Date Field | Doc. No. | Party | Description |
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Aug 14, 2020 | 39 | patent_own | Patent Owner Sanofi-Aventis Deutschland GmbH's Notice of Appeal Under 37 C.F.R. 90.2(a) Download |
Aug 11, 2020 | 38 | board | Termination Decision Document Download |
May 8, 2020 | 37 | | Petitioner's Reply In Support Of Petitioner's Motion To Exclude Download |
May 6, 2020 | 2454 | | Record of Oral Hearing Held on 1.15.2020 Download |
May 6, 2020 | 36 | | Patent Owner's Updated Exhibit List Download |
May 1, 2020 | 2452 | | Transcript of Telephone Conference on 6.19.19 Download |
May 1, 2020 | 2453 | | Email from Patent Owner to Petitioner re: Supplemental Evidence Download |
May 1, 2020 | 35 | | Patent Owner's Opposition to Petitioner's Motion to Exclude Download |
Apr 29, 2020 | 3001 | | Ex. 3001 Download |
Apr 29, 2020 | 34 | | Order - Conduct of the Proceeding - 37 CFR 42.5 Download |
Apr 24, 2020 | 32 | | Petitioner's Motion to Exclude Evidence Download |
Apr 24, 2020 | 33 | | Petitioner's Motion to Exclude Evidence Download |
Apr 17, 2020 | 31 | | Download |
Apr 16, 2020 | 30 | | Granting Patent Owners Motion for Withdrawal of Counsel
37 C.F.R. sec 42.10(e) Download |
Apr 7, 2020 | 29 | | PETITIONER'S MANDATORY CHANGE-OF-INFORMATION NOTICES Download |
Apr 3, 2020 | 27 | | Patent Owner's Request for Oral Argument Download |
Apr 3, 2020 | 28 | | PETITIONER'S NOTICE REGARDING ORAL ARGUMENT Download |
Mar 18, 2020 | 26 | | PETITIONER'S OBJECTIONS TO EVIDENCE SUBMITTED WITH PATENT OWNER SUR-REPLY Download |
Mar 13, 2020 | 2224 | | Expert Opinion on Drug Delivery, Instructions for Authors Download |
Mar 13, 2020 | 2317 | | Deposition of William C. Biggs, dated October 15, 2019 Download |
Mar 13, 2020 | 2318 | | Deposition of DeForest McDuff, dated October 9, 2019 Download |
Mar 13, 2020 | 2451 | | Transcript of Telephonic conference between Sanofi, the Board, Pfizer and Mylan, dated Nov. 18, 2019, in IPR2018-1670, -1676, -1678, -1679, -1680, and -1682 Download |
Mar 13, 2020 | 25 | | Patent Owner's Sur-Reply Download |
Feb 24, 2020 | 24 | | Download |
Feb 20, 2020 | 23 | | ORDER
Changing Due Date 8 Download |
Feb 6, 2020 | 1088 | | Download |
Feb 6, 2020 | 22 | | SUBMISSION OF CORRECTED EXHIBIT Download |
Jan 31, 2020 | 1044 | | Ex. 1044 - Nat'l. Diabetes Statistic Report 2017, Estimates of Diabetes and Its Burden in the United States, CDC, p.1-20 Download |
Jan 31, 2020 | 1045 | | Ex. 1045 - Teresa L. Pearson, "Practical Aspects of Insulin Pen Devices", Journal of Diabetes Science and Technology, Vol. 4, Issue 3, May 2010, p.522-531 Download |
Jan 31, 2020 | 1046 | | Ex. 1046 - Nancy J.V. Bohannon, "Insulin Delivery Using Pen Devices", Postgraduate Medicine, Vol. 106, No.5, Oct. 15, 1999, p. 57-68, ISSN: 0032-5481 (Print) 1941-9260 Download |
Jan 31, 2020 | 1047 | | Ex. 1047 - Marilyn R. Graff, RN, CDE et al., "Assessment by Patients with Diabetes Mellitus of Two Insulin Pen Delivery Systems Versus a Vial and Syringe", Clinical Therapeutics, Vol. 20, No. 3, 1998, P.486-196 Download |
Jan 31, 2020 | 1048 | | Ex. 1048 - Expert Declaration of William Curtis Biggs, M.D., FACE, ECNU in Support of Mylan-Pfizer Reply Download |
Jan 31, 2020 | 1049 | | Ex. 1049 - Curriculum Vitae of William Curtis Biggs Download |
Jan 31, 2020 | 1050 | | Ex. 1050 - Slocum Deposition Exhibit 1050: Annotations of EX2107 (Declaration of Alexander Slocum Ph.D.) Download |
Jan 31, 2020 | 1051 | | Ex. 1051 - Slocum Deposition Exhibit 1051: Hand drawing of modified drive mechanism Download |
Jan 31, 2020 | 1052 | | Ex. 1052 - Slocum Deposition Exhibit 1052: Annotations of excerpted figures from EX2157 Download |
Jan 31, 2020 | 1053 | | Ex. 1053 - Deposition of Alexander H. Slocum, Ph.D., August 27, 2019 Download |
Jan 31, 2020 | 1054 | | Ex. 1054 - Deposition of Alexander H. Slocum, Ph.D., Vol II, August 28, 2019 Download |
Jan 31, 2020 | 1055 | | Ex. 1055 - Deposition of Henry Grabowski, Ph.D., Sep. 5, 2019 Download |
Jan 31, 2020 | 1056 | | Ex. 1056 - Deposition of Robin Goland, Sep. 10, 2019 Download |
Jan 31, 2020 | 1057 | | Download |
Jan 31, 2020 | 1058 | | Ex. 1058 - Certified English Translation of DE Patent 102 37 258A1, Dr. Roney Graf (Issued Mar. 18, 2004) Download |
Jan 31, 2020 | 1059 | | Ex. 1059 - M. Eledrisi, et al., "Twice-Daily Insulin Glargine for Patients with Uncontrolled Type 2 Diabetes Mellitus", Journal of Clinical & Translational Endocrinology 15 (2019), p. 35-36 Download |
Jan 31, 2020 | 1060 | | Ex. 1060 - Declaration and c.v. of DeForrest McDuff, Ph.D. Download |
Jan 31, 2020 | 1061 | | Ex. 1061 - 2011 Orange Book (Excerpts) Download |
Jan 31, 2020 | 1062 | | Download |
Jan 31, 2020 | 1063 | | Ex. 1063 - 2011-02-09 - Sanofi SA Earnings Conference Call Download |
Jan 31, 2020 | 1064 | | Download |
Jan 31, 2020 | 1065 | | Download |
Jan 31, 2020 | 1066 | | Download |
Jan 31, 2020 | 1067 | | Download |
Jan 31, 2020 | 1068 | | Ex. 1068 - Aventis 2002 20-F Form Download |
Jan 31, 2020 | 1069 | | Ex. 1069 - Aventis 2034 20-F Form Download |
Jan 31, 2020 | 1070 | | Ex. 1070 - Sanofi-Aventis 2006 20 F Form Download |
Jan 31, 2020 | 1071 | | Download |
Jan 31, 2020 | 1072 | | Ex. 1072 - Carter, Alan W., "Analysis of the 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, Jan. 2011, p. 156-157 Download |
Jan 31, 2020 | 1073 | | Ex. 1073 - "About Diabetes", CDC Basics, p.1-2, Download |
Jan 31, 2020 | 1074 | | Ex. 1074 - David, J. et al. "Commercial Success: Economic Principles Applied to Patent Litigation", NERA Economic Consulting (copyrighted material), p. 159-160 Download |
Jan 31, 2020 | 1075 | | Ex. 1075 - "Top Ten Tips on Writing Effectiveness Case Studies", By Design Business Association, May 23, 2016, p.1-5 Download |
Jan 31, 2020 | 1076 | | DiMasi, J., et al. "Innovation in the Pharmaceutical Industry: New Estimates of R&D Costs", J. of Health Economics 47 (2016), p. 20-33 Download |
Jan 31, 2020 | 1077 | | Ex. 1077 - Grabowski, H., et al. "Returns on Research and Development for 1990s New Drug Introductions", Pharmacoeconomics 2002; 20 Suppl. 3: p. 11-29 Download |
Jan 31, 2020 | 1078 | | Ex. 1078 - Pietrangelo, Ann "Levemir vs. Lantus: Similarities and Differences", Healthline, Oct. 19, 2016, p.1-14 Download |
Jan 31, 2020 | 1079 | | Ex. 1079 - U.S. Patent 6,100,376 Download |
Jan 31, 2020 | 1080 | | Download |
Jan 31, 2020 | 1081 | | Ex. 1081 - Lantus, "Get to Know the Lantus SoloStar Insulin Pen, p. 1-7 Download |
Jan 31, 2020 | 1082 | | Download |
Jan 31, 2020 | 1083 | | Ex. 1083 - Lantus SoloStar Brochure: "Your Guide to the Lantus SoloStar
Insulin Pen" (2010) Download |
Jan 31, 2020 | 1084 | | Ex. 1084 - McDuff, et al., "Thinking Economically About Commercial Success",
Landslide, March/April 2017, p. 37-40 Download |
Jan 31, 2020 | 1085 | | Ex. 1085 - Nonaka, H., "FTO (Freedom to Operate) in the Pharmaceutical Industry", JSTOR, Pub. by Nomos Verlagsgesellschaft mbH (2018), p. 9-59 Download |
Jan 31, 2020 | 1086 | | Ex. 1086 - Senate Comm. On Finance Questions for the Record, "Drug Pricing in America": A Prescription for Change Part II, Questions for Olivier Brandicourt, CEO Sanofi, Feb. 26, 2019, p. 1-460 Download |
Jan 31, 2020 | 1087 | | Ex. 1087 - S.G. Cowen, "Perspectives", Pharmaceutical Therapeutic Categories Outlook, Oct. 2001, p.134-148 Download |
Jan 31, 2020 | 1088 | | Ex. 1087 - Cowen and Co., "Diabetes: Many New Drugs, But Insulin Still Dominant", Therapeutic Categories Outlook, Feb. 2015, p.477-491 Download |
Jan 31, 2020 | 1089 | | Ex. 1089 - UBS Large Cap Pharmaceuticals Handbook, "U.S. Pharmaceuticals",
Apr. 6, 2018, p.45-53 Download |
Jan 31, 2020 | 1090 | | Ex. 1090 - Campbell, K., "Insulin Costs Are Skyrocketing. This is Why", U.S.
News and World Report, Jun. 29, 2018, p.1-7 Download |
Jan 31, 2020 | 1091 | | Ex. 1091 - U.S. Patent 5,656,722 Download |
Jan 31, 2020 | 1092 | | Ex. 1092 - U.S. Patent 7,476,652 Download |
Jan 31, 2020 | 1093 | | Ex. 1093 - U.S. Patent 7,713,930 Download |
Jan 31, 2020 | 1094 | | Ex. 1094 - WebMD, "Types of Insulin for Diabetes Treatment", p.1-7 Download |
Jan 31, 2020 | 1095 | | Ex. 1095 - Reply Declaration of Charles Clemens Download |
Jan 31, 2020 | 20 | | Download |
Jan 31, 2020 | 21 | | Download |
Nov 18, 2019 | 19 | | ORDER Granting Petitioner's Unopposed Motion for Admission Pro Hac Vice of Charles B. Klein and Dan H. Hoang Download |
Nov 15, 2019 | 18 | | Petitioner's Objections to Evidence Submitted with Patent Owner Response Download |
Nov 8, 2019 | 2185 | | "Sanofi-aventis¿¿¿ SoloSTAR(R) Insulin Pen for Lantus and Apidra Receives the Prestigious GOOD DESIGN Award" Download |
Nov 8, 2019 | 2173 | | Bruce A. Perkins, David Olaleye & Vera Bril, Carpal Tunnel Syndrome in Patients With Diabetic Polyneuropathy Download |
Nov 8, 2019 | 2158 | | Geralyn Spollett, Insulin Devices, Addressing Barriers to Insulin Therapy With the Ideal Pen, 957-967 (The Diabetes EDUCATOR) Download |
Nov 8, 2019 | 2178 | | Shubha Gundmi et al., Hand dysfunction in type 2 diabetes mellitus: Systematic review with meta-analysis Download |
Nov 8, 2019 | 2170 | | U.S. Patent No. 4,747,824 Download |
Nov 8, 2019 | 2132 | | Meike Krzywon et al., Study on the Dosing Accuracy of Commonly
Used Disposable Insulin Pens, 14 Diabetes Tech. & Therapeutics
804-809 (2012) Download |
Nov 8, 2019 | 2190 | | U.S. Share of Sales by Drugs in the LANTUS Franchise Download |
Nov 8, 2019 | 2112 | | Curriculum Vitae of Dr. Robin S. Goland Download |
Nov 8, 2019 | 2148 | | Steenfeldt-Jensen 1st Embodiment Animation Download |
Nov 8, 2019 | 2119 | | 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) Download |
Nov 8, 2019 | 2200 | | Yuzu Sato et al., Clinical Aspects of physical exercise for diabetes/metabolic syndrome Download |
Nov 8, 2019 | 2161 | | SoloSTAR Principles of Operation Download |
Nov 8, 2019 | 2116 | | Andreas Bode, Development of the SoloSTAR insulin pen device
design verification and validation, 6 Expert Opinion on Drug
Delivery 103-112 (2008) Download |
Nov 8, 2019 | 2113 | | 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) Download |
Nov 8, 2019 | 2136 | | Novo Nordisk Form 6-K (Feb. 9, 2009) Download |
Nov 8, 2019 | 2197 | | U.S. New Prescriptions of Long-Acting Pens Download |
Nov 8, 2019 | 2138 | | W. Schady et al, Observations on Severe Ulnar Neuropathy in
Diabetes, 12 J Diabetes and Its Complications 128-132 (1998) Download |
Nov 8, 2019 | 2014 | | Excerpts from Merriam-Webster¿¿¿s Collegiate Dictionary (10th
edition, Merriam-Webster, Inc. 2001), p. 538 Download |
Nov 8, 2019 | 2127 | | U.S. Provisional Patent Application 60/073820 Download |
Nov 8, 2019 | 2105 | | Leinsing Deposition Exhibit 2105: Hand drawings Download |
Nov 8, 2019 | 2140 | | 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) Download |
Nov 8, 2019 | 2180 | | Considering Insulin Pens for Routine Hospital Use - Consider This... (ISMP article) Download |
Nov 8, 2019 | 2145 | | US LANTUS SoloSTAR Launch Book, 2007, PTX-0705,
Document bates stamped SANOFI_00232909-45 Download |
Nov 8, 2019 | 2115 | | Arthritis & Diabetes, What do diabetes and arthritis have in
common? Plenty., Download |
Nov 8, 2019 | 2012 | | MP4 file of Sanofi¿¿¿s Patented Pen animation Download |
Nov 8, 2019 | 2174 | | Jefferson Becker et al., An evaluation of gender, obesity, age and diabetes mellitus as risk factors for carpal tunnel syndrome Download |
Nov 8, 2019 | 2152 | | Steenfeldt-Jensen 5th Embodiment vs. Proposed Modification
Collar Friction Animation Download |
Nov 8, 2019 | 2211 | | Collar Friction Model Demonstrator Animation Download |
Nov 8, 2019 | 2167 | | Giambattista Animation (1) Download |
Nov 8, 2019 | 2027 | | Animation depicting M¿¿ller¿¿¿s first embodiment Download |
Nov 8, 2019 | 2218 | | SoloSTAR Dial Inject Video Download |
Nov 8, 2019 | 2144 | | 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) Download |
Nov 8, 2019 | 2169 | | U.S. Patent No. 4,648,872 Download |
Nov 8, 2019 | 2135 | | 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) Download |
Nov 8, 2019 | 2126 | | 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) Download |
Nov 8, 2019 | 2137 | | Novo Nordisk History Download |
Nov 8, 2019 | 2103 | | Leinsing Deposition Exhibit 2103: Annotations of Figures 6-15 of
Burroughs Download |
Nov 8, 2019 | 2134 | | Arlan L. Rosenbloom, Limitation of Finger Joint Mobility in
Diabetes Mellitus, 3 J. Diabetic Complications 77-87 (1989) Download |
Nov 8, 2019 | 2104 | | Leinsing Deposition Exhibit 2104: Annotations of Figures 5-8 of
the 486 Patent Download |
Nov 8, 2019 | 2189 | | U.S. Total Prescriptions of LANTUS SoloSTAR Download |
Nov 8, 2019 | 2160 | | Jean-Louis Selam, Evolution of Diabetes Insulin Delivery Devices Download |
Nov 8, 2019 | 2109 | | Declaration of Henry R. Grabowski, Ph.D. Download |
Nov 8, 2019 | 2198 | | U.S. Total Prescriptions of Long-Acting Pens Download |
Nov 8, 2019 | 2129 | | 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) Download |
Nov 8, 2019 | 2181 | | Trigger Finger Overview (Mayo Clinic) Download |
Nov 8, 2019 | 2193 | | Formulary Placement of Long-Acting Insulin Pen Products: Medicaid Plans Download |
Nov 8, 2019 | 2172 | | Karl R. Leinsing Declaration in Hologic, Inc. v. Minerva Surgical, Inc. Download |
Nov 8, 2019 | 2216 | | Collar Friction Model Demonstration 2 Download |
Nov 8, 2019 | 2164 | | Deposition of Karl R. Leinsing, dated June 4, 2019 Download |
Nov 8, 2019 | 2100 | | 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) Download |
Nov 8, 2019 | 2184 | | Charles E. Buban, A pen that seeks to improve diabetes care Download |
Nov 8, 2019 | 2205 | | U.S. Marketing-to-Sales Ratios of Select Injectable Insulin Drugs Download |
Nov 8, 2019 | 2159 | | 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 Download |
Nov 8, 2019 | 2212 | | Excerpts from Ernest Rabinowicz, Friction And Wear of Materials Download |
Nov 8, 2019 | 2176 | | Ercan Cetinus et al., Hand grip strength in patients with type 2 diabetes mellitus Download |
Nov 8, 2019 | 2223 | | SoloSTAR Wins 2008 Good Design Award Download |
Nov 8, 2019 | 2206 | | M¿¿ller First Embodiment Animation Download |
Nov 8, 2019 | 2165 | | Opinion and Order regarding Claim Construction, Sanofi-Aventis U.S. LLC v. Mylan Download |
Nov 8, 2019 | 2015 | | The New Oxford American Dictionary (Oxford University Press
2001), p. 789-90 Download |
Nov 8, 2019 | 2199 | | U.S. Share of Long-Acting Pen Products Download |
Nov 8, 2019 | 2163 | | Deposition of Karl R. Leinsing Download |
Nov 8, 2019 | 2108 | | Curriculum Vitae of Alexander Slocum, Ph.D. Download |
Nov 8, 2019 | 2450 | | Deposition of Charles E. Clemens (November 1, 2019) Download |
Nov 8, 2019 | 2162 | | Sanofi Patent Drive Sleeve and Piston Rod Animation Download |
Nov 8, 2019 | 2133 | | LANTUS SoloSTAR Pen Guide Download |
Nov 8, 2019 | 2201 | | 2007 Good Design Award from The Chicago Athenaeum: Museum of Architecture and Design Download |
Nov 8, 2019 | 2150 | | Steenfeldt-Jensen 5th Embodiment Thread and Slot Animation Download |
Nov 8, 2019 | 2207 | | M¿¿ller Second Embodiment Animation Download |
Nov 8, 2019 | 2191 | | Formulary Placement of Long-Acting Insulin Pen Products: Commercial Plans Download |
Nov 8, 2019 | 2125 | | 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) Download |
Nov 8, 2019 | 2110 | | Curriculum Vitae of Henry R. Grabowski, Ph.D. Download |
Nov 8, 2019 | 2204 | | U.S. Total Marketing Expenditures of Long-Acting Insulin Pens Download |
Nov 8, 2019 | 2151 | | Steenfeldt-Jensen 5th Embodiment vs. Proposed Modification
Animation Download |
Nov 8, 2019 | 2196 | | U.S. Dollar Sales of Long-Acting Pens Download |
Nov 8, 2019 | 2186 | | Select Injectable Insulin Drugs Approved by the FDA in the U.S. Download |
Nov 8, 2019 | 2130 | | 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) Download |
Nov 8, 2019 | 2102 | | Leinsing Deposition Exhibit 2102: Hand drawings Download |
Nov 8, 2019 | 2149 | | Steenfeldt-Jensen 2nd Embodiment Animation Download |
Nov 8, 2019 | 2188 | | U.S. New Prescriptions of LANTUS SoloSTAR Download |
Nov 8, 2019 | 2217 | | Collar Friction Model Demonstration 3 Download |
Nov 8, 2019 | 2131 | | ISO 11608-1, Pen-injectors for medical use (1st Ed. Dec. 15, 2000) Download |
Nov 8, 2019 | 2117 | | Sanofi¿¿¿s Patented Pen animation Download |
Nov 8, 2019 | 2118 | | 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) Download |
Nov 8, 2019 | 2182 | | Bone and joint problems associated with diabetes (Mayo Clinic) Download |
Nov 8, 2019 | 2106 | | Leinsing Deposition exhibit 2106: Annotations of Figures 11 and
12 of Giambattista Download |
Nov 8, 2019 | 2166 | | Memorandum and Order regarding Claim Construction, Sanofi- Aventis U.S. LLC v. Merck Download |
Nov 8, 2019 | 2114 | | Teresa L. Pearson, A-Practical-Review-of-Insulin-Pen-Devices,
EMJ Diabet., 58-64 (2014:2) Download |
Nov 8, 2019 | 2195 | | U.S. Share of Long-Acting Pens Among All Pens Download |
Nov 8, 2019 | 2153 | | International Patent Application WO999038554A1 Download |
Nov 8, 2019 | 2177 | | Ragnhild I. Cederlund et al., Hand disorders, hand function, and activities of daily living in elderly men with type 2 diabetes Download |
Nov 8, 2019 | 2175 | | A. Pfutzner et al., Prefilled insulin device with reduced injection force: patient perception and accuracy Download |
Nov 8, 2019 | 2179 | | Joule J. Li et al., Muscle grip strength predicts incident type 2 diabetes: Population-based cohort study Download |
Nov 8, 2019 | 2123 | | Arnd Friedrichs et al., Dose Accuracy and Injection Force of
Different Insulin Glargine Pens, 7 J. Diabetes Sci. and Tech. 1346-
1353 (2013) Download |
Nov 8, 2019 | 2141 | | John Shelmet et al., Preference and resource utilization in elderly
patients: InnoLet versus vial/syringe, 63 Diabetes Res. and Clinical
Prac. 27-35 (2004) Download |
Nov 8, 2019 | 2208 | | Press Release, Lantus / Apdira SoloSTAR help to improve patient satisfaction Download |
Nov 8, 2019 | 2183 | | Peripheral Neuropathy (Mayo Clinic) Download |
Nov 8, 2019 | 2013 | | Excerpts from McGraw Hill Dictionary of Scientific and Technical
Terms (Sixth edition, McGraw-Hill 2003), p. 972 and 1873 Download |
Nov 8, 2019 | 2203 | | U.S. Total Marketing Expenditure of Long Acting Insulin Franchises Download |
Nov 8, 2019 | 2187 | | U.S. Dollar Sales of LANTUS SoloSTAR Download |
Nov 8, 2019 | 2120 | | Estelle Davis, et. al., An evaluation of prefilled insulin pens: a
focus on the Next Generation FlexPen, Med. Devices: Evidence &
Research, 41-50 (2010:3) Download |
Nov 8, 2019 | 2214 | | Excerpts from Alexander H. Slocum, Precision Machine Design Download |
Nov 8, 2019 | 2111 | | Declaration of Dr. Robin S. Goland Download |
Nov 8, 2019 | 2026 | | International Patent WO 99/38554 Download |
Nov 8, 2019 | 2121 | | DBA Design Effectiveness Awards 2009 Download |
Nov 8, 2019 | 2143 | | 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) Download |
Nov 8, 2019 | 2107 | | Declaration of Alexander Slocum, Ph.D. Download |
Nov 8, 2019 | 2146 | | Part 1 - LANTUS COMPASS Study Report (Nov. 29, 2007), PTX-0739,
Document bates stamped SANOFI3_90330807-1025 Download |
Nov 8, 2019 | 2194 | | Formulary Placement of Long-Acting Insulin Pen Products in Healthcare Exchanges Download |
Nov 8, 2019 | 2209 | | Henry Grabowski, John Vernon & Joseph A. DiMasi, Returns on Research and Development for 1990s New Drug Introductions Download |
Nov 8, 2019 | 2168 | | Giambattista Animation (2) Download |
Nov 8, 2019 | 2016 | | 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.) Download |
Nov 8, 2019 | 2128 | | Samita Garg et al., Insulin glargine and glulisine SoloSTAR pens
for the treatment of diabetes, 5 Expert Rev. Med. Devices 113-123
(2008) Download |
Nov 8, 2019 | 2139 | | Alfred Penfornis & Kristian Horvat, Dose Accuracy Compariosn
Between SoloSTAR and FlexPen at Three Different Dose Levels, 10
Diabetes Tech. & Therapeutics 359-362 (2008) Download |
Nov 8, 2019 | 2122 | | SoloSTAR Disposable Pen Injector (The Grand Prix Oct. 22, 2009) Download |
Nov 8, 2019 | 2215 | | Collar Friction Model Demonstration 1 Download |
Nov 8, 2019 | 2192 | | Formulary Placement of Long-Acting Insulin Pen Products: Medicare Plans Download |
Nov 8, 2019 | 17 | | Patent Owner's Response Download |
Nov 8, 2019 | 2101 | | 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) Download |
Nov 8, 2019 | 2028 | | Animation depicting M¿¿ller¿¿¿s second embodiment Download |
Nov 8, 2019 | 2210 | | Julie M. Donohue, Marisa Cevasco & Meredith B. Rosenthal, A Decade of Direct-to-Consumer Advertising of Prescription Drugs Download |
Nov 8, 2019 | 2171 | | U.S. Patent No. 6,248,093 Download |
Nov 8, 2019 | 2124 | | 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) Download |
Nov 8, 2019 | 2147 | | Steenfeldt-Jensen 5th Embodiment Animation Download |
Nov 8, 2019 | 2146 | | Part 1 - LANTUS COMPASS Study Report (Nov. 29, 2007), PTX-0739,
Document bates stamped SANOFI3_90330807-1025 Download |
Nov 8, 2019 | 2142 | | Prix Galien USA Announces 2009 Final Candidates (Prix Galien
USA, August 7, 2009) Download |
Nov 8, 2019 | 2146 | | Part 2 - LANTUS COMPASS Study Report (Nov. 29, 2007), PTX-0739,
Document bates stamped SANOFI3_90330807-1025 Download |
Nov 1, 2019 | 1036 | | Ex. 1036 - Declaration of Charles B. Klein in Support of Motion for Pro Hac Vice Admission Download |
Nov 1, 2019 | 1037 | | Ex. 1037 - Declaration of Dan H. Hoang in Support of Motion for Pro Hac Vice Admission Download |
Nov 1, 2019 | 16 | | Petitioner's Unopposed Motion for Pro Hac Vice Admission of Charles B. Klein and Dan. H. Hoang Download |
Oct 30, 2019 | 15 | | Patent Owner's Notice of Deposition of Charles E. Clemens Download |
Aug 29, 2019 | 14 | | Patent Owner's Objections to Documents Served with the Petition Download |
Aug 15, 2019 | 12 | | Trial Instituted Document Download |
Aug 15, 2019 | 13 | | SCHEDULING ORDER Download |
Jul 30, 2019 | 11 | | Order Conduct of the Proceeding Download |
Jun 24, 2019 | 10 | | Reply in Support of Petitioner's Motion for Joinder Download |
Jun 3, 2019 | 7 | | Power of Attorney for Patent Owner Sanofi-Aventis Deutschland GmbH Download |
Jun 3, 2019 | 9 | | Waiver of Patent Owner's Preliminary Response Download |
Jun 3, 2019 | 8 | | Patent Owner's Response to Petitioner's Motions for Joinder Download |
May 23, 2019 | 6 | | Patent Owner¿¿¿s Mandatory Notices Pursuant to 37 C.F.R. 42.8 Download |
May 23, 2019 | 5 | | Power of Attorney for Patent Owner Sanofi-Aventis Deutschland GmbH Download |
May 21, 2019 | 4 | | Notice of Accord Filing Date Download |
May 2, 2019 | 1016 | | Ex. 1016 - U.S. Patent 6,932,794 B2 - L. Giambattista & A. Bendek Download |
May 2, 2019 | 1021 | | Ex. 1021 - U.S. Patent 6,248,095 B1 - L. Giambattista et al., Download |
May 2, 2019 | 1026 | | Ex. 1026 - GB 0304822.0 - "improvements in and relating to a pen-type injector" (filed Mar. 3, 2003) ('844 Priority Doc.) Download |
May 2, 2019 | 1029 | | Ex. 1029 - Memorandum Opinion, Sanofi-Aventis U.S. LLC v. Merck Sharp & Dohme Corp., No. 16-cv-812 (filed Jan. 12, 2018) Download |
May 2, 2019 | 1032 | | Ex. 1032 - EP 0 608 343 B1 - L. Petersen & N. A. Hansen Download |
May 2, 2019 | 1015 | | Ex. 1015 - U.S. Patent Application US 2002/0052578 A1- C.S. Moller Download |
May 2, 2019 | 1028 | | Ex. 1028 - Mylan GmbH and Biocon's Preliminary Claim Constructions and Supporting Evidence Pursuant to L. Pat. R. 4.2, Sanofi-Aventis U.S., LLC v. Mylan N.V., C.A. No. 17-cv-09105 Download |
May 2, 2019 | 1020 | | Ex. 1020 - U.S. Patent 4,865,591 - B. Sams Download |
May 2, 2019 | 1014 | | Ex. 1014 - U.S. Patent 6,235,004 - S. Steenfeldt-Jensen & S. Hansen Download |
May 2, 2019 | 1023 | | Ex. 1023 - U.S. Patent 5,226,895 - D.C. Harris Download |
May 2, 2019 | 1024 | | Ex. 1024 - U.S. Patent 5,851,079 - R.L. Horstman et al. Download |
May 2, 2019 | 1013 | | Ex. 1013 - U.S. Patent 6,221,046 - A. Burroughs et al. Download |
May 2, 2019 | 1034 | | Ex. 1034 - WO 01/83008 - S. Hansen & T.D. Miller Download |
May 2, 2019 | 3 | | MOTION FOR JOINDER Download |
May 2, 2019 | 1027 | | Ex. 1027 - WO 99/38554 - S.Steenfeldt-Jensen & S.Hansen Download |
May 2, 2019 | 2 | | IPR Petition '069 Download |
May 2, 2019 | 1010 | | Ex. 1010 - File History for U.S. Patent. 9,604,008 Download |
May 2, 2019 | 1031 | | Ex. 1031 - N. Sclater & N.P. Chironis, Mechanisms & Mechanical Devices Sourcebook 191-95, "Twenty Screw Devices" (3d ed., July 2, 2001) Download |
May 2, 2019 | 1030 | | Ex. 1030 - Memorandum Opinion, Sanofi -Aventis U.S. LLC v. Eli Lilly and Co., No. 14-cv-113 (filed Jan. 20, 2015) Download |
May 2, 2019 | 1035 | | Ex. 1035 - K.J. Lipska et al., 320 J. Am. Med. Ass'n 53-62 (2018) Download |
May 2, 2019 | 1011 | | Ex. 1011 - Declaration of Mr. Charles E. Clemens Download |
May 2, 2019 | 1017 | | Ex. 1017 - U.S. Patent 6,582,404 B1 - P.C. Klitgaard et al Download |
May 2, 2019 | 1007 | | Ex. 1007 - File History for U.S. Patent 8,603,044 Download |
May 2, 2019 | 1022 | | Ex. 1022 - U.S. Patent 5,921,966 B1 - A.A. Bendek et al Download |
May 2, 2019 | 1003 | | Ex. 1003 - U.S. Patent 8,992,486, Pen-Type Injector (issued Mar. 31, 2015) Download |
May 2, 2019 | 1019 | | Ex. 1019 - Plaintiffs' Preliminary Claim Constructions and Preliminary Identification of Supporting Intrinsic and Extrinsic Evidence, Sanofi-Aventis U.S. LLC v. Mylan GmbH, No. 2:17-cv-09105 (D.N.J.) Download |
May 2, 2019 | 1001 | | Ex. 1001 - U.S. Patent 8,679,069, Pen-Type Injector (issued Mar. 25, 2014) Download |
May 2, 2019 | 1002 | | Ex. 1002 - U.S. Patent 8,603,044, Pen-Type Injector (issued Dec. 10, 2013) Download |
May 2, 2019 | 1006 | | Ex. 1006 - File History for U.S. Patent 8,679,069 Download |
May 2, 2019 | 1033 | | Ex. 1033 - A.G. Erdman & G.N. Sandor, "Mechanical Advantage", section 3.7 in 1 Mechanism Design: Analysis and Synthesis (1984) Download |
May 2, 2019 | 1005 | | Ex. 1005 - U.S. Patent 9,604,008, Drive Mechanisms Suitable for Use in Drug Delivery Devices (issued Mar. 28, 2017) Download |
May 2, 2019 | 1012 | | Ex. 1012 - Cirriculum Vitae of Charles E. Clemens Download |
May 2, 2019 | 1004 | | Ex. 1004 - U.S. Patent 9,526,844, Pen-Type Injector (issued Dec. 27, 2016) Download |
May 2, 2019 | 1018 | | Ex. 1018 - File History for U.S. Patent 6,582,404 Download |
May 2, 2019 | 1 | | Petitioner's Power of Attorney Download |
May 2, 2019 | 1025 | | Ex. 1025 - Application as filed: U.S. Patent App. 14/946,203 -R.F. Veasey Download |
May 2, 2019 | 1008 | | Ex. 1008 - File History for U.S. Patent 8,992,486 Download |
May 2, 2019 | 1009 | | Ex. 1009 - File History for U.S. Patent 9,526,844 Download |