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Patent Owner

Sanofi-Aventis Deutshland GmbH

Petitioners

Mylan Pharmaceuticals Inc.Pfizer

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Mylan Pharmaceuticals Inc. v. Sanofi-Aventis Deutshland GmbH

IPR2018-01670 | Patent Trial and Appeal Board

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Filed Sept. 10, 2018

Terminated April 2, 2020

Judges Bart Gerstenblith, Hyun Jung, James Tartal, Lynne Browne, and James Mayberry

Case Type Inter Partes Review

Status Final Written Decision

Challenged Patent 12/944,544

Patent No. 8,679,069 assignments

Tech Center 3700

Art Unit 3763

Inventors Robert Frederick Veasey, Robert Perkins, David Aubrey Plumptre

Last Updated: 5 months ago

Filing Date	#	Filing and Exhibits
Entries matching. Show All.
8/10/2022	08-10-2022-Board	Board Trial Certificate Checklist 86: Trial Certificate Checklist
8/3/2022	08-03-2022-Board	Board Other: Fed Circuit mandate 84: Other: fed circuit mandate Board Other: other court decision 85: Other: other court decision
5/29/2020	05-29-2020-Patent_Owner	Event: Notice of Appeal Patent Owner Notice of Appeal 83: Patent Owner Sanofi-Aventis Deutschland GmbH's Notice of Appeal Under 37 C.F.R. 90.2(a)
4/8/2020	04-08-2020-Patent_Owner	Patent Owner Notice 82: Patent Owner¿¿¿s Updated Mandatory Notices Pursuant to 37 C.F.R. ¿¿ 42.8(b)(3)
4/2/2020	04-02-2020-Board	Board Final Decision 81: JUDGMENT Final Written Decision Determining Sole Challenged Claim Unpatentable Denying Petitioner’s Motion to E
4/1/2020	04-01-2020-Board	Board Order 80: ORDER Granting Patent Owner's Motion for Withdrawal of Counsel
3/13/2020	03-13-2020-Petitioner	Petitioner Exhibit List 79: Petitioners' Updated Exhibit List Petitioner Exhibit 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)
2/25/2020	02-25-2020-Board	Board Hearing Transcript 78: Hearing Transcript
2/24/2020	02-24-2020-Patent_Owner	Patent Owner Motion 77: Patent Owner's Motion for Withdrawal of Counsel
2/24/2020	02-24-2020-Board	Board Hearing Transcript 76: EXPUNGED
1/13/2020	01-13-2020-Patent_Owner	Patent Owner Objection 75: Patent Owner's Objections to Petitioner's Demonstratives
1/8/2020	01-08-2020-Patent_Owner	Patent Owner Other (Not for motions) 74: Patent Owner's Demonstratives
1/8/2020	01-08-2020-Petitioner	Petitioner Other (Not for motions) 73: Petitioners' Demonstratives
12/27/2019	12-27-2019-Petitioner	Petitioner Response 72: Petitioners¿¿¿ Response to Patent Owner¿¿¿s Observations on Testimony of Mr. Karl Leinsing
12/27/2019	12-27-2019-Patent_Owner	Patent Owner Response 71: Patent Owner's Responses to Petitioners' Observations
12/23/2019	12-23-2019-Petitioner	Petitioner Reply 70: Petitioner's reply in Support of Petitioner's Motion to Exclude
12/20/2019	12-20-2019-Patent_Owner	Patent Owner Other (Not for motions) 68: Patent Owner's Observations on the Cross-Examination of Mr. Karl Leinsing Patent Owner Exhibit 2227: Transcript of Cross-Examination of Karl Leinsing
12/20/2019	12-20-2019-Petitioner	Petitioner Other (Not for motions) 69: Petitioner's Observations Regarding the Testimony of Alexander Slocum, Ph.D.
12/18/2019	12-18-2019-Petitioner	Petitioner Exhibit List 67: Petitioner's Updated Exhibit List Petitioner Exhibit 1110: Transcript of Telephone Conference on Dec. 11, 2019 Petitioner Exhibit 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) Petitioner Exhibit 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)
12/17/2019	12-17-2019-Board	Board Order Conduct of Proceeding 66: Conduct of the Proceeding 37 C.F.R. sec 42.5
12/16/2019	12-16-2019-Patent_Owner	Patent Owner Opposition 65: Patent Owner's Opposition to Petitioner's Motion to Exclude Patent Owner Exhibit 2226: Email of Patent Owner's Supplemental Evidence
12/9/2019	12-09-2019-Petitioner	Petitioner Motion 64: Petitioner Motion to Exclude
12/5/2019	12-05-2019-Board	Board Order 63: Order - Oral Hearing - 37 CFR 42.70
11/22/2019	11-22-2019-Petitioner	Petitioner Exhibit List 62: Petitioner's Updated Exhibit List Petitioner Exhibit 1108: Transcript of Telephone Conference on November 18, 2019
11/21/2019	11-21-2019-Board	Board Order Conduct of Proceeding 61: ORDER Conduct of the Proceeding 37 C.F.R. ¿¿ 42.5 Board Exhibit 3001: Ex. 3001
11/19/2019	11-19-2019-Petitioner	Petitioner Oral Hearing Request 59: Petitioner's Request for Oral Argument
11/19/2019	11-19-2019-Patent_Owner	Patent Owner Oral Hearing Request 60: Patent Owner's Request for Oral Argument
11/18/2019	11-18-2019-Petitioner	Petitioner Notice 58: Petitioner's Mandatory Change-of-Information Notices
11/6/2019	11-06-2019-Petitioner	Petitioner Objection 57: IPR2018-1670 Objections - 2019-11-06
10/30/2019	10-30-2019-Patent_Owner	Patent Owner Reply 56: Patent Owner's Sur-Reply Patent Owner Exhibit 2223: SoloStar Wins Good Design Award Patent Owner Exhibit 2224: Expert Opinion on Drug Delivery Patent Owner Exhibit 2225: Excerpt from Merck Trial Transcript Patent Owner Exhibit 2316: 2019-10-10 Leinsing Transcript Patent Owner Exhibit 2317: 2019-10-15 Biggs Transcript Patent Owner Exhibit 2318: 2019-10-19 McDuff Transcript Patent Owner Exhibit 2319: EXPUNGED
10/22/2019	10-22-2019-Petitioner	Petitioner Response 55: Petitioner's Response to Patent Owner's List of Alleged Improper Reply Arguments
10/15/2019	10-15-2019-Patent_Owner	Patent Owner Objection 54: Patent Owner's List of Improper Reply Arguments
10/9/2019	10-09-2019-Petitioner	Petitioner Exhibit List 53: Petitioner's Updated Exhibit List
10/7/2019	10-07-2019-Patent_Owner	Patent Owner Notice of Deposition 50: Patent Owner's Notice of Deposition of Karl R. Leinsing Patent Owner Notice of Deposition 51: Patent Owner's Notice of Deposition of William Curtis Biggs Patent Owner Notice of Deposition 52: Patent Owner's Notice of Deposition of DeForest McDuff
10/2/2019	10-02-2019-Patent_Owner	Patent Owner Power of Attorney 48: Power of Attorney for Patent Owner Sanofi-Aventis Deutschland GmbH Patent Owner Notice 49: Patent Owner's Updated Mandatory Notices
9/25/2019	09-25-2019-Patent_Owner	Patent Owner Objection 47: Patent Owner's Objections to Documents Served By Petitioner
9/18/2019	09-18-2019-Petitioner	Petitioner Reply 45: Petitioner's Reply to Patent Owner Response Petitioner Exhibit List 46: Petitioner's Updated Exhibit List Petitioner Exhibit 1044: Nat¿¿¿l. Diabetes Statistic Report 2017, ¿¿¿Estimates of Diabetes and Its Burden in the United States, CDC, p.1-20 Petitioner Exhibit 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 Petitioner Exhibit 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 Petitioner Exhibit 1047: Marilyn R. Graff, RN, CDE et al., ¿¿¿Assessment by Patients with Diabetes Mellitus of Two Insulin Pen Delivery...¿¿¿, Clinical Therapeutics, Vol. 20, No. 3, 1998, p.486-196 Petitioner Exhibit 1048: Expert Declaration of William Curtis Biggs, M.D., FACE, ECNU in Support of Mylan-Pfizer Reply Petitioner Exhibit 1048: CORRECTED - Expert Declaration of William Curtis Biggs, M.D., FACE, ECNU in Support of Mylan-Pfizer Reply Petitioner Exhibit 1049: Curriculum Vitae of William Curtis Biggs, M.D., FACE, ECNU Petitioner Exhibit 1050: Slocum Deposition Exhibit 1050: Annotations of EX2107 (Declaration of Alexander Slocum Ph.D.) Petitioner Exhibit 1051: Slocum Deposition Exhibit 1051: Hand drawing of modified drive mechanism Petitioner Exhibit 1051: Corrected - Slocum Deposition Exhibit 1051: Hand drawing of modified drive mechanism Petitioner Exhibit 1052: Slocum Deposition Exhibit 1052: Annotations of excerpted figures from EX2157 Petitioner Exhibit 1053: Deposition of Alexander H. Slocum, Ph.D., August 27, 2019 Petitioner Exhibit 1054: Deposition of Alexander H. Slocum, Ph.D., Vol II, August 28, 2019 Petitioner Exhibit 1055: Deposition of Henry Grabowski, Ph.D., Sep. 5, 2019 Petitioner Exhibit 1056: Deposition of Robin Goland, Sep. 10, 2019 Petitioner Exhibit 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/ Petitioner Exhibit 1058: Certified English Translation of DE Patent 102 37 258A1, Dr. Roney Graf (Issued Mar. 18, 2004) Petitioner Exhibit 1059: M. Eledrisi, et al., ¿¿¿Twice-Daily Insulin Glargine for Patients with Uncontrolled Type 2 Diabetes Mellitus, J. of Clinical & Translational Endocrinology 15 (2019), p. 35-36 Petitioner Exhibit 1060: Declaration and c.v. of DeForrest McDuff, Ph.D. Petitioner Exhibit 1061: 2011 Orange Book (Excerpts) Petitioner Exhibit 1062: 2019 Orange Book (Excerpt ¿¿¿ ADA 132 of 263) Petitioner Exhibit 1063: 2011-02-09 - Sanofi SA Earnings Conference Call Petitioner Exhibit 1064: 2012-02-08 ¿¿¿ Sanofi SA Earnings Conference Call Petitioner Exhibit 1065: 2013-02-26 ¿¿¿ Sanofi SA at Citi Global HealthCare Conference Petitioner Exhibit 1066: 2014-02-06 ¿¿¿ Sanofi SA Earnings Conference Call Petitioner Exhibit 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 Petitioner Exhibit 1068: Aventis 2002 20-F Form Petitioner Exhibit 1069: Aventis 2003 20-F Form Petitioner Exhibit 1070: Sanofi-Aventis 2006 20-F Form Petitioner Exhibit 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 Petitioner Exhibit 1072: Carter, Alan W., ¿¿¿Analysis of the Injection Force of Solostar¿¿ Compared with Other Disposable Insulin...¿¿¿, J. of Diabetes Sci. and Tech., Vol. 5, Issue 1, Jan. 2011, p. 156-157 Petitioner Exhibit 1073: ¿¿¿About Diabetes¿¿¿, CDC Basics, p.1-2, https://www.cdc.gov/diabetes/bascis/diabetes Petitioner Exhibit 1074: David, J. et al. ¿¿¿Commercial Success: Economic Principles Applied to Patent Litigation¿¿¿, NERA Economic Consulting (copyrighted material), p. 159-160 Petitioner Exhibit 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/ Petitioner Exhibit 1076: DiMasi, J., et al. ¿¿¿Innovation in the Pharmaceutical Industry: New Estimates of R&D Costs¿¿¿, J. of Health Economics47 (2016), p. 20-33 Petitioner Exhibit 1077: Grobowski, H., et al. ¿¿¿Returns on Research and Development for 1990s New Drug Introductions¿¿¿, Pharmacoeconomics 2002; 20 Suppl. 3: p. 11-29 Petitioner Exhibit 1078: Pietrangelo, Ann ¿¿¿Levemir vs. Lantus: Similarities and Differences¿¿¿, Healthline, Oct. 19, 2016, p.1-14, https://www.healthline.com/health/deiabetes/levemir-lantus Petitioner Exhibit 1079: U.S. Patent 6,100,376, ¿¿¿A21, B30 Modified Insulin Derivatives having An Altered Action Profile¿¿¿, M. D¿¿rschug (issued Aug. 8, 2000) Petitioner Exhibit 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 Petitioner Exhibit 1081: Lantus, ¿¿¿Get to Know the Lantus¿¿ SoloStar¿¿ Insulin Pen, p. 1-7, https://www.lantus.com/get-to-know-the-lantus-solostar-pen Petitioner Exhibit 1082: Lantus SoloStar Brochure: ¿¿¿High Blood Sugar, You¿¿¿re Going Down¿¿¿ (2012) Petitioner Exhibit 1083: Lantus SoloStar Brochure: ¿¿¿Your Guide to the Lantus SoloStar Insulin Pen¿¿¿ (2010) Petitioner Exhibit 1084: McDuff, et al., ¿¿¿Thinking Economically About Commercial Success¿¿¿, Landslide, March/April 2017, p. 37-40 Petitioner Exhibit 1085: Nonaka, H., ¿¿¿FTO (Freedom to Operate) in the Pharmaceutical Industry¿¿¿, JSTOR, Pub. by Nomos Verlagsgesellschaft mbH (2018), p. 9-59 Petitioner Exhibit 1086: Senate Comm. On Finance Ques. 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 Petitioner Exhibit 1087: S.G. Cowen, ¿¿¿Perspectives¿¿¿, Pharmaceutical Therapeutic Categories Outlook, Oct. 2001, p.134-148 Petitioner Exhibit 1088: Cowen and Co., ¿¿¿Diabetes: Many New Drugs, But Insulin Still Dominant¿¿¿, Therapeutic Categories Outlook, Feb. 2015, p.477-491 Petitioner Exhibit 1089: UBS Large Cap Pharmaceuticals Handbook, ¿¿¿U.S. Pharmaceuticals¿¿¿, Apr. 6, 2018, p.45-53 Petitioner Exhibit 1090: Campbell, K., ¿¿¿Insulin Costs Are Skyrocketing. This is Why¿¿¿, U.S. New and World Report, Jun. 29, 2018, p.1-7 Petitioner Exhibit 1091: U.S. Patent 5,656,722, ¿¿¿A21, B30, Modified Insulin Derivatives having An Altered Action Profile¿¿¿, M. D¿¿rschug (issued Aug. 12, 1997) Petitioner Exhibit 1092: U.S. Patent 7,476,652, ¿¿¿Acidic Insulin Preparations Having Improved Stability¿¿¿, Brunner-Schwarz (issued Jan. 13, 2009) Petitioner Exhibit 1093: U.S. Patent 7,713,930, ¿¿¿Acidic Insulin Preparations Having Improved Stability¿¿¿, Brunner-Schwarz (issued May 11, 2010) Petitioner Exhibit 1094: WebMD, ¿¿¿Types of Insulin for Diabetes Treatment¿¿¿, p.1-7 https://www.webmd.com/diabetes/diabetes-types-insulin#1 Petitioner Exhibit 1095: Reply Declaration of Karl Leinsing
9/3/2019	09-03-2019-Board	Board Order 44: Order - Granting Patent Owner's Motion for Pro Hac Vice Admission of Anna E. Dwyer - 37 CFR 42.10
8/27/2019	08-27-2019-Petitioner	Petitioner Notice of Deposition 43: Notice of Deposition for Robin S. Goland, M.D.
8/22/2019	08-22-2019-Petitioner	Petitioner Notice of Deposition 42: Notice of Deposition for Henry Grabowski
8/16/2019	08-16-2019-Patent_Owner	Patent Owner Motion 41: Motion for Pro Hac Vice Admission Under 37 C.F.R. 42.10 Patent Owner Exhibit 2221: Declaration of Anna E. Dwyer Patent Owner Exhibit 2222: Biography of Anna E. Dwyer
8/14/2019	08-14-2019-Patent_Owner	Patent Owner Notice 40: Notice of Joint Stipulation to Modify Due Dates 2, 3, 5, and 6
8/13/2019	08-13-2019-Petitioner	Petitioner Notice of Deposition 39: Notice of Deposition of Alexander Slocum, Ph.D.
8/8/2019	08-08-2019-Board	Board Order Conduct of Proceeding 38: Order - 37 C.F.R. 42.5
8/5/2019	08-05-2019-Board	Board Order 37: ORDER - Granting Patent Owner¿¿¿s Motions for Pro Hac Vice Admission of Robert Vlasis 37 C.F.R. 42.10
7/29/2019	07-29-2019-Petitioner	Petitioner Exhibit List 36: Petitioner's Updated Exhibit List Petitioner Exhibit 1043: Transcript of Telephone Conference on July 25, 2019
7/19/2019	07-19-2019-Patent_Owner	Patent Owner Motion 35: Motion for Pro Hac Vice Admission Under 37 C.F.R. ¿¿ 42.10 Patent Owner Exhibit 2219: Declaration of Robert T. Vlasis Patent Owner Exhibit 2220: Biography of Robert T. Vlasis
7/17/2019	07-17-2019-Petitioner	Petitioner Notice 34: Petitioner's Mandatory Change-of-Information Notices
7/9/2019	07-09-2019-Patent_Owner	Patent Owner Exhibit 2109: Declaration of Henry R. Grabowski, Ph.D. (CORRECTED)
7/2/2019	07-02-2019-Petitioner	Petitioner Objection 33: Mylan Pharmaceuticals Inc. Objections To Evidence Submitted With Patent Owner Response
7/1/2019	07-01-2019-Petitioner	Petitioner Exhibit List 32: Petitioner's Updated Exhibit List Petitioner Exhibit 1042: Transcript of Telephone Conference on 6.19.19
6/25/2019	06-25-2019-Patent_Owner	Patent Owner Response 30: Patent Owner's Response Patent Owner Exhibit List 31: Patent Owner's Updated Exhibit List Patent Owner Exhibit 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) Patent Owner Exhibit 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) Patent Owner Exhibit 2102: Leinsing Deposition Exhibit 2102: Hand drawings Patent Owner Exhibit 2103: Leinsing Deposition Exhibit 2103: Annotations of Figures 6-15 of Burroughs Patent Owner Exhibit 2104: Leinsing Deposition Exhibit 2104: Annotations of Figures 5-8 of the 486 Patent Patent Owner Exhibit 2105: Leinsing Deposition Exhibit 2105: Hand drawings Patent Owner Exhibit 2106: Leinsing Deposition exhibit 2106: Annotations of Figures 11 and 12 of Giambattista Patent Owner Exhibit 2107: Declaration of Alexander Slocum, Ph.D. Part 1 Patent Owner Exhibit 2107: Declaration of Alexander Slocum, Ph.D. Part 2 Patent Owner Exhibit 2108: Curriculum Vitae of Alexander Slocum, Ph.D. Patent Owner Exhibit 2109: EXPUNGED Patent Owner Exhibit 2110: Curriculum Vitae of Henry R. Grabowski, Ph.D. Patent Owner Exhibit 2111: Declaration of Dr. Robin S. Goland Patent Owner Exhibit 2111: Declaration of Dr. Robin S. Goland Patent Owner Exhibit 2112: Curriculum Vitae of Dr. Robin S. Goland Patent Owner Exhibit 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) Patent Owner Exhibit 2114: Teresa L. Pearson, A-Practical-Review-of-Insulin-Pen-Devices, EMJ Diabet., 58-64 (2014:2) Patent Owner Exhibit 2115: Arthritis & Diabetes, What do diabetes and arthritis have in common? Plenty., https://www.arthritis.org/living-with-arthritis/comorbidities/diabetes-and-arthritis/ Patent Owner Exhibit 2116: Andreas Bode, Development of the SoloSTAR insulin pen device design verification and validation, 6 Expert Opinion on Drug Delivery 103-112 (2008) Patent Owner Exhibit 2117: Sanofi¿¿¿s Patented Pen animation Patent Owner Exhibit 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) Patent Owner Exhibit 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) Patent Owner Exhibit 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) Patent Owner Exhibit 2121: DBA Design Effectiveness Awards 2009 Patent Owner Exhibit 2122: SoloSTAR Disposable Pen Injector (The Grand Prix Oct. 22, 2009) Patent Owner Exhibit 2123: Arnd Friedrichs et al., Dose Accuracy and Injection Force of Different Insulin Glargine Pens, 7 J. Diabetes Sci. and Tech. 1346-1353 (2013) Patent Owner Exhibit 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) Patent Owner Exhibit 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) Patent Owner Exhibit 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) Patent Owner Exhibit 2127: U.S. Provisional Patent Application 60/073820 Patent Owner Exhibit 2128: Samita Garg et al., Insulin glargine and glulisine SoloSTAR pens for the treatment of diabetes, 5 Expert Rev. Med. Devices 113-123 (2008) Patent Owner Exhibit 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) Patent Owner Exhibit 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) Patent Owner Exhibit 2131: ISO 11608-1, Pen-injectors for medical use (1st Ed. Dec. 15, 2000) Patent Owner Exhibit 2132: Meike Krzywon et al., Study on the Dosing Accuracy of Commonly Used Disposable Insulin Pens, 14 Diabetes Tech. & Therapeutics 804-809 (2012) Patent Owner Exhibit 2133: Lantus SoloSTAR Pen Guide Patent Owner Exhibit 2134: Arlan L. Rosenbloom, Limitation of Finger Joint Mobility in Diabetes Mellitus, 3 J. Diabetic Complications 77-87 (1989) Patent Owner Exhibit 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) Patent Owner Exhibit 2136: Novo Nordisk Form 6-K (Feb. 9, 2009) Part 1 Patent Owner Exhibit 2136: Novo Nordisk Form 6-K (Feb. 9, 2009) Part 2 Patent Owner Exhibit 2137: Novo Nordisk History Patent Owner Exhibit 2138: W. Schady et al, Observations on Severe Ulnar Neuropathy in Diabetes, 12 J Diabetes and Its Complications 128-132 (1998) Patent Owner Exhibit 2139: Alfred Penfornis & Kristian Horvat, Dose Accuracy Compariosn Between SoloSTAR and FlexPen at Three Different Dose Levels, 10 Diabetes Tech. & Therapeutics 359-362 (2008) Patent Owner Exhibit 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) Patent Owner Exhibit 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) Patent Owner Exhibit 2142: Prix Galien USA Announces 2009 Final Candidates (Prix Galien USA, August 7, 2009) Patent Owner Exhibit 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) Patent Owner Exhibit 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) Patent Owner Exhibit 2145: US Lantus SoloSTAR Launch Book, 2007, PTX-0705, Document bates stamped SANOFI_00232909-45 Patent Owner Exhibit 2146: Lantus COMPASS Study Report (Nov. 29, 2007), PTX-0739, Document bates stamped SANOFI3_90330807-1025 Part 1 Patent Owner Exhibit 2146: Lantus COMPASS Study Report (Nov. 29, 2007), PTX-0739, Document bates stamped SANOFI3_90330807-1025 Part 2 Patent Owner Exhibit 2147: Steenfeldt-Jensen 5th Embodiment Animation Patent Owner Exhibit 2148: Steenfeldt-Jensen 1st Embodiment Animation Patent Owner Exhibit 2149: Steenfeldt-Jensen 2nd Embodiment Animation Patent Owner Exhibit 2150: Steenfeldt-Jensen 5th Embodiment Thread and Slot Animation Patent Owner Exhibit 2151: Steenfeldt-Jensen 5th Embodiment vs. Proposed Modification Animation Patent Owner Exhibit 2152: Steenfeldt-Jensen 5th Embodiment vs. Proposed Modification Collar Friction Animation Patent Owner Exhibit 2153: International Patent Application WO999038554A1 Patent Owner Exhibit 2158: Geralyn Spollett, Insulin Devices, Addressing Barriers to Insulin Therapy With the Ideal Pen, 957-967 (The Diabetes EDUCATOR) Patent Owner Exhibit 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, 77 Diabetes Res. and Clinical Prac. 77-83 (2007) Patent Owner Exhibit 2160: Jean-Louis Selam, Evolution of Diabetes Insulin Delivery Devices, 4 J. Diabetes Sci. and Tech. 505-513 (2010) Patent Owner Exhibit 2161: SoloSTAR Principles of Operation, PTX-0553, Document bates stamped SANOFI_00406383-94 Patent Owner Exhibit 2162: Sanofi Patent Drive Sleeve and Piston Rod Animation Patent Owner Exhibit 2163: Deposition of Karl R. Leinsing, dated June 3, 2019 for IPR2018- 01675, -01676, -01678, -01680 Patent Owner Exhibit 2164: Deposition of Karl R. Leinsing, dated June 4, 2019 for IPR2018-01675, -01676, -01678, -01680 Patent Owner Exhibit 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 Patent Owner Exhibit 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 Patent Owner Exhibit 2167: Giambattista Animation (1) Patent Owner Exhibit 2168: Giambattista Animation (2) Patent Owner Exhibit 2169: U.S. Patent No. 4,648,872 Patent Owner Exhibit 2170: U.S. Patent No. 4,747,824 Patent Owner Exhibit 2171: U.S. Patent No. 6,248,093 Patent Owner Exhibit 2172: Karl R. Leinsing Declaration in Hologic, Inc. v. Minerva Surgical, Inc., No. 15-1031 (D. Del. Jan. 26, 2018), Dkt. No. 309 Patent Owner Exhibit 2173: Bruce A. Perkins, David Olaleye & Vera Bril, Carpal Tunnel Syndrome in Patients With Diabetic Polyneuropathy, 25 Diabetes Care 565-569 (2002) Patent Owner Exhibit 2174: 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) Patent Owner Exhibit 2175: A. Pfutzner et al., Prefilled insulin device with reduced injection force: patient perception and accuracy, 24 Current Med. Res. and Opinion 2545-2549 (2008) Patent Owner Exhibit 2176: Ercan Cetinus et al., Hand grip strength in patients with type 2 diabetes mellitus, Diabetes Res. and Clinical Prac. 1-9 (2005) Patent Owner Exhibit 2177: 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) Patent Owner Exhibit 2178: 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) Patent Owner Exhibit 2179: 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) Patent Owner Exhibit 2180: Considering Insulin Pens for Routine Hospital Use - Consider This... (ISMP article), https://www.ismp.org/resources/considering-insulin-pens-routine-hospital-use-consider Patent Owner Exhibit 2181: Trigger Finger Overview (Mayo Clinic), https://www.mayoclinic.org/diseases-conditions/trigger-finger/symptoms-causes/syc-20365100 Patent Owner Exhibit 2182: Bone and joint problems associated with diabetes (Mayo Clinic), https://www.mayoclinic.org/diseases-conditions/diabetes/in-depth/diabetes/art-20049314 Patent Owner Exhibit 2183: Peripheral Neuropathy (Mayo Clinic), https://www.mayoclinic.org/diseases-conditions/peripheral-neuropathy/symptoms-causes/syc-20352061 Patent Owner Exhibit 2184: Charles E. Buban, A pen that seeks to improve diabetes care, INQUIRER.NET (2008), Document Bates stamped SANOFI_00006282-84 Patent Owner Exhibit 2185: "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 Patent Owner Exhibit 2186: Select Injectable Insulin Drugs Approved by the FDA in the U.S. Patent Owner Exhibit 2187: U.S. Dollar Sales of Lantus SoloSTAR Patent Owner Exhibit 2188: U.S. New Prescriptions of Lantus SoloSTAR Patent Owner Exhibit 2189: U.S. Total Prescriptions of Lantus SoloSTAR Patent Owner Exhibit 2190: U.S. Share of Sales by Drugs in the Lantus Franchise Patent Owner Exhibit 2191: Formulary Placement of Long-Acting Insulin Pen Products: Commercial Plans Patent Owner Exhibit 2192: Formulary Placement of Long-Acting Insulin Pen Products: Medicare Plans Patent Owner Exhibit 2193: Formulary Placement of Long-Acting Insulin Pen Products: Medicaid Plans Patent Owner Exhibit 2194: Formulary Placement of Long-Acting Insulin Pen Products in Healthcare Exchanges Patent Owner Exhibit 2195: U.S. Share of Long-Acting Pens Among All Pens Patent Owner Exhibit 2196: U.S. Dollar Sales of Long-Acting Pens Patent Owner Exhibit 2197: U.S. New Prescriptions of Long-Acting Pens Patent Owner Exhibit 2198: U.S. Total Prescriptions of Long-Acting Pens Patent Owner Exhibit 2199: U.S. Share of Long-Acting Pen Products Patent Owner Exhibit 2200: Yuzu Sato et al., Clinical Aspects of physical exercise for diabetes/metabolic syndrome, 77S Diabetes Research and Clinical Practice S87 (2007) Patent Owner Exhibit 2201: 2007 Good Design Award from The Chicago Athenaeum: Museum of Architecture and Design Patent Owner Exhibit 2203: U.S. Total Marketing Expenditure of Long Acting Insulin Franchises Patent Owner Exhibit 2204: U.S. Total Marketing Expenditures of Long-Acting Insulin Pens Patent Owner Exhibit 2205: U.S. Marketing-to-Sales Ratios of Select Injectable Insulin Drugs Patent Owner Exhibit 2206: Moller First Embodiment Animation Patent Owner Exhibit 2207: Moller Second Embodiment Animation Patent Owner Exhibit 2208: Press Release, Lantus / Apdira SoloSTAR help to improve patient satisfaction (June 27, 2011), Document bates stamped SANOFI_00179886-88 Patent Owner Exhibit 2209: Henry Grabowski, John Vernon & Joseph A. DiMasi, Returns on Research and Development for 1990s New Drug Introductions, 20 Pharmacoeconomics 15 (2002) Patent Owner Exhibit 2210: 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) Patent Owner Exhibit 2211: EXPUNGED Patent Owner Exhibit 2212: Excerpts from Ernest Rabinowicz, Friction And Wear of Materials, 2nd Edition, 68-70 (John Wiley & Sons, Inc. 1995) Patent Owner Exhibit 2214: Excerpts from Alexander H. Slocum, Precision Machine Design, 706-709 (Prentice-Hall, Inc. 1992) Patent Owner Exhibit 2215: Collar Friction Model Demonstration 1 Patent Owner Exhibit 2216: Collar Friction Model Demonstration 2 Patent Owner Exhibit 2217: Collar Friction Model Demonstration 3 Patent Owner Exhibit 2218: SoloSTAR Dial Inject Video
6/19/2019	06-19-2019-Board	Board Order Conduct of Proceeding 29: ORDER Conduct of the Proceeding 35 C.F.R. ¿¿ 42.5(a)
6/11/2019	06-11-2019-Patent_Owner	Patent Owner Notice 28: PATENT OWNER'S UPDATED MANDATORY NOTICES PURSUANT TO 37 C.F.R. 42.8
6/3/2019	06-03-2019-Patent_Owner	Patent Owner Power of Attorney 27: Patent Owner's Power of Attorney
5/31/2019	05-31-2019-Patent_Owner	Patent Owner Notice of Deposition 26: Patent Owner's Updated Notice of Deposition of Karl R. Leinsing
5/23/2019	05-23-2019-Patent_Owner	Patent Owner Notice 24: PATENT OWNER¿¿¿S UPDATED MANDATORY NOTICES PURSUANT TO 37 C.F.R. 42.8 Patent Owner Notice of Deposition 25: PATENT OWNER¿¿¿S NOTICE OF DEPOSITION OF KARL R. LEINSING
5/9/2019	05-09-2019-Board	Board Order 23: PANEL CHANGE ORDER Conduct of the Proceedings 37 C.F.R. ¿¿ 42.5
4/16/2019	04-16-2019-Patent_Owner	Patent Owner Objection 22: Patent Owner's Objections to Documents Served with the Petition
4/16/2019	04-16-2019-Petitioner	Petitioner Objection 21: Mylan Pharmacetucials Inc. Objections to Evidence
4/3/2019	04-03-2019-Board	Event: Petition Institution (Granted) Board Institution Decision 19: Trial Instituted Document Board Order 20: Scheduling Order
3/25/2019	03-25-2019-Petitioner	Petitioner Notice 17: Petitoner's Mandatory Change-Of-Information Notices Petitioner Power of Attorney 18: Petitoner's Power of Attorney
3/18/2019	03-18-2019-Patent_Owner	Patent Owner Reply 16: Patent Owner's Sur-reply in Support of Patent Owner Preliminary Response Patent Owner Exhibit 2029: Amended Schedule, Sanofi-Aventis U.S. LLC v. Mylan, N.V., et al., Civil Action No. 17-9105-SRC-CLW (D.N.J. Mar. 18, 2019), Dkt. No. 285
3/15/2019	03-15-2019-Board	Board Order 15: Order - 37 C.F.R. 42.10
3/11/2019	03-11-2019-Petitioner	Petitioner Response 14: Mylan¿¿¿s Reply to Patent Owner¿¿¿s Prelminary Response Petitioner Exhibit 1038: Graph showing PTAB Days to Docketing for Review Proceedings filed between 2016-2018 Petitioner Exhibit 1042: EXPUNGED
3/4/2019	03-04-2019-Patent_Owner	Patent Owner Notice 12: Patent Owner's Updated Mandatory Notices Event: Preliminary Response Patent Owner Preliminary Response 13: Patent Owner's Preliminary Response Patent Owner Exhibit 2001: Press Release, ¿¿¿Mylan Enhances Partnership with Biocon through Strategic Collaboration for Insulin Products,¿¿¿ Feb. 13, 2013 (PR Newswire) Patent Owner Exhibit 2002: 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) Patent Owner Exhibit 2003: 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) Patent Owner Exhibit 2004: 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 Patent Owner Exhibit 2005: 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 Patent Owner Exhibit 2006: 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 Patent Owner Exhibit 2007: 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.) Patent Owner Exhibit 2008: Mylan GMBH¿¿¿s Exhibit D to 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.) Patent Owner Exhibit 2009: 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.) Patent Owner Exhibit 2010: Mylan GMBH¿¿¿s Exhibit D 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.) Patent Owner Exhibit 2011: 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.) Patent Owner Exhibit 2012: MP4 file of Sanofi¿¿¿s Patented Pen animation Patent Owner Exhibit 2013: Excerpts from McGraw Hill Dictionary of Scientific and Technical Terms (Sixth edition, McGraw-Hill 2003), p. 972 and 1873 Patent Owner Exhibit 2014: Excerpts from Merriam-Webster¿¿¿s Collegiate Dictionary (10th edition, Merriam-Webster, Inc. 2001), p. 538 Patent Owner Exhibit 2015: The New Oxford American Dictionary (Oxford University Press 2001), p. 789-90 Patent Owner Exhibit 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.) Patent Owner Exhibit 2017: 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) Patent Owner Exhibit 2018: Report of the Local Patent Rules Committee, Explanatory Notes for 2016 Amendments Patent Owner Exhibit 2019: 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. W. Va.), Dkt. No. 44 Patent Owner Exhibit 2020: 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.) Patent Owner Exhibit 2021: 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 Patent Owner Exhibit 2022: 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. W. Va.), Dkt. No. 46 Patent Owner Exhibit 2023: 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. W. Va.), Dkt. No. 61 Patent Owner Exhibit 2024: 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. W. Va.), Dkt. No. 64 Patent Owner Exhibit 2025: Transcript, Conference Call for Case IPR2018-01675, -01676, -01678, -01680 (P.T.A.B. Feb. 5, 2019) Patent Owner Exhibit 2026: International Patent WO 99/38554 Patent Owner Exhibit 2027: Animation depicting M¿¿ller¿¿¿s first embodiment Patent Owner Exhibit 2028: Animation depicting M¿¿ller¿¿¿s second embodiment
2/28/2019	02-28-2019-Petitioner	Petitioner Motion 11: Mylan pharmaceuticals Inc. Unopposed Motion for Pro Hac Vice Recognition Petitioner Exhibit 1040: Declaration of Elham F. Steiner ISO Unopposed Motion for Pro Hac Vice Recognition Petitioner Exhibit 1041: Elham F. Steiner, Attorney Biography
2/20/2019	02-20-2019-Board	Board Order 10: Authorizing Reply and Sur-Reply 37 C.F.R. § 42.108(c); 37 C.F.R. § 42.5
2/15/2019	02-15-2019-Petitioner	Petitioner Exhibit List 9: Petitioners Updated Exhibit List Petitioner Exhibit 1039: Transcript of Call 02.13.2019
12/3/2018	12-03-2018-Board	Board Notice of Filing Date Accorded to Petition 8: Notice of Accord Filing Date
10/30/2018	10-30-2018-Petitioner	Petitioner Notice 7: Updated Mandatory Notices
10/12/2018	10-12-2018-Petitioner	Petitioner Notice 6: Petitioner's Mandatory Change-of-Information Notices
9/27/2018	09-27-2018-Patent_Owner	Patent Owner Power of Attorney 4: Power of Attorney Patent Owner Mandatory Notice 5: Patent Owner's Mandatory Notices Pursuant To 37 C.F.R. 42.8
9/13/2018	09-13-2018-Petitioner	Petitioner Notice 3: Petitioner¿¿¿s Mandatory Change-of-Information Notices Under 37 C.F.R. ¿¿42.8(A)(3)
9/10/2018	09-10-2018-Petitioner	Event: Petition Petitioner Petition 1: Petition for Inter Partes Review of USP 8,679,069 Petitioner Power of Attorney 2: Petitioner Mylan Pharmaceuticals Inc. Power of Attorney Petitioner Exhibit 1001: USP 8,679,069 - Veasey Petitioner Exhibit 1002: USP 8,603,044 - Veasey Petitioner Exhibit 1003: USP 8,992,486 - Veasey Petitioner Exhibit 1004: USP 9,526,844 - Veasey Petitioner Exhibit 1005: USP 9,604,008 - Veasey Petitioner Exhibit 1006: File History for U.S. Patent 8,679,069 Petitioner Exhibit 1007: File History for U.S. Patent 8,603,044 Petitioner Exhibit 1008: File History for U.S. Patent 8,992,486 Petitioner Exhibit 1009: File History for U.S. Patent 9,526,844 Petitioner Exhibit 1010: File History for U.S. Patent. 9,604,008 Petitioner Exhibit 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 Petitioner Exhibit 1012: Curriculum Vitae of Karl Leinsing MSME,PE Petitioner Exhibit 1013: U.S. Patent 6,221,046 - A. Burroughs et al., ¿¿¿Recyclable Medication Dispensing Device¿¿¿ (issued Apr. 24, 2001) Petitioner Exhibit 1014: U.S. Patent 6,235,004 ¿¿¿ S. Steenfeldt-Jensen & S. Hansen, ¿¿¿Injection Syringe¿¿¿ (issued May 22, 2001) Petitioner Exhibit 1015: U.S. Patent Application US 2002/0053578 A1 ¿¿¿ C.S. M¿¿ller, ¿¿¿Injection Device¿¿¿ (pub¿¿¿d May 2, 2002) Petitioner Exhibit 1016: U.S. Patent 6,932,794 B2 ¿¿¿ L. Giambattista & A. Bendek, ¿¿¿Medication Delivery Pen¿¿¿ (issued Aug. 23, 2005) Petitioner Exhibit 1017: U.S. Patent 6,582,404 B1 ¿¿¿ P.C. Klitgaard et al., ¿¿¿Dose Setting Limiter¿¿¿ (issued June 24, 2003) Petitioner Exhibit 1018: File History for U.S. Patent 6,582,404 Petitioner Exhibit 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) Petitioner Exhibit 1020: U.S. Patent 4,865,591 ¿¿¿ B. Sams, ¿¿¿Measured Dose Dispensing Device¿¿¿ (issued Sep. 12, 1989) Petitioner Exhibit 1021: U.S. Patent 6,248,095 B1 ¿¿¿ L. Giambattista et al., ¿¿¿Low-cost Medication Delivery Pen¿¿¿ (issued June 19, 2001) Petitioner Exhibit 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) Petitioner Exhibit 1023: U.S. Patent 5,226,895 ¿¿¿ D.C. Harris, ¿¿¿Multiple Dose Injection Pen¿¿¿ (issued July 13, 1993) Petitioner Exhibit 1024: U.S. Patent 5,851,079 ¿¿¿ R.L. Horstman et al., ¿¿¿Simplified Undirectional Twist-Up Dispensing Device With Incremental Dosing¿¿¿ (issued Dec. 22, 1998) Petitioner Exhibit 1025: Application as filed: U.S. Patent App. 14/946,203 ¿¿¿ R.F. Veasey, ¿¿¿Relating to a Pen-Type Injector¿¿¿ (filed Nov. 19, 2015) Petitioner Exhibit 1026: GB 0304822.0 ¿¿¿ ¿¿¿Improvements in and relating to a pen-type injector¿¿¿ (filed Mar. 3, 2003) (¿¿¿844 Priority Doc.) Petitioner Exhibit 1027: WO 99/38554 ¿¿¿ S.Steenfeldt-Jensen & S.Hansen, ¿¿¿An Injection Syringe¿¿¿ (pub¿¿¿d Aug. 5, 1999) (Steenfeldt-Jensen PCT) Petitioner Exhibit 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) Petitioner Exhibit 1029: Memorandum Opinion, Sanofi-Aventis U.S. LLC v. Merck Sharp & Dohme Corp., No. 16-cv-812 (filed Jan. 12, 2018) Petitioner Exhibit 1030: N. Sclater & N.P. Chironis, Mechanisms & Mechanical Devices Sourcebook 191-95, ¿¿¿Twenty Screw Devices¿¿¿ (3d ed., July 2, 2001) Petitioner Exhibit 1031: N. Sclater & N.P. Chironis, Mechanisms & Mechanical Devices Sourcebook 191-95, ¿¿¿Twenty Screw Devices¿¿¿ (3d ed., July 2, 2001) Petitioner Exhibit 1032: EP 0 608 343 B1 ¿¿¿ L. Petersen & N.-A. Hansen, ¿¿¿Large Dose Pen¿¿¿ (pub¿¿¿d Oct. 18, 1991) Petitioner Exhibit 1033: A.G. Erdman &G.N. Sandor, ¿¿¿ Mechanical Advantage¿¿¿, ¿¿3.7 in 1 Mechanism Design: Analysis and Synthesis (1984) Petitioner Exhibit 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) Petitioner Exhibit 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).

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Mylan Pharmaceuticals Inc. v. Sanofi-Aventis Deutshland GmbH

IPR2018-01670 | Patent Trial and Appeal Board

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