UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`MYLAN PHARMACEUTICALS INC. and MYLAN LABORATORIES
`LIMITED,
`Petitioner
`
`v.
`
`UCB PHARMA GMBH
`Patent Owner
`
`Patent No. 6,858,650
`Case IPR2016-005101
`
`
`
`
`
`PETITIONER’S MYLAN PHARMACEUTICALS INC.’S
`OPPOSITION TO PATENT OWNER’S MOTION TO EXCLUDE
`EVIDENCE
`
`
`
`
`
`
`
`
`
`
`
`
`
`1 Petitioner Alembic Pharmaceuticals Limited from IPR2016-01596, Torrent
`Pharmaceuticals Limited from IPR2016-01636, and Amerigen Pharmaceuticals
`Limited from IPR2016-01665 have been joined as Petitioners to this proceeding.
`
`

`

`TABLE OF CONTENTS
`
`I.
`
`II.
`
`Introduction ...................................................................................................... 1
`
`Evidence of Commercial Success Is Relevant To The Asserted
`Secondary Considerations Of Long-felt But Unmeet Need ............................ 2
`
`A.
`
`B.
`
`Commercial Success Is Relevant Evidence When
`Considering Whether A Unmet Need Has Been Met ........................... 2
`
`The Lack of Toviaz®’s Commercial Success Is Relevant
`To Demonstrate Toviaz® Has Not Met Any Unmet Need
`In The Marketplace ............................................................................... 6
`
`III. Exhibits 1050-1072 Should Not Be Expunged ............................................... 8
`
`IV. Conclusion ....................................................................................................... 9
`
`
`
`
`
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`TABLE OF AUTHORITY
`
`Cases
`ATD Corp. v. Lydall, Inc.,
`159 F.3d 534 (Fed. Cir. 1998) ............................................................................... 2
`
`Belden Inc. v. Berk-Tek LLC,
`805 F.3d 1064 (Fed. Cir. 2015) ............................................................................. 8
`
`Brookwood Co. Inc. v. Nextex Applications, Inc.,
`IPR2014-00412, Paper 19 (PTAB Sept. 24, 2014) ................................................ 9
`
`Ethicon Endo-Surgery, Inc. v. Covidien LP,
`812 F.3d 1023, 1035 (Fed. Cir. 2016) ................................................................... 5
`
`In re Cyclobenzaprine Hydrochloride Extended-Release
`Capsule Patent Litig., 794 F. Supp. 2d 517 (D. Del. 2011),
`aff'd in part, vacated in part, rev'd in part on other grounds, 676 F.3d 1063
`(Fed. Cir. 2012) ..................................................................................................2, 3
`
`In re Fielder,
`471 F.2d 640 (CCPA 1973) ................................................................................... 3
`
`In re GPAC Inc.,
`57 F.3d 1573 (Fed. Cir. 1988) ............................................................................... 4
`
`In re Kao,
`639 F.3d 1057 (Fed. Cir. 2011) ............................................................................. 4
`
`In re Tiffin,
`448 F.2d 791 (CCPA 1971) ................................................................................... 4
`
`McNeil-PPC, Inc. v. L. Perrigo Co.,
`337 F.3d 1362 (Fed. Cir. 2003) ............................................................................. 6
`
`Merck Sharp & Dohme Corp. v. Hospira Inc.,
`No. CV 14-915-RGA, 2016 WL 5872620 (D. Del. July 10, 2016) ...................... 5
`
`Merck Sharpe & Dohme B.V. v. Warner Chilcott Co.,
`Case No. CV 13-2088-GMS, 2016 WL 4497054 (D. Del. Aug. 26, 2016) .......... 5
`
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`Phigenix, Inc. v. Immunogen, Inc.,
`IPR2014-00676, Paper 39 (PTAB Oct. 27, 2015) ................................................. 8
`
`Samsung Elecs. Co. v. Virginia Innovation Sci., Inc.,
`IPR2013-00569, Paper 42 ...................................................................................... 1
`
`Santarus, Inc. v. Par Pharm., Inc.,
`720 F. Supp. 2d 427 (D. Del. 2010) (Sleet, J.)
`aff'd in part, rev'd in part, 694 F.3d 1344 (Fed. Cir. 2012) ...............................2, 3
`
`Symantic Corp. v. The Trustees of Columbia University in the City of New York,
`IPR2015-00372, Paper 30 (PTAB Sept. 29, 2015) ................................................ 9
`
`Vanda Pharm. Inc. v. Roxane Labs., Inc., No.
`CV 13-1973-GMS, 2016 WL 4490701 (D. Del. Aug. 25, 2016) .......................... 3
`
`Statutes
`
`37 C.F.R. § 42.64(b)(2) ............................................................................................. x
`
`37 C.F.R. § 42.64 ....................................................................................................... 9
`
`Fed. R. Evid. 611(a) ................................................................................................... 8
`
`Other Authorities
`
`Chisum § 5.05[2][a] ................................................................................................... 3
`
`Rules
`
`“Subtests of ‘Nonobviousness’: A Nontechnical Approach to Patent Validity,”
`112 U. Pa. L. Rev. 1169 (1964) ............................................................................. 3
`
`
`
`
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`PETITIONER’S LIST OF EXHIBITS
`
`Ex. 1006:
`
`Ex. 1007:
`
`Ex. 1001: U.S.P.N. 7,384,980
`Ex. 1002:
`File History for U.S.P.N. 7,384,980
`Ex. 1003: Declaration of Dr. Steven Patterson, Ph.D.
`Ex. 1004:
`C.V. for Dr. Steven Patterson, Ph.D
`Ex. 1005:
`“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.
`
`Ex. 1008:
`
`Ex. 1009:
`Ex. 1010:
`
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`EX.
`
`Ex. 1011:
`
`1011:
`
`EX.
`
`1012:
`
`Ex. 1012:
`Ex. 1013:
`
`EX.
`
`1013:
`
`EX.
`
`Ex. 1014:
`
`1014:
`
`EX.
`
`Ex. 1015:
`
`1015:
`
`EX.
`
`Ex. 1016:
`
`1016:
`
`EX.
`
`Ex. 1017:
`
`1017:
`
`EX.
`
`Ex. 1018:
`
`1018:
`
`EX.
`
`1019:
`
`Ex. 1019:
`Ex. 1020:
`
`EX.
`
`1020:
`
`Monkhouse
`
`Lindgren, and S. Andersson
`Lindgren, and S. Andersson
`“Brynne 1998” – Clinical Pharmacology & Therapeutics (May
`“Brynne 1998” — Clinical Pharmacology & Therapeutics (May
`1998), 63(5), 529-539 – “Influence of CYP2D6 polymorphism
`1998), 63(5), 529-539 — “Influence of CYP2D6 polymorphism
`on the pharmacokinetics and pharmacodynamics of tolterodine”;
`on the pharmacokinetics and pharmacodynamics of tolterodine”;
`N. Brynne, P. Dalen, G. Alvan, L. Bertilsson, and J. Gabrielsson
`N. Brynne, P. Dalen, G. Alvan, L. Bertilsson, and J. Gabrielsson
`“Bundgaard” – Elsevier 1985 – “Design of Prodrugs”
`“Bundgaard” — Elsevier 1985 — “Design of Prodrugs”
`“Berge 1977” – Journal of Pharmaceutical Sciences (1977), 66
`“Berge 1977” — Journal of Pharmaceutical Sciences (1977), 66
`(1), 1-19 – “Pharmaceutical Salts”; S. Berge, L., Bighley, and D.
`(1), 1-19 — “Pharmaceutical Salts”; S. Berge, L., Bighley, and D.
`Monkhouse
`“Andersson 1998” – Drug Metabolism and Disposition (1998),
`“Andersson 1998” — Drug Metabolism and Disposition (1998),
`26(6), 528-535 – “Biotransformation of tolterodine, a new
`26(6), 528-535 — “Biotransformation of tolterodine, a new
`muscarinic receptor antagonist, in mice, rats, and dogs”; S.
`muscarinic receptor antagonist, in mice, rats, and dogs”; S.
`Andersson, A. Lindgren, and H. Postlind
`Andersson, A. Lindgren, and H. Postlind
`“Nilvebrant” – Pharmacology and Toxicology (1997), 81, 169-
`“Nilvebrant” — Pharmacology and Toxicology (1997), 81, 169-
`172 – “Antimuscarinic Potency and Bladder Selectivity of PNU-
`172 - “Antimuscarinic Potency and Bladder Selectivity of PNU-
`200577, a Major Metabolite of Tolterodine”; L. Nilvebrant, P.
`200577, a Major Metabolite of Tolterodine”; L. Nilvebrant, P.
`Gillberg, and B. Sparf
`Gillberg, and B. Sparf
`“DeMaagd” – P&T (2012), 37(6), 345-361 – “Management of
`“DeMaagd” — P&T (2012), 37(6), 345-361 — “Management of
`Urinary Incontinence”; G. DeMaagd and T. Davenport
`Urinary Incontinence”; G. DeMaagd and T. Davenport
`“Appell” – Urology (1997), 50, 90-96 – “Clinical efficacy and
`“Appell” — Urology (1997), 50, 90-96 — “Clinical efficacy and
`safety of tolterodine in the treatment of overactive balder: a
`safety of tolterodine in the treatment of overactive balder: a
`pooled analysis”; R. Appell
`pooled analysis”; R. Appell
`“Ashworth” – Home Care Provider (1997), 2(3), 117-120 – “Is
`“Ashworth” — Home Care Provider (1997), 2(3), 117-120 — “Is
`My Antihistamine Safe?”; L. Ashworth
`My Antihistamine Safe?”; L. Ashworth
`“Lipinski” – Advanced Drug Delivery Reviews, 1997
`“Lipinski” — Advanced Drug Delivery Reviews, 1997
`“Bundgaard PCT” – WO 92/08459 Filed 11 November 1991 –
`“Bundgaard PCT” — WO 92/08459 Filed 11 November 1991 —
`
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`Ex. 1021:
`
`Ex. 1022:
`
`Ex. 1023:
`
`Ex. 1024:
`Ex. 1025:
`Ex. 1026:
`
`Ex. 1027:
`
`Ex. 1028:
`
`Ex. 1029:
`
`Ex. 1030:
`
`“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
`
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`Ex. 1031:
`
`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
`Ex. 1032: 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)
`Ex. 1033: Declaration of DeForest McDuff, Ph.D.
`Ex. 1034:
`CV for DeForest McDuff, Ph.D.
`Ex. 1035:
`Toviaz: Donʼt Let Overactive Bladder Stop You In Your Tracks
`Ex. 1036:
`Toviaz U.S. and Worldwide Sales
`Ex. 1037: U.S. OAB Prescriptions and Shares by Drug (2008–2014)
`Ex. 1038: U.S. OAB Sales and Shares by Drug (2008–2014)
`Ex. 1039: 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
`Ex. 1044:
`Present Value of Toviaz U.S. Sales
`Ex. 1045:
`Present Value of Toviaz Worldwide Sales
`Ex. 1046:
`Estimates of Expected R&D Costs
`Ex. 1047:
`Ex. 1048: U.S. OAB Detail Shares by Drug (2008–2015)
`
`Ex. 1040:
`Ex. 1041:
`Ex. 1042:
`
`Ex. 1043:
`
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`EX.
`
`1049:
`
`EX.
`
`1050:
`
`2009-2010 UBS U.S. Pharmaceuticals 8/24/201
`
`EX.
`
`1051:
`
`2011-2014 UBS U.S. Pharmaceuticals 1/4/2016
`
`EX.
`
`1052:
`
`EX.
`
`1053:
`
`2012-2014 Pfizer Form 10-K 2015
`
`EX.
`
`1054:
`
`UBS U.S. Pharmaceuticals 11/26/2010
`
`EX.
`
`1055:
`
`UBS U.S. Pharmaceuticals 11/15/2013
`
`EX.
`
`1056:
`
`EX.
`
`Ex. 1057:
`
`1057:
`
`EX.
`
`Ex. 1058:
`
`1058:
`
`EX.
`
`1059:
`
`Ex. 1059:
`Ex. 1060:
`
`Consumer Price Index (CPI)
`Ex. 1049:
`Consumer Price Index (CPI)
`2009-2010 UBS U.S. Pharmaceuticals 8/24/201
`Ex. 1050:
`2011-2014 UBS U.S. Pharmaceuticals 1/4/2016
`Ex. 1051:
`2009-2011 Pfizer Form 10-K, 2012
`Ex. 1052:
`2009-2011 Pfizer Form 10-K, 2012
`2012-2014 Pfizer Form 10-K 2015
`Ex. 1053:
`Ex. 1054: UBS U.S. Pharmaceuticals 11/26/2010
`Ex. 1055: UBS U.S. Pharmaceuticals 11/15/2013
`Ex. 1056:
`Cowen and Company, “Therapeutic Categories Outlook,”
`Cowen and Company, “Therapeutic Categories Outlook,”
`10/2001
`Cowen and Company, “Therapeutic Categories Outlook,”
`Cowen and Company, “Therapeutic Categories Outlook,”
`10/2002
`Cowen and Company, “Therapeutic Categories Outlook,”
`Cowen and Company, “Therapeutic Categories Outlook,”
`10/2003
`Cowen and Company, “Therapeutic Categories Outlook,” 3/2004
`Cowen and Company, “Therapeutic Categories Outlook,” 3/2004
`Cowen and Company, “Therapeutic Categories Outlook,”
`Cowen and Company, “Therapeutic Categories Outlook,”
`10/2005
`Cowen and Company, “Therapeutic Categories Outlook,”
`Cowen and Company, “Therapeutic Categories Outlook,”
`10/2006
`Cowen and Company, “Therapeutic Categories Outlook,”
`Cowen and Company, “Therapeutic Categories Outlook,”
`10/2007
`Cowen and Company, “Therapeutic Categories Outlook,” 9/2008
`Ex. 1063:
`Cowen and Company, “Therapeutic Categories Outlook,” 9/2008
`Ex. 1064: Grabowski, Henry, John Vernon, and Joseph A. DiMasi (2002),
`Grabowski, Henry, John Vernon, and Joseph A. DiMasi (2002),
`“Returns on Research and Development for 1990s New Drug
`“Retums on Research and Development for 1990s New Drug
`Introductions,” Pharmacoeconomics, 20(3):11-29
`Introductions,” Pharmacoeconornics, 20(3):11-29
`Ex. 1065: Grabowski, Henry and Ronald Hansen, “Briefing Cost of
`Grabowski, Henry and Ronald Hansen, “Briefing Cost of
`Developing a New Drug,” Tufts Center for the Study of Drug
`Developing a New Drug,” Tufts Center for the Study of Drug
`
`10/2001
`
`10/2002
`
`10/2003
`
`10/2005
`
`10/2006
`
`10/2007
`
`EX.
`
`1060:
`
`EX.
`
`Ex. 1061:
`
`1061:
`
`EX.
`
`Ex. 1062:
`
`1062:
`
`EX.
`
`1063:
`
`EX.
`
`1064:
`
`EX.
`
`1065:
`
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`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
`Ex. 1067: 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
`Ex. 1068: Adams, Christopher Paul and Van Vu Brantner (2009),
`“Spending on New Drug Development,” Health Economics
`19(2):130-141
`Ex. 1069: 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?te
`rm=fesoterodine&rank=50
`FDA Approval Letter, NDA 22-030, 10/31/2008
`St. Louis Federal Reserve, U.S.
`CPI, https://research.stlouisfed.org/fred2/data/USACPIALLAIN
`MEI.txt.
`Excerpt of Deposition Transcript of William Roush, dated
`September 9, 2016
`
`Ex. 1070:
`
`Ex. 1071:
`Ex. 1072:
`
`Ex. 1073:
`
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`Ex. 1073A: Deposition Transcript of William Roush, dated September 9,
`2016
`Excerpt of Deposition Transcript of Hans Maag, dated August
`Ex. 1074:
`
`
`16, 2016
`
`Ex. 1074A: Deposition Transcript of Hans Maag, dated August 16, 2016
`Ex. 1075:
`Excerpt of Deposition of Leonard Chyall, dated August 23, 2016
`Ex. 1075A:
`Deposition of Leonard Chyall, dated August 23, 2016
`Ex. 1076:
`Excerpt of Deposition of Claus Meese, dated January 20-21,
`
`2015
`Deposition of Claus Meese, dated January 20-21, 2015
`Ex. 1076A:
`Ex. 1077: Declaration of Alyson L. Wooten Regarding Exhibits 1073-
`10762
`
`
`
`
`2 Served but not filed, as supplemental evidence, pursuant to 37 C.F.R. §
`42.64(b)(2).
`
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`I.
`
`Introduction
`
`Petitioner (“Mylan”) opposes the motion to exclude that Patent Owner
`
`(“UCB”) filed to suppress the expert analysis and opinions that confirms the
`
`challenged patent claims are invalid. Exhibits 1033, 1034, 1036-1072 are relevant
`
`to dispute UCB’s contention that secondary considerations, namely a long felt but
`
`unmet need, support a finding of nonobviousness. “As movant, Patent Owner has
`
`the burden of proof to establish that it is entitled to the requested relief.” Samsung
`
`Elecs. Co. v. Virginia Innovation Sci., Inc., IPR2013-00569, Paper 42 at 30 (PTAB
`
`Feb. 17, 2015). UCB fails to carry its burden on its motion to exclude. (Paper No.
`
`37.)
`
`Exhibit 1033 is the Declaration of DeForest McDuff, an expert in applied
`
`business economics. Dr. McDuff’s qualification as an expert in this field is
`
`demonstrated in his CV, which is submitted as Exhibit 1034. Dr. McDuff’s
`
`Declaration addresses the lack of commercial success of Toviaz® in view of
`
`factors such as the sales, pricing, market share, and earnings of Toviaz®. The
`
`remaining exhibits, 1036-1072, represent the underlying and summary data that
`
`support Dr. McDuff’s opinion.
`
`As explained below, Exhibits 1033, 1034, 1036-1072 are relevant and
`
`admissible.
`
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`II. Evidence of Commercial Success Is Relevant To The Asserted
`Secondary Considerations Of Long-felt But Unmeet Need
`A. Commercial Success Is Relevant Evidence When Considering
`Whether A Unmet Need Has Been Met
`
`UCB does not dispute the accuracy of Dr. McDuff’s testimony but contends
`
`that Exhibits 1033, 1034, and 1036-1072 should be suppressed for lack of
`
`relevance because “UCB has not introduced as a secondary consideration of
`
`nonobviousness, the commercial success of Toviaz®.” Paper 37 at 3, 5. However,
`
`the commercial success of Toviaz® is relevant to whether Toviaz® actually
`
`satisfied any alleged long-felt need as well as whether a nexus exists between the
`
`claimed inventions and propounded evidence of a satisfied long-felt need -- issues
`
`UCB has highlighted in its Response. See Paper 20 at 64-66.
`
`“The Federal Circuit has long recognized the relevance of commercial
`
`success to the question of whether an ‘unmet need’ has been met.” Santarus, Inc.
`
`v. Par Pharm., Inc., 720 F. Supp. 2d 427, 455 n.21 (D. Del. 2010) (Sleet, J.) aff'd
`
`in part, rev'd in part, 694 F.3d 1344 (Fed. Cir. 2012) (citing ATD Corp. v. Lydall,
`
`Inc., 159 F.3d 534, 546 (Fed. Cir. 1998) (applying evidence of commercial success
`
`to demonstrate that “the product met an unsolved need and was quickly adopted by
`
`the automotive industry”)); see also In re Cyclobenzaprine Hydrochloride
`
`Extended-Release Capsule Patent Litig., 794 F. Supp. 2d 517, 538 (D. Del. 2011),
`
`aff'd in part, vacated in part, rev'd in part on other grounds, 676 F.3d 1063 (Fed.
`
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`Cir. 2012) (holding “the commercial success of AMRIX® does not support the
`
`claimed long felt need, as it has only captured a small percentage of the market
`
`despite a massive marketing campaign”). In Santarus, for example, the Court held
`
`that the patented drug Zegerid® could not demonstrate a long-felt need despite
`
`evidence of sales growth over a four-year period after launch, because its “sales
`
`continue to be dwarfed by sales of enteric-coated PPIs.” Santarus, 720 F. Supp. 2d
`
`at 455. Conversely, in Vanda Pharmaceuticals v. Roxane Laboratories, in
`
`discussing evidence of a long-felt need, the Court held that evidence of a “forty-
`
`fold increase in Novartis’s valuation of the [patented] franchise is highly indicative
`
`of non-obviousness.” Vanda Pharm. Inc. v. Roxane Labs., Inc., Case No. CV 13-
`
`1973-GMS, 2016 WL 4490701, at *10 (D. Del. Aug. 25, 2016). The connection
`
`between commercial success and long-felt need has been explained as:
`
`The possibility of market success attendant upon the solution of an
`existing problem may induce innovators to attempt a solution. If in
`fact a product attains a high degree of commercial success, there is a
`basis for inferring that such attempts have been made and have failed.
`Thus the rational is similar to that of long-felt demand and is for the
`same reasons a legitimate test of invention. The operative facts,
`however, are the actions of the buyers rather than those of producers.
`
`Chisum § 5.05[2][a], citing “Subtests of ‘Nonobviousness’: A Nontechnical
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`Approach to Patent Validity,” 112 U. Pa. L. Rev. 1169, 1175 (1964); also cited in
`
`In re Fielder, 471 F.2d 640, 644 (CCPA 1973). Accordingly, the same facts and
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`testimony by Dr. McDuff that demonstrate that Toviaz® was not commercially
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`successful are relevant to whether (a) there was a long-felt need and (b) whether
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`Toviaz® solved and such need.
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`Further, for evidence of nonobviousness to be to be relevant it must be
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`commensurate in scope with the claimed invention. In re Kao, 639 F.3d 1057,
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`1068 (Fed. Cir. 2011) (citing In re Tiffin,
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`448 F.2d 791, 792 (CCPA 1971). “For objective evidence [including long-felt
`
`need] to be accorded substantial weight, its proponent must establish a nexus
`
`between the evidence and the merits of the claimed invention." In re GPAC Inc.,
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`57 F.3d 1573, 1580 (Fed. Cir. 1988). As such, there must be a nexus between the
`
`merits of the claimed invention and the evidence of secondary considerations. To
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`try to satisfy this standard as related to any alleged long-felt need, UCB contends
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`that “[f]esoterodine fumarate is responsible for Toviaz®’s biological activity in
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`patients, including its efficacy, and a nexus therefore exists between the challenged
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`claims and Toviaz®.” Paper 20 at 64 (internal citations omitted). Thus, rebuttal
`
`evidence that what UCB alleges is evidence of a long-felt need (if demonstrated)
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`was met by factors other than the patented invention, such as marketing of an
`
`unpatented feature, existing products, or market demand, is relevant to demonstrate
`
`the absence of a nexus between the patented invention and any alleged satisfaction
`
`of a long-felt need.
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`The Federal Circuit found this sort of nexus evidence relevant in Ethicon
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`Endo-Surgery, Inc. v. Covidien LP, and held that a marketing brochure failed to
`
`establish a long-felt need because it demonstrated “a long-felt need for staples of
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`different heights (a feature in the prior art), not the combination of features that is
`
`the invention here.” 812 F.3d 1023, 1035 (Fed. Cir. 2016). Similarly, in Merck
`
`Sharpe & Dohme B.V. v. Warner Chilcott Co., the Court held that where the
`
`patented invention claimed a drug delivery system, but did not claim a specific
`
`dosing regimen, there was no nexus between the patented invention and any long-
`
`felt need for a hormonal contraceptive with a specific dosing regimen. Case No.
`
`CV 13-2088-GMS, 2016 WL 4497054, at *14 (D. Del. Aug. 26, 2016) (“[T]hese
`
`advantages and long-felt need are not what is inventive in the '581 patent.”); see
`
`also Merck Sharp & Dohme Corp. v. Hospira Inc., Case No. CV 14-915-RGA,
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`2016 WL 5872620, at *11 (D. Del. July 10, 2016) (“The satisfaction of any long-
`
`felt need described by Plaintiff is attributable to [previously patented compound]
`
`ertapenem, not to the stable formulation described in the '323 patent.”).
`
`Accordingly, Dr. McDuff’s testimony about the overactive bladder market
`
`landscape and his analysis of nexus are relevant to whether the patented features of
`
`Toviaz® addressed any alleged long-felt need.
`
`Further, while Exhibits 1039 and 1049 were not specifically cited in Exhibit
`
`1033, they provide useful background regarding the knowledge of one of ordinary
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`skill in the art and are thus relevant to the opinion of Dr. McDuff. Exhibit 1039
`
`describes the market share concerning sales of drugs in the OAB market and is
`
`relevant to, at minimum, paragraph 21 of Exhibit 1033. Exhibit 1049 describes the
`
`Consumer Price Index from 1990-2014 and is relevant to, at minimum, paragraphs
`
`24-26 of Exhibit 1033.
`
`B.
`
`The Lack of Toviaz®’s Commercial Success Is Relevant To
`Demonstrate Toviaz® Has Not Met Any Unmet Need In The
`Marketplace
`
`UCB asserts that the “ability to dose escalate provide[s] a real benefit to a
`
`certain group of patients who ha[ve] been underserved by tolterodine and other
`
`overactive bladder drugs.” Paper 20, at 65. However, the lack of commercial
`
`success of Toviaz® is relevant to demonstrate that the industry did not view this as
`
`a benefit and Toviaz® has not satisfied any need in the marketplace.
`
`Toviaz® was subject to a substantial marketing campaign designed to switch
`
`patients from tolterodine to Toviaz®. Ex. 1033, ¶¶ 40-44; Ex. 1048. While this
`
`campaign alone demonstrates that any potential commercial success is not relevant
`
`to any perceived benefit of the product, sales of Toviaz® demonstrate that
`
`Toviaz® failed to capture market share and does not provide a benefit that has
`
`been recognized by the market place. See McNeil-PPC, Inc. v. L. Perrigo Co., 337
`
`F.3d 1362, 1370 (Fed. Cir. 2003) (“McNeil had launched a massive marketing and
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`advertising campaign in connection with the launch of the . . . product, obscuring
`
`any nexus that might have existed.”); Ex. 1033, ¶¶ 40-44; Ex. 1037-39.
`
`As described in Exhibit 1033, Toviaz® has been identified as the “the
`
`eleventh most heavily promoted drug through DTC advertising in 2010, with $109
`
`million in spending on DTC advertising.” Ex. 1033, ¶ 43. “In the 12 months
`
`ending November 2011, over $252 million was spent promoting the brand . . . .”
`
`Id. During this same period, Toviaz® had the second highest share of voice
`
`measured by details out of the nine branded OAB drugs. Id. at ¶ 44. Despite this
`
`heavy advertising effort, in January 2012, Toviaz® only accounted for 4% of
`
`prescriptions in the OAB market. Id. at ¶ 42. Indeed, Toviaz®’s share of total
`
`U.S. revenue in the OAB market has been low year-after-year - 0.6% in 2009,
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`2.6% in 2010, 3.9% in 2011, 4.5% in 2012, 5.4% at its peak in 2013, and 5.3% in
`
`2014. Ex. 1033, ¶ 21; Ex. 1037. The total revenue earned by Toviaz® when
`
`compared to marketing expenses for the product reveal that the profits of Toviaz®
`
`have been less than zero – negative. Ex. 1033, ¶ 32; Ex. 1038. This product has
`
`failed to meet commercial expectations, has not been commercially successful, and
`
`has not shown a significant advantage in the marketplace. Ex. 1033, ¶¶ 34-37.
`
`This economic information is highly relevant to the UCB’s assertion of
`
`unmet need in the marketplace, and Toviaz®’s sales, or lack thereof, demonstrate
`
`that Toviaz® has not met any such need in the marketplace.
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`III. Exhibits 1050-1072 Should Not Be Expunged
`On August 3, 2016, UCB served objections regarding several exhibits filed
`
`in support of Mylan’s Petition. In response, on August 17, 2016, Mylan filed
`
`responses to those objections along with supplemental evidence (Exhibits 1050-
`
`1072) related to the objections to Exhibits 1033, 1034, 1036-1049. Paper 17 at 10.
`
`Exhibits 1050-1072 provide additional foundation and authenticity support to
`
`support the admissibility of Exhibits 1033, 1034, 1036-1049, which contain and
`
`rely on summaries of evidence prepared by Dr. McDuff. The supplemental
`
`evidence provides the original data that is summarized and used in Exhibits 1033,
`
`1036-1049. As recognized by PTAB, “summaries of ‘voluminous’ data [], as
`
`prepared by [an expert] personally or both others working under his direction,
`
`provide probative value that substantially outweighs any possible prejudice to
`
`Petitioner.” Phigenix, Inc. v. Immunogen, Inc., IPR2014-00676, Paper 39 at 28-29
`
`(PTAB Oct. 27, 2015) (denying Petitioner’s Motion to Exclude). Further, the
`
`Board “has broad discretion to regulate the presentation of evidence under Fed. R.
`
`Evid. 611(a).” Belden Inc. v. Berk-Tek LLC, 805 F.3d 1064, 1081 (Fed. Cir. 2015).
`
`UCB did not file an objection within five business days of the filing and
`
`service of Exhibits 1050-1072, but instead seeks, without prior objection, to have
`
`these exhibits expunged in the Motion to Exclude now before the Board. “A party
`
`wishing to challenge the admissibility of evidence must object timely to the
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`evidence at the point it is offered and then preserve the objection by filing a motion
`
`to exclude the evidence.” 37 C.F.R. § 42.64.
`
`Moreover, while it would have been proper to wait until a motion to exclude
`
`had been filed to file Exhibits 1050-1072, Mylan submits that it now would be
`
`improper to expunge this evidence. See Symantic Corp. v. The Trustees of
`
`Columbia University in the City of New York, IPR2015-00372, -374, -378, Paper
`
`30 (PTAB Sept. 29, 2015). UCB has filed the present Motion to Exclude Exhibits
`
`1033, 1034, 1036-1049, asserting that these exhibits are not relevant to these
`
`proceedings. Paper 37 at 3-4. Thus, in responding to UCB’s objection regarding
`
`the relevance of these exhibits, Mylan is now permitted to submit Exhibits 1050-
`
`1072 to support the admissibility of Exhibits 1033, 1034 and 1036-1049 and it is
`
`proper for the Board to consider this evidence. See, e.g., Brookwood Co. Inc. v.
`
`Nextex Applications, Inc., IPR2014-00412, Paper 19 at 5 (PTAB Sept. 24, 2014)
`
`(recognizing that petitioner’s evidence served in response to an evidentiary
`
`objection may later be filed in opposition to a motion to exclude).
`
`IV. Conclusion
`For the foregoing reasons, UCB’s motion to exclude should be denied.
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`Respectfully submitted,
`
`By: /s/ Mitchell G. Stockwell
`Mitchell G. Stockwell
`Registration No. 39,389
`
`Lead Counsel for Petitioner Mylan
`Pharmaceuticals Inc. and Mylan
`Laboratories Limited
`
`
`
`
`
`
`
`Dated: March 22, 2017
`
`
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`CERTIFICATE OF SERVICE
`
`The undersigned hereby certifies that a copy of PETITIONER’S
`
`OPPOSITION TO PATENT OWNER’S MOTION TO EXCLUDE
`
`EVIDENCE was served on March 22, 2017, by filing this document through the
`
`Patent Trial and Appeal Board End to End system, as well as delivering a copy via
`
`US 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, via email as follows:
`
`Jack Blumenfeld
`jbbefiling@mnat.com
`
`Dimitrios T. Drivas
`Jeffrey J. Oelke
`James S. Trainor, Jr.
`Ryan P. Johnson
`Robert Counihan
`ddrivas@whitecase.com
`joelke@whitecase.com
`jtrainor@whitecase.com
`rjohnson@whitecase.com
`rcounihan@whitecase.com
`
`
`By: /s/ Mitchell G. Stockwell
`Registration No. 39,389
`Counsel for Petitioner
`
`11
`
`
`Dated: March 22, 2017
`
`
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