Bayer Healthcare Pharmaceuticals Inc. v. Watson Pharmaceuticals, Inc. et al

Filing 394

ORDER Vacating 363 Order Resetting the Final Approval Date of Defendants' Abbreviated New Drug Applications. Signed by Judge Kent J. Dawson on 11/26/2013. (Copies have been distributed pursuant to the NEF - AC)

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UNITED STATES DISTRICT COURT
DISTRICT OF NEVADA
__________________________________________
BAYER SCHERING PHARMA AG
)
and BAYER HEALTHCARE
)
PHARMACEUTICALS INC.,
)
)
Plaintiffs/Counter-Defendants,
)
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v.
)
)
WATSON PHARMACEUTICALS, INC.
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and WATSON LABORATORIES, INC.,
)
)
Defendants/Counter-Plaintiffs,
) No. 2:07-cv-01472-KJD-(GWF)
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and
)
)
SANDOZ INC.,
)
)
Defendant/Counter-Plaintiff.
)
__________________________________________)

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[PROPOSED] ORDER VACATING FEBRUARY 11, 2013 ORDER RESETTING THE
FINAL APPROVAL DATE OF DEFENDANTS’ ABBREVIATED NEW DRUG
APPLICATIONS

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This Court entered an Order on February 11, 2013 (Dkt. 363) granting Plaintiffs Bayer

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Pharma AG and Bayer Healthcare Pharmaceuticals, Inc. (“Bayer”) Motion to Reset the Effective

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Date of the FDA's approval for the Defendants to Market Generic YAZ® (“Resetting Order”)(Dkt.

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339). The Federal Circuit stayed that Resetting Order pending appeal on March 13, 2013 (Dkt. 56).

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On April 16, 2013, the Court of Appeals for the Federal Circuit reversed this Court’s March 30,

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2012 decision finding Bayer’s asserted patent valid and enforceable. (Dkt. 63, 4/16/2013 Opinion

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and Judgment, Bayer HealthCare Pharma v. Watson Pharma., 12-1397 (Fed. Cir.).) The Federal

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Circuit also rendered judgment in favor of Watson and Sandoz. (Id.) On August 12, 2013, the

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Federal Circuit denied Bayer’s Motion for Panel Rehearing And Rehearing En Banc. (Dkt. 71,

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8/12/2013 Order, Bayer HealthCare Pharma v. Watson Pharma., 12-1397 (Fed. Cir.).)

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Defendants Watson Pharmaceuticals, Inc., and Watson Laboratories, Inc. (“Watson”) and

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Sandoz Inc. (“Sandoz”) (collectively, “Defendants”) filed Motions to Vacate the Resetting Order in

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the Federal Circuit on September 20, 2013 pursuant to that court’s final judgment in favor of

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Defendants (Dkts. 60 and 61). Because, under 35 U.S.C. § 271(e)(4)(A), the only predicate for the

DCACTIVE-22492387.1

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Resetting Order was a judgment of infringement of a valid patent, the Federal Circuit’s reversal of

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this Court’s finding of invalidity requires that the Resetting Order be vacated.

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This matter having been fully briefed and considered by the Court:

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IT IS HEREBY ORDERED AND ADJUDGED that this Court’s February 11, 2013 Order

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Resetting the Final Approval Date of Defendants’ Abbreviated New Drug Applications is

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VACATED.
IT IS SO ORDERED:

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________________________________
UNITED STATES DISTRICT JUDGE

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November 26, 2013
DATED: ________________________

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DCACTIVE-22492387.1