Astrazeneca UK Ltd v. Watson Laboratories, Inc. (NV)

905 F. Supp. 2d 596, 2012 WL 5900706, 2012 U.S. Dist. LEXIS 166852
District Court, D. Delaware·Decided November 21, 2012·No. C.A. No. 10-915-LPS·Published·Cited by 7 cases

Opinion

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 [598] 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 rosuvastatin calcium litigation, Arrow’s agreements with Egis, and work on rosuvastatin zinc products.

In June 2010, following trial, Judge Far-nan 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 [599] ‘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 also Fed.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. DISCUSSION

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

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Astrazeneca UK Ltd v. Watson Laboratories, Inc. (NV), 905 F. Supp. 2d 596, 2012 WL 5900706, 2012 U.S. Dist. LEXIS 166852 (D. Del. 2012).

905 F. Supp. 2d 596 (Astrazeneca UK Ltd v. Watson Laboratories, Inc. (NV)) — published by Counsel Stack Legal Research, free access to 12M+ legal documents.

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