`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`MYLAN PHARMACEUTICALS INC.
`Petitioner
`
`v.
`
`UCB PHARMA GMBH
`Patent Owner
`
`Patent No. 6,858,650
`Case IPR2016-00510
`
`
`
`
`
`
`
`
`
`
`PETITIONER MYLAN PHARMACEUTICALS INC.’S RESPONSE
`TO PATENT OWNER’S OBJECTIONS AND SUPPLEMENTAL
`EVIDENCE PURSUANT TO 37 C.F.R. § 42.64(b)(2)
`
`
`
`
`
`
`
`
`
`
`Petitioner Mylan Pharmaceuticals Inc. (“Mylan”) submits the following in
`
`Response to Patent Owner UCB Pharma GmbH (“UCB”) Objections to
`
`Admissibility of Evidence served with Mylan’s Petition for Inter Partes Review,
`
`dated and served on August 3, 2016. Mylan reserves all rights to respond to
`
`UCB’s objections to Exhibits that are not specifically referenced below and to
`
`respond further to UCB’s objections to Exhibits that are referenced below.
`
`Objection(s)
`
`Response
`
`Objection(s)
`
`Response
`
`Exhibit 1016
`
`Petitioner has failed to establish publication prior to
`November 16, 1999.
`Petitioner does not offer Exhibit 1016 as prior art. Exhibit
`1016 is a document that may be used by an expert witness
`to ascertain and provide testimony about what a person of
`ordinary skill in the art would have understood prior to the
`priority date of the patent at issue in these proceedings.
`Exhibit 1021
`
`Petitioner has failed to establish publication prior to
`November 16, 1999.
`Petitioner does not offer Exhibit 1021 as prior art. Exhibit
`1021 is a document that may be used by an expert witness
`to ascertain and provide testimony about what a person of
`ordinary skill in the art would have understood prior to the
`priority date of the patent at issue in these proceedings.
`Exhibit 1033
`
`Objection(s)
`
`FRE 401; FRE 402; FRE 403; Lacking foundation.
`
`Exhibit 1033 is the Declaration of DeForest McDuff,
`Petitioner’s expert herein. Exhibit 1033 is relevant at least
`as evidence of commercial success from an economic
`perspective. Mr. McDuff has a specific expertise that will
`1
`
`Response
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`assist in understanding the evidence considered. The facts
`and documents considered by Mr. McDuff in formulating
`his opinions are at least the kinds of evidence experts in
`the field may rely in forming opinions or inferences upon
`the subjects to which Mr. McDuff refers, and these
`materials may be referred to by Mr. McDuff in any further
`testimony as such. See FRE 702, 703. Further, FRE 1006
`permits the use of a summary or chart to present
`voluminous data. The statements in Mr. McDuff’s
`declaration are given under the penalty of perjury.
`Exhibit 1034
`
`Objection(s)
`
`FRE 401; FRE 402; FRE 403; Lacking foundation.
`
`Exhibit 1034 is the CV of DeForest McDuff. Exhibit 1034
`is relevant at least as evidence of the qualifications and
`experience of Mr. McDuff, supporting his expertise
`qualifying him to provide expert testimony in this matter.
`See FRE 702. The statements in Exhibit 1034, an exhibit
`to Mr. McDuff’s declaration, are given under penalty of
`perjury.
`
`Exhibit 1036
`
`FRE 401-403, 801-802, 901-902; Containing hearsay;
`Lacking Foundation; Assuming facts not in evidence.
`Patent Owner further states: “For example, Petitioner relies
`on these exhibits to prove the truth of sale values and
`shares, prescription values and shares, and other
`information described therein, rendering this information
`hearsay to the extent Petitioner attempts to rely on them to
`prove the truth of any matter therein, including any
`purported secondary considerations. See Fed. R. Evid.
`801, 802 (inadmissible hearsay).”
`Exhibit 1036 is an compilation of data from standard sales
`and reporting documents. These documents were
`considered by Mr. McDuff in formulating his opinions, are
`at least the kinds of documents upon which an expert may
`rely, and may be referred to by Mr. McDuff in any further
`testimony as such. See FRE 702, 703. Further, FRE 1006
`
`2
`
`Response
`
`Objection(s)
`
`Response
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`
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`
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`permits the use of a summary or chart to present
`voluminous data. Exhibit 1036 is referenced as an exhibit
`to Mr. McDuff’s declaration, which is given under the
`penalty of perjury.
`Exhibit 1037
`
`FRE 401-403, 801-802, 901-902; Containing hearsay;
`Lacking Foundation; Assuming facts not in evidence.
`Patent Owner further states: “For example, Petitioner relies
`on these exhibits to prove the truth of sale values and
`shares, prescription values and shares, and other
`information described therein, rendering this information
`hearsay to the extent Petitioner attempts to rely on them to
`prove the truth of any matter therein, including any
`purported secondary considerations. See Fed. R. Evid.
`801, 802 (inadmissible hearsay).”
`Exhibit 1037 is an compilation of data from standard sales
`and reporting documents. These documents were
`considered by Mr. McDuff in formulating his opinions, are
`at least the kinds of documents upon which an expert may
`rely, and may be referred to by Mr. McDuff in any further
`testimony as such. See FRE 702, 703. Further, FRE 1006
`permits the use of a summary or chart to present
`voluminous data. Exhibit 1037 is referenced as an exhibit
`to Mr. McDuff’s declaration, which is given under the
`penalty of perjury.
`Exhibit 1038
`
`FRE 401-403, 801-802, 901-902; Containing hearsay;
`Lacking Foundation; Assuming facts not in evidence.
`Patent Owner further states: “For example, Petitioner relies
`on these exhibits to prove the truth of sale values and
`shares, prescription values and shares, and other
`information described therein, rendering this information
`hearsay to the extent Petitioner attempts to rely on them to
`prove the truth of any matter therein, including any
`purported secondary considerations. See Fed. R. Evid.
`801, 802 (inadmissible hearsay).”
`
`3
`
`Objection(s)
`
`Response
`
`Objection(s)
`
`
`
`
`
`Exhibit 1038 is an compilation of data from standard sales
`and reporting documents. These documents were
`considered by Mr. McDuff in formulating his opinions, are
`at least the kinds of documents upon which an expert may
`rely, and may be referred to by Mr. McDuff in any further
`testimony as such. See FRE 702, 703. Further, FRE 1006
`permits the use of a summary or chart to present
`voluminous data. Exhibit 1038 is referenced as an exhibit
`to Mr. McDuff’s declaration, which is given under the
`penalty of perjury.
`Exhibit 1039
`
`FRE 401-403, 801-802, 901-902; Containing hearsay;
`Lacking Foundation; Assuming facts not in evidence.
`Patent Owner further states: “For example, Petitioner relies
`on these exhibits to prove the truth of sale values and
`shares, prescription values and shares, and other
`information described therein, rendering this information
`hearsay to the extent Petitioner attempts to rely on them to
`prove the truth of any matter therein, including any
`purported secondary considerations. See Fed. R. Evid.
`801, 802 (inadmissible hearsay).”
`Exhibit 1039 is an compilation of data from standard sales
`and reporting documents. These documents were
`considered by Mr. McDuff in formulating his opinions, are
`at least the kinds of documents upon which an expert may
`rely, and may be referred to by Mr. McDuff in any further
`testimony as such. See FRE 702, 703. Further, FRE 1006
`permits the use of a summary or chart to present
`voluminous data. Exhibit 1039 is referenced as an exhibit
`to Mr. McDuff’s declaration, which is given under the
`penalty of perjury.
`Exhibit 1040
`
`FRE 401-403, 801-802, 901-902; Containing hearsay;
`Lacking Foundation; Assuming facts not in evidence.
`Patent Owner further states: “For example, Petitioner relies
`on these exhibits to prove the truth of sale values and
`shares, prescription values and shares, and other
`
`4
`
`Response
`
`Objection(s)
`
`Response
`
`Objection(s)
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`
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`
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`information described therein, rendering this information
`hearsay to the extent Petitioner attempts to rely on them to
`prove the truth of any matter therein, including any
`purported secondary considerations. See Fed. R. Evid.
`801, 802 (inadmissible hearsay).”
`Exhibit 1040 is an compilation of data from standard sales
`and reporting documents. These documents were
`considered by Mr. McDuff in formulating his opinions, are
`at least the kinds of documents upon which an expert may
`rely, and may be referred to by Mr. McDuff in any further
`testimony as such. See FRE 702, 703. Further, FRE 1006
`permits the use of a summary or chart to present
`voluminous data. Exhibit 1040 is referenced as an exhibit
`to Mr. McDuff’s declaration, which is given under the
`penalty of perjury.
`Exhibit 1041
`
`FRE 401-403, 801-802, 901-902; Containing hearsay;
`Lacking Foundation; Assuming facts not in evidence.
`Patent Owner further states: “For example, Petitioner relies
`on these exhibits to prove the truth of sale values and
`shares, prescription values and shares, and other
`information described therein, rendering this information
`hearsay to the extent Petitioner attempts to rely on them to
`prove the truth of any matter therein, including any
`purported secondary considerations. See Fed. R. Evid.
`801, 802 (inadmissible hearsay).”
`Exhibit 1041 is an compilation of data from standard sales
`and reporting documents. These documents were
`considered by Mr. McDuff in formulating his opinions, are
`at least the kinds of documents upon which an expert may
`rely, and may be referred to by Mr. McDuff in any further
`testimony as such. See FRE 702, 703. Further, FRE 1006
`permits the use of a summary or chart to present
`voluminous data. Exhibit 1041 is referenced as an exhibit
`to Mr. McDuff’s declaration, which is given under the
`penalty of perjury.
`
`
`5
`
`Response
`
`Objection(s)
`
`Response
`
`
`
`
`
`Exhibit 1042
`
`FRE 401-403, 801-802, 901-902; Containing hearsay;
`Lacking Foundation; Assuming facts not in evidence.
`Patent Owner further states: “For example, Petitioner relies
`on these exhibits to prove the truth of sale values and
`shares, prescription values and shares, and other
`information described therein, rendering this information
`hearsay to the extent Petitioner attempts to rely on them to
`prove the truth of any matter therein, including any
`purported secondary considerations. See Fed. R. Evid.
`801, 802 (inadmissible hearsay).”
`Exhibit 1042 is an compilation of data from published
`literature, and standard sales and reporting documents.
`These documents were considered by Mr. McDuff in
`formulating his opinions, are at least the kinds of
`documents upon which an expert may rely, and may be
`referred to by Mr. McDuff in any further testimony as
`such. See FRE 702, 703. Further, FRE 1006 permits the
`use of a summary or chart to present voluminous data.
`Exhibit 1042 is referenced as an exhibit to Mr. McDuff’s
`declaration, which is given under the penalty of perjury.
`Exhibit 1043
`
`FRE 401-403, 801-802, 901-902; Containing hearsay;
`Lacking Foundation; Assuming facts not in evidence.
`Patent Owner further states: “For example, Petitioner relies
`on these exhibits to prove the truth of sale values and
`shares, prescription values and shares, and other
`information described therein, rendering this information
`hearsay to the extent Petitioner attempts to rely on them to
`prove the truth of any matter therein, including any
`purported secondary considerations. See Fed. R. Evid.
`801, 802 (inadmissible hearsay).”
`Exhibit 1043 is an compilation of data from published
`literature, and standard sales and reporting documents.
`These documents were considered by Mr. McDuff in
`formulating his opinions, are at least the kinds of
`documents upon which an expert may rely, and may be
`
`6
`
`Objection(s)
`
`Response
`
`Objection(s)
`
`Response
`
`
`
`
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`referred to by Mr. McDuff in any further testimony as
`such. See FRE 702, 703. Further, FRE 1006 permits the
`use of a summary or chart to present voluminous data.
`Exhibit 1043 is referenced as an exhibit to Mr. McDuff’s
`declaration, which is given under the penalty of perjury.
`Exhibit 1044
`
`FRE 401-403, 801-802, 901-902; Containing hearsay;
`Lacking Foundation; Assuming facts not in evidence.
`Patent Owner further states: “For example, Petitioner relies
`on these exhibits to prove the truth of sale values and
`shares, prescription values and shares, and other
`information described therein, rendering this information
`hearsay to the extent Petitioner attempts to rely on them to
`prove the truth of any matter therein, including any
`purported secondary considerations. See Fed. R. Evid.
`801, 802 (inadmissible hearsay).”
`Exhibit 1044 is an compilation of data from published
`literature, and standard sales and reporting documents.
`These documents were considered by Mr. McDuff in
`formulating his opinions, are at least the kinds of
`documents upon which an expert may rely, and may be
`referred to by Mr. McDuff in any further testimony as
`such. See FRE 702, 703. Further, FRE 1006 permits the
`use of a summary or chart to present voluminous data.
`Exhibit 1044 is referenced as an exhibit to Mr. McDuff’s
`declaration, which is given under the penalty of perjury.
`Exhibit 1045
`
`FRE 401-403, 801-802, 901-902; Containing hearsay;
`Lacking Foundation; Assuming facts not in evidence.
`Patent Owner further states: “For example, Petitioner relies
`on these exhibits to prove the truth of sale values and
`shares, prescription values and shares, and other
`information described therein, rendering this information
`hearsay to the extent Petitioner attempts to rely on them to
`prove the truth of any matter therein, including any
`purported secondary considerations. See Fed. R. Evid.
`801, 802 (inadmissible hearsay).”
`
`7
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`Objection(s)
`
`Response
`
`Objection(s)
`
`
`
`
`
`Exhibit 1045 is an compilation of data from published
`literature, and standard sales and reporting documents.
`These documents were considered by Mr. McDuff in
`formulating his opinions, are at least the kinds of
`documents upon which an expert may rely, and may be
`referred to by Mr. McDuff in any further testimony as
`such. See FRE 702, 703. Further, FRE 1006 permits the
`use of a summary or chart to present voluminous data.
`Exhibit 1045 is referenced as an exhibit to Mr. McDuff’s
`declaration, which is given under the penalty of perjury.
`Exhibit 1046
`
`FRE 401-403, 801-802, 901-902; Containing hearsay;
`Lacking Foundation; Assuming facts not in evidence.
`Patent Owner further states: “For example, Petitioner relies
`on these exhibits to prove the truth of sale values and
`shares, prescription values and shares, and other
`information described therein, rendering this information
`hearsay to the extent Petitioner attempts to rely on them to
`prove the truth of any matter therein, including any
`purported secondary considerations. See Fed. R. Evid.
`801, 802 (inadmissible hearsay).”
`Exhibit 1046 is an compilation of data from published
`literature, and standard sales and reporting documents.
`These documents were considered by Mr. McDuff in
`formulating his opinions, are at least the kinds of
`documents upon which an expert may rely, and may be
`referred to by Mr. McDuff in any further testimony as
`such. See FRE 702, 703. Further, FRE 1006 permits the
`use of a summary or chart to present voluminous data.
`Exhibit 1046 is referenced as an exhibit to Mr. McDuff’s
`declaration, which is given under the penalty of perjury.
`Exhibit 1047
`
`FRE 401-403, 801-802, 901-902; Containing hearsay;
`Lacking Foundation; Assuming facts not in evidence.
`Patent Owner further states: “For example, Petitioner relies
`on these exhibits to prove the truth of sale values and
`shares, prescription values and shares, and other
`
`8
`
`Response
`
`Objection(s)
`
`Response
`
`Objection(s)
`
`
`
`
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`information described therein, rendering this information
`hearsay to the extent Petitioner attempts to rely on them to
`prove the truth of any matter therein, including any
`purported secondary considerations. See Fed. R. Evid.
`801, 802 (inadmissible hearsay).”
`Exhibit 1047 is an compilation of data from published
`literature, publically available USPTO and FDA
`documents, and standard sales and reporting documents.
`These documents were considered by Mr. McDuff in
`formulating his opinions, are at least the kinds of
`documents upon which an expert may rely, and may be
`referred to by Mr. McDuff in any further testimony as
`such. See FRE 702, 703. Further, FRE 1006 permits the
`use of a summary or chart to present voluminous data.
`Exhibit 1047 is referenced as an exhibit to Mr. McDuff’s
`declaration, which is given under the penalty of perjury.
`Exhibit 1048
`
`FRE 401-403, 801-802, 901-902; Containing hearsay;
`Lacking Foundation; Assuming facts not in evidence.
`Patent Owner further states: “For example, Petitioner relies
`on these exhibits to prove the truth of sale values and
`shares, prescription values and shares, and other
`information described therein, rendering this information
`hearsay to the extent Petitioner attempts to rely on them to
`prove the truth of any matter therein, including any
`purported secondary considerations. See Fed. R. Evid.
`801, 802 (inadmissible hearsay).”
`Exhibit 1048 is an compilation of data from standard sales
`and reporting documents. These documents were
`considered by Mr. McDuff in formulating his opinions, are
`at least the kinds of documents upon which an expert may
`rely, and may be referred to by Mr. McDuff in any further
`testimony as such. See FRE 702, 703. Further, FRE 1006
`permits the use of a summary or chart to present
`voluminous data. Exhibit 1048 is referenced as an exhibit
`to Mr. McDuff’s declaration, which is given under the
`penalty of perjury.
`
`9
`
`Response
`
`Objection(s)
`
`Response
`
`
`
`
`
`Exhibit 1049
`
`FRE 401-403, 801-802, 901-902; Containing hearsay;
`Lacking Foundation; Assuming facts not in evidence.
`Patent Owner further states: “For example, Petitioner relies
`on these exhibits to prove the truth of sale values and
`shares, prescription values and shares, and other
`information described therein, rendering this information
`hearsay to the extent Petitioner attempts to rely on them to
`prove the truth of any matter therein, including any
`purported secondary considerations. See Fed. R. Evid.
`801, 802 (inadmissible hearsay).”
`Exhibit 1049 is an compilation of data from published
`materials reporting the Consumer Price Index. These
`documents were considered by Mr. McDuff in formulating
`his opinions, are at least the kinds of documents upon
`which an expert may rely, and may be referred to by Mr.
`McDuff in any further testimony as such. See FRE 702,
`703. Further, FRE 1006 permits the use of a summary or
`chart to present voluminous data. Exhibit 1049 is
`referenced as an exhibit to Mr. McDuff’s declaration,
`which is given under the penalty of perjury.
`
`Objection(s)
`
`Response
`
`
`
`Further, in response, Mylan hereby submits the following additional
`
`supplemental evidence. Petitioner submits that this supplemental evidence
`
`provides additional foundation and authenticity support, and should resolve Patent
`
`Owner’s objections to Exhibits 1033, 1034, 1036 – 1049.
`
`Exhibit 1050
`
`2009-2010 UBS U.S. Pharmaceuticals 8/24/2011
`
`Exhibit 1051
`
`2011-2014 UBS U.S. Pharmaceuticals 1/4/2016
`
`Exhibit 1052
`
`2009-2011 Pfizer Form 10-K, 2012
`
`10
`
`
`
`
`
`Exhibit 1053
`
`2012-2014 Pfizer Form 10-K 2015
`
`Exhibit 1054
`
`UBS U.S. Pharmaceuticals 11/26/2010
`
`Exhibit 1055
`
`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
`Development, 11/18/2014.
`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.
`
`11
`
`Exhibit 1056
`
`Exhibit 1057
`
`Exhibit 1058
`
`Exhibit 1059
`
`Exhibit 1060
`
`Exhibit 1061
`
`Exhibit 1062
`
`Exhibit 1063
`
`Exhibit 1064
`
`Exhibit 1065
`
`Exhibit 1066
`
`Exhibit 1067
`
`Exhibit 1068
`
`
`
`
`
`Exhibit 1069
`
`Exhibit 1070
`
`Exhibit 1071
`
`Exhibit 1072
`
`
`
`
`
`
`Date: August 17, 2016
`
`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
`
`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=fe
`soterodine&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.
`txt.
`
`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
`
`12
`
`
`
`CERTIFICATE OF SERVICE
`
`The undersigned hereby certifies that a copy of this RESPONSE TO
`
`PATENT OWNER’S OBJECTIONS AND SUPPLEMENTAL EVIDENCE
`
`PURSUANT TO 37 C.F.R. § 42.64(b)(2) was served on August 17, 2016, by
`
`filing this document through the PRPS, 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: August 17, 2016