`
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`Paper No. _____
`Filed: April 27, 2015
`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`_____________________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`_____________________________
`
`AGILA SPECIALTIES INC. and MYLAN PHARMACEUTICALS INC.,
`Petitioner,
`
`v.
`
`CUBIST PHARMACEUTICALS, INC.,
`Patent Owner.
`_____________________________
`
`Case IPR2015-00144
`Patent 8,058,238
`_____________________________
`
`
`PETITIONERS’ AND PATENT OWNER’S JOINT MOTION TO
`TERMINATE PROCEEDING UNDER 35 U.S.C. § 317
`
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`Case IPR2015-00144
`Patent 8,058,238
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`I.
`
`RELIEF REQUESTED AND STATEMENT OF FACTS
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`
`
`Pursuant to 35 U.S.C. § 317(a), 37 C.F.R. § 42.72, and the Board’s
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`authorization of this motion by e-mail on April 23, 2015, Petitioners Agila
`
`Specialties Inc. and Mylan Pharmaceuticals Inc., and Patent Owner Cubist
`
`Pharmaceuticals, Inc., jointly request termination of Inter Partes Review (“IPR”)
`
`IPR2015-00144 of U.S. Patent No. 8,058,238.
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`1. Brief Explanation of Why Termination is Appropriate
`
`Agila Specialties Inc. and Mylan Pharmaceuticals Inc. filed a Petition for
`
`IPR in this proceeding on October 23, 2014 (Paper 1), and Cubist Pharmaceuticals,
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`Inc.’s Preliminary Response was filed on February 12, 2015 (Paper 21). A
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`decision whether to institute this inter partes review has not yet been issued by the
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`Board. The parties have reached a settlement agreement to withdraw the IPR
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`petition and to terminate this inter partes review.
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`This agreement has been made in writing, and a true and correct copy is
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`filed with this Office, pursuant to 35 U.S.C. § 317(b), as Exhibit 1047. Because
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`the document is also being filed on the public docket in related district court
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`litigation, there is no need for it to be treated as confidential or kept separate from
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`the present case files.
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`-1-
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`Case IPR2015-00144
`Patent 8,058,238
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`Termination is thus proper because the parties jointly request termination
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`and the Office has not yet issued an institution decision or otherwise decided the
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`merits of the proceeding.
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`2. Related Litigation Involving the Patent at Issue
`
`
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`There is a single pending related district court litigation involving the
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`parties to this proceeding: Cubist Pharmaceuticals, Inc. v. Strides, Inc. and Agila
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`Specialties Private Limited, Case No. 13-cv-1679-GMS, in the United States
`
`District Court for the District of Delaware (the “Related Litigation”). The parties in
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`the Related Litigation are Plaintiff Cubist Pharmaceuticals, Inc. (“Cubist”) and
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`Defendants Strides, Inc. (n/k/a Agila Specialties Inc.) and Agila Specialties Private
`
`Limited (collectively, “Agila”). Cubist and Strides, Inc. are also parties to this
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`inter partes review proceeding.
`
`The parties have identified other related litigation matters in their
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`respective notices filed with the Board, i.e., Paper 1, p. 4; Paper 7, pp. 2-3; and
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`Paper 18, pp. 2-3. These matters are either no longer pending or involve other
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`defendants.
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`3. Related Proceedings Currently Before The Office
`
`As between the instant parties there are three additional proceedings
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`involving the patent, IPR2015-00141, IPR2015-00142, and IPR2015-00143, and
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`there are other IPRs involving the parties on different patents that are also at issue
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`-2-
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`Case IPR2015-00144
`Patent 8,058,238
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`in the Related Litigation. The various IPRs and their corresponding patents are as
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`follows:-
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`IPR2015-00131 (Patent No. 6,468,967);
`
`IPR2015-00132 (Patent No. 6,852,689);
`
`IPR2015-00140 (Patent No. 8,129,342);
`
`IPR2015-00141 (Patent No. 8,058,238);
`
`IPR2015-00142 (Patent No. 8,058,238);
`
`IPR2015-00143 (Patent No. 8,058,238); and
`
`IPR2015-00144 (Patent No. 8,058,238).
`
`Similar Joint Motions to Terminate Proceedings are also being filed in the above-
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`listed IPR proceedings. The Office has not yet issued an institution decision in any
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`of these proceedings.
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`A petition for IPR has been filed by Fresenius-Kabi USA LLC against
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`Patent No. 6,852,689, i.e., IPR2015-00223, and against Patent No. 6,468,967 i.e.,
`
`IPR2015-00227. The Fresenius-Kabi IPR petitions are not part of this agreement.
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`4. Current Status of the Related Litigation
`
`Cubist previously filed a complaint against Agila in the Related
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`Litigation alleging infringement of U.S. Patent Nos. 6,468,967, 6,852,689,
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`8,058,238, and 8,129,342. On April 23, 2015, Cubist and Agila filed with the
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`Delaware Court a “Stipulation to Narrow Issues in the Litigation, Covenant Not to
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`Case IPR2015-00144
`Patent 8,058,238
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`Sue, and Settlement of IPR Proceedings” (the “Stipulation”). As more fully set
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`forth in the Stipulation filed herewith, Plaintiff agreed to limit the asserted claims
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`against Agila in the Related Litigation and covenanted not to sue Agila for
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`infringement of the remaining unasserted claims in exchange for Defendants
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`stipulating to infringement for the purposes of the Related Litigation to the extent
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`the asserted claims are not found invalid or unenforceable pursuant to a final non-
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`appealable decision and, inter alia, requesting termination of this inter partes
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`review proceeding.
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`II. CONCLUSION
`
`For the foregoing reasons, Petitioners Agila Specialties Inc. and Mylan
`
`Pharmaceuticals Inc., and Patent Owner Cubist Pharmaceuticals, Inc. respectfully
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`request termination of Case No. IPR2015-00144 involving U.S. Patent No.
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`8,058,238.
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`
`
`Date: April 27, 2015
`
`
`
`
`
`Date: April 27, 2015
`
`
`
`
`Respectfully submitted,
`
`/Peter R. Munson/
`Peter R. Munson, Lead Counsel
`Reg. No. 43,821
`Counsel for Petitioner Agila Specialties
`Inc. and Mylan Pharmaceuticals Inc.
`
`/Emily R. Whelan/
`Emily R. Whelan, Lead Counsel
`Reg. No. 50,391
`Counsel for Patent Owner Cubist
`Pharmaceuticals, Inc.
`
`
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`-4-
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`Case IPR2015-00144
`Patent 8,058,238
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`III. APPENDIX – LIST OF EXHIBITS
`
`
`
`Exhibit
`
`Reference
`
`1001
`
`High Purity Lipopeptides, U.S. Patent No. 8,058,238 (filed Apr.
`
`24, 2007) (issued Nov. 15, 2011).
`
`1002
`
`High Purity Lipopeptides, U.S. Patent No. 8,129,342 (filed Sept.
`
`1003
`
`1004
`
`1005
`
`22, 2010) (issued Mar. 6, 2012).
`
`File History U.S. Patent No. 8,058,238
`
`File History U.S. Patent No. 8,129,342
`
`Declaration of Catherine N. Mulligan re U.S. Patent No.
`
`8,052,238
`
`1006
`
`Declaration of Catherine N. Mulligan re U.S. Patent No.
`
`8,129,342
`
`1007
`
`Chromatographic Purification Process, U.S. Patent No. 4,874,843
`
`(filed Dec. 3, 1987) (issued Oct. 17, 1989).
`
`1008
`
`Richard H. Baltz, Lipopeptide Antibiotics Produced by
`
`Streptomyces roseosporus and Streptomyces fradiae, in
`
`BIOTECHNOLOGY OF ANTIBIOTICS (W.R. Strohl ed.,1997).
`
`(“Baltz”)
`
`1009
`
`Peptide Antibiotics, U.S. Patent No. 4,331,594 (filed Nov. 14,
`
`1980) (issued May 25, 1982).
`
`1010
`
`Anhydro- and Isomer-A-21978C Cyclic Peptides, U.S. Patent
`
`No. 5,912,226 (filed Dec. 16, 1991) (issued Jun. 15, 1999).
`
`1011
`
`F.M. Huber et al., The formation of daptomycin by supplying
`
`-5-
`
`
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`Case IPR2015-00144
`Patent 8,058,238
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`
`Exhibit
`
`Reference
`
`decanoic acid to Streptomyces roseosporus cultures producing
`
`the antibiotic complex A21978C, J. BIOTECHNOL. 7:283-92
`
`(1988).
`
`1012
`
`F.M. Huber et al., Dispersal of insoluble fatty acid precursors in
`
`stirred reactors as a mechanism to control antibiotic factor
`
`distribution, in BIOTECHNOLOGY PROCESSES (Ho and Oldshue
`
`eds., 1987).
`
`1013
`
`Catherine N. Mulligan & Bernard F. Gibbs, Recovery of
`
`Biosurfactants by Ultrafiltration, J. CHEM. TECHNOL.
`
`BIOTECHNOL. 47:23-9 (1990).
`
`1014
`
`Sung-Chyr Lin and Horng-Jyh Jiang, Recovery and Purification
`
`of the Lipopeptide Biosurfactant Bacillus subtilis by
`
`Ultrafiltration, BIOTECHNOLOGY TECHNIQUES, 11:413-16 (1997).
`
`(“Lin I”)
`
`1015
`
`Sung-Chyr Lin et al., General Approach for the Development of
`
`High-Performance Liquid Chromatography Methods for
`
`Biosurfactant Analysis and Purification, JOURNAL OF
`
`CHROMATOGRAPHY, 825:145-49 (1998). (“Lin II”)
`
`1016
`
`Method of Producing Surfactin with the Use of Mutant of
`
`Bacillus Subtilis, U.S. Patent No. 5,227,294 (filed June 20, 1991)
`
`(issued Jul. 13, 1993).
`
`1017
`
`Mohamad Osman et al., Tuning micelles of a bioactive
`
`heptapeptide biosurfactant via extrinsically induced
`
`conformational transition of surfactin assembly, J. PEPTIDE SCI.,
`
`-6-
`
`
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`Case IPR2015-00144
`Patent 8,058,238
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`
`Exhibit
`
`Reference
`
`4:449-58 (1998). (“Osman”)
`
`1018
`
`F.P. Tally et al., Daptomycin: A Novel Agent for Gram-positive
`
`Infections, EXPERT OPIN. INVEST. DRUGS 8:1223-38 (1999).
`
`1019
`
`BIOSURFACTANTS: RESEARCH TRENDS & APPLICATIONS
`
`(Catherine N. Mulligan ed., 2014).
`
`1020
`
`Sung-Chyr Lin, Biosurfactant: Recent Advances, J. CHEM. TECH.
`
`BIOTECHNOL. 66:109-20 (1996).
`
`1021
`
`Kei Arima et al., Surfactin, a crystalline peptide lipid surfactant
`
`produced by Bacillus subtilis: Isolation, characterization and its
`
`inhibition of fibrin clot formation, BIOCHEM. BIOPHYS. RES.
`
`COMM. 31:488-94 (1968).
`
`1022
`
`Atsushi Kakinuma et al., Confirmation of the structure of
`
`surfactin by mass spectrometry, AG. BIOL. CHEM. 33:1669-72
`
`(1969).
`
`1023
`
`A.W. Bernheimer et al., Nature and properties of a cytolytic
`
`agent produced by Bacillus subtilis, J. GEN.MICROBIOL. 61:361-
`
`69 (1970).
`
`1024
`
`David G. Cooper, Biosurfactants, MICROBIOL. SCI. 3:145-47
`
`(1986).
`
`1025
`
`Dirk Vollenbroich et al., Antimycoplasma properties and
`
`application on cell surface of surfactin, a lipopeptide antibiotic
`
`from Bacillus subtilis, APPL. ENVIRON.MICROBIOL. 63:44-69
`
`(1997).
`
`1026
`
`Catherine N. Mulligan et al., Selection of microbes producing
`
`-7-
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`
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`Case IPR2015-00144
`Patent 8,058,238
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`
`Exhibit
`
`Reference
`
`biosurfactants in media without hydrocarbons, J. FERMENT.
`
`TECHNOL. 62:311-14 (1984).
`
`1027
`
`Catherine N. Mulligan & Bernard F. Gibbs, Correlation of
`
`nitrogen metabolism with biosurfactant production, APPL.
`
`ENVIRON. MICROBIOL. 55:3016-69 (1989).
`
`1028
`
`Catherine N. Mulligan et al., Enhanced biosurfactant production
`
`by a mutant Bacillus subtilis strain, APPL.MICROBIOL.31:486-69
`
`(1989).
`
`1029
`
`Enhanced Production of Biosurfactant Through the Use of a
`
`Mutated B Subtilis Strain, U.S. Patent No. 5,037,758 (filed Jan.
`
`1989) (issued Aug. 6, 1991).
`
`1030
`
`H.E. Reiling et al., Pilot plant production of rhamnolipid
`
`biosurfactant by Pseudomonas aeruoginosa, APPL. ENVIRON.
`
`MICROBIOL., 51:985-89 (1986).
`
`1031
`
`Sung-Chyr Lin et al., Structural and immunological
`
`characterization of a biosurfactant produced by Bacillus
`
`licheniformis JF-2, APPL. ENV.MICROBIOL. 60:31-8 (1994).
`
`1032
`
`Jitendra D. Desai and Ibrahim M. Banat, Microbial production of
`
`surfactants and their commercial potential, MOL. BIOL. REV.
`
`61:47- 64, 57 (1997).
`
`1033
`
`Plaintiff’s Complaint, Filed October 9, 2013, ECF No. 1. Cubist
`
`Pharmaceuticals, Inc. v. Strides, Inc. and Agila Specialties
`
`Private Ltd., Case No. 13-cv-1679-GMS (D. Del. filed Oct. 9,
`
`2013).
`
`-8-
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`Case IPR2015-00144
`Patent 8,058,238
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`Exhibit
`
`Reference
`
`1034
`
`Proof of Service of Strides, Inc., Filed October 23, 2013, ECF
`
`No. 6. Cubist Pharmaceuticals, Inc. v. Strides, Inc. and Agila
`
`Specialties Private Ltd., Case No. 13-cv-1679-GMS (D. Del.
`
`filed Oct. 9, 2013).
`
`1035
`
`Proof of Service of Agila Specialties Private Limited, Filed
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`October 23, 2013, ECF No. 7. Cubist Pharmaceuticals, Inc. v.
`
`Strides, Inc. and Agila Specialties Private Ltd., Case No. 13-cv-
`
`1679-GMS (D. Del. filed Oct. 9, 2013).
`
`1036
`
`Plaintiff’s Complaint, Filed October 9, 2013 ECF No. 1. Cubist
`
`Pharmaceuticals, Inc. v. Strides, Inc. and Agila Specialties
`
`Private Ltd., Case No. 13-cv-06016-NLH, (D. N.J. filed Oct. 9,
`
`2013, voluntarily dismissed Oct. 24, 2013).
`
`1037
`
`Plaintiff’s Notice of Voluntary Dismissal, Filed October 24,
`
`2013, ECF No.8. Cubist Pharmaceuticals, Inc. v. Strides, Inc. and
`
`Agila Specialties Private Ltd., Case No. 13-cv-06016-NLH, (D.
`
`N.J. filed Oct. 9, 2013, voluntarily dismissed Oct. 24, 2013).
`
`1038
`
`Proof of Service to Cubist Pharmaceuticals, Inc. dated October
`
`24, 2014, of IPR2015-00140, -00141, -00142, -00143 and -
`
`00144.
`
`1039
`
`Express Mail receipt stamped with an October 23, 2014 received
`
`date for filing of Inter Partes Review Petition of U.S. Patent No.
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`8,058,238, challenging claims 10-36, 43-47 and 176-192,
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`Exhibits 1- 37, Motion to Request Acceptance of Mailed Petition
`
`and accompanying Powers of Attorney forms.
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`-9-
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`Case IPR2015-00144
`Patent 8,058,238
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`Exhibit
`
`Reference
`
`1040
`
`Payment receipt from USPTO reflecting payment date of
`
`October 23, 2014 re IPR2015-00144
`
`1041
`
`1042
`
`Electronic filing receipt of October 24, 2014 re IPR2015-00144
`
`Notice of Filing Date Accorded to Petition and Time for Filing
`
`Patent Owner Preliminary Response. (Board’s notice according a
`
`filing date of October 23, 2014). Paper Number 4
`
`1043
`
`Declaration of Adriana Serrano in Support of Agila’s Motion to
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`Correct Accorded Filing Date Under 37 C.F.R. §§1.10, 42.20 and
`
`42.22
`
`1044
`
`Declaration of Lorelei P. Westin in Support of Agila’s Motion to
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`Correct Accorded Filing Date Under 37 C.F.R. §§1.10, 42.20 and
`
`42.22
`
`1045
`
`Memorandum Opinion, Filed December 8, 2014 ECF No. 135.
`
`Cubist Pharmaceuticals, Inc. v. Hospira, Inc., Case No. 12-367-
`
`GMS, (D. Delaware)
`
`1046
`
`Court Order, Filed December 8, 2014 ECF No. 136. Cubist
`
`Pharmaceuticals, Inc. v. Hospira, Inc., Case No. 12-367-GMS,
`
`(D. Delaware)
`
`1047
`
`Stipulation To Narrow Issues In The Litigation, Covenant Not To
`
`Sue, And Settlement of IPR Proceedings
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`
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`
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`-10-
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`Case IPR2015-00144
`Patent 8,058,238
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`CERTIFICATE OF SERVICE
`
`I certify that the foregoing Petitioners’ and Patent Owner’s Joint
`
`Motion to Terminate Proceeding Under 35 U.S.C. § 317 was served on this 27th
`
`day of April, 2015, on the Patent Owner at the correspondence address of the
`
`Patent Owner as follows:
`
`
`Emily R. Whelan
`WILMER CUTLER PICKERING
`HALE AND DORR LLP
`60 State Street
`Boston, MA 02109
`emily.whelan@wilmerhale.com
`
`Jane M. Love, Ph.D.
`WILMER CUTLER PICKERING
`HALE AND DORR LLP
`7 World Trade Center
`250 Greenwich Street
`New York, New York 10007
`jane.love@wilmerhale.com
`
`
`
`
`
`
`
`
`
`Andrej Barbic, Ph.D.
`WILMER CUTLER PICKERING
`HALE AND DORR LLP
`60 State Street
`Boston, MA 02109
`andrej.barbic@wilmerhale.com
`
`Gerard M. Devlin, Jr.
`Merck & Co., Inc.
`2000 Galloping Hill Road
`Kenilworth, NJ 07033
`gerard_devlin@merck.com
`
`
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`
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`Date: April 27, 2015
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`
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`
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`Respectfully submitted,
`
`
`
`/Peter R. Munson/
`Peter R. Munson, Lead Counsel
`Reg. No. 43,821
`Counsel for Petitioner Agila Specialties
`Inc. and Mylan Pharmaceuticals Inc.
`
`-11-
`
`
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