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905 F. Supp. 2d 596
D. Del.
2012
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Background

  • AstraZeneca sued Watson in 2010 alleging infringement of the '314 patent via NDA 202172; Egis later joined for inducement of infringement.
  • The '314 patent is a reissue of the '440 patent related to rosuvastatin salts, with the court construing “a cation capable of forming a non-toxic pharmaceutically acceptable salt” to include alkali/alkaline earth metals or unsubstituted ammonium.
  • On June 1, 2012 Watson moved for summary judgment of no infringement under the doctrine of equivalents; AstraZeneca moved for partial summary judgment on issue preclusion regarding validity/enforceability.
  • Prior related litigation involved the 2007 Cobalt actions and the 2010 calcium litigation, with Watson filing its NDA for rosuvastatin zinc on July 15, 2010 and trial anticipated for December 2012.
  • The court outlined the standard for summary judgment and the burden on the moving party to show no genuine issue of material fact, allowing drawing inferences in plaintiff’s favor if needed.

Issues

Issue Plaintiff's Argument Defendant's Argument Held
Does the doctrine of equivalents bar infringement finding here? AstraZeneca argues DOE applies despite narrow claim language. Watson contends narrow language precludes broader DOE. Denied without prejudice (trial to resolve DOE scope).
Is validity/unenforceability barred by issue preclusion for Watson? Validity is a single issue precluded by prior calcium litigation. Watson argues not all validity theories precluded; successor concerns. Granted as to Watson (preclusion; Watson bound as Cobalt’s successor).
Is Egis bound by issue preclusion as Watson’s proxy? Egis should be precluded as the proxy of Watson. Egis not a party and cooperation agreement does not establish proxy. Denied as to Egis (not precluded).

Key Cases Cited

  • Sage Prods., Inc. v. Devon Indus., Inc., 126 F.3d 1420 (Fed.Cir.1997) (limits doctrine of equivalents when claim language is narrowly defined)
  • Wm. Wrigley Jr. Co. v. Cadbury Adams USA LLC, 688 F.3d 1356 (Fed.Cir.2012) (doctrine cannot expand narrowly claimed subject matter; foreseeability and narrowing language matter)
  • Abraxis Bioscience, Inc. v. Mayne Pharma Inc., 467 F.3d 1370 (Fed.Cir.2006) (doctrine of equivalents may apply when not clearly given up during prosecution; unforeseen equivalents possible)
  • Tanabe Seiyaku Co. v. Int’l Trade Comm’n, 109 F.3d 726 (Fed.Cir.1997) (preclusion of re-capturing after deliberate removal of subject matter from examination)
  • Bicon, Inc. v. Straumann Co., 441 F.3d 945 (Fed.Cir.2006) (doctrine cannot expand claim scope where claim describes a detailed structure excluding others)
  • Cadbury Adams USA LLC v. Wrigley Co., , (not provided in text) (Fed.Cir.2012) (central to discussion of whether DOE can broaden narrowing claim scope)
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Case Details

Case Name: Astrazeneca UK Ltd v. Watson Laboratories, Inc. (NV)
Court Name: District Court, D. Delaware
Date Published: Nov 21, 2012
Citations: 905 F. Supp. 2d 596; 2012 U.S. Dist. LEXIS 166852; 2012 WL 5900706; C.A. No. 10-915-LPS
Docket Number: C.A. No. 10-915-LPS
Court Abbreviation: D. Del.
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