Date Field | Doc. No. | Party | Description |
---|
Aug 6, 2020 | 81 | petitioner | Petitioner's Notice of Cross-Appeal Download |
Aug 6, 2020 | 82 | petitioner | Petitioner Pfizer Inc.'s Notice of Cross-Appeal Download |
Jul 23, 2020 | 80 | patent_own | Download |
May 29, 2020 | 79 | | Termination Decision Document Download |
Apr 8, 2020 | 78 | | Download |
Apr 7, 2020 | 77 | | Petitioners' Mandatory Change-of-Information Notices Download |
Apr 1, 2020 | 76 | | ORDER
Granting Patent Owner's Motion for Withdrawal of Counsel Download |
Mar 25, 2020 | 75 | | Download |
Mar 13, 2020 | 1118 | | Sanofi-Aventis U.S. LLC v. Mylan GmbH, Case 2:17-cv-09105 (SRC), slip op. (D.N.J. entered Mar. 9, 2020) (collateral opinion on infringement and validity) Download |
Mar 13, 2020 | 74 | | Petitioners' Updated Exhibit List Download |
Feb 25, 2020 | 73 | | Hearing Transcript Download |
Feb 24, 2020 | 70 | | Hearing Transcript Download |
Feb 24, 2020 | 71 | | Hearing Transcript Download |
Feb 24, 2020 | 72 | | Download |
Jan 13, 2020 | 69 | | Patent Owner's Objections to Petitioners' Demonstratives Download |
Jan 8, 2020 | 67 | | Petitioners' Demonstratives Download |
Jan 8, 2020 | 68 | | Patent Owner's Demonstratives Download |
Dec 27, 2019 | 65 | | Patent Owner's Responses to Petitioners' Observations Download |
Dec 27, 2019 | 66 | | Download |
Dec 23, 2019 | 64 | | Petitioner's reply in Support of Petitioner's Motion to Exclude Download |
Dec 20, 2019 | 2227 | | Transcript of the Cross-Examination of Karl Leinsing Download |
Dec 20, 2019 | 62 | | Patent Owner's Observations on the Cross-Examination of Mr. Karl Leinsing Download |
Dec 20, 2019 | 63 | | Petitioner's Observations Regarding the Testimony of Alexander Slocum, Ph.D. Download |
Dec 18, 2019 | 1110 | | Transcript of Telephone Conference on Dec. 11, 2019 Download |
Dec 18, 2019 | 1114 | | Transcript, Slocum direct testimony in Sanofi-Aventis U.S. LLC v. Mylan GmbH, Case 2:17-cv-09105-SRC-CLW (D.N.J., Dec. 4, 2019) Download |
Dec 18, 2019 | 1115 | | Transcript, Slocum direct testimony in Sanofi-Aventis U.S. LLC v. Mylan GmbH, Case 2:17-cv-09105-SRC-CLW (D.N.J., Dec. 5, 2019) Download |
Dec 18, 2019 | 61 | | Petitioner's Updated Exhibit List Download |
Dec 17, 2019 | 60 | | Order Conduct of the Proceeding Download |
Dec 16, 2019 | 2226 | | Email of Patent Owner's Supplemental Evidence Download |
Dec 16, 2019 | 59 | | Patent Owner's Opposition to Petitioners' Motion to Exclude Download |
Dec 9, 2019 | 58 | | Petitioner Motion to Exclude Download |
Dec 5, 2019 | 57 | | ORDER Oral Hearing Download |
Nov 19, 2019 | 55 | | Petitioner's Request for Oral Argument Download |
Nov 19, 2019 | 56 | | Patent Owner's Request for Oral Argument Download |
Nov 18, 2019 | 54 | | Petitioner's Mandatory Change-of-Information Notices Download |
Nov 6, 2019 | 53 | | IPR2018-1684 Objections - 2019-11-06 Download |
Oct 30, 2019 | 2224 | | Expert Opinion on Drug Delivery Download |
Oct 30, 2019 | 2318 | | 2019-10-9 McDuff Transcript Download |
Oct 30, 2019 | 2225 | | Excerpt from Merck Trial Transcript Download |
Oct 30, 2019 | 2317 | | 2019-10-15 Biggs Transcript Download |
Oct 30, 2019 | 2316 | | 2019-10-10 Leinsing Transcript Download |
Oct 30, 2019 | 2223 | | SoloStar Wins Good Design Award Download |
Oct 30, 2019 | 2319 | | 07.15.2019 - R. Veasey Declaration Download |
Oct 30, 2019 | 52 | | Patent Owner's Sur-Reply Download |
Oct 9, 2019 | 51 | | Petitioner's Updated Exhibit List Download |
Oct 7, 2019 | 48 | | Patent Owner's Notice of Deposition of Karl R. Leinsing Download |
Oct 7, 2019 | 49 | | Patent Owner's Notice of Deposition of William Curtis Biggs Download |
Oct 7, 2019 | 50 | | Patent Owner's Notice of Deposition of DeForest McDuff Download |
Oct 2, 2019 | 47 | | Patent Owner's Updated Mandatory Notices Download |
Oct 2, 2019 | 46 | | Power of Attorney for Patent Owner Sanofi-Aventis Deutschland GmbH Download |
Sep 27, 2019 | 45 | | Petitioner's Mandatory Change-of-Information Notices Download |
Sep 25, 2019 | 44 | | Patent Owner's Objections to Documents Served By Petitioner Download |
Sep 18, 2019 | 42 | | Petitioner's Reply to Patent Owner Response Download |
Sep 18, 2019 | 43 | | Petitioner's Updated Exhibit List Download |
Sep 18, 2019 | 1083 | | Lantus SoloStar Brochure: ¿¿¿Your Guide to the Lantus SoloStar Insulin Pen¿¿¿ (2010) Download |
Sep 18, 2019 | 1053 | | Deposition of Alexander H. Slocum, Ph.D., August 27, 2019 Download |
Sep 18, 2019 | 1073 | | ¿¿¿About Diabetes¿¿¿, CDC Basics, p.1-2, https://www.cdc.gov/diabetes/bascis/diabetes Download |
Sep 18, 2019 | 1081 | | Lantus, ¿¿¿Get to Know the Lantus¿¿ SoloStar¿¿ Insulin Pen, p. 1-7, https://www.lantus.com/get-to-know-the-lantus-solostar-pen Download |
Sep 18, 2019 | 1070 | | Sanofi-Aventis 2006 20 F Form Download |
Sep 18, 2019 | 1060 | | Declaration and c.v. of DeForrest McDuff, Ph.D. Download |
Sep 18, 2019 | 1074 | | David, J. et al. ¿¿¿Commercial Success: Economic Principles Applied to Patent Litigation¿¿¿, NERA Economic Consulting (copyrighted material), p. 159-160 Download |
Sep 18, 2019 | 1069 | | Aventis 2003 20-F Form Download |
Sep 18, 2019 | 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 |
Sep 18, 2019 | 1067 | | Asamoah et al., ¿¿¿Insulin Pen ¿¿¿ The ¿¿¿iPod¿¿¿ for Insulin Delivery (Why Pen Wins Over Syringe)¿¿¿, J. of Diabetes Sci. and Technology, Vol. 2, Issue 2, March 2008, p.292-296 Download |
Sep 18, 2019 | 1048 | | CORRECTED - Expert Declaration of William Curtis Biggs, M.D., FACE, ECNU in Support of Mylan-Pfizer Reply Download |
Sep 18, 2019 | 1085 | | Nonaka, H., ¿¿¿FTO (Freedom to Operate) in the Pharmaceutical Industry¿¿¿, JSTOR, Pub. by Nomos Verlagsgesellschaft mbH (2018), p. 9-59 Download |
Sep 18, 2019 | 1057 | | Benita Lee, MPH, ¿¿¿How Much Does Insulin Cost? Here¿¿¿s How 23 Brands Compare¿¿¿, Good RX, Aug. 23, 2019, pp. 1-11, https:www.goodrx.com/glo/how-much-does-insuling-cost,compare-brands/ Download |
Sep 18, 2019 | 1056 | | Deposition of Robin Goland, Sep. 10, 2019 Download |
Sep 18, 2019 | 1079 | | U.S. Patent 6,100,376, ¿¿¿A21, B30, Modified Insulin Derivatives having An Altered Action Profile¿¿¿, M. D¿¿rschug (issued Aug. 8, 2000) Download |
Sep 18, 2019 | 1050 | | Slocum Deposition Exhibit 1050: Annotations of EX2107 (Declaration of Alexander Slocum Ph.D.) Download |
Sep 18, 2019 | 1049 | | Curriculum Vitae of William Curtis Biggs, M.D., FACE, ECNU Download |
Sep 18, 2019 | 1090 | | Campbell, K., ¿¿¿Insulin Costs Are Skyrocketing. This is Why¿¿¿, U.S. New and World Report, Jun. 29, 2018, p.1-7 Download |
Sep 18, 2019 | 1051 | | Slocum Deposition Exhibit 1051: Hand drawing of modified drive mechanism Download |
Sep 18, 2019 | 1063 | | 2011-02-09 - Sanofi SA Earnings Conference Call Download |
Sep 18, 2019 | 1082 | | Lantus SoloStar Brochure: ¿¿¿High Blood Sugar, You¿¿¿re Going Down¿¿¿ (2012) Download |
Sep 18, 2019 | 1065 | | 2013-02-26 ¿¿¿ Sanofi SA at Citi Global HealthCare Conference Download |
Sep 18, 2019 | 1092 | | U.S. Patent 7,476,652, ¿¿¿Acidic Insulin Preparations Having Improved Stability¿¿¿, Brunner-Schwarz (issued Jan. 13, 2009) Download |
Sep 18, 2019 | 1054 | | Deposition of Alexander H. Slocum, Ph.D., Vol II, August 28, 2019 Download |
Sep 18, 2019 | 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 |
Sep 18, 2019 | 1075 | | ¿¿¿Top Ten Tips on Writing Effectiveness Case Studies¿¿¿, By Design Business Association, May 23, 2016, p.1-5, https://www.dba.org.uk/review-top-ten-tips-on-writing-effectiveness-case-studies/ Download |
Sep 18, 2019 | 1076 | | DiMasi, J., et al. ¿¿¿Innovation in the Pharmaceutical Industry: New Estimates of R&D Costs¿¿¿, J. of Health Economics47 (2016), p. 20-33 Download |
Sep 18, 2019 | 1089 | | UBS Large Cap Pharmaceuticals Handbook, ¿¿¿U.S. Pharmaceuticals¿¿¿, Apr. 6, 2018, p.45-53 Download |
Sep 18, 2019 | 1095 | | Declaration of Karl Leinsing in Support of Support of Mylan-Pfizer Reply Download |
Sep 18, 2019 | 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 ¿¿¿ (Online) Journal homepage: https://www.tandfonline.com/loi/ipgm20 Download |
Sep 18, 2019 | 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 |
Sep 18, 2019 | 1062 | | 2019 Orange Book (Excerpt ¿¿¿ ADA 132 of 263) Download |
Sep 18, 2019 | 1061 | | 2011 Orange Book (Excerpts) Download |
Sep 18, 2019 | 1091 | | U.S. Patent 5,656,722, ¿¿¿A21, B30, Modified Insulin Derivatives having An Altered Action Profile¿¿¿, M. D¿¿rschug (issued Aug. 12, 1997) Download |
Sep 18, 2019 | 1093 | | U.S. Patent 7,713,930, ¿¿¿Acidic Insulin Preparations Having Improved Stability¿¿¿, Brunner-Schwarz (issued May 11, 2010) Download |
Sep 18, 2019 | 1044 | | Nat¿¿¿l. Diabetes Statistic Report 2017, ¿¿¿Estimates of Diabetes and Its
Burden in the United States, CDC, p.1-20 Download |
Sep 18, 2019 | 1084 | | McDuff, et al., ¿¿¿Thinking Economically About Commercial Success¿¿¿, Landslide, March/April 2017, p. 37-40 Download |
Sep 18, 2019 | 1058 | | Certified English Translation of DE Patent 102 37 258A1, Dr. Roney Graf (Issued Mar. 182004) Download |
Sep 18, 2019 | 1094 | | WebMD, ¿¿¿Types of Insulin for Diabetes Treatment¿¿¿, p.1-7 https://www.webmd.com/diabetes/diabetes-types-insulin#1 Download |
Sep 18, 2019 | 1066 | | 2014-02-06 ¿¿¿ Sanofi SA Earnings Conference Call Download |
Sep 18, 2019 | 1071 | | Correa, Carlos, ¿¿¿Ownership of Knowledge ¿¿¿ the Role of Patents in Pharmaceutical R&D¿¿¿, Round Table, Bulletin of World Health Org., 2004; 82; p.1-7 Download |
Sep 18, 2019 | 1048 | | CORRECTED - Expert Declaration of William Curtis Biggs, M.D., FACE, ECNU in Support of Mylan-Pfizer Reply Download |
Sep 18, 2019 | 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 |
Sep 18, 2019 | 1078 | | Pietrangelo, Ann ¿¿¿Levemir vs. Lantus: Similarities and Differences¿¿¿, Healthline, Oct. 19, 2016, p.1-14, https://www.healthline.com/health/deiabetes/levemir-lantus Download |
Sep 18, 2019 | 1052 | | Slocum Deposition Exhibit 1052: Annotations of excerpted figures from EX2157 Download |
Sep 18, 2019 | 1087 | | S.G. Cowen, ¿¿¿Perspectives¿¿¿, Pharmaceutical Therapeutic Categories Outlook, Oct. 2001, p.134-148 Download |
Sep 18, 2019 | 1068 | | Aventis 2002 20-F Form Download |
Sep 18, 2019 | 1080 | | Lewcock, Anna, ¿¿¿Sanofi¿¿¿s SoloStar Hits US Market Despite Patent Suit¿¿¿, in-Pharma Technologist.com, Jul. 20, 2007, https://www.in-pharmatechnologist.com/Article/2007/07/31/Sanofi-s-SoloStar-hits-US-market-despite-patent-suit Download |
Sep 18, 2019 | 1088 | | Cowen and Co., ¿¿¿Diabetes: Many New Drugs, But Insulin Still Dominant¿¿¿, Therapeutic Categories Outlook, Feb. 2015, p.477-491 Download |
Sep 18, 2019 | 1055 | | Deposition of Henry Grabowski, Ph.D., Sep. 5, 2019 Download |
Sep 18, 2019 | 1077 | | Grabowski, H., et al. ¿¿¿Returns on Research and Development for 1990s New Drug Introductions¿¿¿, Pharmacoeconomics 2002; 20 Suppl. 3: p. 11-29 Download |
Sep 18, 2019 | 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 |
Sep 18, 2019 | 1064 | | 2012-02-08 ¿¿¿ Sanofi SA Earnings Conference Call Download |
Sep 18, 2019 | 1048 | | Expert Declaration of William Curtis Biggs, M.D., FACE, ECNU in Support of Mylan-Pfizer Reply Download |
Sep 3, 2019 | 41 | | Order - Granting Patent Owner's Motions for Pro Hac Vice Admission of Anna E. Dwyer - 37 CFR 42.10 Download |
Aug 27, 2019 | 40 | | Notice of Deposition for Robin S. Goland, M.D. Download |
Aug 22, 2019 | 39 | | Notice of Deposition for Henry Grabowski Download |
Aug 16, 2019 | 38 | | Motion for Pro Hac Vice Admission Under 37 C.F.R. 42.10 Download |
Aug 16, 2019 | 2221 | | Declaration of Anna E. Dwyer in Support of Motion for Pro Hac Vice Admission Under 37 C.F.R. 42.10 Download |
Aug 16, 2019 | 2222 | | Biography of Anna E. Dwyer Download |
Aug 15, 2019 | 37 | | DECISION Instituting Inter Partes Review and Granting Motion for Joinder Download |
Aug 14, 2019 | 36 | | Notice of Joint Stipulation To Modify Due Dates 2, 3, 5, and 6 Download |
Aug 13, 2019 | 35 | | Notice of Deposition of Alexander Slocum, Ph.D. Download |
Aug 8, 2019 | 34 | | Order - 37 C.F.R. 42.5 Download |
Aug 5, 2019 | 33 | | Download |
Jul 29, 2019 | 1043 | | Transcript of Telephone Conference on July 25, 2019 Download |
Jul 29, 2019 | 32 | | Petitioner's Updated Exhibit List Download |
Jul 19, 2019 | 2219 | | Declaration of Robert T. Vlasis Download |
Jul 19, 2019 | 30 | | PANEL CHANGE ORDER
Conduct of the Proceedings
37 C.F.R. ¿¿ 42.5 Download |
Jul 19, 2019 | 31 | | Motion for Pro Hac Vice Admission Under 37 C.F.R. 42.10 Download |
Jul 19, 2019 | 2220 | | Biography of Robert T. Vlasis Download |
Jul 17, 2019 | 29 | | Petitioner's Mandatory Change-of-Information Notices Download |
Jul 9, 2019 | 2109 | | Declaration of Henry R. Grabowski, Ph.D. (CORRECTED) Download |
Jul 1, 2019 | 28 | | Mylan Pharmaceuticals Inc. Objections to Evidence Submitted with Patent Owner Response Download |
Jun 25, 2019 | 2212 | | Excerpts from Ernest Rabinowicz, Friction And Wear of Materials, 2nd Edition Download |
Jun 25, 2019 | 2217 | | Collar Friction Model Demonstration 3 Download |
Jun 25, 2019 | 2205 | | U.S. Marketing-to-Sales Ratios of Select Injectable Insulin Drugs Download |
Jun 25, 2019 | 2218 | | SoloSTAR Dial Inject Video Download |
Jun 25, 2019 | 2211 | | Collar Friction Model Demonstrator Animation Download |
Jun 25, 2019 | 2195 | | U.S. Share of Long-Acting Pens Among All Pens Download |
Jun 25, 2019 | 2199 | | U.S. Share of Long-Acting Pen Products Download |
Jun 25, 2019 | 2194 | | Formulary Placement of Long-Acting Insulin Pen Products in Healthcare Exchanges Download |
Jun 25, 2019 | 2198 | | U.S. Total Prescriptions of Long-Acting Pens Download |
Jun 25, 2019 | 2203 | | U.S. Total Marketing Expenditure of Long Acting Insulin Franchises Download |
Jun 25, 2019 | 2216 | | Collar Friction Model Demonstration 2 Download |
Jun 25, 2019 | 2201 | | 2007 Good Design Award from The Chicago Athenaeum: Museum of Architecture and Design Download |
Jun 25, 2019 | 2204 | | U.S. Total Marketing Expenditures of Long-Acting Insulin Pens Download |
Jun 25, 2019 | 2192 | | Formulary Placement of Long-Acting Insulin Pen Products: Medicare Plans Download |
Jun 25, 2019 | 2200 | | Yuzu Sato et al., Clinical Aspects of physical exercise for diabetes/metabolic syndrome Download |
Jun 25, 2019 | 27 | | Patent Owner's Response Download |
Jun 25, 2019 | 2207 | | M¿¿ller Second Embodiment Animation Download |
Jun 25, 2019 | 2197 | | U.S. New Prescriptions of Long-Acting Pens Download |
Jun 25, 2019 | 2206 | | M¿¿ller First Embodiment Animation Download |
Jun 25, 2019 | 2214 | | Excerpts from Alexander H. Slocum, Precision Machine Design Download |
Jun 25, 2019 | 2196 | | U.S. Dollar Sales of Long-Acting Pens Download |
Jun 25, 2019 | 2215 | | Collar Friction Model Demonstration 1 Download |
Jun 25, 2019 | 2209 | | Henry Grabowski, John Vernon & Joseph A. DiMasi, Returns on Research and Development for 1990s New Drug Introductions Download |
Jun 25, 2019 | 2210 | | Julie M. Donohue, Marisa Cevasco & Meredith B. Rosenthal, A Decade of Direct-to-Consumer Advertising of Prescription Drugs Download |
Jun 25, 2019 | 2208 | | Press Release, Lantus / Apdira SoloSTAR help to improve patient satisfaction (June 27, 2011) Download |
Jun 25, 2019 | 2193 | | Formulary Placement of Long-Acting Insulin Pen Products: Medicaid Plans Download |
Jun 25, 2019 | 2174 | | Jefferson Becker et al., An evaluation of gender, obesity, age and diabetes mellitus as risk factors for carpal tunnel syndrome Download |
Jun 25, 2019 | 2122 | | SoloSTAR Disposable Pen Injector (The Grand Prix Oct. 22, 2009) Download |
Jun 25, 2019 | 2153 | | International Patent Application WO999038554A1 Download |
Jun 25, 2019 | 2121 | | DBA Design Effectiveness Awards 2009 Download |
Jun 25, 2019 | 2179 | | Joule J. Li et al., Muscle grip strength predicts incident type 2 diabetes: Population-based cohort study Download |
Jun 25, 2019 | 2161 | | SoloSTAR Principles of Operation Download |
Jun 25, 2019 | 2127 | | U.S. Provisional Patent Application 60/073820 Download |
Jun 25, 2019 | 2103 | | Leinsing Deposition Exhibit 2103: Annotations of Figures 6-15 of
Burroughs Download |
Jun 25, 2019 | 2125 | | Julia Pfutzner et al., Evaluation of Dexterity in Insulin-Treated Patients with Type 1 and Type 2 Diabetes Mellitus Download |
Jun 25, 2019 | 2133 | | Lantus SoloSTAR Pen Guide Download |
Jun 25, 2019 | 2189 | | U.S. Total Prescriptions of Lantus SoloSTAR Download |
Jun 25, 2019 | 2160 | | Jean-Louis Selam, Evolution of Diabetes Insulin Delivery Devices Download |
Jun 25, 2019 | 2188 | | U.S. New Prescriptions of Lantus SoloSTAR Download |
Jun 25, 2019 | 2142 | | Prix Galien USA Announces 2009 Final Candidates Download |
Jun 25, 2019 | 2111 | | Declaration of Dr. Robin S. Goland Download |
Jun 25, 2019 | 2168 | | Giambattista Animation (2) Download |
Jun 25, 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 Download |
Jun 25, 2019 | 2165 | | 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 Download |
Jun 25, 2019 | 2138 | | W. Schady et al, Observations on Severe Ulnar Neuropathy in Diabetes Download |
Jun 25, 2019 | 2112 | | Curriculum Vitae of Dr. Robin S. Goland Download |
Jun 25, 2019 | 2105 | | Leinsing Deposition Exhibit 2105: Hand drawings Download |
Jun 25, 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 Download |
Jun 25, 2019 | 2187 | | U.S. Dollar Sales of Lantus SoloSTAR Download |
Jun 25, 2019 | 2182 | | Bone and joint problems associated with diabetes (Mayo Clinic) Download |
Jun 25, 2019 | 2104 | | Leinsing Deposition Exhibit 2104: Annotations of Figures 5-8 of
the 486 Patent Download |
Jun 25, 2019 | 2113 | | Bradley M. Wright et al., A Review Of Insulin Pen Devices And
Use In The Elderly Diabetic Population Download |
Jun 25, 2019 | 2123 | | Arnd Friedrichs et al., Dose Accuracy and Injection Force of Different Insulin Glargine Pens Download |
Jun 25, 2019 | 2183 | | Peripheral Neuropathy (Mayo Clinic) Download |
Jun 25, 2019 | 2180 | | Considering Insulin Pens for Routine Hospital Use (ISMP article) Download |
Jun 25, 2019 | 2176 | | Ercan Cetinus et al., Hand grip strength in patients with type 2 diabetes mellitus Download |
Jun 25, 2019 | 2146 | | Lantus COMPASS Study Report (Nov. 29, 2007), Part Two Download |
Jun 25, 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 Download |
Jun 25, 2019 | 2144 | | Alastair Clarke & Geralyn Spollett, Dose accuracy and injection force dynamics of a novel disposable insulin pen Download |
Jun 25, 2019 | 2172 | | Karl R. Leinsing Declaration in Hologic, Inc. v. Minerva Surgical, Inc., No. 15-1031 (D. Del. Jan. 26, 2018), Dkt. No. 309 Download |
Jun 25, 2019 | 2190 | | U.S. Share of Sales by Drugs in the Lantus Franchise Download |
Jun 25, 2019 | 2120 | | Estelle Davis, et. al., An evaluation of prefilled insulin pens: a focus on the Next Generation FlexPen¿¿ Download |
Jun 25, 2019 | 2163 | | Deposition of Karl R. Leinsing, dated June 3, 2019 for IPR2018-
01675, -01676, -01678, -01680 Download |
Jun 25, 2019 | 2175 | | A. Pfutzner et al., Prefilled insulin device with reduced injection force: patient perception and accuracy Download |
Jun 25, 2019 | 2170 | | U.S. Patent No. 4,747,824 Download |
Jun 25, 2019 | 2115 | | Arthritis & Diabetes, What do diabetes and arthritis have in
common? Plenty Download |
Jun 25, 2019 | 2148 | | Steenfeldt-Jensen 1st Embodiment Animation Download |
Jun 25, 2019 | 2136 | | Novo Nordisk Form 6-K (Feb. 9, 2009), Part One Download |
Jun 25, 2019 | 2135 | | Douglas Merritt et al., Dose Accuracy and Injection Force of Disposable Pens Delivering Pramlintide for the Treatment of Diabetes Download |
Jun 25, 2019 | 2145 | | US Lantus SoloSTAR Launch Book, 2007 Download |
Jun 25, 2019 | 2146 | | Lantus COMPASS Study Report (Nov. 29, 2007), Part Two Download |
Jun 25, 2019 | 2141 | | John Shelmet et al., Preference and resource utilization in elderly patients: InnoLet versus vial/syringe Download |
Jun 25, 2019 | 2126 | | Jerome S. Fischer et al., United States Patient Preference and Usability for the New Disposable Insulin Device Solostar¿¿ versus Other Disposable Pens Download |
Jun 25, 2019 | 2147 | | Steenfeldt-Jensen 5th Embodiment Animation Download |
Jun 25, 2019 | 2132 | | Meike Krzywon et al., Study on the Dosing Accuracy of Commonly Used Disposable Insulin Pens Download |
Jun 25, 2019 | 2173 | | Bruce A. Perkins, David Olaleye & Vera Bril, Carpal Tunnel Syndrome in Patients With Diabetic Polyneuropathy Download |
Jun 25, 2019 | 2128 | | Samita Garg et al., Insulin glargine and glulisine SoloSTAR pens for the treatment of diabetes Download |
Jun 25, 2019 | 2151 | | Steenfeldt-Jensen 5th Embodiment vs. Proposed Modification
Animation Download |
Jun 25, 2019 | 2178 | | Shubha Gundmi et al., Hand dysfunction in type 2 diabetes mellitus: Systematic review with meta-analysis Download |
Jun 25, 2019 | 2152 | | Steenfeldt-Jensen 5th Embodiment vs. Proposed Modification Collar Friction Animation Download |
Jun 25, 2019 | 2108 | | Curriculum Vitae of Alexander Slocum, Ph.D. Download |
Jun 25, 2019 | 2139 | | Alfred Penfornis & Kristian Horvat, Dose Accuracy Compariosn Between SoloSTAR and FlexPen at Three Different Dose Levels Download |
Jun 25, 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 Download |
Jun 25, 2019 | 2167 | | Giambattista Animation (1) Download |
Jun 25, 2019 | 2107 | | Declaration of Alexander Slocum, Ph.D., Part One Download |
Jun 25, 2019 | 2102 | | Leinsing Deposition Exhibit 2102: Hand drawings Download |
Jun 25, 2019 | 2106 | | Leinsing Deposition exhibit 2106: Annotations of Figures 11 and
12 of Giambattista Download |
Jun 25, 2019 | 2137 | | Novo Nordisk History Download |
Jun 25, 2019 | 2158 | | Geralyn Spollett, Insulin Devices, Addressing Barriers to Insulin
Therapy With the Ideal Pen Download |
Jun 25, 2019 | 2171 | | U.S. Patent No. 6,248,093 Download |
Jun 25, 2019 | 2169 | | U.S. Patent No. 4,648,872 Download |
Jun 25, 2019 | 2186 | | Select Injectable Insulin Drugs Approved by the FDA in the U.S. Download |
Jun 25, 2019 | 2150 | | Steenfeldt-Jensen 5th Embodiment Thread and Slot Animation Download |
Jun 25, 2019 | 2136 | | Novo Nordisk Form 6-K (Feb. 9, 2009), Part One Download |
Jun 25, 2019 | 2177 | | Ragnhild I. Cederlund et al., Hand disorders, hand function, and activities of daily living in elderly men with type 2 diabetes Download |
Jun 25, 2019 | 2107 | | Declaration of Alexander Slocum, Ph.D., Part One Download |
Jun 25, 2019 | 2116 | | Andreas Bode, Development of the SoloSTAR insulin pen device
design verification and validation Download |
Jun 25, 2019 | 2184 | | Charles E. Buban, A pen that seeks to improve diabetes care Download |
Jun 25, 2019 | 2119 | | Sherwyn Schwartz, Correct Use of a New Reusable Insulin Injection Pen by Patients with Diabetes: A Design Validation Study Download |
Jun 25, 2019 | 2114 | | Teresa L. Pearson, A-Practical-Review-of-Insulin-Pen-Devices Download |
Jun 25, 2019 | 2101 | | Leinsing Deposition Exhibit 2101: Estelle Davis, et. al., An
evaluation of prefilled insulin pens: a focuse on the Next
Generation FlexPen¿¿ Download |
Jun 25, 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 |
Jun 25, 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 Download |
Jun 25, 2019 | 2164 | | Deposition of Karl R. Leinsing, dated June 4, 2019 for IPR2018-01675, -01676, -01678, -01680 Download |
Jun 25, 2019 | 2117 | | Sanofi¿¿¿s Patented Pen animation Download |
Jun 25, 2019 | 2166 | | 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 Download |
Jun 25, 2019 | 2131 | | ISO 11608-1, Pen-injectors for medical use Download |
Jun 25, 2019 | 2162 | | Sanofi Patent Drive Sleeve and Piston Rod Animation Download |
Jun 25, 2019 | 2134 | | Arlan L. Rosenbloom, Limitation of Finger Joint Mobility in Diabetes Mellitus Download |
Jun 25, 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 Download |
Jun 25, 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 Download |
Jun 25, 2019 | 2185 | | Press Release: Sanofi-aventis¿¿¿ SoloSTAR Insulin Pen for Lantus and Apidra Receives the Prestigious GOOD DESIGN Award Download |
Jun 25, 2019 | 2110 | | Curriculum Vitae of Henry R. Grabowski, Ph.D. Download |
Jun 25, 2019 | 2149 | | Steenfeldt-Jensen 2nd Embodiment Animation Download |
Jun 25, 2019 | 2181 | | Trigger Finger Overview (Mayo Clinic) Download |
Jun 25, 2019 | 2191 | | Formulary Placement of Long-Acting Insulin Pen Products:Commercial Plans Download |
Jun 25, 2019 | 2109 | | Declaration of Henry R. Grabowski, Ph.D. Download |
Jun 25, 2019 | 2109 | | Declaration of Henry R. Grabowski, Ph.D. Download |
Jun 25, 2019 | 2107 | | Declaration of Alexander Slocum, Ph.D., Part Two Download |
Jun 25, 2019 | 2136 | | Novo Nordisk Form 6-K (Feb. 9, 2009), Part Two Download |
Jun 25, 2019 | 2146 | | Lantus COMPASS Study Report (Nov. 29, 2007), Part One Download |
Jun 11, 2019 | 26 | | PATENT OWNER'S UPDATED MANDATORY NOTICES PURSUANT TO 37 C.F.R. 42.8 Download |
Jun 3, 2019 | 25 | | Patent Owner's Power of Attorney Download |
May 31, 2019 | 24 | | Patent Owner's Updated Notice of Deposition of Karl R. Leinsing Download |
May 23, 2019 | 23 | | PATENT OWNER¿¿¿S NOTICE OF DEPOSITION OF KARL R. LEINSING Download |
May 23, 2019 | 22 | | PATENT OWNER¿¿¿S UPDATED MANDATORY NOTICES PURSUANT TO 37 C.F.R. 42.8 Download |
May 9, 2019 | 21 | | PANEL CHANGE ORDER
Conduct of the Proceedings
37 C.F.R. ¿¿ 42.5 Download |
Apr 16, 2019 | 20 | | Patent Owner's Objections to Documents Served with the Petition Download |
Apr 16, 2019 | 19 | | Mylan Pharmacetucials Inc. Objections to Evidence Download |
Apr 3, 2019 | 18 | | Scheduling Order Download |
Apr 3, 2019 | 17 | | Trial Instituted Document Download |
Mar 25, 2019 | 15 | | Petitioner's Mandatory Change-Of-Information Notices Download |
Mar 25, 2019 | 16 | | Petitioner's Power of Attorney Download |
Mar 15, 2019 | 14 | | Order - 37 C.F.R. 42.10 Download |
Mar 4, 2019 | 13 | | Patent Owner's Preliminary Response Download |
Mar 4, 2019 | 2004 | | Animation depicting M¿¿ller¿¿¿s first embodiment Download |
Mar 4, 2019 | 2003 | | International Patent WO 99/38554 Download |
Mar 4, 2019 | 12 | | Patent Owner's Updated Mandatory Notices Download |
Mar 4, 2019 | 2005 | | Animation depicting M¿¿ller¿¿¿s second embodiment Download |
Mar 4, 2019 | 2002 | | U.S. Patent No. 6,004,297 Download |
Mar 4, 2019 | 2001 | | MP4 file of Sanofi¿¿¿s Patented Pen animation Download |
Feb 28, 2019 | 1040 | | Declaration of Elham F. Steiner ISO Unopposed Motion for Pro Hac Vice Recognition Download |
Feb 28, 2019 | 1041 | | Elham F. Steiner, Attorney Biography Download |
Feb 28, 2019 | 11 | | Mylan Pharmaceuticals Inc. Unopposed Motion for Pro Hac Vice Recognition Download |
Feb 20, 2019 | 10 | | Authorizing Reply and Sur-Reply
37 C.F.R. § 42.108(c); 37 C.F.R. § 42.5 Download |
Feb 15, 2019 | 9 | | Petitioners Updated Exhibit List Download |
Feb 15, 2019 | 1039 | | Transcript of Call 02.13.2019 Download |
Dec 3, 2018 | 8 | | Notice of Accord Filing Date Download |
Oct 30, 2018 | 7 | | Updated Mandatory Notices Download |
Oct 12, 2018 | 6 | | Petitioner's Mandatory Change-of-Information Notices Download |
Sep 27, 2018 | 4 | | Power of Attorney for Patent Owner Sanofi-Aventis Deutschland GMBH Download |
Sep 27, 2018 | 5 | | Patent Owner's Mandatory Notices Pursuant to 37 C.F.R. 42.8 Download |
Sep 13, 2018 | 3 | | Petitioner¿¿¿s Mandatory Change-of-Information Notices Under 37 C.F.R. ¿¿42.8(A)(3) Download |
Sep 10, 2018 | 1029 | | Memorandum Opinion, Sanofi-Aventis U.S. LLC v. Merck Sharp & Dohme Corp., No. 16-cv-812 (filed Jan. 12, 2018) Download |
Sep 10, 2018 | 1013 | | U.S. Patent 6,221,046 - A. Burroughs et al., ¿¿¿Recyclable Medication Dispensing Device¿¿¿ (issued Apr. 24, 2001) Download |
Sep 10, 2018 | 1008 | | File History for U.S. Patent 8,992,486 Download |
Sep 10, 2018 | 1014 | | U.S. Patent 6,235,004 ¿¿¿ S. Steenfeldt-Jensen & S. Hansen, ¿¿¿Injection Syringe¿¿¿ (issued May 22, 2001) Download |
Sep 10, 2018 | 1007 | | File History for U.S. Patent 8,603,044 Download |
Sep 10, 2018 | 1016 | | U.S. Patent 6,932,794 B2 ¿¿¿ L. Giambattista & A. Bendek, ¿¿¿Medication Delivery Pen¿¿¿ (issued Aug. 23, 2005) Download |
Sep 10, 2018 | 1031 | | N. Sclater & N.P. Chironis, Mechanisms & Mechanical Devices Sourcebook 191-95, ¿¿¿Twenty Screw Devices¿¿¿ (3d ed., July 2, 2001) Download |
Sep 10, 2018 | 2 | | Petition for Inter Partes Review of USP 9,604,008 Download |
Sep 10, 2018 | 1005 | | USP 9,604,008 Download |
Sep 10, 2018 | 1032 | | EP 0 608 343 B1 ¿¿¿ L. Petersen & N.-A. Hansen, ¿¿¿Large Dose Pen¿¿¿ (pub¿¿¿d Oct. 18, 1991) Download |
Sep 10, 2018 | 1024 | | U.S. Patent 5,851,079 ¿¿¿ R.L. Horstman et al., ¿¿¿Simplified Unidirectional Twist-Up Dispensing Device With Incremental Dosing¿¿¿ (issued Dec. 22, 1998) Download |
Sep 10, 2018 | 1030 | | Memorandum Opinion, Sanofi -Aventis U.S. LLC v. Eli Lily and Co., No. 14-cv-113 (filed Jan. 20, 2015) Download |
Sep 10, 2018 | 1025 | | Application as filed: U.S. Patent App. 14/946,203 ¿¿¿ R.F. Veasey, ¿¿¿Relating to a Pen-Type Injector¿¿¿ (filed Nov. 19, 2015) Download |
Sep 10, 2018 | 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.) (filed Sep. 5 2018) Download |
Sep 10, 2018 | 1022 | | U.S. Patent 6,921,995 B1 ¿¿¿ A.A. Bendek et al., ¿¿¿Medication Delivery Pen Having An Improved Clutch Assembly¿¿¿ (issued July 13, 1999) Download |
Sep 10, 2018 | 1002 | | USP 8,603,044 Download |
Sep 10, 2018 | 1015 | | U.S. Patent Application US 2002/0053578 A1 ¿¿¿ C.S. M¿¿ller, ¿¿¿Injection Device¿¿¿ (pub¿¿¿d May 2, 2002) Download |
Sep 10, 2018 | 1020 | | U.S. Patent 4,865,591 ¿¿¿ B. Sams, ¿¿¿Measured Dose Dispensing Device¿¿¿ (issued Sep. 12, 1989) Download |
Sep 10, 2018 | 1017 | | U.S. Patent 6,582,404 B1 ¿¿¿ P.C. Klitgaard et al., ¿¿¿Dose Setting Limiter¿¿¿ (issued June 24, 2003) Download |
Sep 10, 2018 | 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 (filed Sep. 5, 2018) Download |
Sep 10, 2018 | 1 | | Petitioner Mylan Pharmaceuticals Inc. Power of Attorney Download |
Sep 10, 2018 | 1034 | | WO 01/83008 ¿¿¿ S. Hansen & T.D. Miller., ¿¿¿An Injection Device, A Preassembled Dose Setting And Injection Mechanism For An Injection Device, And A Method Of Assembling An Injection Device¿¿¿ (pub¿¿¿d Nov. 8, 2001) Download |
Sep 10, 2018 | 1018 | | File History for U.S. Patent 6,582,404 Download |
Sep 10, 2018 | 1027 | | WO 99/38554 ¿¿¿ S.Steenfeldt-Jensen & S.Hansen, ¿¿¿An Injection Syringe¿¿¿ (pub¿¿¿d Aug. 5, 1999) (Steenfeldt-Jensen PCT) Download |
Sep 10, 2018 | 1004 | | USP 9,526,844 Download |
Sep 10, 2018 | 1010 | | File History for U.S. Patent. 9,604,008 Download |
Sep 10, 2018 | 1012 | | Curriculum Vitae of Karl Leinsing MSME,PE Download |
Sep 10, 2018 | 1003 | | USP 8,992,486 Download |
Sep 10, 2018 | 1035 | | K.J. Lipska et al., Association of Initiation of Basal Insulin Analogs vs Neutral Protamine Hagedorn Insulin With Hypoglycemia-Related Emergency Department Visits ... 320 J. Am. Med. Ass¿¿¿n 53-62 (2018). Download |
Sep 10, 2018 | 1009 | | File History for U.S. Patent 9,526,844 Download |
Sep 10, 2018 | 1023 | | U.S. Patent 5,226,895 ¿¿¿ D.C. Harris, ¿¿¿Multiple Dose Injection Pen¿¿¿ (issued July 13, 1993) Download |
Sep 10, 2018 | 1001 | | USP 8,679,069 Download |
Sep 10, 2018 | 1033 | | A.G. Erdman &G.N. Sandor, ¿¿¿ Mechanical Advantage¿¿¿, ¿¿3.7 in 1 Mechanism Design: Analysis and Synthesis (1984) Download |
Sep 10, 2018 | 1006 | | File History for U.S. Patent 8,679,069 Download |
Sep 10, 2018 | 1011 | | Expert Declaration of Karl Leinsing MSME, PE in Support of Petition for Inter Partes Review of U.S. Patent Nos. 8,679,069; 8,603,044; 8,992,486; 9,526,844 and 9,604,008 Download |
Sep 10, 2018 | 1026 | | GB 0304822.0 ¿¿¿ ¿¿¿Improvements in and relating to a pen-type injector¿¿¿ (filed Mar. 3, 2003) (¿¿¿844 Priority Doc.) Download |
Sep 10, 2018 | 1021 | | U.S. Patent 6,248,095 B1 ¿¿¿ L. Giambattista et al., ¿¿¿Low-cost Medication Delivery Pen¿¿¿ (issued June 19, 2001) Download |