UNITED STATES PATENT AND TRADEMARK OFFICE
`___________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`___________________
`
`COALITION FOR AFFORDABLE DRUGS X LLC,
`Petitioner,
`
`v.
`
`ANACOR PHARMACEUTICALS, INC.,
`Patent Owner.
`___________________
`Case No.: IPR2015-01776
`Patent No.: 7,582,621
`__________________
`
`PETITIONER’S UPDATED EXHIBIT LIST
`
`
`
`
`
`
`___________________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`___________________
`
`COALITION FOR AFFORDABLE DRUGS X LLC,
`Petitioner,
`
`v.
`
`ANACOR PHARMACEUTICALS, INC.,
`Patent Owner.
`___________________
`Case No.: IPR2015-01776
`Patent No.: 7,582,621
`__________________
`
`PETITIONER’S UPDATED EXHIBIT LIST
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`Appendix of Exhibits
`Patent No. 7,582,621
`
`EXHIBIT
`
`DESCRIPTION
`
`FILED
`
`Ex. 1004
`
`Ex. 1009
`Ex. 1010
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`Ex. 1011
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`Ex. 1012
`Ex. 1013
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`Ex. 1014
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`Ex. 1015
`
`Ex. 1016
`
`Ex. 1001 U.S. Patent No. 7,582,621 (“the ’621 Patent”)
`Ex. 1002
`Patent Cooperation Treaty Pub. No. WO 1995/033754 to
`Austin et al. (“Austin”)
`Ex. 1003 U.S. Patent Pub. No. 2002/0165121 to Brehove
`(“Brehove”)
`Patent Cooperation Treaty Pub. No. WO 2003/009689 A1
`to Freeman et al. (“Freeman”)
`Ex. 1005 U.S. Patent No. 6,042,845 to Sun et al. (“Sun”)
`Ex. 1006 Declaration of Stephen Kahl, Ph.D. (“Kahl Decl.”)
`Ex. 1007
`Curriculum Vitae of Stephen B. Kahl, Ph.D.
`Ex. 1008 Declaration of S. Narasimha Murthy, Ph.D. (“Murthy
`Decl.”)
`Curriculum Vitae of S. Narasimha Murthy, Ph.D.
`Prosecution History: U.S. Appl. No. 11/357,687 dated
`February 16, 2006
`Prosecution History: Response To Restriction Requirement
`dated June 6, 2008
`Prosecution History: Office Action dated August 26, 2008
`Prosecution History: Reply to First Office Action dated
`January 23, 2009
`Prosecution History: Notice of Allowance dated April 22,
`2009
`Prosecution History Of Continuation Application:
`Response to Office Action dated May 18, 2009
`Prosecution History: Petition For Reconsideration Of
`Patent Term Adjustment Under 37 C.F.R. 1.705(d) dated
`September 25, 2009
`Prosecution History: Grant of Petition For Reconsideration
`Of Patent Term Adjustment Under 37 C.F.R. 1.705(d)
`dated April 23, 2010
`Prosecution History: Petition To Correct Inventorship
`Under 37 C.F.R. § 1.324 dated May 20, 2010
`Prosecution History: Grant Of Petition To Correct
`Inventorship Under 37 C.F.R. § 1.324 dated July 16, 2013
`Ex. 1020 U.S. Patent No. 2,831,866 to W.A. Freeman et al. (“the
`’866 Patent”)
`
`Ex. 1017
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`Ex. 1018
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`Ex. 1019
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`Appendix of Exhibits
`Patent No. 7,582,621
`
`EXHIBIT
`
`DESCRIPTION
`
`FILED
`
`Ex. 1021 U.S. Patent No. 3,093,659 to Bell et al. (“Bell”)
`Ex. 1022 U.S. Patent No. 3,297,525 to Grier (“Grier”)
`Ex. 1023 U.S. Patent No. 3,370,957 to Wagner et al (“Wagner”)
`Ex. 1024
`BioborJF® Specification Sheet (2015)
`Ex. 1025
`BioborJF® Material Safety Data Sheet (2004)
`Ex. 1026 U.S. Patent No. 4,202,894 to Pfiffner (“Pfiffner”)
`Ex. 1027 Michael P. Groziak, Boron Therapeutics On The Horizon,
`8 AM. J. OF THERAPEUTICS 321-28 (2001) (“Groziak”)
`Sudaxshina Murdan, Drug Delivery to the Nail Following
`Topical Application, 236 INT’L J. OF PHARM., 1-26 (2002)
`(“Murdan”)
`Ex. 1029 U.S. Patent No. 4,822,822 to Arita et al. (“Arita”)
`Ex. 1030 Declaration of Ryan J. Fletcher (“Fletcher Decl.”)
`Ex. 1031 Kerydin® Prices, available at
`http://www.goodrx.com/kerydin
`Ex. 1032 Q1 Medicare 2015 Kerydin® Price, available at
`http://www.q1medicare.com/PartD-2015MedicarePlan-
`RetailDrugPriceprint.php?stateReg=13MI&ndc=55724011
`121&formulary=00015191&contractId=H2322&planId=00
`8&segmentId=0&zipCountyCode=26115&cplanType=M&
`cletter=K&cmode=state
`Ex. 1033 Declaration of Brent E. Routman in Support of Petitioner’s
`Motion for Admission Pro Hac Vice
`Ex. 1034 Declaration of Peter A. Gergely in Support of Petitioner’s
`Motion for Admission Pro Hac Vice
`Ex. 1035 Declaration of Ryan J. Fletcher in Support of Petitioner’s
`Motion for Admission Pro Hac Vice
`Supplemental Declaration of Ryan J. Fletcher
`Biobor, R.E.D. Facts, EPA-738-R-93-004 (June 1993),
`http://nepis.epa.gov/Exe/ZyPDF.cgi?Dockey=200009P5.P
`DF
`Excerpts From The Certified Prosecution History For U.S.
`Patent No. 6,878,365, Including The MSDS Sheet For
`BioborJF®
`Supplemental Declaration of Stephen Kahl, Ph.D.
`
`Ex. 1028
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`Ex. 1036
`Ex. 1037
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`Ex. 1038
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`Ex. 1039
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`Appendix of Exhibits
`Patent No. 7,582,621
`
`EXHIBIT
`
`DESCRIPTION
`
`FILED
`
`Ex. 1040
`
`Supplemental Kerydin® Prices, available at
`http://www.goodrx.com/kerydin;
`http://www.goodrx.com/how-goodrx-works;
`http://www.goodrx.com/press
`Ex. 1041 Q1 Medicare 2015 Kerydin® Price, available at
`https://q1medicare.com/PartD-2016MedicarePlan-
`RetailDrugPrice.php?ndc=10337090544&letter=K&formul
`ary=00016286&stateReg=13MI&contractId=H2322&planI
`d=008&segmentId=0#History;
`https://q1medicare.com/PartD-About-Us-About-Us-About-
`Us-About.php
`Supplemental Declaration of S. Narasimha Murthy, Ph.D.
`
`Ex. 1042
`
`Ex. 1043 Declaration of Stephen Kahl, Ph.D., dated August 22, 2016
`
`Ex. 1044 Declaration of S. Narasimha Murthy, Ph.D., dated August
`23, 2016
`Ex. 1045 Deposition Transcripts of Dr. Majella Lane dated July 7-8,
`2016
`Ex. 1046 Deposition Transcripts of Dr. Mahmoud A. Ghannoum
`dated July 18-19, 2016
`Ex. 1047 Deposition Transcript of Dr. Howard Maibach dated July
`13, 2016
`Ex. 1048 Deposition Transcripts of Dr. Paul J. Reider dated July 21-
`22, 2016
`12 Progress in Heterocyclic Chemistry, ch. 1, 1-21 (G.W.
`Gribble & T.L. Gilchrist eds., 1st ed., 2000) (Reider Dep.
`Ex. 5)
`Ronald C. Wester et al., In Vivo Percutaneous Absorption
`of Boric Acid, Borax, and Disodium Octaborate
`Tetrahydrate in Humans Compared to in Vitro Absorption
`in Human Skin from Infinite and Finite Doses, 45
`Toxicological Sci. 42-51 (1998) (Maibach Dep. Ex. 9)
`Press Release, Anacor, Anacor Co-Founders Recognized
`for Scientific Achievements (June 10, 2009), available at
`http://investor.anacor.com/releasedetail.cfm?releaseid=527
`603.
`
`Ex. 1049
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`Ex. 1050
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`Ex. 1051
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`Appendix of Exhibits
`Patent No. 7,582,621
`
`EXHIBIT
`
`DESCRIPTION
`
`FILED
`
`Ex. 1052
`
`Ex. 1054
`
`Ex. 1056
`
`Ex. 1059
`
`Patent Cooperation Treaty Pub. No. WO 2004/056322 A2
`to Ving Lee and Stephen Benkovic (Reider Dep. Ex. 9)
`Ex. 1053 U.S. Patent App. Pub. No. 2004/0259833 A1 to Benkovic
`et al.
`Susan A. Hubbard, Comparative Toxicology of Borates, 66
`Biological Trace Element Research, Proceedings of the
`Second Int’l Symposium on the Health Effect of Boron and
`Its Compounds 343-57 (Humana Press, 1998) (“Hubbard”)
`Ex. 1055 U.S. Patent No. 7,465,836 to Lee et al. (“Lee”) (Reider
`Dep. Ex. 10)
`Stephen J. Baker, Therapeutic Potential of Boron-
`Containing Compounds, 1 Future Med. Chem. (7) 1275-
`1288 (2009) (Reider Dep. Ex. 7)
`Ex. 1057 Wenjie Li et al., An Improved Protocol for the preparation
`of 3-Pyridyl- and Some Arylboronic Acids, 67 J. Org.
`Chem. 5394-97 (2002)
`Ex. 1058 Donald E. Garrett, Borates Handbook of Deposits,
`Processing, Properties, and Use, 333-429 (Academic Press,
`1998)
`Stephen J. Baker et al., Boron-Containing Inhibitors of
`Synthetases, 40 Chem. Soc. Rev. 4279-85 (2011) (Reider
`Dep. Ex. 8)
`Ex. 1060 Wenqian Yang et al., Boronic Acid Compounds as
`Potential Pharmaceutical Agents, 23 Med. Research Rev.,
`No. 3, 346-68 (2003)
`Ronald C. Wester et al., In Vivo Percutaneous Absorption
`of Boron as Boric Acid, Borax, and Disodium Octaborate
`Tetrahydrate in Humans: A Summary, 66 Biological Trace
`Element Research, Proceedings of the Second Int’l
`Symposium on the Health Effect of Boron and Its
`Compounds 101-09 (Humana Press, 1998)
`Patent Cooperation Treaty Pub. No. WO 2005/013892 A3
`to Lee et al.
`Patent Cooperation Treaty Pub. No. WO 2007/095638 A3
`to Baker et al.
`Certified U.S. Provisional App. No. 60/654,060 (“the ’060
`Provisional”)
`
`Ex. 1061
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`Ex. 1062
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`Ex. 1063
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`Ex. 1064
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`Appendix of Exhibits
`Patent No. 7,582,621
`
`EXHIBIT
`
`DESCRIPTION
`
`FILED
`
`Ex. 1066
`
`Ex. 1068
`
`Ex. 1069
`
`Ex. 1065 Dirk Mertin & Bernhard C. Lippold, In-vitro Permeability
`of the Human Nail and of a Keratin Membrane from
`Bovine Hooves: Prediction of the Penetration Rate of
`Antimycotics through the Nail Plate and their Efficacy, 49
`J. Pharm. Pharmacol. 866-72 (1997) (Lane Dep. Ex. 7)
`(Ghannoum Dep. Ex. 1)
`Stephen J. Baker et al., Progress on New Therapeuties for
`Fungal Nail Infections, 40 Ann. Reps. in Med. Chem. 333-
`45 (2005)
`Ex. 1067 ASTM® D5134 Qualitative Reference Naphtha Standard,
`Safety Data Sheet, Version 3.10, available at
`http://www.sigmaaldrich.com/MSDS/MSDS/DisplayMSD
`SPage.do?country=US&language=en&productNumber=48
`265-
`U&brand=SUPELCO&PageToGoToURL=http%3A%2F%
`2Fwww.sigmaaldrich.com%2Fcatalog%2Fproduct%2Fsup
`elco%2F48265u%3Flang%3Den
`(Reider Deposition Ex. No. 12)
`Tavaborole, Material Safety Data Sheet, available at
`http://www.syninnova.com/generatemsdspdf.php?pid=SL-
`264
`Center for Drug Evaluation and Research Approval
`Package for Jublia® topical solution, 10%, available at
`http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/2
`03567Orig1s000ApLtr.pdf
`Prosecution History for U.S. Patent No. 7,582,621
`
`Ex. 1070
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`Ex. 1071
`
`Center for Drug Evaluation and Research Approval
`Package for Kerydin® topical solution, 5%, available at
`http://www.accessdata.fda.gov/drugsatfda_docs/nda/2014/2
`04427Orig1s000Approv.pdf
`Ex. 1072 Katalin Hideghéty et al., Tissue Uptake of BSH in Patients
`with Glioblastoma in the EORTC 11961 Phase I BNCT
`Trial, 62 J. Neuro-Oncology 145-156 (2003)
`Ex. 1073 Heikki Joensuu et al., Boron Neutron Capture Therapy of
`Brain Tumors: Clinical Trials at the Finnish Facility Using
`Boronophenylalanine, 62 J. Neuro-Oncology 123-134
`7
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`Appendix of Exhibits
`Patent No. 7,582,621
`
`EXHIBIT
`
`DESCRIPTION
`
`FILED
`
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`Ex. 1074
`
`Ex. 1075
`
`(2003)
`Roger Henriksson et al., Boron Neutron Capture Therapy
`(BNCT) for Glioblastoma Multiforme: A Phase II Study
`Evaluating a Prolonged High-Dose of Borono-
`phenylalanine (BPA), 88 Radiotherapy & Oncology 183-
`191 (2008)
`Poster Presentation, A.S. Kushwaha et al., Trans-ungual
`Delivery of AR-12, a Novel Antifungal Drug, Am. Ass’n of
`Pharm. Scientists Conference (October 29, 2015) (Murthy
`Dep. Ex. 1)
`Ex. 1076 Yoichi Kobayashi et al., In Vitro Permeation of Several
`Drugs Through the Human Nail Plate: Relationship
`Between Physicochemical Properties and Nail
`Permeability of Drugs, 21 Eur. J. of Pharm. Sci. 471-77
`(2004) (Lane Dep. Ex. 5)
`Ex. 1077 Donald L. Greer, Evolving Role of Nondermatophytes in
`Onychomycosis, 34 Int’l J. Dermatol., no. 8, 521-24 (Aug.
`1995) (Ghannoum Dep. Ex. 5)
`R. Galimberti et al., The Activity of Ketoconazole in the
`Treatment of Onychomycosis, 2 Rev. Infectious Diseases,
`no.4, 596-98 (Oxford Univ. Press., 1980) (Ghannoum Dep.
`Ex. 2)
`Ex. 1079 Aditya K. Gupta, M.D., et al., Ciclopirox Nail Lacquer
`Topical Solution 8% in the Treatment of Toenail
`Onychomycosis, 43 J. Am. Acad. Dermatol., no. 4, S70-S80
`(Oct. 2000) (Ghannoum Dep. Ex. 4)
`Ex. 1080 Declaration of Ryan J. Fletcher, Ph.D.
`
`Ex. 1078
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`8
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