UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`MYLAN PHARMACEUTICALS INC., MYLAN LABORATORIES LIMITED,
`ALEMBIC PHARMACEUTICALS LIMITED, TORRENT
`PHARMACEUTICALS LIMITED, AND AMERIGEN PHARMACEUTICALS
`LIMITED
`Petitioners,
`
`v.
`
`UCB PHARMA GMBH
`Patent Owner.
`
`Patent No. 6,858,650
`Case IPR2016-00510
`
`
`
`
`
`PETITIONER MYLAN PHARMACEUTICALS INC.’S AMENDED
`LIST OF EXHIBITS PURSUANT TO 37 C.F.R. § 42.63(e)
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`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`MYLAN PHARMACEUTICALS INC., MYLAN LABORATORIES LIMITED,
`ALEMBIC PHARMACEUTICALS LIMITED, TORRENT
`PHARMACEUTICALS LIMITED, AND AMERIGEN PHARMACEUTICALS
`LIMITED
`Petitioners,
`
`v.
`
`UCB PHARMA GMBH
`Patent Owner.
`
`Patent No. 6,858,650
`Case IPR2016-00510
`
`
`
`
`
`PETITIONER MYLAN PHARMACEUTICALS INC.’S AMENDED
`LIST OF EXHIBITS PURSUANT TO 37 C.F.R. § 42.63(e)
`
`
`
`
`
`
`
`
`
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`
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`LIST OF EXHIBITS
`U.S.P.N. 6,858,650
`File History for U.S.P.N. 6,858,650
`Declaration of Dr. Steven Patterson, Ph.D.
`C.V. for Dr. Steven Patterson, Ph.D
`“Johansson” – WO 94/11337 Filed 6 November 1992 – “Novel
`3,3-Diphenylpropylamines, Their Use and Preparation”
`“Andersson Review” – BJU International (1999), 84, 923-947 –
`“The Pharmacological Treatment of Urinary Incontinence”; K-E
`Andersson, R. Appell, L.D. Cardozo, C. Chapple, H.P. Drutz,
`A.E. Finkbeiner, F. Haab, and R. Vela Navarrete
`“Brynne 1997” – International Journal of Clinical Pharmacology
`and Therapeutics (1997), 35, 287-295 – “Pharmacokinetics and
`pharmacodynamics of tolterodine in man: a new drug for the
`treatment of urinary bladder overactivity”; N. Brynne, M.M.S.
`Stahl, B. Hallen, P.O. Edlund, L. Palmer, P. Hoglund, and J.
`Gabrielsson
`“Thomas” – British Heart Journal (1995), 74, 53-56 –
`“Concentration dependent cardiotoxicity of terodine in patients
`treated for urinary incontinence”; S. Thomas, P. Higham, K
`Hartigan-Go, F. Kamali, P. Wood, R. Campbell, and G. Ford
`“Detrol® Label” – Pharmacia & Upjohn
`“Postlind” – Drug Metabolism and Disposition (1998), 26 (4),
`289-293 – “Tolterodine, A New Muscarinic Receptor
`Antagonist, Is Metabolized by Cytochromes P450 2D6 and 3A in
`Human Liver Microsomes”; H. Postlind, A. Danielson, A.
`
`1
`
`Ex. 1001:
`Ex. 1002:
`Ex. 1003:
`Ex. 1004:
`Ex. 1005:
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`Ex. 1006:
`
`Ex. 1007:
`
`Ex. 1008:
`
`Ex. 1009:
`Ex. 1010:
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`
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`
`
`
`
`Lindgren, and S. Andersson
`“Brynne 1998” – Clinical Pharmacology & Therapeutics (May
`1998), 63(5), 529-539 – “Influence of CYP2D6 polymorphism
`on the pharmacokinetics and pharmacodynamics of tolterodine”;
`N. Brynne, P. Dalen, G. Alvan, L. Bertilsson, and J. Gabrielsson
`“Bundgaard” – Elsevier 1985 – “Design of Prodrugs”
`“Berge 1977” – Journal of Pharmaceutical Sciences (1977), 66
`(1), 1-19 – “Pharmaceutical Salts”; S. Berge, L., Bighley, and D.
`Monkhouse
`“Andersson 1998” – Drug Metabolism and Disposition (1998),
`26(6), 528-535 – “Biotransformation of tolterodine, a new
`muscarinic receptor antagonist, in mice, rats, and dogs”; S.
`Andersson, A. Lindgren, and H. Postlind
`“Nilvebrant” – Pharmacology and Toxicology (1997), 81, 169-
`172 – “Antimuscarinic Potency and Bladder Selectivity of PNU-
`200577, a Major Metabolite of Tolterodine”; L. Nilvebrant, P.
`Gillberg, and B. Sparf
`“DeMaagd” – P&T (2012), 37(6), 345-361 – “Management of
`Urinary Incontinence”; G. DeMaagd and T. Davenport
`“Appell” – Urology (1997), 50, 90-96 – “Clinical efficacy and
`safety of tolterodine in the treatment of overactive balder: a
`pooled analysis”; R. Appell
`“Ashworth” – Home Care Provider (1997), 2(3), 117-120 – “Is
`My Antihistamine Safe?”; L. Ashworth
`“Lipinski” – Advanced Drug Delivery Reviews, 1997
`“Bundgaard PCT” – WO 92/08459 Filed 11 November 1991 –
`
`2
`
`Ex. 1011:
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`Ex. 1012:
`Ex. 1013:
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`Ex. 1014:
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`Ex. 1015:
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`Ex. 1016:
`
`Ex. 1017:
`
`Ex. 1018:
`
`Ex. 1019:
`Ex. 1020:
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`
`
`
`
`“Topical Compositions for Transdermal Delivery of Prodrug
`Derivatives of Morphine”
`“AUA Guideline” – American Urological Association Eductatio
`and Research (2014) – “Diagnosis and Treatment of Overactive
`Bladder (Non-Neorogenic) in Adults: AUA/SUFU Guideline”;
`E. Gormley, et al
`“Pfizer 2012 Press Release” – Aug. 2, 2012 “Study Shows
`Toviaz is Effective in Reducing Urge Urinary Incontinence in
`Patients with Overactive Bladder After Suboptimal Response to
`Detrol LA” – www.pfizer.com
`“PM360” – April 1, 2012 “Overactive Bladder
`Market: Managing the Future” – www. pm360online.com
`“Toviaz® Label” – Pfizer Labs
`“FDA Approval Letter” –NDA20-771
`“FDA Guidance” – Applications Covered by Section 505(b)(2) –
`October 1999 – FDA (CDER)
`“Gould” – International Journal of Pharmaceutics (1986), 3, 201-
`217 – “Salt Section for Basic Drugs”; P. Gould
`“Alabaster” – Discovery & Development of Selective M3
`Antagonists for Clinical Use, 60 Life Science 1053 (1997)
`“Takeuchi” – 1,2,3,4-Tetrahydro-2-Isoquinolinecarboxylate
`Derivatives: A Novel Class of Selective Muscarinic Antagonists,
`III, in 213th ACS National Meeting, San Francisco, Abst. 046
`(Apr. 13-17, 1997)
`“Goldberg” – DuP 532, an angiotensin II receptor antagonist:
`First administration and comparison with losartan, Clinical
`
`3
`
`Ex. 1021:
`
`Ex. 1022:
`
`Ex. 1023:
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`Ex. 1024:
`Ex. 1025:
`Ex. 1026:
`
`Ex. 1027:
`
`Ex. 1028:
`
`Ex. 1029:
`
`Ex. 1030:
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`
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`
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`Pharmacology & Therapeutics, January 1997
`“Begley” – The Blood-brain Barrier: Principles for TGargeting
`Peptides and Drugs to the Central Nervous System, J. Phar.
`Pharmacol. 1996, 48:136-146
`Dkt 6 2015-01-28 Summons Returned Executed, Case No. 1:15-
`cv-00079-GMS, Pfizer,et al v Mylan Pharmaceutical Inc.(Dist.
`of DE)
`Declaration of DeForest McDuff, Ph.D.
`CV for DeForest McDuff, Ph.D.
`Toviaz: Donʼt Let Overactive Bladder Stop You In Your Tracks
`Toviaz U.S. and Worldwide Sales
`U.S. OAB Prescriptions and Shares by Drug (2008–2014)
`U.S. OAB Sales and Shares by Drug (2008–2014)
`U.S. OAB Market Share, Prescriptions, and Sales by Drug
`(2000–2007)
`Prescription Path of Toviaz and Other OABs
`Sales Path of Toviaz and Other OABs
`Sales Path of Toviaz Compound to Pharmaceutical Industry
`Benchmarks
`Comparison of Toviaz Sales to Compound to Pharmaceutical
`Industry Benchmarks
`Chart of Sales Path of Toviaz
`Present Value of Toviaz U.S. Sales
`Present Value of Toviaz Worldwide Sales
`Estimates of Expected R&D Costs
`U.S. OAB Detail Shares by Drug (2008–2015)
`
`4
`
`Ex. 1031:
`
`Ex. 1032:
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`Ex. 1033:
`Ex. 1034:
`Ex. 1035:
`Ex. 1036:
`Ex. 1037:
`Ex. 1038:
`Ex. 1039:
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`Ex. 1040:
`Ex. 1041:
`Ex. 1042:
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`Ex. 1043:
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`Ex. 1044:
`Ex. 1045:
`Ex. 1046:
`Ex. 1047:
`Ex. 1048:
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`
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`
`
`Consumer Price Index (CPI)
`2009-2010 UBS U.S. Pharmaceuticals 8/24/201
`2011-2014 UBS U.S. Pharmaceuticals 1/4/2016
`2009-2011 Pfizer Form 10-K, 2012
`2012-2014 Pfizer Form 10-K 2015
`UBS U.S. Pharmaceuticals 11/26/2010
`UBS U.S. Pharmaceuticals 11/15/2013
`Cowen and Company, “Therapeutic Categories Outlook,”
`10/2001
`Cowen and Company, “Therapeutic Categories Outlook,”
`10/2002
`Cowen and Company, “Therapeutic Categories Outlook,”
`10/2003
`Cowen and Company, “Therapeutic Categories Outlook,” 3/2004
`Cowen and Company, “Therapeutic Categories Outlook,”
`10/2005
`Cowen and Company, “Therapeutic Categories Outlook,”
`10/2006
`Cowen and Company, “Therapeutic Categories Outlook,”
`10/2007
`Cowen and Company, “Therapeutic Categories Outlook,” 9/2008
`Grabowski, Henry, John Vernon, and Joseph A. DiMasi (2002),
`“Returns on Research and Development for 1990s New Drug
`Introductions,” Pharmacoeconomics, 20(3):11-29
`Grabowski, Henry and Ronald Hansen, “Briefing Cost of
`Developing a New Drug,” Tufts Center for the Study of Drug
`
`5
`
`Ex. 1049:
`Ex. 1050:
`Ex. 1051:
`Ex. 1052:
`Ex. 1053:
`Ex. 1054:
`Ex. 1055:
`Ex. 1056:
`
`Ex. 1057:
`
`Ex. 1058:
`
`Ex. 1059:
`Ex. 1060:
`
`Ex. 1061:
`
`Ex. 1062:
`
`Ex. 1063:
`Ex. 1064:
`
`Ex. 1065:
`
`
`
`
`
`Ex. 1067:
`
`Ex. 1068:
`
`Development, 11/18/2014
`Ex. 1066: Moore, Thomas and Curt Furberg (2014), “Development Times,
`Clinical Testing, Postmarketing Follow-up, and Safety Risks for
`the New Drugs Approved by the US Food and Drug
`Administration: The Class of 2008,” JAMA Intern Med.
`174(1):90-95
`Adams, Christopher P. and Van V. Brantner (2006), “Estimating
`the Cost of New Drug Development: Is It Really Worth $802
`Million?,” Health Affairs 25(2):420-428
`Adams, Christopher Paul and Van Vu Brantner (2009),
`“Spending on New Drug Development,” Health Economics
`19(2):130-141
`Novel Derivatives of 3,3-Diphenylpropylamines, European
`Patent No. 0,957,073 (filed 5/12/1998; issued 11/17/1999)
`ClinicalTrials.gov, Two Phase Extension Trial of SP668 to
`Investigate the Safety and Tolerability of Sustained Release
`Fesoterodine in Subjects with Overactive Bladder: A Double-
`Blind Phase Followed by an Open-Label Extension Phase,
`https://www.clinicaltrials.gov/ct2/show/NCT00220389?term=fes
`oterodine&rank=50
`FDA Approval Letter, NDA 22-030, 10/31/2008
`St. Louis Federal Reserve, U.S. CPI,
`https://research.stlouisfed.org/fred2/data/USACPIALLAINMEI.t
`xt.
`Excerpt of Deposition Transcript of William Roush, dated
`September 9, 2016
`
`Ex. 1069:
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`Ex. 1070:
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`Ex. 1071:
`Ex. 1072:
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`Ex. 1073:
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`
`6
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`
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`Ex. 1074:
` Ex. 1074A
`
`Ex. 1073A: Deposition Transcript of William Roush, dated September 9,
`20161
`Excerpt of Deposition Transcript of Hans Maag, dated August
`16, 2016
`Deposition Transcript of Hans Maag, dated August 16, 20162
`Excerpt of Deposition of Leonard Chyall, dated August 23, 2016
`Deposition of Leonard Chyall, dated August 23, 20163
`Excerpt of Deposition of Claus Meese, dated January 20-21,
`2015
`Deposition of Claus Meese, dated January 20-21, 20154
`Declaration of Alyson L. Wooten Regarding Exhibits 1073-1076
`and 1073A-1076A5
`
`Ex. 1075:
`Ex. 1075A:
`Ex. 1076:
`
`Ex. 1076A:
`Ex. 1077
`
`
`1 Served but not filed, as supplemental information, pursuant to 37 C.F.R. §
`42.64(b)(2). A request for permission to file a motion to file submit supplemental
`information pursuant to 37 C.F.R. § 42.123(a) has been sent to the Board
`concurrently with this filing.
`2 Served but not filed, as supplemental information, pursuant to 37 C.F.R. §
`42.64(b)(2). A request for permission to file a motion to file submit supplemental
`information pursuant to 37 C.F.R. § 42.123(a) has been sent to the Board
`concurrently with this filing.
`3 Served but not filed, as supplemental information, pursuant to 37 C.F.R. §
`42.64(b)(2). A request for permission to file a motion to file submit supplemental
`information pursuant to 37 C.F.R. § 42.123(a) has been sent to the Board
`concurrently with this filing.
`4 Served but not filed, as supplemental information, pursuant to 37 C.F.R. §
`42.64(b)(2). A request for permission to file a motion to file submit supplemental
`information pursuant to 37 C.F.R. § 42.123(a) has been sent to the Board
`concurrently with this filing.
`5 Served but not filed, as supplemental evidence, pursuant to 37 C.F.R. §
`42.64(b)(2).
`
`7
`
`
`
`
`
`Back-Up Counsel
`D. Clay Holloway
`Reg. No. 58,011
`cholloway@kilpatricktownsend.com
`Kilpatrick Townsend & Stockton LLP
`1100 Peachtree Street, NE
`Suite 2800
`Atlanta, Georgia 30309
`(404) 815 6500
`
`Alyson L. Wooten
`Reg. No. 58,045
`awooten@kilpatricktownsend.com
`Kilpatrick Townsend & Stockton LLP
`1100 Peachtree Street, NE
`Suite 2800
`Atlanta, Georgia 30309
`(404) 815 6500
`
`8
`
`
`Date: February 13, 2017
`
`By: /s/ Mitchell G. Stockwell
`Mitchell G. Stockwell
`Registration No. 39,389
`Lead Counsel for Petitioner
`Lead Counsel
`Mitchell G. Stockwell
`Reg. No. 39,389
`mstockwell@kilpatricktownsend.com
`Kilpatrick Townsend & Stockton
`LLP
`1100 Peachtree Street, NE
`Suite 2800
`Atlanta, Georgia 30309
`(404) 815 6500
`
`
`
`
`
`
`
`CERTIFICATE OF SERVICE
`
`The undersigned hereby certifies that a copy of PETITIONER MYLAN
`
`PHARMACEUTICALS INC.’S AMENDED LIST OF EXHIBITS
`
`PURSUANT TO 37 C.F.R. § 42.63(e) was served on February 13, 2017, by
`
`filing this document through the Patent Trial and Appeal Board End to End system,
`
`as well as delivering a copy via electronic mail upon the following attorneys of
`
`record:
`
`Jeffrey Ginsberg
`Kenyon & Kenyon LLP
`One Broadway
`New York, New York 10004-1007
`
`with a courtesy copy to counsel for Pfizer Inc. and UCB Pharma GMBH, Plaintiffs
`
`in the underlying litigation as follows:
`
`Jack Blumenfeld
`Morris, Nichols, Arsht & Tunnell LLP
`1201 North Market Street
`Wilmington DE 19899
`Dimitrios T. Drivas
`Jeffrey J. Oelke
`James S. Trainor, Jr.
`Ryan P. Johnson
`Robert Counihan
`WHITE &CASE LLP
`1155 Avenue of the Americas
`New York, NY 10036
`
`By: /s/ Mitchell G. Stockwell
`Registration No. 39,389
`Counsel for Petitioner
`
`
`
`
`Dated: February 13, 2017
`
`
`
`
`
`
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