Wyeth v. Sandoz Inc, No. 5:07-CV-234-D.

• Court: United States District Courts. 4th Circuit. Eastern District of North Carolina
• Writing for the Court: JAMES C. DEVER III
• Citation: 703 F.Supp.2d 508
• Parties: WYETH, Plaintiff,v.SANDOZ, INC., Defendant.
• Decision Date: 15 July 2010
• Docket Number: No. 5:07-CV-234-D.

703 F.Supp.2d 508

WYETH, Plaintiff,
v.
SANDOZ, INC., Defendant.

No. 5:07-CV-234-D.

United States District Court,
E.D. North Carolina,
Western Division.

March 12, 2010.
Order Denying Certificate of Appealability July 15, 2010.

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Richard W. Ellis, Ellis & Winters, Raleigh, NC, for Plaintiff.

F. Hill Allen, IV, Tharrington Smith, Raleigh, NC, for Defendant.

Paul K. Sun, Jr., Ellis & Winters, Raleigh, NC.ORDERJAMES C. DEVER III, District Judge.

Plaintiff Wyeth filed this patent infringement action against Sandoz, Inc. (“Sandoz”), alleging that Sandoz's generic extended release venlafaxine product infringes U.S. Patent Nos. 6,274,171 B1 (“the '171 patent”), 6,403,120 B1 (“the '120 patent”), and 6,419,958 B2 (“the '958 patent”) (collectively “the Wyeth patents”). Wyeth has moved for summary judgment regarding Sandoz's direct infringement, active inducement of infringement, and contributory infringement of claims 20-25 of the '171 patent, claims 1, 2, 13, and 14 of the '120 patent, and claims 1-6 of the ' 958 patent [D.E. 118]. Sandoz, in turn, has moved for summary judgment regarding Sandoz's noninfringement of the asserted claims [D.E. 121] and concerning the alleged invalidity of the patents [D.E. 123]. As explained below, Wyeth's motion for summary judgment is granted, and Sandoz's motions for summary judgment are denied.

I.

Wyeth manufactures Effexor® XR, an extended release venlafaxine hydrochloride medication that is used to treat depressive,

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social anxiety, and panic disorders. A division of Wyeth holds the FDA-approved New Drug Application (“NDA”), which encompasses the asserted claims. Sandoz seeks to market a generic extended release venlafaxine formulation and has filed an Abbreviated New Drug Application (“ANDA”) with the FDA to effect this goal. The court held a Markman hearing to construe the disputed patent claims and familiarity with that order is presumed Wyeth v. Sandoz, Inc., 570 F.Supp.2d 815, 833 (E.D.N.C.2008) see Markman v. Westview Instruments, Inc., 52 F.3d 967, 976 (Fed.Cir.1995) (en banc), aff'd, 517 U.S. 370, 372, 116 S.Ct. 1384, 134 L.Ed.2d 577 (1996).

Wyeth and Sandoz each seek summary judgment under Rule 56 of the Federal Rules of Civil Procedure. Summary judgment is proper when there is no genuine issue of material fact, and the moving party is entitled to judgment as a matter of law. See Fed.R.Civ.P. 56(c); Celotex Corp. v. Catrett, 477 U.S. 317, 322, 106 S.Ct. 2548, 91 L.Ed.2d 265 (1986); Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 247, 106 S.Ct. 2505, 91 L.Ed.2d 202 (1986). The moving party bears the initial burden of demonstrating the absence of a genuine issue of material fact. Celotex Corp., 477 U.S. at 325, 106 S.Ct. 2548. After the moving party has met this burden, the nonmoving party “must come forward with specific facts showing that there is a genuine issue for trial.” Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 587, 106 S.Ct. 1348, 89 L.Ed.2d 538 (1986) (quotation & emphasis omitted). A genuine dispute about a material fact exists “if the evidence is such that a reasonable jury could return a verdict for the nonmoving party.” Anderson, 477 U.S. at 248, 106 S.Ct. 2505. The court views the evidence and the inferences drawn from the evidence in the light most favorable to the nonmoving party. Scott v. Harris, 550 U.S. 372, 378, 127 S.Ct. 1769, 167 L.Ed.2d 686 (2007).

II.

Initially, the court addresses the issue of direct infringement in Wyeth's motion for summary judgment. Before turning to the details of the direct infringement claim, the court briefly reviews the legal landscape.

The FDA determines whether a generic version of a patented drug should be approved for marketing to the public. See 21 U.S.C. § 355(a). Congress enacted the Drug Price Competition and Patent Term Restoration Act of 1984, Pub.L. No. 98-417, 98 Stat. 1585 (codified as amended at 21 U.S.C. §§ 355, 360cc; 35 U.S.C. §§ 156, 271) [hereinafter the “Hatch-Waxman Act”], in part, to permit generic drug manufacturers to use original manufacturers' studies to show that generic drugs are safe and effective, thereby allowing generic drug manufacturers to enter the market more easily when patents expire. See, e.g., Warner-Lambert Co. v. Apotex Corp., 316 F.3d 1348, 1357-60 (Fed.Cir.2003). Under the Hatch-Waxman Act, “a generic drug manufacturer may seek expedited approval to market a generic version of an already-approved drug by submitting an ANDA.” Glaxo, Inc. v. Novopharm, Ltd., 110 F.3d 1562, 1568 (Fed.Cir.1997). “If a patent relevant to the ANDA has not expired, the generic drug manufacturer must certify either that the generic drug will not enter the market before the patent's expiration date or that the patent is invalid or will not be infringed by the manufacture, use, or sale of the drug for which the [ANDA] is submitted.” Id. (quotation omitted) (alteration in original); see 21 U.S.C. § 355(j)(2)(A); 35 U.S.C. § 271(e). Specifically, an applicant submitting an ANDA must certify one of four statements: (1) that the drug has not been patented; (2)

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that any such patent on the drug has expired; (3) if there is a current patent, the date on which the patent will expire; or (4) that the patent “is invalid or will not be infringed by the manufacture, use, or sale of the new drug for which the [ANDA] is submitted.” 21 U.S.C. § 355(j)(2)(A)(vii)(I)-(IV).

Upon a certification of noninfringement, a patent owner who disagrees with the certification may bring an infringement action. See 35 U.S.C. § 271(e)(2). “[A] district court's inquiry in a suit brought under § 271(e)(2) is the same as it is in any other infringement suit, viz., whether the patent in question ... ‘will not be infringed by the manufacture, use, or sale of the drug for which the ANDA is submitted.’ ” Glaxo, 110 F.3d at 1569 (quoting 21 U.S.C. § 355(j)(2)(A)(vii)(IV)) (alteration & emphasis omitted); see, e.g., Warner-Lambert Co., 316 F.3d at 1366. If the court determines that infringement would occur if the generic drug were manufactured, used, or sold, then “the patent owner is entitled to an order that FDA approval of the ANDA ... not be effective until the patent expires.” Bristol-Myers Squibb Co. v. Royce Labs., Inc., 69 F.3d 1130, 1135 (Fed.Cir.1995); see 35 U.S.C. § 271(e)(4)(A).

To analyze infringement, a court first determines the meaning and scope of the asserted patent claims, and then compares the properly construed claims to the product that allegedly infringes. See Markman, 52 F.3d at 976. “[T]he claims of a patent define the invention to which the patentee is entitled the right to exclude.” Phillips v. AWH Corp. 415 F.3d 1303, 1312 (Fed.Cir.2005) (en banc) (quotation omitted). This court has determined, as a matter of law, the proper scope of Wyeth's patent claims. See Wyeth, 570 F.Supp.2d at 833.

Second, a court compares the accused product to the construed claims. The accused product directly infringes if it “incorporates every limitation of a claim, either literally or under the doctrine of equivalents.” MicroStrategy Inc. v. Bus. Objects, S.A., 429 F.3d 1344, 1352 (Fed.Cir.2005) (quotation omitted). Where the parties' disagreement is primarily over proper claim interpretation, the direct infringement analysis “collapses into claim construction and is amenable to summary judgment.” Gen. Mills, Inc. v. Hunt-Wesson, Inc., 103 F.3d 978, 983 (Fed.Cir.1997).

Sandoz argues that it cannot directly infringe the asserted method claims because, as a manufacturer, it will not administer its proposed drug to patients. See Def.'s Opp'n 2. However, “section 271(e)(2) creates an ‘act of infringement’ based upon the filing of an ANDA,” Allergan, Inc. v. Alcon Labs., Inc., 324 F.3d 1322, 1330 (Fed.Cir.2003) (per curiam), to obtain approval “to engage in the commercial manufacture, use, or sale of a drug ... the use of which is claimed in a patent before the expiration of such patent.” 35 U.S.C. § 271(e)(2): see Warner-Lambert Co., 316 F.3d at 1354; Glaxo, Inc., 110 F.3d at 1568-69. Sandoz is a “manufacturer” who submitted an ANDA. Def.'s Opp'n 2; Pl.'s Reply 1. Thus, Sandoz may be liable for direct infringement.

Wyeth-Ayerst Laboratories (now known as Wyeth Pharmaceuticals), a division of Wyeth, holds the approved NDA No. 20-699 for Effexor® XR capsules, an extended release dosage form containing venlafaxine hydrochloride. Am. Compl. ¶ 8; see Answer ¶ 8. The asserted claims cover the FDA-approved uses. With its ANDA, Sandoz certified that the manufacture, use, or sale of its generic version will not infringe Wyeth's patents. See Answer ¶¶ 12, 23, 34. Specifically, Sandoz certified that the asserted claims are “invalid, unenforceable,

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and/or will not be infringed by the manufacture, use, or sale of the Sandoz, Inc. venlafaxine hydrochloride extended-release capsule.” Id.

In its Markman ruling, this court clarified:

The method claims describe the “use aspects” of the invention and are claimed in terms of performance criteria. See, e.g., '171 patent, col. 12:63-13:3 (claim 20)(“A method for providing a therapeutic blood plasma concentration of venlafaxine over a twenty four hour period with diminished incidences of nausea and emesis....”); id. at col. 13:4-12 (claim 21) (“A method for eliminating the troughs and peaks of drug concentration in a patient[']s blood plasma....”).

Wyeth, 570 F.Supp.2d at 822 (emphasis omitted) (alteration in original). ¹ The asserted claims have essentially the same specification and involve methods to treat depression and related disorders. The limitations of the asserted claims include: (1) an extended release formulation, that provides a therapeutic blood plasma concentration of venlafaxine over a twenty-four-hour period, which comprises administering orally to a patient, an encapsulated spheroid containing venlafaxine...