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. IPR2018-016751
`U.S. Patent No. 8,603,044
`
`
`
`
`
`
`
`
`
`PATENT OWNER’S OBSERVATIONS ON THE
`CROSS-EXAMINATION OF MR. KARL LEINSING
`
`
`1 Pfizer Inc., who filed a petition in IPR2019-00977, 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
`
`2005
`
`2006
`
`2007
`
`2008
`
`2009
`
`2010
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`
`
`
`
`
`
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`
`
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`

`

`Exhibit #
`
`Description
`
`2011
`
`2012
`
`2013
`
`2014
`
`2015
`
`2016
`
`2017
`
`2018
`
`2019
`
`2020
`
`2021
`
`2022
`
`2023
`
`
`
`
`
`
`
`
`
`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
`Excerpts from McGraw Hill Dictionary of Scientific and
`Technical Terms (Sixth edition, McGraw-Hill 2003), p. 972 and
`1873
`Excerpts from Merriam-Webster’s Collegiate Dictionary (10th
`edition, Merriam-Webster, Inc. 2001), p. 538
`The New Oxford American Dictionary (Oxford University Press
`2001), p. 789-90
`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-
`cv-09105-SRC-CLW (D.N.J.) (confidentiality designation
`removed)
`Report of the Local Patent Rules Committee, Explanatory Notes
`for 2016 Amendments
`
`ii
`
`

`

`Exhibit #
`
`Description
`
`2024
`
`2025
`
`2100
`
`2101
`
`Transcript, Conference Call for Case IPR2018-01675, -01676, -
`01678, -01680 (P.T.A.B. Feb. 5, 2019)
`Redline of Amended Patent Owner Preliminary Response (filed
`February 20, 2019)
`2026-2099 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)
`
`
`2102
`2103
`
`2104
`
`2105
`2106
`
`2107
`2108
`2109
`2110
`2111
`2112
`
`2113
`
`2114
`
`iii
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`
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`
`
`
`
`
`
`

`

`Exhibit #
`
`Description
`
`2115
`
`2116
`
`2117
`
`2118
`
`2119
`
`2120
`2121
`2122
`
`2123
`
`2124
`
`2125
`
`2126
`
`2127
`
`
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`
`
`
`
`
`
`
`
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`
`
`
`
`
`
`
`
`
`
`
`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)
`Reserved
`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
`
`

`

`Exhibit #
`
`Description
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`2128
`
`2129
`
`2130
`
`2131
`
`2132
`
`2133
`2134
`
`2135
`
`2136
`2137
`2138
`
`2139
`
`2140
`
`2141
`
`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
`
`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)
`
`
`
`vi
`
`

`

`Exhibit #
`
`Description
`
`2160
`
`2161
`
`2162
`2163
`
`2164
`
`2165
`
`2166
`
`2167
`2168
`2169
`2170
`2171
`2172
`
`2173
`
`2174
`
`2175
`
`2176
`
`Jean-Louis Selam, Evolution of Diabetes Insulin Delivery
`Devices, 4 J. Diabetes Sci. and Tech. 505-513 (2010)
`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)
`
`
`
`vii
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`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`

`

`Exhibit #
`
`Description
`
`2177
`
`2178
`
`2179
`
`2180
`
`2181
`
`2182
`
`2183
`
`2184
`
`2185
`
`2186
`2187
`2188
`2189
`2190
`2191
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`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)
`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
`
`
`viii
`
`

`

`Exhibit #
`
`Description
`
`2192
`
`2193
`
`2194
`
`2195
`2196
`2197
`2198
`2199
`
`2200
`
`2201
`
`2202
`2203
`
`2204
`2205
`2206
`2207
`
`2208
`
`2209
`
`2210
`
`2211
`
`Formulary Placement of Long-Acting Insulin Pen Products:
`Medicare Plans
`Formulary Placement of Long-Acting Insulin Pen Products:
`Medicaid Plans
`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
`
`ix
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`
`
`
`
`
`
`
`
`

`

`Exhibit #
`
`Description
`
`2212
`
`Excerpts from Ernest Rabinowicz, Friction And Wear of
`Materials, 2nd Edition, 68-70 (John Wiley & Sons, Inc. 1995)
`Reserved
`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 Vlasis
`Biography of Robert 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 Supplement Evidence
`Transcript of Cross- Examination of Karl Leinsing dated
`December 3, 2019
`2228-2315 Reserved
`
`2213
`2214
`
`2215
`2216
`2217
`2218
`2219
`2220
`2221
`2222
`2223
`2224
`2225
`
`2226
`2227
`
`2316
`
`2317
`2318
`2319
`
`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)
`
`
`x
`
`
`
`
`
`

`

`
`
`Patent Owner submits, for the Board’s consideration, the following
`
`observations on the testimony of Petitioner’s technical expert, Mr. Karl Leinsing,
`
`during his December 3, 2019 cross-examination in Sanofi-Aventis U.S. LLC, et al.
`
`v. Mylan GmbH, et al., Case No. 2:17-cv-09105-SRC-CLW (D.N.J.).
`
`OBSERVATION NO. 1:
`
`
`
`Mr. Leinsing was impeached when testifying regarding the importance of
`
`injection force. Initially, Mr. Leinsing testified that “I wouldn’t say there’s a lot of
`
`focus on [reducing injection force]” and that “it is a factor, but it’s not an important
`
`factor.” Ex. 2227 at 336:25-337:14. However, Mr. Leinsing was then confronted
`
`with his prior sworn testimony stating the opposite:
`
`QUESTION: Trigger finger.
`You answered: Well, I think that’s the index finger, probably either
`weakness or strength thereof. And we design the pens so you can have
`very reduced force of injection because diabetic patients typically don’t
`have the strength to inject the medicine like a patient without diabetes.
`So there’s a lot of focus in pen injectors to reduce the force of
`injection.
`QUESTION: So you would agree then that reducing the force of
`injection is an important consideration in injection [sic] design?
`ANSWER: Yes.
`That was your testimony, correct?
`A: Yes.
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`Ex. 2227 at 337:17-338:5.
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`1
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`OBSERVATION NO. 2:
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`Mr. Leinsing was impeached when testifying regarding the injection force
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`problems that were known regarding the original FlexPen. Specifically, while Mr.
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`Leinsing agreed that the FlexPen lines up with Steenfeldt-Jensen’s fifth embodiment
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`and that there were injection force problems with the FlexPen from day one, Mr.
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`Leinsing disagreed that Novo Nordisk went through a “huge design process” to
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`address the injection force issue. Ex. 2227 at 338:6-16. However, Mr. Leinsing was
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`then confronted with his prior sworn testimony stating the opposite:
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`QUESTION: How does the next generation FlexPen differ from the
`original FlexPen?
`[ANSWER:] So I know some of those changes, like I said, when they
`went from the original to the final one, there might be some changes
`that are blurred in there, but the big change I know about for the Next
`Generation is the pen they flipped where the post and where their bore
`was on the pen and created a pivot bearing up near the button to reduce
`the friction.
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`There were problems since day one of FlexPen having high
`injection force. I mentioned that other journal that documented that, I
`think, in 2006. They made a design change. They went through a huge
`design process, and they flipped that button around.
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`Ex. 2227 at 338:23-339:10.
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`In addition to undermining Mr. Leinsing’s credibility, this testimony is
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`relevant to and contradicts Mr. Leinsing’s apparent testimony in this proceeding that
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`a POSA would be able to simply use known options to address injection force
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`problems. See Ex. 1106 at ¶ 73.
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`OBSERVATION NO. 3:
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`Mr. Leinsing was impeached when testifying about when he had possession
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`of an original FlexPen. Specifically, Mr. Leinsing testified during his direct
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`examination that he had an original FlexPen in his possession in 2002. Ex. 2227 at
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`328:25-329:9. This was shown to directly conflict with his prior sworn testimony
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`that he first became aware of the original FlexPen two years ago:
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`QUESTION: You testified recently today about your familiarity with
`the FlexPen and the Next Generation FlexPen correct?
`ANSWER: Yes.
`QUESTION: When did you first become aware of the FlexPen, the
`original?
`ANSWER: About two – two years ago or so.
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`Ex. 2227 at 329:6-330:18.
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`OBSERVATION NO. 4:
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`The impeachment of Mr. Leinsing was confirmed by the Court:
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`“THE COURT: Just so we have the record clear, the impeachment of
`this witness was based upon A, prior art inconsistent statements, and B,
`the inconsistency between expert reports in different matters pertaining
`to the legal standard which was applied. In short, there were very
`specific impeachment attacks. That is very different from whether or
`not this man in some other case was contacted about potentially being
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`3
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`a witness, because, quite frankly, it is his testimony on this case based
`upon prior testimony which was impeached.”
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`Ex. 2227 at 356:2-11.
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`OBSERVATION NO. 5:
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`Mr. Leinsing’s credibility was undermined when testifying the regarding the
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`amount the injection force would increase as a result of swapping the thread on the
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`nut element 40 and the slot on driver tube 85 in Steenfeldt-Jensen’s fifth
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`embodiment. Specifically, Mr. Leinsing confirmed that his expert report in the
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`litigation did not include any force calculations regarding the proposed modification.
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`Ex. 2227 at 341:6-12. Mr. Leinsing further testified in his opinion the injection force
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`increase “would be very close to a wash.” Ex. 2227 at 341:16. However, Mr.
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`Leinsing confirmed that he had entered values into Dr. Slocum’s spreadsheet that
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`showed a 25 to 30% increase in the injection force resulting from the proposed
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`modification, but he did not save that spreadsheet. Ex. 2227 at 341:12-22.
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`4
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`Respectfully submitted,
`/Elizabeth Stotland Weiswasser/
`Elizabeth Stotland Weiswasser
`Reg. No. 55,721
`Weil, Gotshal & Manges LLP
`767 Fifth Avenue
`New York, NY 10153
`Phone: 212-310-8000
`elizabeth.weiswasser@weil.com
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`Dated: December 20, 2019
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`5
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`CERTIFICATE OF SERVICE
`The undersigned hereby certifies that on December 20, 2019, the foregoing
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`PATENT OWNER’S OBSERVATIONS ON THE CROSS-EXAMINATION
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`OF MR. KARL LEINSING was served via electronic mail, upon the following:
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`Richard Torczon
`Wesley Derryberry
`Tasha Thomas
`Lora Green
`WILSON SONSINI GOODRICH & ROSATI
`1700 K Street NW, 5th Floor
`Washington, D.C. 20006
`rtorczon@wsgr.com
`wderryberry@wsgr.com
`tthomas@wsgr.com
`lgreen@wsgr.com
`
`Douglas H. Carsten
`Jeffrey W. Guise
`Arthur Dykhuis
`WILSON SONSINI GOODRICH & ROSATI
`12235 El Camino Real, Suite 200
`San Diego, CA 92130
`dcarsten@wsgr.com
`jguise@wsgr.com
`adykhuis@wsgr.com
`
`Lorelei Westin
`WILSON SONSINI GOODRICH & ROSATI
`650 Page Mill Road
`Palo Alto, CA 94304
`lwestin@wsgr.com
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`Nicole W. Stafford
`WILSON SONSINI GOODRICH & ROSATI
`900 South Capital of Texas Highway
`Las Cimas, IV Fifth Floor
`Austin, TX 78746
`nstafford@wsgr.com
`
`Elham F. Steiner (Pro Hac Vice)
`WILSON SONSINI GOODRICH & ROSATI
`12235 El Camino Real
`San Diego CA 92130
`esteiner@wsgr.com
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`Jad Mills
`WILSON SONSINI GOODRICH & ROSATI
`701 Fifth Avenue, Suite 5100
`Seattle, WA 98104
`jmills@wsgr.com
`
`Jovial Wong
`WINSTON & STRAWN LLP
`1700 K Street, NW
`Washington, D.C. 20006
`jwong@winston.com
`
`/Lauren J. McDuffie/
`Lauren J. McDuffie
`IP Paralegal
`Weil, Gotshal & Manges LLP
`2001 M Street, NW, Suite 600
`Washington, DC 20036
`lauren.mcduffie@weil.com
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