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`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`
`
`
`MYLAN PHARMACEUTICALS INC.
`and PFIZER, INC.,
`
`Petitioners,
`
`v.
`
`SANOFI-AVENTIS DEUTSCHLAND GMBH,
`
`Patent Owner
`
`
`Case No. IPR2018-016761
`U.S. Patent No. 8,603,044
`
`
`
`
`
`PATENT OWNER’S OPPOSITION TO PETITIONERS’ MOTION TO
`EXCLUDE
`
`
`
`
`
`
`
`1 Pfizer Inc., who filed a petition in IPR2019-00978, has been joined as petitioner
`in this proceeding.
`
`
`
`
`
`

`

`EXHIBIT LIST
`Description
`Press Release, “Mylan Enhances Partnership with Biocon through
`Strategic Collaboration for Insulin Products”, Feb. 13, 2013 (PR
`Newswire), available at http://newsroom.mylan.com/press-
`releases?item=122834
`Press Release, “Mylan Commences Phase III Clinical Trials for its
`Generic Version of Advair Diskus® and Insulin Analog to Lantus®”,
`Sept. 16, 2014 (PR Newswire), available at
`http://newsroom.mylan.com/press-releases?item=123251
`Press Release, “Mylan and Biocon Present Clinical Data on Insulin
`Glargine at the American Diabetes Association’s 77th Scientific
`Sessions”, June 10, 2017 (PR Newswire), available at
`http://newsroom.mylan.com/2017-06-10-Mylan-and-Biocon-
`Present-Clinical-Data-on-Insulin-Glargine-at-the-American-
`Diabetes-Associations-77th-Scientific-Sessions
`Complaint for Patent Infringement, Sanofi-Aventis U.S. LLC,
`Sanofi-Aventis Deutschland GmbH v. Eli Lilly and Company, C.A.
`No. 1-14-cv-00113-RGA (D. Del), Dkt. No. 1
`Complaint for Patent Infringement, Sanofi-Aventis U.S. LLC,
`Sanofi-Aventis Deutschland GmbH, and Sanofi Winthrop Industrie
`v. Merck Sharp & Dohme Corp., C.A. No. 1-16-cv-00812-RGA (D.
`Del), Dkt. No. 1
`Stipulation and Proposed Order, Sanofi-Aventis U.S. LLC v. Mylan,
`N.V., Civil Action No. 17-9105-SRC-SLW (D.N.J. Feb 5, 2018),
`Dkt. No. 45
`Complaint for Patent Infringement, Sanofi-Aventis U.S. LLC et al.
`v. Mylan N.V. et al., Case No. 2:17-cv-09105-SRC-CLW (D.N.J.
`Oct. 24, 2017), Dkt. No. 1
`Excerpts from Defendants’ Invalidity Contentions, dated Jan. 25,
`2018, Sanofi-Aventis U.S. LLC et al. v. Mylan N.V. et al., Case No.
`2:17-cv-09105-SRC-CLW (D.N.J.)
`Excerpts from Mylan GMBH’s Amended Invalidity Contentions,
`dated April 25, 2018, Sanofi-Aventis U.S. LLC et al. v. Mylan N.V.
`et al., Case No. 2:17-cv-09105-SRC-CLW (D.N.J.)
`Excerpts from Mylan GMBH’s Exhibit C to Amended Invalidity
`Contentions, dated April 25, 2018, Sanofi-Aventis U.S. LLC et al. v.
`Mylan N.V. et al., Case No. 2:17-cv-09105-SRC-CLW (D.N.J.)
`
`i
`
`Exhibit #
`
`2001
`
`2002
`
`2003
`
`2004
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`2005
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`2006
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`2007
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`2008
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`2009
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`2010
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`

`

`Exhibit #
`
`2011
`
`2012
`
`2013
`
`2014
`2015
`
`2016
`
`2017
`2018
`
`2019
`
`2020
`
`2021
`
`2022
`
`2023
`
`2024
`
`2025
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`
`
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`
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`
`
`
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`
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`
`
`
`Description
`Aug. 13, 2018 Service of Sanofi’s Responses to Mylan’s Amended
`Contentions, Sanofi-Aventis U.S. LLC et al. v. Mylan N.V. et al.,
`Case No. 2:17-cv-09105-SRC-CLW (D.N.J.)
`MP4 file of Sanofi’s Patented Pen animation
`Excerpt from Defendants’ opening claim construction brief, dated
`October 12, 2018, Sanofi-Aventis U.S. LLC et al. v. Mylan N.V. et
`al., Case No. 2:17-cv-09105-SRC-CLW (D.N.J.)
`Memorandum Opinion, Sanofi-Aventis U.S. LLC v. Merck Sharp &
`Corp., Case No. 16-cv-812-RGA (D. Del.), Dkt. No. 192
`International Patent WO 99/3855
`Excerpt from Joint claim construction statement, Ex. A, dated
`October 8, 2018, Sanofi-Aventis U.S. LLC et al. v. Mylan N.V. et
`al., Case No. 2:17-cv-09105-SRC-CLW (D.N.J.)
`Animation depicting Møller’s first embodiment
`Animation depicting Møller’s second embodiment
`Defendants’ Opposition to Plaintiffs’ Motion to Stay dated Nov.
`22, 2017, Sanofi-Aventis U.S. LLC et al. v. Mylan N.V. et al., Case
`No. 1:17-cv-00181-IMK (N.D. Va.), Dkt. No. 44
`Joint Proposed Discovery Plan dated Dec. 14, 2017, Sanofi-Aventis
`U.S. LLC et al. v. Mylan N.V. et al., Case No. 2:17-cv-09105-SRC-
`CLW (D.N.J.)
`Letter from A. Calmann to Judge Waldor dated Apr. 24, 2018,
`Sanofi-Aventis U.S. LLC et al. v. Mylan N.V. et al., Case No. 2:17-
`cv-09105-SRC-CLW (D.N.J.), Dkt. No. 90
`Motion to Expedite Defendants’ Motion Requesting an Expedited
`Scheduling Conference dated Nov. 22, 2017 , Sanofi-Aventis U.S.
`LLC et al. v. Mylan N.V. et al., Case No. 1:17-cv-00181-IMK (N.D.
`Va.), Dkt. No. 46
`Initial Planning Meeting Report and Discovery Proposals dated
`Dec. 22, 2017, Sanofi-Aventis U.S. LLC et al. v. Mylan N.V. et al.,
`Case No. 1:17-cv-00181-IMK (N.D. Va.), Dkt. No. 61
`Transcript of Motion / Scheduling Conference dated Jan. 3, 2018,
`Sanofi-Aventis U.S. LLC et al. v. Mylan N.V. et al., Case No. 1:17-
`cv-00181-IMK (N.D. Va.), Dkt. No. 64
`Excerpts from Transcript, Conference Call dated Aug. 2, 2018,
`Sanofi-Aventis U.S. LLC et al. v. Mylan N.V. et al., Case No. 2:17-
`
`ii
`
`

`

`Exhibit #
`
`2026
`
`2100
`
`Description
`cv-09105-SRC-CLW (D.N.J.) (confidentiality designation
`removed)
`Report of the Local Patent Rules Committee, Explanatory Notes for
`2016 Amendments
`Transcript, Conference Call for Case IPR2018-01675, -01676, -
`2027
`01678, -01680 (P.T.A.B. Feb. 5, 2019)
`2028-2099 Reserved
`Leinsing Deposition Exhibit 2100: Thomas van der Burg, Injection
`Force of SoloSTAR® Compared with Other Disposable Insulin Pen
`Devices at Constant Volume Flow Rates, J. of Diabetes Sci. and
`Tech., Vol. 5, Issue 1, 150-155 (Jan. 2001)
`Leinsing Deposition Exhibit 2101: Estelle Davis, et. al., An
`evaluation of prefilled insulin pens: a focuse on the Next
`Generation FlexPen®, Med. Devices: Evidence & Research, 41-
`50 (2010:3)
`Leinsing Deposition Exhibit 2102: Hand drawings
`Leinsing Deposition Exhibit 2103: Annotations of Figures 6-15 of
`Burroughs
`Leinsing Deposition Exhibit 2104: Annotations of Figures 5-8 of
`the 486 Patent
`Leinsing Deposition Exhibit 2105: Hand drawings
`Leinsing Deposition exhibit 2106: Annotations of Figures 11 and
`12 of Giambattista
`Declaration of Alexander Slocum, Ph.D.
`Curriculum Vitae of Alexander Slocum, Ph.D.
`Reserved
`Reserved
`Declaration of Dr. Robin S. Goland
`Curriculum Vitae of Dr. Robin S. Goland
`Bradley M. Wright et al., A Review Of Insulin Pen Devices And
`Use In The Elderly Diabetic Population, 3 Clinical Medicine
`Insights: Endocrinology & Diabetes 54-63 (2010)
`Teresa L. Pearson, A-Practical-Review-of-Insulin-Pen-Devices,
`EMJ Diabet., 58-64 (2014:2)
`
`2101
`
`2102
`2103
`
`2104
`2105
`2106
`2107
`2108
`2109
`2110
`2111
`2112
`
`2113
`
`2114
`
`iii
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`

`

`Exhibit #
`
`2115
`
`2116
`
`2117
`
`2118
`
`2119
`
`2120
`
`2121
`2122
`
`2123
`
`2124
`
`2125
`
`2126
`
`2127
`
`Description
`Arthritis & Diabetes, What do diabetes and arthritis have in
`common? Plenty., https://www.arthritis.org/living-with-
`arthritis/comorbidities/diabetes-and-arthritis/
`Andreas Bode, Development of the SoloSTAR insulin pen device
`design verification and validation, 6 Expert Opinion on Drug
`Delivery 103-112 (2008)
`Sanofi’s Patented Pen animation
`John Carter, Usability, Participant Acceptance, and Safety of a
`Prefilled Insulin Injection Device in a 3-Month Observational
`Survey in Everyday Clinical Practice in Australia, J. Diabetes Sci
`& Tech., Vol. 3, Issue 6, 1425-1438 (Nov. 2009)
`Sherwyn Schwartz, Correct Use of a New Reusable Insulin
`Injection Pen by Patients with Diabetes: A Design Validation
`Study, 4 J. Diabetes Sci. and Tech. 1229-1235 (2010)
`Estelle Davis, et. al., An evaluation of prefilled insulin pens: a
`focuse on the Next Generation FlexPen®, Med. Devices: Evidence
`& Research, 41-50 (2010:3)
`DBA Design Effectiveness Awards 2009
`SoloSTAR Disposable Pen Injector (The Grand Prix Oct. 22, 2009)
`Arnd Friedrichs et al., Dose Accuracy and Injection Force of
`Different Insulin Glargine Pens, 7 J. Diabetes Sci. and Tech. 1346-
`1353 (2013)
`Stacey A. Seggelke et al., Effect of Glargine Insulin Delivery
`Method (Pen Device Versus Vial/Syringe) on Glycemic Control and
`Patient Preferences in Patients with Type 1 and Type 2 Diabetes,
`20 ENDOCRINE PRACTICE, 536, 536, 538–539 (2014)
`Julia Pfutzner et al., Evaluation of Dexterity in Insulin-Treated
`Patients with Type 1 and Type 2 Diabetes Mellitus, 5 J. Diabetes
`Sci. and Tech. 158-165 (2011)
`Jerome S. Fischer et al., United States Patient Preference and
`Usability for the New Disposable Insulin Device Solostar® versus
`Other Disposable Pens, 2 JOURNAL OF DIABETES SCIENCE
`AND TECHNOLOGY 1157-1160 (2008)
`U.S. Provisional Patent Application 60/073820
`
`iv
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`

`

`Exhibit #
`
`2128
`
`2129
`
`2130
`
`2131
`
`2132
`
`2133
`2134
`
`2135
`
`2136
`2137
`2138
`
`2139
`
`2140
`
`2141
`
`
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`
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`
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`
`
`
`
`
`
`
`
`
`
`
`
`
`Description
`Samita Garg et al., Insulin glargine and glulisine SoloSTAR pens
`for the treatment of diabetes, 5 Expert Rev. Med. Devices 113-123
`(2008)
`Nicolae Hancu et al., A Pan-European and Canadian Prospective
`Survey to Evaluate Patient Satisfaction with the SoloSTAR Insulin
`Injection Device in Type 1 and Type 2 Diabetes, 5 J. Diabetes Sci.
`and Tech. 1224-1234 (2011)
`Norbert Hermanns, Bernhard Kulzer & Thomas Haak, Dosing
`Accuracy with a Novel Pen Device (SoloSTAR) as Performed by
`Patients with Diabetes in a Clinical Setting, 10 Diabetes Tech. &
`Threapeutics 322-327 (2008)
`ISO 11608-1, Pen-injectors for medical use (1st Ed. Dec. 15, 2000)
`Meike Krzywon et al., Study on the Dosing Accuracy of Commonly
`Used Disposable Insulin Pens, 14 Diabetes Tech. & Therapeutics
`804-809 (2012)
`Lantus SoloSTAR Pen Guide
`Arlan L. Rosenbloom, Limitation of Finger Joint Mobility in
`Diabetes Mellitus, 3 J. Diabetic Complications 77-87 (1989)
`Douglas Merritt et al., Dose Accuracy and Injection Force of
`Disposable Pens Delivering Pramlintide for the Treatment of
`Diabetes, 4 J. Diabetes Sci. and Tech. 1438-1446 (2010)
`Novo Nordisk Form 6-K (Feb. 9, 2009)
`Novo Nordisk History
`W. Schady et al, Observations on Severe Ulnar Neuropathy in
`Diabetes, 12 J Diabetes and Its Complications 128-132 (1998)
`Alfred Penfornis & Kristian Horvat, Dose Accuracy Compariosn
`Between SoloSTAR and FlexPen at Three Different Dose Levels, 10
`Diabetes Tech. & Therapeutics 359-362 (2008)
`Riccardo Perfetti, Reusable and Disposable Insulin Pens for the
`Treatment of Diabetes: Understanding the Global Differences in
`User Preference and an Evaluation of Inpatient Insulin Pen Use,
`12 Diabetes Tech. & Therapeutics 79-85 (2010)
`John Shelmet et al., Preference and resource utilization in elderly
`patients: InnoLet versus vial/syringe, 63 Diabetes Res. and Clinical
`Prac. 27-35 (2004)
`
`v
`
`

`

`Exhibit #
`
`2142
`
`2143
`
`2144
`
`2145
`
`2146
`2147
`2148
`2149
`2150
`2151
`
`2152
`2153
`2154
`2155
`2156
`2157
`2158
`
`2159
`
`2160
`
`
`
`
`
`
`
`
`
`Description
`Prix Galien USA Announces 2009 Final Candidates (Prix Galien
`USA, August 7, 2009)
`Thomas Haak et al., Comparison of Usability and Patient
`Preference for the New Disposable Insulin Device SoloStar Versus
`FlexPen, Lilly Disposable Pen, and a Prototype Pen: An Open-
`Label Study, 29 CLINICAL THERAPEUTICS, 650-660 (2007)
`Alastair Clarke & Geralyn Spollett, Dose accuracy and injection
`force dynamics of a novel disposable insulin pen, 4 EXPERT
`OPINION ON DRUG DELIVERY 165-174 (2007)
`US Lantus SoloSTAR Launch Book, 2007, PTX-0705, Document
`bates stamped SANOFI_00232909-45
`Lantus COMPASS Study Report (Nov. 29, 2007), PTX-0739,
`Document bates stamped SANOFI3_90330807-1025
`Steenfeldt-Jensen 5th Embodiment Animation
`Steenfeldt-Jensen 1st Embodiment Animation
`Steenfeldt-Jensen 2nd Embodiment Animation
`Steenfeldt-Jensen 5th Embodiment Thread and Slot Animation
`Steenfeldt-Jensen 5th Embodiment vs. Proposed Modification
`Animation
`Steenfeldt-Jensen 5th Embodiment vs. Proposed Modification
`Collar Friction Animation
`International Patent Application WO999038554A1
`Reserved
`Reserved
`Reserved
`Reserved
`Geralyn Spollett, Insulin Devices, Addressing Barriers to Insulin
`Therapy With the Ideal Pen, 957-967 (The Diabetes EDUCATOR)
`Serpil Savas et al., The effects of the diabetes related soft tissue
`hand lesions and the reduced hand strength on functional disability
`of hand in type 2 diabetic patients, 77 Diabetes Res. and Clinical
`Prac. 77-83 (2007)
`Jean-Louis Selam, Evolution of Diabetes Insulin Delivery Devices,
`4 J. Diabetes Sci. and Tech. 505-513 (2010)
`
`vi
`
`

`

`Exhibit #
`
`2161
`2162
`2163
`
`2164
`
`2165
`
`2166
`
`2167
`2168
`2169
`2170
`2171
`2172
`
`2173
`
`2174
`
`2175
`
`2176
`
`2177
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Description
`SoloSTAR Principles of Operation, PTX-0553, Document bates
`stamped SANOFI_00406383-94
`Sanofi Patent Drive Sleeve and Piston Rod Animation
`Deposition of Karl R. Leinsing, dated June 3, 2019 for IPR2018-
`01675, -01676, -01678, -01680
`Deposition of Karl R. Leinsing, dated June 4, 2019 for IPR2018-
`01675, -01676, -01678, -01680
`Opinion and Order regarding Claim Construction, Sanofi-Aventis
`U.S. LLC v. Mylan, N.V., Civil Action No. 17-9105-SRC-SLW
`(D.N.J. May 9, 2019), Dkt. No. 319
`Memorandum and Order regarding Claim Construction, Sanofi-
`Aventis U.S. LLC v. Merck, No. 16-812-RGA (D. Del. Jan. 12,
`2018), Dkt. No. 192
`Giambattista Animation (1)
`Giambattista Animation (2)
`U.S. Patent No. 4,648,872
`U.S. Patent No. 4,747,824
`U.S. Patent No. 6,248,093
`Karl R. Leinsing Declaration in Hologic, Inc. v. Minerva Surgical,
`Inc., No. 15-1031 (D. Del. Jan. 26, 2018), Dkt. No. 309
`Bruce A. Perkins, David Olaleye & Vera Bril, Carpal Tunnel
`Syndrome in Patients With Diabetic Polyneuropathy, 25 Diabetes
`Care 565-569 (2002)
`Jefferson Becker et al., An evaluation of gender, obesity, age and
`diabetes mellitus as risk factors for carpal tunnel syndrome, 113
`Clinical Neurophysiology 1429-1434 (2002)
`A. Pfutzner et al., Prefilled insulin device with reduced injection
`force: patient perception and accuracy, 24 Current Med. Res. and
`Opinion 2545-2549 (2008)
`Ercan Cetinus et al., Hand grip strength in patients with type 2
`diabetes mellitus, Diabetes Res. and Clinical Prac. 1-9 (2005)
`Ragnhild I. Cederlund et al., Hand disorders, hand function, and
`activities of daily living in elderly men with type 2 diabetes, 23 J.
`Diabetes and Its Complications 32-99 (2009)
`
`
`vii
`
`

`

`Exhibit #
`
`2178
`
`2179
`
`2180
`
`2181
`
`2182
`
`2183
`
`2184
`
`2185
`
`2186
`2187
`2188
`2189
`2190
`2191
`
`2192
`
`2193
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Description
`Shubha Gundmi et al., Hand dysfunction in type 2 diabetes
`mellitus: Systematic review with meta-analysis, 61 Annals of
`Physical and Rehabilitation Med. 99-104 (2018)
`Joule J. Li et al., Muscle grip strength predicts incident type 2
`diabetes: Population-based cohort study, 65 Metabolism Clinical
`and Experimental 883-892 (2016)
`Considering Insulin Pens for Routine Hospital Use - Consider
`This... (ISMP article), https://www.ismp.org/resources/considering-
`insulin-pens-routine-hospital-use-consider
`Trigger Finger Overview (Mayo Clinic),
`https://www.mayoclinic.org/diseases-conditions/trigger-
`finger/symptoms-causes/syc-20365100
`Bone and joint problems associated with diabetes (Mayo Clinic),
`https://www.mayoclinic.org/diseases-conditions/diabetes/in-
`depth/diabetes/art-20049314
`Peripheral Neuropathy (Mayo Clinic),
`https://www.mayoclinic.org/diseases-conditions/peripheral-
`neuropathy/symptoms-causes/syc-20352061
`Charles E. Buban, A pen that seeks to improve diabetes care,
`INQUIRER.NET (2008), Document Bates stamped
`SANOFI_00006282-84
`"Sanofi-aventis’ SoloSTAR(R) Insulin Pen for Lantus and Apidra
`Receives the Prestigious GOOD DESIGN Award", (PR Newswire
`Feb. 14), Document Bates stamped SANOFI_00006299-301
`Select Injectable Insulin Drugs Approved by the FDA in the U.S.
`U.S. Dollar Sales of Lantus SoloSTAR
`U.S. New Prescriptions of Lantus SoloSTAR
`U.S. Total Prescriptions of Lantus SoloSTAR
`U.S. Share of Sales by Drugs in the Lantus Franchise
`Formulary Placement of Long-Acting Insulin Pen Products:
`Commercial Plans
`Formulary Placement of Long-Acting Insulin Pen Products:
`Medicare Plans
`Formulary Placement of Long-Acting Insulin Pen Products:
`Medicaid Plans
`
`viii
`
`

`

`Exhibit #
`
`2194
`2195
`2196
`2197
`2198
`2199
`
`2200
`
`2201
`2202
`2203
`2204
`2205
`2206
`2207
`
`2208
`
`2209
`
`2210
`
`2211
`2212
`2213
`
`Description
`Formulary Placement of Long-Acting Insulin Pen Products in
`Healthcare Exchanges
`U.S. Share of Long-Acting Pens Among All Pens
`U.S. Dollar Sales of Long-Acting Pens
`U.S. New Prescriptions of Long-Acting Pens
`U.S. Total Prescriptions of Long-Acting Pens
`U.S. Share of Long-Acting Pen Products
`Yuzu Sato et al., Clinical Aspects of physical exercise for
`diabetes/metabolic syndrome, 77S Diabetes Research and Clinical
`Practice S87 (2007)
`2007 Good Design Award from The Chicago Athenaeum: Museum
`of Architecture and Design
`Reserved
`U.S. Total Marketing Expenditure of Long Acting Insulin
`Franchises
`U.S. Total Marketing Expenditures of Long-Acting Insulin Pens
`U.S. Marketing-to-Sales Ratios of Select Injectable Insulin Drugs
`Møller First Embodiment Animation
`Møller Second Embodiment Animation
`Press Release, Lantus / Apdira SoloSTAR help to improve patient
`satisfaction (June 27, 2011), Document bates stamped
`SANOFI_00179886-88
`Henry Grabowski, John Vernon & Joseph A. DiMasi, Returns on
`Research and Development for 1990s New Drug Introductions, 20
`Pharmacoeconomics 15 (2002)
`Julie M. Donohue, Marisa Cevasco & Meredith B. Rosenthal, A
`Decade of Direct-to-Consumer Advertising of Prescription Drugs,
`357 N. Engl. J. Med. 673 (2007)
`Collar Friction Model Demonstrator Animation
`Excerpts from Ernest Rabinowicz, Friction And Wear of Materials,
`2nd Edition, 68-70 (John Wiley & Sons, Inc. 1995)
`Reserved
`
`ix
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`
`
`
`
`
`
`
`

`

`Exhibit #
`
`2214
`2215
`2216
`2217
`2218
`2219
`2220
`2221
`2222
`2223
`2224
`2225
`
`Description
`Excerpts from Alexander H. Slocum, Precision Machine Design,
`706-709 (Prentice-Hall, Inc. 1992)
`Collar Friction Model Demonstration 1
`Collar Friction Model Demonstration 2
`Collar Friction Model Demonstration 3
`SoloSTAR Dial Inject Video
`Declaration of Robert T. Vlasis
`Biography of Robert T. Vlasis
`Declaration of Anna E. Dwyer
`Biography of Anna E. Dwyer
`SoloSTAR wins the 2008 Good Design award (February 8, 2008)
`Expert Opinion on Drug Delivery
`Excerpt from the Trial Transcript for Sanofi v. Merck, 16cv812
`(RGA) (District of Delaware) (May 29, 2018)
`Email of Patent Owner’s Supplemental Evidence
`2226
`2227-2315 Reserved
`2316
`Deposition of Karl Robert Leinsing, MSME, P.E. (October 10,
`2019)
`Deposition of William C. Biggs, MD (October 15, 2019)
`Deposition of DeForest McDuff, Ph. D. (October 9, 2019)
`Declaration of Robert Veasey (July 15, 2019)
`
`
`2317
`2318
`2319
`
`
`
`
`
`x
`
`

`

`
`
`Pursuant to the Board’s Scheduling Order (Paper 21), as modified (see Paper
`
`40), Patent Owner Sanofi submits this opposition to Petitioners’ motion to exclude.
`
`I.
`
`
`
`ARGUMENT
`A-E & J-L. EX2001-EX2011, EX2019-EX2026
`Petitioners move to exclude these exhibits under FRE402-403 as lacking
`
`relevance and risking confusing the issues. These exhibits were offered to show
`
`information that was relevant to § 325(d) issues raised during the preliminary stage
`
`of this proceeding. Specifically:
`
`• EX2001-EX2003 were offered
`
`to show Mylan’s development and
`
`commercialization of a follow-on insulin glargine product;
`
`• EX2004, EX2005 and EX2007 were offered to show that Sanofi asserted the
`
`challenged patent against another competitor;
`
`• EX2006 was offered to show the parties’ joint request for a trial date in a
`
`related litigation;
`
`• EX2008-EX2010 were offered to show that Mylan asserted the same
`
`grounds of invalidity raised in the Petition in a related district court
`
`litigation;
`
`• EX2011 was offered to show that Mylan received Sanofi’s responses to
`
`Mylan’s invalidity contentions in a related district court litigation prior to
`
`filing the Petition in this proceeding; and
`
`
`
`1
`
`

`

`• EX2019-EX2026 were offered to show the timeline of the co-pending
`
`litigation.
`
`As such, these exhibits do not lack relevance and should remain in the record.
`
`There is no risk of confusing the issues, because insofar as these exhibits are not
`
`cited in connection with any disputed issues raised in the post-institution papers,
`
`the Board will have no further reason to refer to them.
`
`EX2012 – MP4 file of Sanofi’s Patented Pen animation
`F.
`Petitioners move to exclude this exhibit as hearsay under FRE801-804.
`
`
`
`FRE703, however, permits experts to rely upon hearsay if reasonable to do so in
`
`the expert’s field. EX2012 is identical to EX2117, which Dr. Slocum relied upon
`
`in his testimony to explain the operation of the injector pens in the challenged
`
`patents and it was reasonable to do so. Computer models such as shown in EX2011
`
`are used and relied upon in mechanical engineering. See, e.g., EX1053, 34:8-36:19.
`
`Moreover, Dr. Slocum explained that the model shown in EX2012 “fairly and
`
`accurate[ly] shows an embodiment described in the challenged patents.” See Ex.
`
`2107, ¶ 65. Thus, because it was reasonable for Dr. Slocum to rely on this exhibit
`
`for his analysis, it should not be excluded.
`
`G. EX2013 – Mylan claim construction brief (D.N.J., excerpts)
`Petitioners move to exclude this exhibit under FRE402 as lacking relevance
`
`
`
`and risking confusing the issues. This exhibit was offered to show that, consistent
`
`
`
`2
`
`

`

`with Federal Circuit case law, Mylan agreed that the same claim term used in
`
`related patents having different specifications should be given the same
`
`construction. Similarly, Sanofi argued that the term “main housing” should have
`
`the same construction across all five of the challenged patents because they are
`
`related. As such, the exhibit does not lack relevance and should remain in the
`
`record. There is no risk of confusing the issues, because insofar as this exhibit is
`
`not cited in connection with any disputed issues raised in the post-institution
`
`papers, the Board will have no further reason to refer to it.
`
`H. EX2014 – District Court construction (Merck litigation)
`Petitioners move to exclude this exhibit under FRE402-403 as lacking
`
`
`
`relevance and risking confusing the issues. How a district court has construed the
`
`same term in the same challenged patent is probative of the construction that
`
`should be applied in this proceeding. Indeed, the Board considered this evidence in
`
`its institution decision without any confusion. See Paper 20 at 16.
`
`EX2017, EX2018 – Animation for Møller embodiment
`I.
`Petitioners move to exclude this exhibit as hearsay under FRE801-804.
`
`
`
`FRE703, however, permits experts to rely upon hearsay if reasonable to do so in
`
`the expert’s field. EX2017 and EX2018 are identical to EX2206 and EX2207,
`
`respectively, which Dr. Slocum relied upon to explain the operation of the injector
`
`pens in the prior art reference and it was reasonable to do so. Computer models
`
`
`
`3
`
`

`

`such as those shown in EX2017 and EX2018 are used and relied upon in
`
`mechanical engineering. See, e.g., EX1053, 34:8-36:19. Moreover, Dr. Slocum
`
`explained that the models shown in EX2017 and EX2018 “accurately depict[]” the
`
`first and second embodiments. See, e.g., EX2107 ¶ 150. Because it was reasonable
`
`for Dr. Slocum to rely on these exhibits, they should not be excluded.
`
`M. EX1054 – Professor Slocum Redirect (pp. 391-406)
`Petitioners move to exclude Dr. Slocum’s redirect testimony, which
`
`
`
`concerns descriptions of the “clutch” and “housing” contained in the challenged
`
`patents, under FRE702(a). Petitioners’ motion, however, does not address the
`
`substance of this testimony. Instead, Petitioners argue that (1) Dr. Slocum was not,
`
`as of 2003, knowledgeable about pen injector art and that (2) he relies on Mr.
`
`Veasey for limited information relevant to his opinions. See Paper 64 at 5-7. These
`
`arguments are unrelated to subject matter of the redirect testimony (what
`
`Petitioners ask to be excluded). Nonetheless, as explained below in Section O, (1)
`
`having personal knowledge in 2003 of pen injectors is neither required by law nor
`
`by the parties here to satisfy the level of skill in the art, and (2) Petitioners’
`
`criticisms with respect to Mr. Veasey are unfounded. For these reasons and those
`
`explained in Section O, the redirect testimony should not be excluded.
`
`
`
`4
`
`

`

`EX2100-EX2102, EX2104-EX2106, EX2111-EX2153, EX2158-
`N.
`EX2201, EX2203-EX2212, EX2214-EX2218 and EX2225 – exhibits not
`cited
`Petitioners move to exclude these exhibits under FRE402-403 because they
`
`
`
`are not discussed in the Response.
`
`
`
`As an initial matter, EX2117-2118, 2127, 2136, 2147-2150, 2152, 2162-
`
`2165, 2175, 2206-2207, 2211, and 2215-2217 are in fact cited in the Response.
`
`See, e.g., Paper 31 at 5-7, 11, 14, 18-19, 32, 34-37, 40-41, 43-44, 47, 51, 55. Thus,
`
`contrary to Petitioners’ argument, these exhibits are relevant, and their relevance
`
`outweighs any risk of confusion or prejudice.
`
`
`
`Also, EX2100-EX2102 and EX2104-2106 are exhibits to the deposition of
`
`Karl Leinsing, Petitioners’ technical expert. They are relevant because they
`
`provide necessary context for Mr. Leinsing’s cross-examination, which Petitioner
`
`has not sought to exclude. The relevance of these deposition exhibits outweighs
`
`any risk of confusion or prejudice.
`
`
`
`Additionally each of these exhibits was among the materials that Patent
`
`Owner’s expert Dr. Slocum considered and reasonably relied upon in forming his
`
`opinions regarding the validity of the challenged patent and thus should be
`
`admitted under FRE703. Further, at least EX2100-2102, 2113, 2120, 2126, 2131,
`
`2134-2138, 2147-2150, 2152-2153, 2158-2161, 2166-2171, 2173-2183, 2206,
`
`2207, 2211, and 2214-2218 were expressly cited by Dr. Slocum in his declaration
`
`
`
`5
`
`

`

`testimony. See, e.g., Ex. 2107, ¶¶ 26-29, 36, 41, 44-46, 48-53, 56-57, 95-97, 114,
`
`127, 137, 145, 149, 237, 428, 432, 474. As such, these exhibits are relevant
`
`because they provide necessary context for understanding Dr. Slocum’s testimony,
`
`and their relevance outweighs any risk of confusion or prejudice.
`
`
`
`EX2125, 2140-2141, 2185, and 2200 were also considered and expressly
`
`cited by Dr. Goland in forming her opinions regarding benefits of the SoloSTAR
`
`pen, which embodies at least one challenged claim, and thus should be admitted
`
`under FRE703. See, e.g., EX2111, ¶¶ 23, 25, 43. These exhibits are relevant
`
`because they provide necessary context for understanding Dr. Goland’s testimony,
`
`and their relevance outweighs any risk of confusion or prejudice.
`
`O. EX2107 – Slocum Declaration
`Petitioners move to exclude this exhibit under FRE702, 703 and 705. Dr.
`
`
`
`Slocum’s declaration is the product of reliable, scientific, and well-researched
`
`efforts to assess the validity of the challenged patents. In contrast to Mr. Leinsing’s
`
`declarations, Dr. Slocum’s declaration is replete with citations supporting his
`
`opinions, including citations to peer-reviewed literature on the state of the art
`
`during the relevant timeframe (see EX2107 ¶¶25-61), mathematical analysis
`
`providing an objective measure of the considerations that would motivate a POSA
`
`(see, e.g., EX2107, App’x A-B, D-F), and detailed explanations of the scientific
`
`principles underlying his opinions (see, e.g., EX2107, ¶¶ 232-241).
`
`
`
`6
`
`

`

`
`
`Petitioners’ arguments ignore these hallmarks of reliability and instead make
`
`aspersions about (1) Dr. Slocum’s lack of personal experience in 2003 with pen
`
`injectors, (2) Dr. Slocum’s reliance on limited, corroborated, and unrebutted
`
`information and a physical model provided by Mr. Veasey, and (3) alleged, but
`
`unfounded, problems with appendices A-F of Dr. Slocum’s declaration.
`
`1.
`
`Personal Experience with Pen Injectors in 2003 Is Not
`Required
`Petitioners’ contention that Dr. Slocum was not specifically knowledgeable
`
`
`
`in 2003 about pen injector art is inconsequential. As an initial matter, both Mr.
`
`Leinsing and Dr. Slocum agree that the level of ordinary skill in the art does not
`
`require specific knowledge of, or experience with, pen injectors at all. See EX1011
`
`¶ 106, EX2107 ¶ 102. Indeed, at a district court trial where both experts applied the
`
`same definitions for the level of ordinary skill as in this IPR, Dr. Slocum was
`
`qualified as an expert to testify on the validity of one of the challenged patents
`
`based on his expertise in mechanical engineering.
`
`
`
`Further, and regardless of what the pertinent art is, an expert need not be
`
`qualified in the pertinent art at the time of the invention. See Rowe Price
`
`Investment Servs., Inc. v. Secure Access, LLC, Case CBM2015-00027, slip op. at
`
`21–22 (PTAB June 13, 2016) (Paper 31) (“In holding that, to testify as an expert
`
`under FRE 702, one must be qualified as an expert in the pertinent art, the Federal
`
`Circuit has not placed temporal restrictions, such as requiring an expert be
`7
`
`
`
`

`

`qualified in the pertinent art at the time of the invention”) (citing Sundance, Inc. v.
`
`DeMonte Fabricating Ltd., 550 F.3d 1356, 1363–64 (Fed. Cir. 2008)); U.S.
`
`Endoscopy Group, Inc. v. CDX Diagnostics, Inc., Case IPR2014-00639, slip op. at
`
`18 (PTAB Sept. 14, 2015) (Paper 27) (“A witness must provide testimony about
`
`the level of skill in the art as of the critical date; however, the witness need not
`
`have acquired that knowledge as of the critical date.”). Accordingly, even if pen
`
`injector knowledge were required, Dr. Slocum need not have had that knowledge
`
`in 2003. The fact that he now has knowledge of the pen injector field as of 2003 is
`
`more than enough.
`
`
`
`Dr. Slocum acquired this knowledge to put himself in the shoes of a POSA
`
`working on pen injectors in 2003 through several means. He (i) researched the
`
`prior art, (ii) canvassed literature on pre-critical date pen injectors, design
`
`considerations, and design standards, and (iii) conversed with those in the industry
`
`(i.e., Mr. Veasey and Dr. Goland). See, e.g., EX2107 ¶¶ 25-61. This research
`
`informed Dr. Slocum’s opinions on what a POSA would have known or done in
`
`2003.
`
`
`
`Moreover, Dr. Slocum’s thorough documentation of facts and data
`
`supporting what a POSA would have done in 2003 is more reliable than the
`
`approach taken by Petitioners’ own expert. Mr. Leinsing does not cite any
`
`materials for many of his opinions and instead relies on his memory of prior
`
`
`
`8
`
`

`

`experience, which he concedes “was a long time ago.” EX2163, 121:17-25 (also
`
`stating that he cannot remember all the pen injectors he was aware of in 2003 or
`
`any of the names of the pen injectors); see also, e.g., id. 118:14-120:12 (explaining
`
`that he does not remember what acceptable levels for injection force were in 2003);
`
`cf. EX1053, 78:6-79:3. For example, Mr. Leinsing does not cite facts or data to
`
`support much of his attempted rebuttal of Dr. Slocum’s scientific analysis for why
`
`a POSA would not have modified Steenfeldt-Jensen’s fifth embodiment. See
`
`EX1106 ¶¶ 72-76; see also 37 C.F.R. § 42.65 (“Expert testimony that does not
`
`disclose the underlying facts or data on which the opinion is based is entitled to
`
`little or no weight.”).
`
`2.
`
`Petitioners’ Criticisms of the Information and Physical
`Model Obtained from Mr. Veasey Are Unfounded
`The information and physical model that Dr. Slocum obtained from Mr.
`
`
`
`Veasey are reliable. Petitioners mischaracterize Dr. Slocum as blindly accepting
`
`uncorroborated information and a model from Mr. Veasey and argue that his input
`
`undermines Dr. Slocum’s entire declaration. The record demonstrates otherwise.
`
`The reliability of the three categories of information and one model provided by
`
`Mr. Veasey is corroborated by Dr. Slocum’s independent research and analysis.
`
`Moreover, Petitioners do not rebut the accuracy of the information.
`
`
`
`First, Dr. Slocum spoke with Mr. Veasey about design considerations for
`
`pen injectors art in 2003. See EX2107 ¶ 46. Dr. Slocum also conducted his own
`9
`
`
`
`

`

`investigation and research into design considerations and the state of the art, which
`
`is well documented in his declaration. See EX2107 ¶¶ 25-61. Petitioners do not
`
`contend that any of the design considerations cited by Dr. Slocum are incorrect or
`
`would render his opinions unreliable.
`
`
`
`Second, Dr. Slocum spoke to Mr. Veasey to confirm that the FlexPen is the
`
`commercialization of Steenfeldt-Jensen’s fifth embodiment. See EX2107 ¶ 29.
`
`Petitioners do not dispute this fact. See EX2163, 141:13-142:2.
`
`
`
`Third, Dr. Slocum used Mr. Veasey’s measurements of an actual FlexPen to
`
`quantify the impact of Mr. Leinsing’s proposed modification to Steenfeldt-Jensen’s
`
`fifth