inc., Nos. 04 C 8078, 05 C 1490 (N.D.Ill. Nov. 10, 2005) ("Ranbaxy-Andrx").1 Andrx appeals, arguing (1) that Abbott is collaterally estopped from asserting certain claims in the three patents because of findings of invalidity and unenforceability of the patents in proceedings against other defendants; and (2) that the district court erred in finding that Abbott is likely to succeed in proving infringement with respect to any of the asserted claims of the three patents. Because we find that collateral estoppel does not apply and the district court did not abuse its discretion in finding Abbott is likely to succeed on the merits, we affirm.
Abbott Laboratories accused several manufacturers of infringement of its patents related to its extended release clarithromycin product, Biaxin XL®. Three such cases are relevant to this appeal — Abbott's cases against Teva Pharmaceuticals ("Teva"), Ranbaxy, and Andrx, the defendant in the instant appeal. Each of these defendants sought approval to manufacture and market a generic version of Biaxin XL® and accordingly filed abbreviated new drug applications ("ANDAs") with the Food and Drug Administration ("FDA"). Each of the ANDAs was approved. Abbott's claims of infringement against these three defendants are all being heard before a single district judge in the Northern District of Illinois. Abbott filed motions for preliminary injunctions against each of the three generic drug manufacturers seeking to enjoin their production and marketing of extended release clarithromycin. The instant appeal is from the district court's grant of a preliminary injunction against Andrx based on the court's conclusion that Abbott is likely to prove infringement of the '718, '616, and '407 patents, and that Andrx is not likely to succeed in proving its defenses.
The '718 patent describes and claims extended release formulations comprising erythromycin derivatives combined with a pharmaceutically acceptable polymer. The extended release formulations enable patients to take one pill per day rather than twice, as had been required with the immediate release formulation. The '616 is a continuation-in-part of the '718 patent and claims a method of reducing adverse gastrointestinal side effects, relative to immediate release formulations of erythromycin-derived drug formulations, by using extended release formulations. The '407 patent is a continuation patent of the '616 patent and claims erythromycin derivative formulations with certain specified pharmacokinetic properties. The claims at issue in this appeal are solely those on which Abbott based its motion for a preliminary injunction against Andrx: claims 1, 4, and 6 of the '718 patent, claim 2 of the '616 patent, and claims 8 and 16 of the '407 patent.
Certain holdings in Abbott's cases against Ranbaxy and Teva are relevant to our analysis in this appeal. First, in the district court's order resolving Abbott's motion for a preliminary injunction against Ranbaxy, the court held that Ranbaxy had shown that it was likely to succeed in proving that the '616 and '407 patents are unenforceable due to inequitable conduct. Ranbaxy-Andrx, slip op. at 7. Second, the district court held, in an order resolving Abbott's preliminary injunction motion against Teva, that Teva had raised a substantial question that claim 2 of the '616 patent was obvious under 35 U.S.C. § 103, and therefore Teva was likely to succeed in proving invalidity of that claim. Abbott Labs. v. Andrx Pharms., Inc., No. 05 C 1490, slip op. at 22 (N.D. Ill. June 8, 2005) ("Teva I"). Finally, on appeal from Teva I, this court held that Teva had also raised substantial questions as to the validity of claims 2, 4, and 6 of the '718 patent. Abbott Labs. v. Andrx Pharms., Inc., 452 F.3d 1331, 1348 (Fed.Cir.2006) ("Teva II").
Turning to the history of the instant appeal, Abbott's complaint against Andrx sought, inter alia, declaratory judgment of infringement of the '407, '616, and '718 patents. On May 18, 2005, Abbott moved to preliminarily enjoin Andrx from marketing its generic version of extended release clarithromycin ("the Andrx product"). In opposition to Abbott's motion, Andrx contended that it does not infringe any of the asserted patents, either literally or under the doctrine of equivalents. In addition, Andrx defended against Abbott's motion by arguing that Abbott's patents are invalid for indefiniteness under 35 U.S.C. § 112, ¶ 2 (all three patents), invalid for anticipation under 35 U.S.C. § 102(b) (the '718 and '616 patents), and invalid for obviousness under 35 U.S.C. § 103. Ranbaxy-Andrx, slip op. at 53-58.
The district court held a hearing on September 21, 2005 on Abbott's preliminary injunction motion against Andrx and issued a single order resolving both Abbott's motion against Andrx and Abbott's motion against Ranbaxy. With respect to Andrx, the court held that Abbott succeeded in proving a likelihood of success on its claims that Andrx infringes claims 1, 4, and 6 of the '718 patent under the doctrine of equivalents; induces and contributes to infringement under the doctrine of equivalents of claim 2 of the '616 patent; and literally infringes claims 8 and 16 of the '407 patent. Ranbaxy-Andrx, slip op. at 39-53. As to Andrx's invalidity defenses, the district court held that Andrx failed to meet its burden of raising a substantial question of invalidity as to any of the three asserted patents. Id., slip op. at 53-58. Accordingly, the court granted Abbott's motion for a preliminary injunction based on the '718, '616, and '407 patents.
Andrx appeals the district court's preliminary injunction order enjoining it from manufacturing and marketing its extended release clarythromycin product. Because this court's opinion in Teva II issued after the filing of briefs in Andrx's appeal, the parties' briefs did not address the estoppel effect, if any, of that opinion on the instant appeal. We therefore granted Abbott's motion, made after oral argument, requesting leave to provide supplemental briefing, requesting the parties to brief the court regarding the extent to which Teva II has a collateral estoppel or other binding effect on the instant appeal. Accordingly, both Abbott and Andrx filed supplemental briefs on this issue.2
We have jurisdiction over this appeal pursuant to 28 U.S.C. § 1292(c)(1).
On appeal, Andrx presents two distinct arguments as to why the district court erred in granting a preliminary injunction. First, Andrx asserts that Abbott is collaterally estopped from seeking a preliminary injunction based on holdings in the preliminary injunction proceedings against Teva and Ranbaxy that all of the asserted claims are invalid or unenforceable. Second, Andrx argues that the district court erred in finding that it could infringe any of the asserted patents. Specifically, Andrx contends that it cannot infringe the '718 and '616 patents under the doctrine of equivalents because it does not contain the "pharmaceutically acceptable polymer" required by all the asserted claims. Andrx also contends that the district court erred in concluding that Abbott showed a likelihood of prevailing in asserting infringement of the '407 patent because the court specifically found that the Andrx product did not satisfy one limitation of the asserted claims.
We address each of Andrx's arguments in turn below, reviewing the district court's decision to grant a motion for preliminary injunction for an abuse of discretion. Novo Nordisk of N. Am., Inc. v. Genentech, Inc., 77 F.3d 1364, 1367 (Fed. Cir.1996). "To overturn the grant of a preliminary injunction, we must find that the district court made a clear error of judgment in weighing the relevant factors or based its exercise of discretion on an error of law or on clearly erroneous factual findings." Pfizer, Inc. v. Teva Pharms., USA, Inc., 429 F.3d 1364, 1372 (Fed.Cir. 2005).
The four factors relevant to the district court's decision to grant or deny a preliminary injunction are "(1) the likelihood of the patentee's success on the merits; (2) irreparable harm if the...
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