Abbott Laboratories v. Sandoz, Inc.

• Decision Date: 18 May 2009
• Docket Number: No. 2007-1446.,No. 2007-1400.,2007-1400.,2007-1446.
• Citation: 566 F.3d 1282
• Parties: ABBOTT LABORATORIES, Plaintiff-Appellant, and Astellas Pharma, Inc., Plaintiff-Appellant, v. SANDOZ, INC., Defendant-Appellee, and Sandoz GMBH, Defendant, and Teva Pharmaceuticals USA, Inc. and Teva Pharmaceutical Industries, Ltd., Defendants-Appellees, and Ranbaxy Laboratories, Ltd. and Ranbaxy, Inc., Defendants, and Par Pharmaceutical Companies, Inc. and Par Pharmaceutical, Defendants. Lupin Limited, Plaintiff/Counterclaim Defendant-Appellee, and Lupin Pharmaceuticals, Inc., Counterclaim Defendant-Appellee, v. Abbott Laboratories, Defendant/Counterclaimant-Appellant, and Astellas Pharma, Inc., Defendant/Counterclaimant-Appellant.
• Court: U.S. Court of Appeals — Federal Circuit

566 F.3d 1282

ABBOTT LABORATORIES, Plaintiff-Appellant, and Astellas Pharma, Inc., Plaintiff-Appellant, v. SANDOZ, INC., Defendant-Appellee, and Sandoz GMBH, Defendant, and Teva Pharmaceuticals USA, Inc. and Teva Pharmaceutical Industries, Ltd., Defendants-Appellees, and Ranbaxy Laboratories, Ltd. and Ranbaxy, Inc., Defendants, and

Par Pharmaceutical Companies, Inc. and Par Pharmaceutical, Defendants.

Lupin Limited, Plaintiff/Counterclaim Defendant-Appellee, and Lupin Pharmaceuticals, Inc., Counterclaim Defendant-Appellee, v. Abbott Laboratories, Defendant/Counterclaimant-Appellant, and Astellas Pharma, Inc., Defendant/Counterclaimant-Appellant.

No. 2007-1400.

No. 2007-1446.

United States Court of Appeals, Federal Circuit.

May 18, 2009.

James F. Hurst, Winston & Strawn LLP, of Chicago, IL, argued for all plaintiffs-appellants in 2007-1400 and defendants/counterclaimants-appellants in 2007-1446. With him on the briefs for Abbott Laboratories were Todd J. Ehlman, Kathleen B. Barry, and Ivan M. Poullaos, and Steffen N. Johnson, of Washington, DC. Of counsel on the brief for Abbott Laboratories were William F. Cavanaugh, Jr., Jeffrey I.D. Lewis, and Stuart E. Pollack, Patterson Belknap Webb & Tyler LLP, of New York, NY. Of counsel was John C. Knapp. On the briefs for Astellas Pharma, Inc., were Richard D. Kelly, Stephen G. Baxter and Frank J. West, Oblon, Spivak, McClelland, Maier & Neustadt, P.C., of Alexandria, VA.

Meredith Martin Addy, Brinks, Hofer, Gilson & Lione, of Chicago, IL, argued for defendant-appellee Sandoz, Inc. With her on the brief were Thomas J. Filarski, Mark H. Remus, C. Noel Kaman, and Laura A. Lydigsen. Of counsel was Rashad L. Morgan.

Thomas J. Meloro, Jr., Wilkie Farr & Gallagher LLP, of New York, NY, argued for defendants-appellees Teva Pharmaceuticals USA, Inc., et al. With him on the brief was Neal K. Feivelson. Of counsel were Michael W. Johnson and Alexander H. Swirnoff.

Deanne M. Mazzochi, Rakoczy Molino Mazzochi Siwik, LLP, of Chicago, IL, argued for plaintiff/counterclaim defendant-appellee Lupin Limited and counterclaim defendant-appellee, Lupin Pharmaceuticals, Inc. in 2007-1446. With her on the brief were William A. Rakoczy, Paul J. Molino, and Amy D. Brody.

Before RADER, PLAGER, and BRYSON, Circuit Judges. MICHEL, Chief Judge, and RADER, BRYSON, GAJARSA, LINN, DYK, PROST, and MOORE, Circuit Judges, have joined Section III.A.2 of the opinion. Dissenting opinion as to Section III.A.2 filed by NEWMAN, Circuit Judge, in which MAYER and LOURIE, Circuit Judges, join. Dissenting opinion filed by LOURIE, Circuit Judge. SCHALL, Circuit Judge, did not participate as a member of the en banc court.

RADER, Circuit Judge.

In this case, the same patent, U.S. Patent No. 4,935,507 (the '507 patent), occasions litigation in both the United States District Court for the Eastern District of Virginia and the United States District Court for the Northern District of Illinois. The Virginia District Court granted the motion of Lupin Ltd. and Lupin Pharmaceuticals Inc. (collectively Lupin) for summary judgment of noninfringement. In the other case, the Illinois District Court denied a preliminary injunction to Abbott Laboratories, the exclusive licensee of the '507 patent, based on the claim construction from the Eastern District of Virginia.

Because the Eastern District of Virginia correctly construed the claims of the '507 patent and correctly discerned no genuine issues of material fact on literal infringement of claims 2-5 or infringement by equivalents of claims 1-5, this court affirms its partial summary judgment of noninfringement. Likewise, this court affirms the Northern District of Illinois' denial of Abbott's motion for a preliminary injunction, based in large part on the same correct claim construction.

I.

Abbott Laboratories, the exclusive licensee of the '507 patent, markets crystalline cefdinir according to the '507 patent under the trade name Omnicef. The Virginia case arose when Lupin sought a declaratory judgment of noninfringement against Abbott Laboratories and Astellas Pharma Inc., the owner of the '507 patent (collectively Abbott). The Food and Drug Administration had previously approved Lupin's Abbreviated New Drug Application (ANDA) to market a generic version of Omnicef. Lupin's generic product contains almost exclusively the Crystal B form of crystalline cefdinir (cefdinir monohydrate), whereas Abbott's Omnicef product contains the Crystal A form of crystalline cefdinir (cefdinir anhydrate). Further, Lupin makes its products with processes other than those claimed in the '507 patent. For these reasons, Lupin brought the Virginia action to clarify that its proposed product would not infringe a valid patent. Abbott counterclaimed for infringement. The Eastern District of Virginia construed the claims, Lupin Ltd. v. Abbott Laboratories, 484 F.Supp.2d 448 (E.D.Va.2007) (Lupin CC Order), and ultimately granted-in-part Lupin's motion for summary judgment of noninfringement, as to both literal and equivalent infringement for claims 2-5 and as to equivalent infringement for claim 1, Lupin Ltd. v. Abbott Labs., 491 F.Supp.2d 563 (E.D.Va. 2007) (Lupin SJ Order). The parties stipulated to the dismissal without prejudice of the remaining claims (invalidity) and counterclaims (literal infringement of claim 1).

In the Illinois action, Abbott sued Sandoz, Inc. and Sandoz GmbH (collectively Sandoz), Teva Pharmaceuticals USA, Inc. and Teva Pharmaceuticals Industries, Ltd. (collectively Teva), Ranbaxy Laboratories, Ltd., Ranbaxy, Inc., Par Pharmaceutical Companies, Inc., and Par Pharmaceutical (all defendants, collectively, Sandoz and Teva) for infringement of the '507 patent. Like Lupin, Sandoz and Teva had previously filed ANDAs, seeking to market generic versions of Omnicef. Abbott sought a preliminary injunction in the Illinois case. For purposes of that motion, the parties agreed to adopt the Eastern District of Virginia's claim construction from the Lupin case. Abbott Labs. v. Sandoz, Inc., 486 F.Supp.2d 767 (N.D.Ill.2007) (Sandoz PI Order). Despite this agreement, the parties to the Sandoz case disagreed as to how to interpret some of the Eastern District of Virginia's constructions, necessitating some clarification by the Northern District of Illinois. 486 F.Supp.2d at 770-71 (disputing "Crystal A," "peaks," and "about," and seeking construction of "powder X-ray diffraction pattern," which the Eastern District of Virginia had not defined). Ultimately, the Northern District of Illinois, based on the claim construction from Virginia, denied the preliminary injunction.

Both cases arrived at this court on appeal. This court heard the cases together and decides them together with this decision.

II.

The '507 patent has five claims, all of which Abbott asserts against Lupin as well as Sandoz and Teva. Claim 1 claims crystalline cefdinir, using its chemical name, and defining its unique characteristics with powder X-ray diffraction (PXRD) angle peaks:

1. Crystalline 7-[2-(2-a minothiazol-4-yl)-2-hydroxyiminoacetamido]-3-vinyl-3-cephem.-4-carboxylic acid (syn isomer) which shows the peaks at the diffraction angles shown in the following table in its powder X-ray diffraction pattern:

                   --------------------------------------
                          diffraction angle (°)
                   --------------------------------------
                               about 14.7°
                               about 17.8°
                               about 21.5°
                               about 22.0°
                               about 23.4°
                               about 24.5°
                               about 28.1°
                   --------------------------------------
                

'507 patent, col.16 ll.13-27. In contrast, claims 2-5 claim crystalline cefdinir, without any PXRD peak limitations, but with descriptions of processes used to obtain the crystalline cefdinir. Claims 2 and 5 are independent:

2. Crystalline 7-[2-(2-a minothiazol-4-yl)-2-hydroxyiminoacetamido] -3-vinyl-3-cephem-4-carboxylic acid (syn isomer) which is obtainable by acidifying a solution containing 7-[2-(2-aminothiazol-4-yl)-2-hydroxyiminoacetamido]-3-vinyl -3-cephem-4-carboxylic acid (syn isomer) at room temperature or under warming.

5. Crystalline 7-[2-(2-aminothiazol-4-yl)-2-hydroxyiminoacetamido]-3-vinyl -3-cephem-4-carboxylic acid (syn isomer) which is obtainable by dissolving 7-[2-(2-aminothiazol-4-yl)-2 -hydroxyiminoacetamido]-3-vinyl-3-cephem-4- carboxylic acid (syn isomer) in an alcohol, continuing to stir the solution slowly under warming, then cooling the solution to room temperature and allowing the solution to stand.

Id. at col. 16 ll.29-34, 43-50.

These claims use PXRD as a way to claim the structure and characteristics of the unique crystalline form. PXRD is a method for identifying and distinguishing different crystalline compounds. The method beams X-rays toward a powdered chemical. The method then measures the ways the rays reflect or bend upon contact with the chemical. The diffraction angles and intensities vary with the type and purity of the test compound. A graph then plots the diffraction angle on one axis and the intensity on another. These graphs yield a unique "fingerprint" for each crystalline form of a chemical. A more sensitive form of X-ray diffraction is single crystal X-ray diffraction (SCXRD). As this name suggests, this method uses only a single crystal as a sample. SCXRD does not detect intensity, but produces a more precise diffraction angle measurement.

The '507 patent was not the first cefdinir patent. Rather, Astellas' prior art U.S. Patent No. 4,559,334 (the '334 patent) describes the discovery of cefdinir as a compound demonstrating high antimicrobial activity. '334 patent, col. 11 ll.18-24. The '334 patent expired on May 6, 2007.

The '507 patent claims priority to Japanese Patent Application No. 62-206199 (the JP '199 application), which claimed two crystalline forms of cefdinir, "Crystal A" and "Crystal B." The JP '199 application claimed Crystals A and B very specifically, defining Crystal A by three infrared...