UNITED STATES PATENT AND TRADEMARK OFFICE
`
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_____________________
`
`APOTEX INC.,
`Petitioner,
`
`v.
`
`PFIZER INC.,
`Patent Owner.
`
`_____________________
`
`Inter Partes Review No.: IPR2021-01132
`_____________________
`
`U.S. Patent No. 6,890,927 to Bogle et al.
`Issued: May 10, 2005
`
`Title: TARTRATE SALTS OF 5,8, 14-TRIAZATERACYCLO[10.3.1.02,11
`04.9]-HEXADECA-2(11),3,5,7,9-PENTAENE AND
`PHARMACEUTICAL COMPOSITIONS THEREOF
`_____________________
`
`JOINT MOTION TO TERMINATE PROCEEDING
`PURSUANT TO 35 U.S.C. § 317 AND 37 C.F.R. § 42.72 AND
`JOINT REQUEST TO KEEP PAPERS SEPARATE
`AS BUSINESS CONFIDENTIAL INFORMATION
`
`
`
`
`
`
`
`
`
`_____________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_____________________
`
`APOTEX INC.,
`Petitioner,
`
`v.
`
`PFIZER INC.,
`Patent Owner.
`
`_____________________
`
`Inter Partes Review No.: IPR2021-01132
`_____________________
`
`U.S. Patent No. 6,890,927 to Bogle et al.
`Issued: May 10, 2005
`
`Title: TARTRATE SALTS OF 5,8, 14-TRIAZATERACYCLO[10.3.1.02,11
`04.9]-HEXADECA-2(11),3,5,7,9-PENTAENE AND
`PHARMACEUTICAL COMPOSITIONS THEREOF
`_____________________
`
`JOINT MOTION TO TERMINATE PROCEEDING
`PURSUANT TO 35 U.S.C. § 317 AND 37 C.F.R. § 42.72 AND
`JOINT REQUEST TO KEEP PAPERS SEPARATE
`AS BUSINESS CONFIDENTIAL INFORMATION
`
`
`
`
`
`
`
`
`
`I.
`
`INTRODUCTION
`Pursuant to 35 U.S.C. § 317 and 37 C.F.R. § 42.72, Petitioner Apotex Inc.
`
`(“Apotex”) and Patent Owner Pfizer Inc. (“Pfizer”; and together with Apotex, “the
`
`Parties”) jointly request termination of Inter Partes Review No. IPR2021-01132.
`
`The Parties have settled all of their disputes involving U.S. Patent
`
`No. 6,890,927 (“the ‘927 patent”). As part of that resolution, the Parties have agreed
`
`to seek to terminate this proceeding.
`
`Pursuant to 37 C.F.R. § 42.74(b), the Parties’ settlement agreement made in
`
`contemplation of termination of this proceeding is in writing, and a true and correct
`
`copy of such document is being filed herewith as Petitioner’s Exhibit 1025.
`
`The Parties hereby jointly request that the settlement agreement at Petitioner’s
`
`Exhibit 1025 be treated as business confidential information, and be kept separate
`
`from the files of the above captioned IPR pursuant to 35 U.S.C. § 317(b) and 37
`
`C.F.R. § 42.74(c).
`
`II. BACKGROUND
`On June 17, 2021, Apotex filed a request for Inter Partes Review of claims 1-
`
`2 of the ‘927 patent. See IPR2021-01132, Paper 1. On October 12, 2021, Pfizer filed
`
`a Patent Owner Preliminary Response. See IRP2021-01132, Paper 6. The Board has
`
`not issued an Institution Decision.
`
`2
`
`
`
`
`
`On October 19, 2021, the Parties agreed to settle all of their disputes
`
`concerning the ‘927 patent.
`
`On the same day (October 19, 2021), the Parties informed the Board of
`
`settlement and requested authorization to file a joint motion to terminate the
`
`proceeding with respect to both Apotex and Pfizer. On October 20, 2021, the Board
`
`authorized the filing of the requested joint motion to terminate this proceeding as to
`
`both Parties. The Board additionally authorized the Parties to include with the joint
`
`motion to terminate a request to treat the settlement as business confidential
`
`information.
`
`III. TERMINATION IS APPROPRIATE
`Termination of this IPR is appropriate as the Board has not yet “decided the
`
`merits of the proceeding” in this proceeding. See, e.g., Office Patent Trial Practice
`
`Guide, 77 Fed. Reg. 48756, 48768 (Aug. 14, 2012). More specifically, the Board has
`
`not issued any decision regarding Apotex’s request for Institution as noted above.
`
`Notably, no dispute remains between Apotex and Pfizer involving the ‘927
`
`patent:
`
`i.
`
`the Parties have agreed to jointly request termination of the Inter Partes
`
`Review, IPR2021-01132; and
`
`ii.
`
`the litigation between the Parties involving the ‘927 patent has been
`
`dismissed as part of the settlement. Pfizer Inc. et. al. v. Apotex Inc. and
`3
`
`
`
`
`
`Apotex Corp., Civil Action No. 1:21-cv-01402-CFC (D. Del.), D.I. 8,
`
`Order (Oct. 19, 2021).
`
`IV. RELATED LITIGATION STATUS
`As noted above, the related district court action between Pfizer and Apotex
`
`has been settled and dismissed.
`
`AGREEMENT
`SETTLEMENT
`V. TREAT
`CONFIDENTIAL INFORMATION
`Apotex and Pfizer hereby request that the settlement agreement (including any
`
`BUSINESS
`
`AS
`
`related attachments) filed herewith as Petitioner’s Exhibit 1025 be treated as
`
`business confidential information, be kept separate from the file of the above
`
`captioned IPR, and be made available only to Federal Government agencies on
`
`written request, or to any person on a showing of good cause pursuant to 35 U.S.C.
`
`§ 317(b) and 37 C.F.R. § 42.74(c). In view of that request, the settlement agreement
`
`has been filed for access by the “Parties and Board Only.”
`
`VI. CONCLUSION
`For the foregoing reasons, Apotex and Pfizer jointly request that the Board
`
`terminate this Inter Partes Review proceeding, and treat the settlement agreement
`
`filed herewith as business confidential information and maintain said agreement
`
`separate from the file of the above captioned IPR.
`
`
`
`4
`
`
`
`
`
`
`
`
`Dated: October 21, 2021
`
`
`
`
`
`
`
`Respectfully submitted,
`
`RAKOCZY MOLINO MAZZOCHI SIWIK LLP
`
`/s/ Deanne M. Mazzochi
`Deanne M. Mazzochi (Reg. No. 50,158)
`Paul J. Molino (Reg. No. 45,350)
`Jeffrey A. Marx (Reg. No. 56,977)
`6 West Hubbard Street, Suite 500
`Chicago, IL 60654
`Telephone: (312) 222-6305
`Facsimile: (312) 222-6325
`dmazzochi@rmmslegal.com
`paul@rmmslegal.com
`jmarx@rmmslegal.com
`
`Counsel for Petitioner Apotex Inc.
`
`/s/ Michael Liu
`Andrew V. Trask (Reg. No. 59,239)
`Michael Xun Liu (Reg. No. 68,815)
`Williams & Connolly LLP
`725 Twelfth Street NW
`Washington, D.C. 20005
`T: (202) 434-5000
`F: (202) 434-5029
`atrask@wc.com
`mliu@wc.com
`
`Richard V. Zanzalari
`Pfizer Inc.
`Eastern Point Road, MS-9114
`Groton, CT 06340
`richard.zanzalari@pfizer.com
`USPTO Registration No. 49,032
`
`Bryan C. Zielinski
`Pfizer Inc.
`10555 Science Center Drive
`5
`
`
`
`
`
`La Jolla, CA 92121
`bryan.c.zielinski@pfizer.com
`USPTO Registration No. 34,462
`
`Counsel for Patent Owner Pfizer Inc.
`
`
`
`
`
`
`6
`
`
`
`
`
`
`
`1001
`
`“927 patent
`
`U.S. Patent No. 6,890,927 B2
`
`1002
`
`Gould Decl
`
`Expert Declaration of Dr. Philip Gould in Support of
`Petition for Inter Partes Review of U.S. Patent
`No. 6,890,927
`
`1003
`
`Gould CV
`
`Dr. Philip Gould Curriculum Vitae
`
`1004
`
`1005
`
`:
`
`927 patent PH
`
`File History for U.S. Patent Application No.
`10/139,730, issued as the ‘927 patent
`
`International Patent Application No.
`WO 1999/035131, to Coe etal.
`
`PETITIONER’S UPDATED LIST OF EXHIBITS FOR IPR2021-01132
`
`1006
`
`US ‘550
`
`U.S. Patent No. 6,410,550
`
`1007
`
`US °990 PH
`
`File History for U.S. Patent Application No.
`
`CA ‘490
`
`Canadian Patent Application No. 2,467,490
`
`1009
`
`1010
`
`1011
`
`Stephen M.Bergeet al., Pharmaceutical Salts, 66 J.
`PHARM.SCIS. | (1977)
`
`Philip L. Gould, Salt Selection for Basic Drugs, 33
`INT’LJ. PHARM.201 (1986)
`
`JAMES I. WELLS, PHARMACEUTICAL
`PREFORMULATION: THE PHYSICOCHEMICAL
`PROPERTIES OF DRUG SUBSTANCES21 (1988)
`
`09/402,010, issued as US ‘550 1008
`1012
`
`Lyle D. Bighleyet al., Salt Forms ofDrugs and
`Absorption, in 13 ENCYCLOPEDIA OF
`PHARMACEUTICAL TECHNOLOGY 453 (James
`Swarbrick & James C. Boylan eds., 1996)
`
`
`
`1013
`
`Paulekuhn
`
`1014 Morris
`
`1015
`
`Bastin
`
`1016
`
`Nyqvist
`
`1017
`
`Jessen
`
`1018
`1019
`1020
`1021
`
`US ‘495
`
`US ‘376
`
`US ‘198
`
`US ‘388
`
`1022
`
`Stahl
`
`1023
`
`Pharmeuropa 2000
`
`1024
`
`Aakeroy
`
`G. Steffen Paulekuhn et al., Trends in Active
`Pharmaceutical Ingredient Salt Selection Based on
`Analysis of the Orange Book Database, 50 J.
`MEDICINAL CHEMISTRY 6665 (2007)
`
`Kenneth R. Morris et al., An Integrated Approach to
`the Selection of Optimal Salt Form for a New Drug
`Candidate, 105 INT’L J. PHARM. 209 (1994)
`
`Richard J. Bastin et al., Salt Selection and
`Optimisation Procedures for Pharmaceutical New
`Chemical Entities, 4 ORGANIC PROCESS RSCH. &
`DEV. 427 (2000)
`
`International Patent Application No.
`WO 1998/054166, to Nyqvist et al.
`
`International Patent Application No.
`WO 2000/055131, to Jessen et al.
`
`U.S. Patent No. 5,834,495
`
`U.S. Patent No. 5,073,376
`
`U.S. Patent No. 2,870,198
`
`U.S. Patent No. 6,794,388
`
`HANDBOOK OF PHARMACEUTICAL SALTS 329 (P.
`Heinrich Stahl & Camille G. Wermuth eds., 1st ed.
`2002)
`
`European Directorate for the Quality of Medicines
`and Healthcare, Enquiry: Alkyl Mesilate
`(Methanesulphonate) Impurities in Mesilate Salts, 12
`PHARMEUROPA 27 (2000)
`
`Christer B. Aakeroy & Peter B. Hitchcock;
`Hydrogen-bonded Layers of Hydrogentartrate
`Anions: Two-dimensional Building Blocks for Crystal
`Engineering, 3 J. MATERIAL CHEMISTRY 1129 (1993)
`8
`
`
`
`
`
`1025
`
`
`
`Confidential Settlement Agreement – FILED
`UNDER SEAL
`
`
`9
`
`
`
`
`
`CERTIFICATE OF SERVICE
`
`
`
`The undersigned hereby certifies that a complete copy of the following
`
`materials:
`
`•
`
`•
`
`•
`
`JOINT MOTION TO TERMINATE PROCEEDING PURSUANT TO
`35 U.S.C. § 317 AND 37 C.F.R. § 42.72 AND JOINT REQUEST TO
`KEEP PAPERS SEPARATE AS BUSINESS CONFIDENTIAL
`INFORMATION
`
`PETITIONER’S UPDATED EXHIBIT LIST
`
`PETITIONER’S EXHIBIT 1025
`
`were served via electronic mail on October 21, 2021, on the following attorneys of
`
`record at:
`
`
`
`Andrew V. Trask
`atrask@wc.com
`
`Michael Xun Liu
`mliu@wc.com
`
`
`
`
`
`Dated: October 20, 2021
`
`
`
`
`
`Richard V. Zanzalari
`richard.zanzalari@pfizer.com
`
`Bryan C. Zielinski
`bryan.c.zielinski@pfizer.com
`
`Respectfully Submitted,
`
`RAKOCZY MOLINO MAZZOCHI SIWIK LLP
`
`/s/ Deanne M. Mazzochi
`Deanne M. Mazzochi (Reg. No. 50,158)
`6 West Hubbard Street, Suite 500
`Chicago, IL 60654
`Telephone: (312) 222-6305
`Facsimile: (312) 222-6325
`dmazzochi@rmmslegal.com
`
`Counsel for Petitioner Apotex Inc.
`
`
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