Abbott Laboratories v. Sandoz, Inc.
| Decision Date | 03 May 2007 |
| Docket Number | No. 07 C 1721.,07 C 1721. |
| Citation | 486 F.Supp.2d 767 |
| Parties | ABBOTT LABORATORIES and Astellas Pharma, Inc., Plaintiffs, v. SANDOZ, INC., Sandoz GmbH, Teva Pharmaceuticals USA, Inc., Teva Pharmaceutical Industries, Ltd., Ranbaxy, Inc., Ranbaxy Laboratories, Ltd., Par Pharmaceutical Companies, Inc., and Par Pharmaceutical, Defendants. |
| Court | U.S. District Court — Northern District of Illinois |
James F. Hurst, Todd Jay Ehlman, Ivan Michael Poullaos, Kathleen B. Barry, Winston & Strawn, LLP, Chicago, IL, Jeffrey I.D. Lewis, John C. Knapp, William F. Cavanaugh, Jr., Patterson, Belknap, Webb & Tyler, New York, NY, Frank J. West, Richard D. Kelly, Oblon, Spivak, McClelland, Maier & Neustadt, P.C., Alexandria, VA, for Plaintiffs.
Thomas J. Filarski, Christin Noel Kaman, Mark Herbert Remus, Meredith Martin Addy, Brinks, Hofer, Gilson & Lione, Jordan A. Sigale, Julie P. Samuels, Loeb & Loeb LLP, Frederick Christopher Laney, Kara Leta Szpondowski, Niro, Scavone, Haller & Niro, LTD., Mary L. Swietnicki, Philip C. Stahl, Grippo & Elden LLC, Chicago, IL, Alexander H. Swirnoff, Chandra E. Garry, Michael W. Johnson, Neal Feivelson, Thomas J. Meloro, Willkie Farr & Gallagher LLP, New York, NY, Payson J. Lemeilleur, Darrell L. Olson, Joseph M. Reisman, Knobbe, Martens, Olson & Bear LLP, Irvine, CA, for Defendants.
Before the court is plaintiffs Abbott Laboratories ("Abbott") and Astellas Pharma, Inc.'s ("Astellas") motion for a preliminary injunction. Abbott seeks a preliminary injunction preventing defendants Sandoz, Inc. and Sandoz GmbH ("Sandoz") and defendants Teva Pharmaceutical Industries, Ltd. and Teva Pharmaceuticals USA, Inc. ("Teva") from manufacturing, selling, offering for sale, importing or distributing their respective generic cefdinir products before a decision on the merits in this case. For the following reasons, the plaintiffs' motion for a preliminary injunction is denied.
Cefdinir is an antibiotic which has sales exceeding $600 million annually worldwide. In 1983, plaintiff Astellas's corporate predecessor, Fujisawa, developed the compound cefdinir, which treats bacterial infections, and thereafter secured U.S. Patent No. 4,559,334 ("'334 patent"). The '334 patent claimed an amorphous form of cefdinir, which was not useful for making pharmaceutical products because it was difficult to store, unstable, and not appropriately soluble. Astellas then developed a crystalline form of cefdinir, which is practical as a pharmaceutical product, and secured U.S. Patent No. 4,935,507 ("'507 patent") in 1990 on that product. Abbott has the exclusive license for the '507 patent and markets its Omnicef brand cefdinir, a form of crystalline cefdinir sold as two products.
The '334 patent expires on May 6, 2007 at 11:59 p.m., EDT. The '507 patent expires on December 4, 2011. On April 6, 2007, the United States Food and Drug Administration ("FDA") approved defendant Sandoz's Abbreviated New Drug Applications ("ANDA"), Nos. 06-5330 and 06-5337, to market and sell generic cefdinir products. Defendant Teva filed its AND As on June 29, 2005 and November 1, 2005 (Nos. 65-332 and 65-368), but the FDA has not yet approved them.
The parties agree that Abbott's '334 patent expiration permits generic products to launch if those new products do not infringe on the '507 patent. The '507 patent is a crystalline form of cefdinir, namely, cefdinir anhydrate, called "Crystal A" in the '507 patent. Plaintiffs contend that the defendants' generic products, which the parties agree are cefdinir monohydrate, infringe the '507 patent because cefdinir monohydrate is contained within the claims of the '507 patent, and also because the defendants' generic products may contain a small percentage of cefdinir anhydrate (allegedly approximately 2% for Teva, and approximately .2% for Sandoz). Defendants claim that their competing products do not infringe because cefdinir monohydrate is not covered by the claims in the '507 patent and deny that their products contain any cefdinir anhydrate at all.
In order to prevail on a motion for preliminary injunction, plaintiffs must show (1) a reasonable likelihood of success on the merits; (2) irreparable harm if an injunction is not granted; (3) a balance of hardships tipping in its favor; and (4) the injunction's favorable impact on the public interest. Amazon.com, Inc. v. Barnesandnoble.com, Inc., 239 F.3d 1343, 1350 (Fed. Cir.2001); Reebok Int'l Ltd. v. J. Baker, Inc., 32 F.3d 1552, 1555 (Fed.Cir.1994). Plaintiff has the burden of proving each of these factors. Roland v. Air Line Employees Ass'n, Int'l, 753 F.2d 1385, 1392 (7th Cir.1985).
Because the present case arises under United States patent law, the Patent Act grants authority to this court to grant or deny an injunction to prevent the infringement of a patent.
The several courts having jurisdiction of cases under this title may grant injunctions in accordance with the principles of equity to prevent the violation of any right secured by patent, on such terms as the court deems reasonable.
35 U.S.C § 283. We begin our discussion by examining each of the required elements for a preliminary injunction.
The first element of a motion for preliminary injunction is to determine whether the moving party likely will succeed on the merits of the underlying litigation. In patent cases, the movant has an added burden. Here, plaintiffs must show that (1) they will likely prove that defendants infringed the '507 patent, and (2) their infringement claim will likely withstand defendants' challenges to the validity and enforceability of the '507 patent. See Abbott Labs. v. Andrx Pharms., Inc., 452 F.3d 1331, 1335 (Fed.Cir.2006). "In other words, if [defendants] raise a `substantial question' concerning validity, enforceability, or infringement (i.e. assert a defense that [plaintiff] cannot show `lacks substantial merit') the preliminary injunction should not issue." Id., quoting Genentech, Inc. v. Novo Nordisk, A/S, 108 F.3d 1361, 1364 (Fed.Cir.1997).
In order to assess the likelihood of infringement, the court must (1) first determine, as a matter of law, the correct meaning and scope of the asserted claims, and then (2) compare the properly construed claims to the accused infringing product. See Markman v. Westview Instruments, Inc., 52 F.3d 967, 970-71 (Fed. Cir.1995); Cybor Corp. v. FAS Techs., Inc., 138 F.3d 1448, 1454 (Fed.Cir.1998).
In a carefully considered and well written Markman ruling, United States District Judge Robert E. Payne, of the United States District Court for the Eastern District of Virginia, Richmond Division, held the following regarding construction of the '507 patent.
Claims 2-5 of the '507 patent are construed as product-by-process claims. The '507 patent's disputed claim terms have the following definitions:
(1) "Crystalline" means "Crystal A;"
(2) "shows" requires the display of a powder X-ray diffraction pattern which demonstrates the existence of the relevant peaks to a scientifically acceptable degree of certainty either visually or by other appropriate means of data display,
(3) "peaks" is the plural of "peak;" a "peak" exists at a powder x-ray diffraction angle that corresponds to an intensity measurement greater than measurements attributable to "noise" if that angle is immediately preceded by and immediately followed by powder X-ray diffraction angle with a lower intensity measurement; "noise" refers to those portions of a PXRD pattern produced by intrinsic measurement error, and which cannot be associated with a scientifically significant quantity of the material which is the subject of the PXRD test;
(4) "about" encompasses measurement errors inherently associated with powder X-ray diffraction testing.
Lupin, Ltd. v. Abbott Labs. & Astellas Pharma, Inc., 484 F.Supp.2d 448, 466, 2007 WL 1238617, *16, (E.D.Va2007). The parties have stipulated that Judge Payne's ruling shall be adopted by this court as its determination, as a matter of law with respect to this preliminary injunction proceeding, of the correct meaning and scope of the asserted claims. Therefore, this court hereby adopts Judge Payne's Markman ruling.
First we must resolve the parties' disagreement as to the correct interpretation of Judge Payne's ruling. Afterwards, we will analyze their arguments and evidence to determine whether the defendants' products in fact infringe the '507 patent. We will begin this analysis with a closer look at the actual '507 patent itself.
The first claim of the '507 patent construed by Judge Payne is the following:
1. Crystalline 742-(2-a minothiazol-4-yl)-2-hydrox-yi minoacetamido]-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
U.S. Patent No. 4,935,507 col. 16 11.12-28 (filed Aug. 8, 1998). Based on this first claim, Judge Payne ruled, and the parties agree, that the crystalline cefdinir described in Claim 1, and in fact in Claims 2-5 (not reproduced here) is "Crystal A." They do, however, disagree as to which forms of crystalline cefdinir fall within the definition of "Crystal A." The plaintiffs, predictably enough, maintain that the defendants' products, although different substances than the plaintiffs' cefdinir anhydrate product, are included within the definition of Crystal A. Defendants, of course, disagree.
They also disagree as to how to interpret Judge Payne's ruling on "peaks" and "about." Finally, they disagree on how to construe "powder X-ray diffraction pattern" ("PXRD"), which was not discussed in Judge Payne's ruling. All three of these...
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