Astrazeneca U.K. Ltd. v. Watson Labs., Inc.

• Decision Date: 21 November 2012
• Docket Number: C.A. No. 10–915–LPS.
• Citation: 905 F.Supp.2d 596
• Parties: ASTRAZENECA UK LIMITED, IPR Pharmaceuticals, Inc., and Shionogi Seiyaku Kabushiki Kaisha, Plaintiffs, v. WATSON LABORATORIES, INC. (NV) and Egis Pharmaceuticals PLC, Defendants.
• Court: U.S. District Court — District of Delaware

905 F.Supp.2d 596

ASTRAZENECA UK LIMITED, IPR Pharmaceuticals, Inc., and Shionogi Seiyaku Kabushiki Kaisha, Plaintiffs,

v.WATSON LABORATORIES, INC. (NV) and Egis Pharmaceuticals PLC, Defendants.

C.A. No. 10–915–LPS.

United States District Court, D. Delaware.

Nov. 21, 2012.

Womble Carlyle Sandridge & Rice, Mary W. Bourke, Dana Kathryn Severance, Wilmington, DE, McCarter & English, LLP, Thomas A. Stevens, Wilmington, DE, Finnegan, Henderson, Farabow, Garrett & Dunner, LLP, Ford F. Farabow, Washington, DC, Charles E. Lipsey, Kenneth M. Frankel, York M. Faulkner, Reston, VA, John D. Livingstone, Atlanta, GA, Mary K. Ferguson, Ph.D., Cambridge, MA, Attorneys for Plaintiffs.

Potter Anderson & Corroon LLP, Richard L. Horwitz, David E. Moore, Wilmington, DE, Knobbe, Martens, Olson & Bear, LLP Steven A. Maddox, Washington, DC Payson LeMeilleur, Jared C. Bunker, Irvine, CA, Attorneys for Defendants.

MEMORANDUM OPINION

STARK, District Judge.

Presently before the Court is Defendant's motion for summary judgment of no infringement under the doctrine of equivalents (D.I. 283) and Plaintiffs' motion for partial summary judgment on issue preclusion (D.I. 279). For the reasons discussed below, the Court will deny without prejudice Defendant's motion and deny in part and grant in part Plaintiffs' motion.

I. BACKGROUND

On October 26, 2010, AstraZeneca UK Limited, IPR Pharmaceuticals, Inc., and Shionogi Seiyaku Kabushiki Kaisha (“AstraZeneca” or “Plaintiffs”) filed a complaint alleging that Watson Laboratories, Inc. (NV)'s (“Watson” or “Defendant”) New Drug Application (“NDA”) No. 202172 infringes U.S. Patent No. RE37, 314 (the “'314 patent”). (D.I. 1) On November 23, 2011, Plaintiffs amended their complaint to add claims against Egis Pharmaceuticals PLC (“Egis” or collectively with Watson, “Defendants”) for inducement of infringement. (D.I. 133)

The '314 patent is a reissue of U.S. Patent No. 5,260,440 (the “'440 patent”) and is related to rosuvastatin in certain salt forms. On February 2, 2012, the Court construed the disputed claim term “a cation capable of forming a non-toxic pharmaceutically acceptable salt” to mean “an alkali metal ion, alkaline earth metal ion, or ammonium ion, wherein the ammonium ion is unsubstituted.” (D.I. 214)

On June 1, 2012, Defendant filed a motion for summary judgment of no infringement under the doctrine of equivalents. (D.I. 283) On the same date, AstraZeneca filed a motion for partial summary judgment that issue preclusion bars Defendants from relitigating the validity and enforceability of the '314 patent. (D.I. 279) The Court heard oral argument on both motions on September 24, 2012. (D.I. 370) (“Tr.”) ¹ Trial is scheduled to begin on December 12, 2012.

II. PERTINENT PROCEDURAL HISTORY

On December 11, 2007, AstraZeneca sued Cobalt Pharmaceuticals Inc. and Cobalt Laboratories Inc. (collectively, “Cobalt”) alleging infringement of the '314 patent under 35 U.S.C. § 271(e)(2)(A) based on Cobalt's Abbreviated New Drug Application for Cobalt's rosuvastatin calcium. See C.A. No. 07–811–JJF (D.Del. 2010). Cobalt contended that the '314 patent was invalid due to obviousness, improper reissue, and lack of enablement,² and unenforceable based on inequitable conduct.

On March 27, 2009, Arrow Group International Limited (“Arrow”) entered into an agreement with Egis to manufacture rosuvastatin zinp in Hungary and provide it to Arrow in the United States to sell through Cobalt. Arrow and Egis agreed that Arrow would conduct litigation relating to '314 patent and file an NDA for rosuvastatin zinc.

On December 2, 2009, Watson Pharmaceuticals, Inc. (“Watson's parent”) acquired the Arrow Group, which included Cobalt. Watson's parent assumed control over Cobalt's rosuvastatincalcium litigation, Arrow's agreements with Egis, and work on rosuvastatin zinc products.

In June 2010, following trial, Judge Farnan rejected Cobalt's defense that the '314 patent was invalid and unenforceable. See In re Rosuvastatin Calcium Patent Litigation, 719 F.Supp.2d 388, 410 (D.Del.2010) (hereinafter the “2010 calcium litigation”). On August 10, 2010, the 2010 calcium litigation defendants filed their notices of appeal to the Federal Circuit.

On July 15, 2010, Watson filed its NDA for rosuvastatin zinc with the U.S. Food and Drug Administration. The instant litigation followed.

III. LEGAL STANDARDS

A grant of summary judgment is appropriate only where “the pleadings, the discovery and disclosure materials on file, and any affidavits show that there is no genuine issue as to any material fact and that the movant is entitled to judgment as a matter of law.” Fed.R.Civ.P. 56(c)(2). The moving party bears the burden of demonstrating the absence of a genuine issue of material fact. See Matsushita Elec. Indus. Co., Ltd. v. Zenith Radio Corp., 475 U.S. 574, 586 n. 10, 106 S.Ct. 1348, 89 L.Ed.2d 538 (1986). If the moving party has carried its burden, the nonmovant must then “come forward with ‘specific facts showing that there is a genuine issue for trial.’ ” Id. at 587, 106 S.Ct. 1348 (quoting Fed.R.Civ.P. 56(e)). The Court will “draw all reasonable inferences in favor of the nonmoving party, and it may not make credibility determinations or weigh the evidence.” Reeves v. Sanderson Plumbing Prods., Inc., 530 U.S. 133, 150, 120 S.Ct. 2097, 147 L.Ed.2d 105 (2000). If the Court is able to determine that “there is no genuine issue as to any material fact” and that the movant is entitled to judgment as a matter of law, summary judgment is appropriate. See Hill v. City of Scranton, 411 F.3d 118, 125 (3d Cir.2005); see alsoFed.R.Civ.P. 56(c).

To defeat a motion for summary judgment, the non-moving party must “do more than simply show that there is some metaphysical doubt as to the material facts.” Matsushita, 475 U.S. at 586, 106 S.Ct. 1348;see also Podobnik v. U.S. Postal Serv., 409 F.3d 584, 594 (3d Cir.2005) (stating party opposing summary judgment “must present more than just bare assertions, conclusory allegations or suspicions to show the existence of a genuine issue”) (internal quotation marks omitted). Moreover, the “mere existence of some alleged factual dispute between the parties will not defeat an otherwise properly supported motion for summary judgment;” a factual dispute is genuine only where “the evidence is such that a reasonable jury could return a verdict for the nonmoving party.” Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 247–48, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986); see also Celotex Corp. v. Catrett, 477 U.S. 317, 322, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986) (entry of summary judgment is mandated “against a party who fails to make a showing sufficient to establish the existence of an element essential to that party's case, and on which that party will bear the burden of proof at trial”).

IV. DISCUSSIONA. Motion for Summary Judgment of No Infringement Under the Doctrine of Equivalents

Watson seeks summary judgment on the ground that Plaintiffs cannot prove infringement under the doctrine of equivalents. Watson's primary; contention is that because the patentees used narrow claim language, Plaintiffs are precluded from relying on the doctrine of equivalents to expand the patent's scope. In response, Plaintiffs argue that the doctrine of equivalents applies and protects patentees from infringers who make insubstantial changes to the claimed invention.

In order to protect the public notice function of patents, the Federal Circuit has articulated several rules of law that limit the application of the doctrine of equivalents. First, the doctrine cannot be used to expand a patentee's narrowly defined claim element. See Sage Prods., Inc. v. Devon Indus., Inc., 126 F.3d 1420, 1424 (Fed.Cir.1997). Second, the doctrine cannot be used when a patent explicitly or implicitly excludes subject matter. See SciMed Life Sys., Inc. v. Advanced Cardiovascular Sys., Inc., 242 F.3d 1337, 1345–47 (Fed.Cir.2001). Finally, the doctrine cannot be used to redefine, read out, or vitiate a claim limitation. See Freedman Seating Co. v. Am. Seating Co., 420 F.3d 1350, 1358 (Fed.Cir.2005).

In Sage, 126 F.3d at 1424, the Federal Circuit stated that “for a patentee who has claimed an invention narrowly, there may not be infringement under the doctrine of equivalents in many cases, even though the patentee might have been able to claim more broadly.” The Court further noted that the doctrine of equivalents, when applied broadly, conflicts with the public notice function of patents. “[A]s between the patentee who had a clear opportunity to negotiate broader claims but did not do so, and the public at large, it is the patentee who must bear the cost of its failure to seek protection for this foreseeable alteration of its claimed stricture.” Id. at 1424–25. In analyzing the patent before it, the Court in Sage observed “clear structural limitations” in a relatively simple structure, no linguistic impediments to claiming a broader scope, and no subsequent changes in the art. See id. Thus, a skilled patent drafter would foresee the limiting nature of the chosen claim language, and infringement under the doctrine of equivalents was not proven. See id.

More recently, in Wm. Wrigley Jr. Co. v. Cadbury Adams USA LLC, 683 F.3d 1356, 1366 (Fed.Cir.2012), the Court similarly concluded that a patentee could not expand the coverage of its patent through the doctrine of equivalents. The patentee, Cadbury Adams USA LLC (“Cadbury”), competed with the accused infringer, Wrigley Jr. Co. (“Wrigley”), in the chewing gum market. Cadbury's U.S. Patent No. 5,009,893 (the “'893 patent”) claimed chewing gum that combined menthol and WS–3, an N-substituted-p-menthane carboxamide cooling agent. For its part, Wrigley owned U.S. Patent No. 6,627,233, which covered the combination of menthol and WS–23. It was undisputed that N-substituted-p-menthane carboxamide does not cover WS–23. Instead, the parties' dispute was whether the term N-substituted-p-menthane carboxamide...