Paper No. _____
`Filed: April 25, 2016
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________________
`
`
`
`MYLAN PHARMACEUTICALS INC. and MYLAN LABORATORIES
`LIMITED,
`Petitioners
`
`v.
`
`BAXTER INTERNATIONAL INC. and BAXTER HEALTHCARE S. A.,
`Patent Owners
`
`
`
`
`
`_____________________________
`
`Case IPR2016-00217
`Patent No. 6,310,094
`_____________________________
`
`
`
`JOINT MOTION TO TERMINATE PROCEEDING
`PURSUANT TO 35 U.S.C. § 317
`
`
`
`
`Filed: April 25, 2016
`
`
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________________________
`
`
`
`MYLAN PHARMACEUTICALS INC. and MYLAN LABORATORIES
`LIMITED,
`Petitioners
`
`v.
`
`BAXTER INTERNATIONAL INC. and BAXTER HEALTHCARE S. A.,
`Patent Owners
`
`
`
`
`
`_____________________________
`
`Case IPR2016-00217
`Patent No. 6,310,094
`_____________________________
`
`
`
`JOINT MOTION TO TERMINATE PROCEEDING
`PURSUANT TO 35 U.S.C. § 317
`
`
`
`
`
`Case No. IPR2016-00217
`U.S. Patent No. 6,310,094
`
`I. INTRODUCTION
`
`Pursuant to 35 U.S.C. § 317(a), Petitioners Mylan Pharmaceuticals Inc. and
`
`Mylan Laboratories Limited (“Petitioners”) and Baxter International, Inc. and Baxter
`
`Healthcare S. A. (“Patent Owners”) (together, “the Parties”) jointly request
`
`termination of the inter partes Review of U.S. Patent No. 6,310,094, Case No.
`
`IPR2016-00217. In accordance with 37 C.F.R. § 42.20(b), the Parties sought, and
`
`received, authorization from the Board to file this motion on April 25, 2016.
`
`The Parties have settled their disputes. The Parties’ settlement is memorialized
`
`in a Settlement Agreement, a true and correct copy of this agreement is filed as
`
`Exhibit 1026. The parties desire that the Settlement Agreement be maintained as
`
`business confidential information under 37 C.F.R. § 42.74(c) and a joint request to
`
`that effect is being filed concurrently herewith.
`
`II. TERMINATION IS APPROPRIATE
`
`Termination of this proceeding is proper because the IPR is in its early stages.
`
`The Board has not yet “decided the merits of the proceeding before the request for
`
`termination is filed.” 35 U.S.C. § 317(a); 77 Fed. Reg. 48768 (“The Board expects
`
`that a proceeding will terminate after the filing of a settlement agreement, unless the
`
`Board has already decided the merits of the proceeding.”). See Oracle Corp. v.
`
`Community United IP, LLC, Case No. CBM2013-00015, Paper No. 13 (PTAB Jul. 25,
`
`2013) (citing Office Patent Trial Practice Guide, 77 Fed. Reg. 48756, 48768 (Aug. 14,
`
`2012)).
`
`1
`
`
`
`Case No. IPR2016-00217
`U.S. Patent No. 6,310,094
`
`At this early point in the proceeding, no decision on institution has been issued
`
`by the Board. Thus, the Board has not yet decided the merits of the proceeding at the
`
`time this motion for termination is filed.
`
`The litigation between the Parties related to this proceeding has also been
`
`settled.1 And the Parties are unaware of any other matter before the USPTO that
`
`would be affected by the settlement and termination of this proceeding, and there are
`
`no other proceedings before the Board involving the ʼ094 Patent.
`
`For all these reasons, the Parties respectfully request the Board terminate this
`
`proceeding, Case No. IPR2016-00217.
`
`
`Respectfully submitted,
`
`
`
`
`
`
`
`/ Steven W. Parmelee /
`Steven W. Parmelee
`Registration No. 31,990
`Wilson Sonsini Goodrich & Rosati
`701 Fifth Avenue, Suite 5100
`Seattle, WA 98104
`Tel.: 206-883-2542
`Email: sparmelee@wsgr.com
`
`Attorneys for Petitioners
`
`
`
`
`
`
`
`
`
`Dated: April 25, 2016
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`1 Other litigations involving the ʼ094 Patent are still pending, but do not involve
`
`the Petitioners.
`
`2
`
`
`
`
`
`
`
`
`
`/ James W. Hill /
`James W. Hill
`Registration No. 46,396
`Wilmer Cutler Pickering Hale and Dorr LLP
`350 South Grand Avenue, Suite 2100
`Los Angeles, CA 90071
`Tel.: 213-443-5300
`Email: James.Hill@wilmerhale.com
`
`Attorneys for Patent Owners
`
`
`Case No. IPR2016-00217
`U.S. Patent No. 6,310,094
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`3
`
`
`
`Case No. IPR2016-00217
`U.S. Patent No. 6,310,094
`
`Exhibit No.
`
`Description
`
`LIST OF EXHIBITS
`
`1001
`
`1002
`
`1003
`
`1004
`
`1005
`
`1006
`
`1007
`
`1008
`
`1009
`
`1010
`
`1011
`
`1012
`
`1013
`
`1014
`
`1015
`
`1016
`
`1017
`
`U.S. Patent No. 6,310,094 to Liu et al.
`
`Declaration of Robert J. Linhardt, Ph.D.
`
`Curriculum Vitae of Robert J. Linhardt, Ph.D.
`
`File history of 6,310,094 to Liu et al.
`Brevibloc® Injection. (1999). In Physicians’ Desk Reference (53rd
`ed., 624-626). Montvale, NJ: PDR Network.
`
`Y.C. Lee et al., High-Performance Liquid Chromatographic
`Method for the Determination of Esmolol Hydrochloride. 73 J.
`PHARM. SCI. 1660 (1984)
`
`S. Turco and R. E. King, Chapters 4 and 8, STERILE DOSAGE
`FORMS: THEIR PREPARATION AND CLINICAL APPLICATION (3rd ed.,
`1987)
`
`U.S. Patent No. 5,129,894 to Sommermeyer et al.
`
`Brevibloc Injection Label, Center for Drug Evaluation and
`Research, 1988.
`
`L. Blanski et al., Esmolol, the first ultra-short-acting intravenous
`beta blocker for use in critically ill patients, 17 HEART LUNG 80
`(1988)
`
`D.J. Pearce, Brevibloc drug errors, 43 CAN. J. ANESTH. 419
`(1996)
`
`U.S. Patent No. 4,857,552 to Rosenberg et al.
`Chapters 36 and 84, REMINGTON’S 19TH EDITION: THE SCIENCE
`
`AND PRACTICE OF PHARMACY. (A. Gennaro ed. 1995)
`
`D. M. Baaske et al., Stability of esmolol hydrochloride in
`intravenous solutions, 51 AM. J. HOSP. PHARM. 2693 (1994)
`
`P. Pittenger, The Biologic Standardization of Local Anesthetics
`With Special Reference to Effect of Sterilization on Solutions of
`Cocaine and Procaine, 12 J. AM. PHARM. ASSOC. 229 (1923)
`
`J. B. Murray et al. Stability of Cocaine in Aqueous Solution 3 J.
`CLIN. PHARM. 1 (1978)
`
`J. T. Murphy et al., Preparation, Sterilization, and Preservation
`of Ophthalmic Solutions: Experimental Studies and a Practical
`
`4
`
`
`
`Case No. IPR2016-00217
`U.S. Patent No. 6,310,094
`
`Method, 53 AMA ARCH. OPHTHALMOL. 63 (1955)
`
`K. A. Connors et al., CHEMICAL STABILITY OF
`PHARMACEUTICALS: A HANDBOOK FOR PHARMACISTS (2nd ed.,
`1986)
`
`T. Higuchi et al., Heat Sterilization of Thermally Labile Solutions,
`39 J. AM. PHARM. ASSOC. 411 (1950)
`
`L. D. Bridenbaugh et al., Does Repeated Heat Sterilization of
`Local Anesthetic Drugs Affect Potency? 25 ANESTHESIOLOGY 372
`(1964)
`
`J. Katz, Stability of Local Anesthetics After Autoclaving:
`Determined By Gas Chromatography, 27 ANESTHESIOLOGY 835
`(1966)
`
`P. Galais et al., Assay of para-Aminobenzoic Acid Formed by
`Hydrolysis of Procaine in CP1B Solution, 52 CHROMATOGRAPHIA
`115 (2000)
`
`Department of Health And Human Services, Food and Drug
`Administrations, Proposed Rules, 56 FED. REG. 51354 (1991)
`
`USP 23 Official Monographs, UNITED STATES PHARMACOPEIA
`(1995)
`
`Complaint, Baxter Healthcare Corp. et al. v. Mylan Laboratories
`Ltd. et al., No. 1:14-cv-07094 (JBS-JS)
`
`Confidential Settlement Agreement
`
`1018
`
`1019
`
`1020
`
`1021
`
`1022
`
`1023
`
`1024
`
`1025
`
`1026
`
`5
`
`
`
`Case No. IPR2016-00217
`U.S. Patent No. 6,310,094
`
`CERTIFICATE OF SERVICE
`
`
`
`Pursuant to 37 C.F.R. § 42.6(e), this is to certify that I caused to be served a
`
`true and correct copy of the foregoing Joint Motion to Terminate and Exhibit 1026, by
`
`electronic service, on this 25th day of April 2016, on the Patent Owners at the
`
`correspondence address of the Patent Owners as follows:
`
`
`James W. Hill
`David L. Cavanaugh
`Owen K. Allen
`Wilmer Cutler Pickering Hale and Dorr LLP
`350 South Grand Avenue, Suite 2100
`Los Angeles, CA 90071
`Tel: 213-443-5300
`Fax: 213-443-5400
`James.Hill@wilmerhale.com
`David.Cavanaugh@wilmerhale.com
`Owen.Allen@wilmerhale.com
`
`
`
`
`
`Respectfully submitted,
`
`
`
`/ Steven W. Parmelee /
`Steven W. Parmelee, Lead Counsel
`Reg. No. 31,990
`
`
`
`
`
`
`
`Dated: April 25, 2016
`
`
`
`6
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