DIABETES LANDSCAPE Market, Technology and Intellectual Property

DIABETES LANDSCAPE Market, Technology and Intellectual Property A Joint Research Report from Espicom and UBM TechInsights.

This report is the result of a collaborative venture between UBM TechInsights and Espicom Business Intelligence, each party bringing its own skills and knowledge to provide an unmatched analysis. UBM TechInsights UBM TechInsights is the leading provider of sophisticated information and advice to technology firms. Companies in need of technical analysis and IP management consulting rely on our deep expertise in the underlying technologies used in today s medical devices. For further information: www.ubmtechinsights.com/medical Espicom Business Intelligence Espicom is a highly-regarded and established independent provider of business intelligence services for the global medtech industries. Based in the UK and with over 30 years of continuous research and editorial experience in the global health industry, Espicom is one of the longest established, independent business intelligence providers operating today. Espicom produces original analysis, news and forecasts using its skilled and experienced team of full-time in-house analysts, researchers and editorial experts. Over 50,000 users in more than 50 countries worldwide rely on Espicom s essential market data. For further information: www.espicom.com/medical Diabetes Landscape: Market, Technology and Intellectual Property Copyright 2012 Espicom Business Intelligence 2012, UBM Semiconductor Insights All rights reserved. No part of this publication may be reproduced or used in any form or by any means graphic, electronic or mechanical, including photocopying, recording, taping or storage in information retrieval systems without the express permission of the publisher. Every care has been taken to ensure that the information contained in this report is correct. The publisher accepts no liability for decisions made on the basis of information contained herein. ii

Diabetes Landscape: Table of Contents CONTENTS EXECUTIVE SUMMARY Volume I... 1 Current Technologies... 2 Geographic Trends... 2 Volume II... 2 Intellectual Property Trends... 3 Technology Trends... 3 VOLUME I - DIABETES INDUSTRY ANALYSIS 1.0 MARKET OVERVIEW...7 1.1 BACKGROUND...7 1.1.1 Diagnosis and Management of Diabetes... 8 Insulin-Dependant Diabetes Patients... 9 Current Trends in Diabetes Care... 9 1.2 THE GLOBAL DIABETES BURDEN...10 1.2.1 Diabetes Prevalence... 10 Fig.1.0: Diabetes Prevalence by Geographic Region, 2011-2030...11 Diabetes Prevalence for the Top 10 Countries, 2011-2030 (million)...11 Burden of Metabolic Risk Factors of Chronic Diseases Collaborating Group Study... 12 1.2.2 Mortality... 12 1.2.3 Diabetes Complications... 13 1.2.4 The Cost of Diabetes... 14 1.3 THE DIABETES DEVICE MARKET...15 1.3.1 Product Segments... 16 Fig.1.2: Diabetes Device Market by Major Product Category, 2011...16 Fig.1.3: Percentage of US Diabetes Patients by Treatment Type, 2007-2009...17 Fig.1.4: Diabetes Device Market by Product Type, 2011...18 1.3.2 Current Market Trends... 19 Fig.1.5: Global Diabetes Device Market, 2011 (US$ billion)...19 Global Diabetes Market by Product Type, 2005-2011 (US$ million)...20 Fig.1.6: Global Diabetes Market By Product Type, 2005-2011 (US$ billion)...20 Global Diabetes Market Growth Rates by Product Type, 2006-2011 (%)...21 Fig.1.7: Global Diabetes Device Market Growth Rates, 2006-2011 (%)...21 1.3.3 Regional Perspective... 21 Fig.1.8: Global Diabetes Device Market by Region, 2011...22 Fig.1.9: US Market by Product Type, 2011...22 Fig.1.10: European Market by Product Type, 2011...23 Fig.1.11: Other Regions by Product Type, 2011...23 1.4 COMPETITIVE ENVIRONMENT...24 Fig.1.12: Diabetes Device Market Share by Company, 2011...25 Key Companies Diabetes Care Sales, 2005-2011 (US$ million)...25 Non-US Companies Diabetes Sales in Reported Currency, 2005-2011 (million)...25 Leading Companies International Diabetes Care Sales, 2005-2011 (US$ million)...26 Leading Companies US Diabetes Care Sales, 2005-2011 (US$ million)...26 1.4.1 New Market Entrants...26 1.4.2 Market Withdrawals... 27 1.4.3 Rounding Out Product Portfolios...28 Key Companies: Market Presence & Position by Product Area...28 Key Companies: Current & Future Potential Market Presence by Product Area...29 1.4.4 Market Consolidation...29 1.5 GROWTH DRIVERS, RESTRAINTS AND FUTURE OPPORTUNITIES...30 1.5.1 Regulatory and Reimbursement Environment... 31 iii

Table of Contents Diabetes Landscape: 1.5.2 Connectivity and Data Integration...32 The Role of Telemonitoring in Diabetes Care...32 Safety Issues...33 1.5.3 Emerging Technologies...34 New-Generation Insulin Delivery Devices... 34 Development of a Closed-Loop System...35 Rival Technologies...35 1.6 MARKET EXPECTATIONS... 38 Fig.1.13: Global Diabetes Device Market, 2011-2017E (US$ billion)...38 Global Diabetes Market Forecast by Product Type, 2011-2017E (US$ million)... 39 Global Diabetes Market Forecast Growth Rates by Product, 2011-2017E (%)... 39 Fig.1.14: Global Monitoring Market Forecast, 2011-2017E (US$ billion)... 39 Fig.1.15: Global Insulin Delivery Market Forecast, 2011-2017(E) (US$ billion)...40 Fig.1.16: Diabetes Device Market by Product, 2017E...40 2.0 DIABETES MONITORING PRODUCTS...41 Overview: Glucose Monitoring Products...42 2.1 MARKET DYNAMICS... 44 Fig.2.1: Global Glucose Monitoring Market, 2005-2011 (US$ billion)...44 Fig.2.2: Global Blood Monitoring Market Growth, 2005-2011 (%)...44 Fig.2.3: Glucose Monitoring Market by Product Type, 2011... 45 Fig.2.4: Blood Glucose Testing Market by Geographic Region, 2011... 45 Public Companies Glucose Monitoring Sales, 2005-2011 (US$ million)... 45 Fig.2.5: Glucose Monitoring Market Shares by Company, 2011...46 2.2 MANUAL SELF-MONITORING BLOOD GLUCOSE PRODUCTS... 47 Fig.2.6: Example of a Classic BGM & Test Strip: Bayer s Contour Meter...48 2.2.1 Current Market Environment... 48 Fig.2.7: Global SMBG Market, 2005-2011 (US$ million)...49 Fig.2.8: Global SMBG Market Growth Rates, 2005-2011 (%)...49 Fig.2.9: SMBG Market by Product Type, 2011...49 Regional Markets and Reimbursement... 50 Fig.2.10: SMBG Market by Region, 2011...50 Market Developments...51 Fig.2.11: Mendor s Discreet (left) & Roche s Accu-Check Mobile with Attached Lancing Device (right)... 51 Fig.2.12: BodyTel Europe s GlucoTel BGM... 51 Fig.2.13: Medisana s GlucoDock Attached to an Apple iphone... 52 Accuracy Standards...53 Market Forecast... 54 Summary: SMBG Growth Drivers, Restraints & Opportunities... 55 Fig.2.14: Global SMBG Market, 2011-2017E (US$ billion)... 55 Fig.2.15: Global SMBG Market Growth Rates, 2012-2017E (%)... 56 2.2.2 Competitive Environment...56 Public Companies BGM Sales, 2005-2011 (US$ million)... 57 Fig.2.16: SMBG Market Share by Company, 2011... 57 Fig.2.17: United States SMBG Market Share by Company, 2011... 58 Fig.2.18: SMBG International Market Share by Company, 2011... 58 2.2.3 Market-Leading Self-Testing Blood Glucose Meters...59 1. Abbott s Blood Glucose Monitors...59 2. Arkray s Glucocard Products... 60 3. Bayer s Blood Glucose Monitoring Systems...61 4. Contour USB... 62 5. Contour, Contour TS, Contour Link and Breeze 2... 62 6. DIDGET Meter... 63 7. Elite and Elite XL... 63 LifeScan OneTouch Products... 63 iv

Diabetes Landscape: Table of Contents Nipro Diagnostics TRUE Products... 66 Roche Diabetes Care s Products...67 2.2.4 Other Market Participants...68 Competing Self-Testing Blood Glucose Monitoring Products...68 Product Highlights...71 2.2.5 Products in Development...77 Intuity Medical s POGO Blood Glucose Monitoring System... 77 Pepex Biomedical s Trio Products... 77 2.3 CONTINUOUS GLUCOSE MONITORING... 78 Fig.2.19: Example of a CGM: Medtronic s Guardian REAL-Time System... 78 2.3.1 The Benefits of CGM...78 2.3.2 Barriers to Adoption...79 The Cost of CGM... 79 2.3.3 Clinical Trial Results - Highlighting Benefits and Drawbacks...79 2.3.4 The TD1 Exchange: User Experiences of CGM...81 2.3.5 CGM Market Trends and Opportunities...82 Fig.2.20: Global CGM Market, 2006-2011 (US$ million)... 82 Fig.2.21: Percentage of CGM Sales Volumes by Hardware & Consumables, 2011... 82 Regional Adoption Rates, Regulatory and Reimbursement Environment... 83 Fig.2.22: CGM Market by Region, 2011... 83 Future Prospects... 84 Fig.2.23: Global CGM Market Forecast, 2011-2017E (US$ million)... 85 Fig.2.24: Global CGM Market Forecast Growth Rates, 2011-2017E (%)...86 Summary: CGM Benefits, Challenges & Opportunities...86 2.3.6 Competitive Environment...87 Leading Companies Reported CGM Sales, 2006-2011 (US$ million)... 87 Fig.2.25: Global CGM Market Shares by Company, 2011...88 Fig.2.26: US CGM Market Shares by Company, 2011...88 Fig.2.27: International CGM Market Shares by Company, 2011...89 2.3.7 Currently-Available Products...89 Medtronic s Guardian REAL-Time CGM System... 89 DexCom s CGMs... 90 Abbott s FreeStyle Navigator...91 A Menarini Diagnostics GlucoDay S...92 2.3.8 Products in Development...92 Abbott s Navigator II...92 DexCom s Research and Development...92 New-Generation Implantable CGM Sensors...93 Minimally-Invasive CGM in Development... 95 2.4 NON-INVASIVE GLUCOSE MONITORING... 100 2.4.1 Competitive Environment... 100 2.4.2 AIMEDICS HypoMon...101 2.4.3 Biosign Technologies UFIT TEN-20 Non-Invasive Blood Pressure and Glucose Meter 101 2.3.4 Biovotion s Multisensor Glucose Monitoring System...102 2.3.5 Integrity Applications GlucoTrack...103 Clinical Study Results... 103 2.3.6 Optical Technologies...105 C8 MediSensors Optical Glucose Monitor... 105 EyeSense s Optical Sensor... 105 Freedom Meditech s I-SugarX Glucose Monitoring System... 106 Grove Instruments Grove Glucometer... 106 Lein Applied Diagnostics... 107 LighTouch Medical s Non-Invasive Glucose Monitor... 107 Massachusetts Institute of Technology s Raman Spectroscopy System... 108 Medtronic s PreciSense Technology... 108 v

Table of Contents Diabetes Landscape: OrSense s NBM-200G Non-Invasive Blood Glucose Meter... 108 St Louis Medical Devices Near-Infrared Light-Based System... 109 Smart Tattoos... 109 2.3.7 Tear Fluid Glucose Sensors...110 Mayo Clinic, Arizona State University and BioAccel...110 University of Washington and Microsoft Research...111 The University of Western Ontario s Glucose Monitoring Contact Lenses...111 2.3.8 Breath-Based Glucose Monitoring...112 PositiveID s EasyChek...112 Xhale s Breath-Based Glucose Monitor...112 Brown University and Saliva-Based Glucose Testing...112 3.0 INSULIN DELIVERY PRODUCTS...114 3.1 ADDRESSABLE PATIENT POPULATION...116 Fig.3.1: Percentage of US Diabetes Patients by Treatment Type, 2007-2009... 116 3.2 MARKET TRENDS...117 Insulin Delivery Market by Product Type 2005-2011 (US$ million)...117 Fig.3.2: Global Insulin Delivery Market, 2005-2011 (US$ billion)...117 Fig.3.3: Global Insulin Delivery Market Growth Rates, 2006-2011 (%)... 118 Fig.3.4: Percentage of Insulin Delivery Market by Product Type, 2011... 118 Fig.3.5: Insulin Delivery Market by Geographic Region, 2011... 119 3.2.1 Competitive Environment...120 Key Companies Insulin Delivery Sales, 2006-2011 (US$ million)... 120 Fig.3.6: Insulin Delivery Market Share by Company, 2011... 120 3.3 FUTURE MARKET PROSPECTS... 121 Summary: Insulin Delivery Market Growth Drivers, Restraints & Opportunities... 121 Insulin Delivery Market Forecast by Product Type 2011-2017E (US$ million)... 122 Fig.3.7: Global Insulin Delivery Market Forecast, 2011-2017 (US$ billion)... 122 Fig.3.8: Global Insulin Delivery Market Estimated Growth Rates, 2012-2017 (%)... 122 Fig.3.9: Estimated Insulin Delivery Market by Product Type, 2017... 123 3.4 MANUAL INSULIN INJECTION PRODUCTS... 124 Fig.3.10: Manual Insulin Delivery Method by Product Type, 2011... 124 Fig.3.11: Percentage of Novo Nordisk Insulin Sold in Pens by Region, 2011... 125 Fig.3.12: Manual Insulin Delivery Market by Geographic Region, 2011... 125 3.4.1 Insulin Pens...126 Fig.3.13: Example Insulin Pen: Novo Nordisk s NovoPen 4... 126 Fig.3.14: Global Insulin Pen Market: Disposable vs Reusable Pens, 2011... 126 Competitive Environment...127 Fig.3.15: Insulin Pen Use by Manufacturer, 2011... 127 Currently-Available Products... 128 3.4.2 Needles and Syringes...130 Fig.3.16: Insulin Needles & Syringes Market by Manufacturer, 2011... 131 Pen Needles...131 3.5 INSULIN PUMPS... 133 Fig.3.17: Example Insulin Pump: Medtronic s MiniMed Paradigm REAL-Time Revel... 133 Fig.3.18: Example Insulin Pump: Roche s Accu-Check Spirit... 133 Insulin Pump Market: Growth Drivers, Restraints & Opportunities... 134 3.5.1 The TD1 Exchange: User Experiences of CGM...135 3.5.2 Current Market Trends...136 Fig.3.19: Global Insulin Pump Market, 2005-2011 (US$ million)... 136 Fig.3.20: Global Insulin Pump Market Growth Rates, 2006-2011 (%)... 136 Fig.3.21: Insulin Pump Market by Product, 2011... 137 Regional Perspective...137 Fig.3.22: Insulin Pump Market by Region, 2011... 137 Fig.3.23: Insulin Pump Adoption Rates for Type 1 Diabetes Patients by Key Country, 2010 (%)... 138 vi

Diabetes Landscape: Table of Contents Regulatory Environment - FDA Infusion Pump Improvement Initiative... 139 Negative Publicity and the Potential for Cyber Attacks... 140 Market Outlook...141 Fig.3.24: Global Insulin Pump Market Forecast, 2011-2017 (US$ million)... 141 Fig.3.25: Global Insulin Pump Market Estimated Growth Rates, 2012-2017 (%)... 141 3.5.3 Competitive Environment...142 Key Companies Insulin Pump Sales, 2005-2011 (US$ million)... 142 Fig.3.26: Insulin Pump Market Shares, 2011... 143 3.5.4 Currently-Available Insulin Pumps...143 Animas Insulin Pumps... 143 Asante Solutions Pearl Insulin Pump... 144 D Medical Industries Spring Pumps and Infusion Sets... 144 Medtronic s MiniMed Paradigm Revel Insulin Pump and Infusion Sets... 145 Sooil Development s Diabecare Insulin Pumps... 146 Roche Insulin Pumps... 146 Tandem Diabetes Care s t:slim Insulin Delivery System...147 Insulin Delivery Patch Pumps...147 3.5.5 Products in Development...150 Becton Dickinson-JDRF Micro-Needle Technology... 150 CeQur s Insulin Patch Infuser... 150 D Medical Industries Spring Hybrid Patch Pump... 150 Debiotech s JewelPUMP...151 Insulet s Second-Generation OmniPod...151 Insuline Medical s InsuPatch and InsuPad...151 Roche s SOLO Micropump... 152 3.6 ALTERNATIVE INSULIN DELIVERY DEVICES... 153 3.6.1 Generex Biotechnology s Oral-lyn...153 3.6.2 Insulin Inhalers...154 Development Considerations... 154 Fig.3.27: MannKind s Dreamboat (Gen2) Insulin Inhaler... 155 4.0 COMBINED CGM-INSULIN PUMP SYSTEMS...157 4.1 CURRENTLY-AVAILABLE PRODUCTS... 158 4.1.1 Medtronic s Paradigm Integrated Diabetes Management Products...158 Paradigm REAL-Time Revel... 158 Fig.4.1: MiniMed Paradigm REAL-Time System... 158 Enlite CGM Sensor... 159 Clinical Trials... 159 ONSET Study... 160 REAL Trend Study... 160 4.1.2 Animas Vibe...161 4.2 PRODUCTS IN DEVELOPMENT... 162 4.2.1 D Medical Industries Combined CGM-Pump System...162 5.0 ARTIFICIAL PANCREAS TECHNOLOGY... 163 5.1 SEMI-CLOSED LOOP SYSTEMS... 165 5.1.2 Medtronic s Paradigm Veo System with Low Glucose Suspend...165 Fig.5.1: Medtronic s Paradigm Veo System with Low Glucose Suspend... 165 ASPIRE Study... 166 5.2 RESEARCH & DEVELOPEMNT... 167 5.2.1 FDA Artificial Pancreas Development Guidelines...167 5.2.2 Key Closed-Loop Development Projects...168 The Juvenile Diabetes Research Foundation s Artificial Pancreas Project... 168 Mayo Clinic... 172 UC Santa Barbara, Sansum Diabetes Research Institute, Mayo Clinic, Universities of Virginia & Padova 172 AP@home Project... 172 vii

Table of Contents Diabetes Landscape: MD-Logic Artificial Pancreas System... 173 Medtronic s Closed-Loop System...174 Rensselaer Polytechnic Institute...175 6.0 POC MANUFACTURERS...176 6.1 POC COMPANY DIRECTORY... 176 6.2 LEADING COMPANY PROFILES... 184 6.2.1 Abbott Laboratories...184 Recent Key Events...184 Blood Glucose Monitors... 185 In Development - Navigator II CGM System... 186 Alliance with Insulet... 187 Litigation... 187 Financial Performance... 188 Abbott Diabetes Care Sales by Region, 2006-2011 (US$ million)...188 Fig.6.1: Percentage of Abbott Diabetes Care Revenue by Region, 2011...188 6.2.2 Arkray...189 Recent Key Events... 189 Blood Glucose Self-Testing... 189 Current Alliances and Contracts...191 6.2.3 Bayer...192 Recent Key Events... 192 Blood Glucose Monitoring Systems... 192 Current Alliances... 194 Litigation... 195 Financial Performance... 195 Bayer Diabetes Care Revenue, 2005-2011 (EUR million)... 195 6.2.4 Becton, Dickinson and Company...196 Recent Key Events... 196 BD Diabetes Care Products... 196 Collaboration with the JDRF... 197 Litigation with Insulet... 197 Financial Performance... 197 BD Diabetes Care Sales by Region, 2006-2011 (US$ million)... 198 Fig.6.2: Percentage of BD Diabetes Care s Revenue by Region, 2011... 198 6.2.5 DexCom...199 Recent Key Events... 199 SEVEN PLUS CGM System... 200 GlucoClear... 201 Research and Development... 201 SweetSpot Diabetes Care Acquisition... 201 Current Alliances... 202 Litigation with Abbott... 203 Financial Performance... 204 DexCom - Operating Results, 2007-2011 (US$ thousands)...205 6.2.6 Insulet... 206 Recent Key Events... 207 OmniPod Insulin Management System... 207 Current Alliances... 208 Acquisition of Neighborhood Diabetes... 209 Litigation with Becton, Dickinson and Company... 209 Financial Performance... 209 Insulet - Operating Results, 2007-2011 (US$ thousands)... 210 6.2.7 Johnson & Johnson...211 Recent Key Events... 211 viii

Diabetes Landscape: Table of Contents Animas Operations...212 LifeScan Operations...214 Financial Performance...217 J&J Diabetes Care Revenue, 2006-2011 (US$ million)... 218 Fig.6.3: J&J Diabetes Care Sales by Region, 2011... 218 Fig.6.4: J&J Diabetes Care Sales, 2004-2011 (US$ million)... 218 6.2.8 Medtronic...219 Recent Key Events... 219 Integrated Diabetes Management Products... 220 Guardian REAL-Time CGM System... 221 ipro Professional Use CGM Products... 222 Enlite CGM Sensor... 222 MiniMed Paradigm Revel Insulin Pump and Infusion Sets... 222 CareLink Software... 223 Blood Glucose Meters... 223 Clinical Trials... 224 Research and Development... 225 Alliance with Bayer... 225 Financial Performance... 226 Fig.6.5: Medtronic Diabetes Revenue, 2005-2011 (US$ million)...226 Medtronic - Diabetes Sales by Region, 2008-2011 (US$ million)... 227 Fig.6.6: Medtronic Diabetes Revenue by Region, 2011... 227 Fig.6.7: Medtronic Diabetes Revenue by Product Type, 2010*... 227 6.2.9 Nipro Diagnostics... 229 Recent Key Events...229 Blood Glucose Monitoring Products... 230 Blood Glucose Monitors... 230 6.2.10 Roche Diabetes Care...232 Recent Key Events... 232 Diabetes Care Products... 233 Accu-Chek Combo BGM and Pump System... 234 Insulin Pumps... 234 Data Management Tools... 235 In Development - SOLO Micropump... 235 Current Alliances and Contracts... 236 Litigation... 236 Financial Performance... 237 Roche Diabetes Care Sales by Product, 2010-2011 (SFr million)... 237 Roche Diabetes Care Sales by Region, 2006-2011 (SFr million)... 237 Fig.6.8: Roche Diabetes Care - Revenue by Product Line, 2011...238 Fig.6.9: Roche Diabetes Care - Revenue by Region, 2011...238 6.2.11 Ypsomed... 239 Recent Key Events... 239 mylife Diabetes Care Products... 240 Ypsomed Delivery Systems... 240 Acquisition of ICU Medical s Orbit Infusion Set Business... 241 Current Alliances... 241 Financial Performance... 242 Ypsomed - Operating Results, Y/E 31st March 2007-2011 (SFr millions)... 243 Ypsomed - Results by Business Segment, Y/E 31st March 2009-2011 (SFr millions)... 243 Ypsomed - Revenue by Geographic Region, Y/E 31st March 2009-2011 (SFr millions)...244 Fig.6.10: Ypsomed - Revenue by Business Segment, Fiscal 2010...244 Fig.6.11: Ypsomed - Revenue by Geographic Location, Fiscal 2010... 245 7.0 APPENDICES... 246 ix

Table of Contents Diabetes Landscape: 7.1 LIST OF ABBREVIATIONS...246 7.2 - REPORT METHODOLOGY... 247 Sources...247 Market forecasts... 248 VOLUME II - DIABETES TECHNOLOGY AND INTELLECTUAL PROPERTY ANALYSIS 1.0 SUMMARY... 251 Figure 1.1 Diabetes Landscape by Technology... 252 Figure 1.2 High Level Overview of Diabetes Patent Activity...254 Figure 1.3 Bar Chart of Totals for each Technology Group... 255 Figure 1.4 Top 20 Assignees Patents from this Study... 256 Figure 1.5 - Blood Extraction by Priority Date by Assignee... 257 Figure 1.6 Number of Patents versus Revenue for Highlighted Companies...258 Figure 1.7 Litigation Analysis... 259 Table 1.1 Table of Highlighted Companies and Technologies...260 2.0 INTRODUCTION... 262 3.0 TECHNOLOGY... 264 Figure 3.1 Diabetes Landscape by Technology... 265 Figure 3.2 Self Monitoring of Blood Glucose...266 Figure 3.3 Blood Glucose Test Strip Operation... 267 Figure 3.4 Continuous Glucose Monitoring (CGM)... 267 Figure 3.5 Artificial Pancreas Representative Diagram... 269 4.0 OVERVIEW OF PATENT ACTIVITIES... 270 Figure 4.1 High Level Overview of Diabetes Patent Activity... 271 4.1 Analysis of Patents Sorted by this Study... 273 Figure 4.2 Bar Chart of Totals for each Technology Group... 273 Figure 4.3 Top 20 Assignees Patents from This Study... 274 Figure 4.4 Patents by Priority Date... 275 Figure 4.5 Priority Date by Top 5 Companies... 276 Figure 4.6 Patents by Published Date...277 Figure 4.7 Patents by Source Jurisdiction... 278 Figure 4.8 Top 10 IPC Codes from the Patents Analyzed... 279 Figure 4.9 Total U.S. Patents by Assignee...280 Figure 4.10 USP Classification Analysis within the U.S. Dataset... 281 5.0 PATENT ANALYSIS BY TECHNOLOGY SUBCATEGORY... 282 5.1 Detection and Monitoring Periodic Invasive Blood Extraction...283 Figure 5.1 Blood Extraction Top Assignees... 283 Priority Date by Year and Source:... 284 Figure 5.2 - Blood Extraction by Priority Date...284 Priority Date by Year by Top 5 Assignees within the Subcategory:... 285 Figure 5.3 - Blood Extraction by Priority Date by Assignee... 285 Published Date by Year and Source:... 286 Figure 5.4 - Blood Extraction by Published Date...286 IPC Analysis Top 10 Codes:... 287 Figure 5.5 - Blood Extraction by IPC Code... 287 USPC Analysis Top 10 Codes:... 288 Figure 5.6 - Blood Extraction by USPC Code...288 Figure 5.7 Blood Extraction - Text Clustering Analysis...289 Source Jurisdiction:... 290 Figure 5.8 - Blood Extraction by Source Jurisdiction...290 Top Patents... 291 Table 5.1 - Top Patents Identified in the Blood Extraction Group... 291 x

Diabetes Landscape: Table of Contents US6461496B1: Abbott Laboratories...292 Figure 5.9 Representative Image in US6461496... 292 Figure 5.10 Top 20 Companies Citing US6461496... 293 US5916230A: Bayer AG... 294 Figure 5.11 Representative Images of US5916230...294 Figure 5.12 Top 20 Companies Citing US5916230... 295 5.2 Detection and Monitoring Periodic Invasive Test Strips...296 Figure 5.13 Test Strips Top Assignees...296 Priority Date by Year and Source:... 297 Figure 5.14 - Test Strips by Priority Date... 297 Priority Date by Year by Assignee:... 297 Figure 5.15 - Test Strips by Priority Date by Assignee... 297 Published Date by Year:... 298 Figure 5.16 - Test Strips by Published Date...298 IPC Analysis Top 10 Codes:... 299 Figure 5.17 - Test Strips by IPC Code...299 USPC Analysis Top 10 Codes:... 300 Figure 5.18 - Test Strips by USPC Code...300 Text Clustering Analysis:... 301 Figure 5.19 Test Strips - Text Clustering Analysis... 301 Source Jurisdiction:... 302 Figure 5.20 - Test Strips by Source Jurisdiction...302 Top Patents... 303 Table 5.2 - Top Patents Identified in the Test Strips Group...303 US5496453A: Arkray, Inc.... 304 Figure 5.21 Representative Image in US5496453...304 Figure 5.22 Top 20 Companies Citing US5496453...305 US5563042: Johnson & Johnson... 306 Figure 5.23 Representative Image in US5563042...306 Figure 5.24 Top 20 Companies Citing US5563042...307 5.3 Detection and Monitoring Periodic Invasive Devices...308 Figure 5.25 Devices Top Assignees...308 Priority Date by Year:... 309 Figure 5.26 - Devices by Priority Date...309 Priority Date by Year by Assignee:... 309 Figure 5.27 - Devices by Priority Date by Assignee...309 Published Date by Year and Source:...310 Figure 5.28 - Devices by Published Date... 310 IPC Analysis Top 10 Codes:...311 Figure 5.29 - Devices by IPC Code...311 USPC Analysis Top 10 Codes:...312 Figure 5.30 - Devices by USPC Code... 312 Text Clustering Analysis:...313 Figure 5.31 Devices - Text Clustering Analysis... 313 Source Jurisdiction:...314 Figure 5.32 - Devices by Source Jurisdiction... 314 Top Patents...315 Table 5.3 - Top Patents Identified in the Devices Group... 315 US6233471: Johnson & Johnson...316 Figure 5.33 Representative Image in US6233471... 316 Figure 5.34 Top 20 Companies Citing US6233471... 317 5.4 Detection and Monitoring Periodic Minimally Invasive Interstitial Fluid... 318 Figure 5.35 Interstitial Fluid Top Assignees... 318 Priority Date by Year:...319 Figure 5.36 - Interstitial Fluid by Priority Date... 319 xi

Table of Contents Diabetes Landscape: Priority Date by Year by Assignee:...319 Figure 5.37 - Interstitial Fluid by Priority Date... 319 Published Date by Year:... 320 Figure 5.38 - Interstitial Fluid by Published Date... 320 IPC Analysis - Top 10 Codes:...321 Figure 5.39 - Interstitial Fluid by IPC Code... 321 USPC Analysis Top 10 Codes:... 322 Figure 5.40 - Interstitial Fluid by USPC Code... 322 Text Clustering Analysis:... 323 Figure 5.41 Interstitial Fluid - Text Clustering Analysis... 323 Source Jurisdiction:... 324 Figure 5.42 - Interstitial Fluid by Source Jurisdiction... 324 Top Patents... 325 Table 5.4 - Top Patents Identified in the Interstitial Fluid Group... 325 US5582184: Alere Incorporated...326 Figure 5.43 Representative Image in US5582184... 326 Figure 5.44 Top 20 Companies Citing US5582184... 327 5.5 Detection and Monitoring Periodic Minimally Invasive Skin Diffusion... 328 Figure 5.45 Skin Diffusion Top Assignees... 328 Priority Date by Year:... 329 Figure 5.46 - Skin Diffusion by Priority Date... 329 Priority Date by Year by Assignee:... 329 Figure 5.47 - Skin Diffusion by Priority Date by Assignee... 329 Published Date by Year:... 330 Figure 5.48 - Skin Diffusion by Published Date... 330 IPC Analysis Top 10 Codes:... 331 Figure 5.49 - Skin Diffusion by IPC Code... 331 USPC Analysis Top 10 Codes:... 332 Figure 5.50 - Skin Diffusion by USPC Code... 332 Text Clustering Analysis:... 333 Figure 5.51 Skin Diffusion - Text Clustering Analysis... 333 Source Jurisdiction:... 334 Figure 5.52 - Skin Diffusion by Source Jurisdiction... 334 Top Patents... 334 Table 5.5 - Top Patents Identified in the Skin Diffusion Group... 334 US6454710: Johnson & Johnson...335 Figure 5.53 Representative Image in US6454710... 335 Figure 5.54 Top 20 Companies Citing US6454710... 336 5.6 Detection and Monitoring Periodic Non Invasive Optical... 337 Figure 5.55 Non Invasive - Optical Top Assignees... 337 Priority Date by Year:... 338 Figure 5.56 - Non Invasive - Optical by Priority Date... 338 Priority Date by Year by Assignee:... 338 Figure 5.57 - Non Invasive - Optical by Priority Date... 338 Published Date by Year:... 339 Figure 5.58 - Non Invasive - Optical by Published Date... 339 IPC Analysis Top 10 Codes:... 340 Figure 5.59 - Non Invasive - Optical by IPC Code...340 USPC Analysis Top 10 Codes:... 341 Figure 5.60 - Non Invasive - Optical by USP Class Code... 341 Text Clustering Analysis:... 342 Figure 5.61 Non Invasive - Optical - Text Clustering Analysis... 342 Source Jurisdiction:... 343 Figure 5.62 - Non Invasive - Optical by Source Jurisdiction... 343 Top Patents...344 xii

Diabetes Landscape: Table of Contents Table 5.6- Top Patents Identified in the Non Invasive Optical Group...344 US5743262: Masimo Corporation... 345 Figure 5.63 Representative Image in US5743263... 345 Figure 5.64 Top 20 Companies Citing US5743263...346 US6040578: Sensys Medical Inc...347 Figure 5.65 Patent Diagram of US6040578... 347 Figure 5.66 Top 20 Companies Citing US6040578...348 5.7 Detection and Monitoring Periodic Non Invasive Other...349 Figure 5.67 Non-Invasive Other Top Assignees...349 Priority Date by Year:... 350 Figure 5.68 Non-Invasive Other by Priority Date... 350 Priority Date by Year by Assignee:... 350 Figure 5.69 - Non-Invasive Other by Priority Date by Assignee... 350 Published Date by Year:... 351 Figure 5.70 - Non-Invasive Other by Published Date... 351 IPC Analysis Top 10 Codes:... 352 Figure 5.71 - Non Invasive Other by IPC Code... 352 USPC Analysis Top 10 Codes:... 353 Figure 5.72 - Non Invasive Other by USPC Code... 353 Text Clustering Analysis:... 354 Figure 5.73 Non Invasive Other - Text Clustering Analysis... 354 Source Jurisdiction:... 355 Figure 5.74 Non-Invasive - Other by Source Jurisdiction... 355 Top Patents... 355 Table 5.7 - Top Patents Identified in the Non Invasive Other Group... 355 US6572542: Medtronic Inc...356 Figure 5.75 Representative Image in US6572542... 356 Figure 5.76 Top 20 Companies Citing US6572542... 357 5.8 Detection and Monitoring Continuous Non-Implanted... 358 Figure 5.77 Continuous Non-Implanted Top Assignees... 358 Priority Date by Year:... 359 Figure 5.78 - Continuous Non-Implanted by Priority Date... 359 Priority Date by Year by Assignee:... 359 Figure 5.79 - Continuous Non-Implanted by Priority Date by Assignee... 359 Published Date by Year:... 360 Figure 5.80 - Continuous Non-Implanted by Published Date...360 IPC Analysis Top 10 Codes:... 361 Figure 5.81 - Continuous Non-Implanted by IPC Code... 361 USPC Analysis Top 10 Codes:... 362 Figure 5.82 - Continuous Non-Implanted by USPC Code...362 Figure 5.83 Continuous Non-Implanted -Text Clustering Analysis... 363 Source Jurisdiction:... 364 Figure 5.84 - Continuous Non-Implanted by Source Jurisdiction...364 Top Patents... 365 Table 5.8 - Top Patents Identified in the Continuous Non-Implanted Group... 365 US6931327: Dexcom, Inc.... 366 Figure 5.85 Representative Image in US6931327...366 Figure 5.86 Top 20 Companies Citing US6931327... 367 5.9 Detection and Monitoring Continuous Implanted...368 Figure 5.87 Continuous Implanted Top Assignees...368 Priority Date by Year:... 369 Figure 5.88 - Continuous Implanted by Priority Date... 369 Priority Date by Year by Assignee:... 369 Figure 5.89 - Continuous Implanted by Priority Date by Assignee... 369 Published Date by Year:... 370 xiii

Table of Contents Diabetes Landscape: Figure 5.90 - Continuous Implanted by Published Date... 370 IPC Analysis Top 10 Codes:... 371 Figure 5.91 - Continuous Implanted by IPC Code... 371 USPC Analysis Top 10 Codes:... 372 Figure 5.92 - Continuous Implanted by USPC Code... 372 Text Clustering Analysis:... 373 Figure 5.93 Continuous Implanted - Text Clustering Analysis... 373 Source Jurisdiction:...374 Figure 5.94 - Continuous Implanted by Source Jurisdiction... 374 Top Patents... 375 Table 5.9 - Top Patents Identified in the Continuous Implanted Group... 375 Figure 5.95 Representative Image in US6001067... 376 Figure 5.96 Top 20 Companies Citing US6001067... 377 5.10 Treatment Manual Syringe... 378 Figure 5.97 Syringe Top Assignees... 378 Priority Date by Year:... 379 Figure 5.98 - Syringe by Priority Date... 379 Priority Date by Year by Assignee:... 379 Figure 5.99 - Syringe by Priority Date by Assignee... 379 Published Date by Year:... 380 Figure 5.100 - Syringe by Published Date...380 IPC Analysis Top 10 Codes:... 381 Figure 5.101 - Syringe by IPC Code... 381 USPC Analysis Top 10 Codes:... 382 Figure 5.102 - Syringe by USPC Code...382 Text Clustering Analysis:... 383 Figure 5.103 Syringe - Text Clustering Analysis...383 Source Jurisdiction:... 384 Figure 5.104 - Syringe by Source Jurisdiction...384 Top Patents... 384 Table 5.10 - Top Patents Identified in the Syringe Group...384 US6254586: Medtronic, Inc.... 385 Figure 5.105 Representative Image in US6254586...385 Figure 5.106 Top 20 Companies Citing US6254586...386 5.11 Treatment Manual Pen...387 Figure 5.107 Pen Top Assignees... 387 Priority Date by Year:... 388 Figure 5.108 - Pen by Priority Date...388 Priority Date by Year by Assignee:... 388 Figure 5.109 - Pen by Priority Date by Assignee...388 Published Date by Year:... 389 Figure 5.110 - Pen by Published Date...389 IPC Analysis Top 10 Codes:... 390 Figure 5.111 - Pen by IPC Code...390 USPC Analysis Top 10 Codes:... 391 Figure 5.112 - Pen by USPC Code... 391 Text Clustering Analysis:... 392 Figure 5.113 Pen - Text Clustering Analysis... 392 Source Jurisdiction:... 393 Figure 5.114 - Pen by Source Jurisdiction... 393 Top Patents... 394 Table 5.11 - Top Patents Identified in the Pen Group...394 US6192891: Becton, Dickinson and Company...395 Figure 5.115 Representative Image in US6192891... 395 Figure 5.116 Top 20 Companies Citing US6192891...396 xiv

Diabetes Landscape: Table of Contents US5514097: Roche Holding Ltd....397 Figure 5.117 Representative Image in US5514097... 397 Figure 5.118 Top 20 Companies Citing US5514097...398 5.12 Treatment Manual - Patch...399 Figure 5.119 Patch Top Assignees...399 Priority Date by Year:...400 Figure 5.120 - Patch by Priority Date...400 Priority Date by Year by Assignee:...400 Figure 5.121 - Patch by Priority Date by Assignee...400 Published Date by Year:... 401 Figure 5.122 - Patch by Published Date...401 IPC Analysis Top 10 Codes:... 402 Figure 5.123 - Patch by IPC Code...402 USPC Analysis Top 10 Codes:... 403 Figure 5.124 - Patch by USPC Code...403 Text Clustering Analysis:...404 Figure 5.125 Patch - Text Clustering Analysis...404 Source Jurisdiction:... 405 Figure 5.126 - Patch by Source Jurisdiction...405 Top Patents... 405 Table 5.12 - Top Patents Identified in the Patch Group...405 US6682757: Purdue Pharma LP... 406 Figure 5.127 Representative Image in US6682757...406 Figure 5.128 Top 20 Companies Citing US6682757...407 5.13 Treatment Manual Other...408 Figure 5.129 Treatment - Other Top Assignees...408 Priority Date by Year:...409 Figure 5.130 Treatment Other by Priority Date...409 Priority Date by Year by Assignee:... 409 Figure 5.131 Treatment Other by Priority Date by Assignee...409 Published Date by Year:...410 Figure 5.132 - Treatment Other by Published Date... 410 IPC Analysis Top 10 Codes:...411 Figure 5.133 Treatment Other by IPC Code... 411 USPC Analysis Top 10 Codes:...412 Figure 5.134 Treatment - Other by USPC Code... 412 Text Clustering Analysis:...413 Figure 5.135 Treatment Other - Text Clustering Analysis... 413 Source Jurisdiction:...414 Figure 5.136 Treatment - Other by Source Jurisdiction... 414 Top Patents...414 Table 5.13 - Top Patents Identified in the Treatment Other Group... 414 US6313093: Novartis AG...415 Figure 5.137 Top 20 Companies Citing US6313093... 415 5.14 Treatment Automatic External Pump... 416 Figure 5.138 External Pump Top Assignees... 416 Priority Date by Year:...417 Figure 5.139 - External Pump by Priority Date... 417 Priority Date by Year by Assignee:...417 Figure 5.140 - External Pump by Priority Date by Assignee... 417 Published Date by Year:...418 Figure 5.141 - External Pump by Published Date... 418 IPC Analysis Top 10 Codes:...419 Figure 5.142 - External Pump by IPC Code... 419 USPC Analysis Top 10 Codes:... 420 xv

Table of Contents Diabetes Landscape: Figure 5.143 - External Pump by USPC Code... 420 Text Clustering Analysis:... 421 Figure 5.144 External Pump - Text Clustering Analysis... 421 Source Jurisdiction:... 422 Figure 5.145 - External Pump by Source Jurisdiction... 422 Top Patents... 422 Table 5.14 - Top Patents Identified in the External Pump Group... 422 US6740059: Insulet Corporation Devices... 423 Figure 5.146 Representative Image in US6740059... 423 Figure 5.147 Top 20 Companies Citing US6740059... 424 5.15 Treatment Automatic Implanted Pump... 425 Figure 5.148 Implanted Pump Top Assignees... 425 Priority Date by Year:... 426 Figure 5.149 - Implanted Pump by Priority Date... 426 Priority Date by Year by Assignee:... 426 Figure 5.150 - Implanted Pump by Priority Date by Assignee... 426 Published Date by Year:... 427 Figure 5.151 - Implanted Pump by Published Date... 427 IPC Analysis Top 10 Codes:... 428 Figure 5.152 - Implanted Pump by IPC Code... 428 USPC Analysis Top 10 Codes:... 429 Figure 5.153 - Implanted Pump by USPC Code... 429 Text Clustering Analysis:... 430 Figure 5.154 Implanted Pump - Text Clustering Analysis... 430 Source Jurisdiction:... 431 Figure 5.155 - Implanted Pump by Source Jurisdiction... 431 Top Patents... 431 Table 5.15 - Top Patents Identified in the Implanted Pump Group... 431 US5569186: Medtronic, Inc.... 432 Figure 5.156 Representative Image in US5569186... 432 Figure 5.157 Top 20 Companies Citing US5569186... 433 5.16 Treatment Automatic SW and Algorithms...434 Figure 5.158 SW/Algorithm Top Assignees... 434 Priority Date by Year:... 435 Figure 5.159 - SW/Algorithm by Priority Date... 435 Priority Date by Year by Assignee:... 435 Figure 5.160 - SW/Algorithm by Priority Date by Assignee... 435 Published Date by Year:... 436 Figure 5.161 - SW/Algorithm by Published Date... 436 IPC Analysis Top 10 Codes:... 437 Figure 5.162 - SW/Algorithm by IPC Code... 437 USPC Analysis Top 10 Codes:... 438 Figure 5.163 - SW/Algorithm by USPC Code... 438 Text Clustering Analysis:... 439 Figure 5.164 SW/Algorithm - Text Clustering Analysis... 439 Source Jurisdiction:...440 Figure 5.165 - SW/Algorithm by Source Jurisdiction...440 Top Patents... 441 Table 5.16 - Top Patents Identified in the SW/Algorithms Group...441 US6168563: Robert Bosch GmbH... 442 Figure 5.166 Front Page Diagram of US6168573...442 Figure 5.167 Top 20 Companies Citing US6168573...443 US6809653: Medtronic, Inc.... 444 Figure 5.168 Representative Image in US6809653...444 Figure 5.169 Top 20 Companies Citing US6809653...445 xvi

Diabetes Landscape: Table of Contents 5.17 Artificial Pancreas...446 Figure 5.170 Artificial Pancreas Top Assignees...446 Priority Date by Year:... 447 Figure 5.171 - Artificial Pancreas by Priority Date...447 Priority Date by Year by Assignee:... 447 Figure 5.172 - Artificial Pancreas by Priority Date by Assignee...447 Published Date by Year:...448 Figure 5.173 - Artificial Pancreas by Published Date...448 IPC Analysis Top 10 Codes:... 449 Figure 5.174 - Artificial Pancreas by IPC Code...449 USPC Analysis Top 10 Codes:... 450 Figure 5.175 - Artificial Pancreas by USPC Code... 450 Text Clustering Analysis:... 451 Figure 5.176 Artificial Pancreas - Text Clustering Analysis... 451 Source Jurisdiction:... 452 Figure 5.177 - Artificial Pancreas by Source Jurisdiction... 452 Top Patents... 453 Table 5.17 - Top Patents Identified in the Artificial Pancreas Group... 453 US6175752: Abbott Laboratories... 454 Figure 5.178 Representative Image in US6175752...454 Figure 5.179 Top 20 Companies Citing US6175752... 455 US6122536: Johnson & Johnson... 456 Figure 5.180 Representative Image in US6122536... 456 Figure 5.181 Top 20 Companies Citing US6122536... 457 6.0 PATENT ANALYSIS BY KEY COMPANIES... 458 Figure 6.1 Number of Patents versus Revenue for Highlighted Companies... 459 Litigation... 460 Figure 6.2 Litigation Analysis...460 6.1 Johnson & Johnson... 461 Johnson & Johnson Overall Patent Portfolio...461 Priority Date by Year:... 461 Figure 6.3 Johnson & Johnson Overall Patent Portfolio by Priority Year... 461 Published Date by Year:... 462 Figure 6.4 Johnson & Johnson Overall Patent Portfolio by Published Year...462 Source Jurisdiction:... 462 Figure 6.5 Johnson & Johnson Overall Patent Portfolio Source Jurisdiction...462 Johnson & Johnson Patents Specific to This Study... 463 Figure 6.6 Johnson & Johnson Diabetes Patents by Technology Group...463 Priority Date by Year:...464 Figure 6.7 - Johnson & Johnson Diabetes Patents by Priority Year...464 Publication Date by Year:... 464 Figure 6.8 Johnson & Johnson Diabetes Patents by Published Year...464 IPC Analysis Top 10 Codes:... 465 Figure 6.9 Johnson & Johnson Diabetes Patents by IPC Code...465 USPC Analysis Top 10 Codes:...466 Figure 6.10 Johnson & Johnson Diabetes Patents by USPC Code...466 Source Jurisdiction:... 467 Figure 6.11 Johnson & Johnson Diabetes Patents by Source Jurisdiction...467 6.2 Abbott Laboratories...468 Abbott Overall Patent Portfolio... 468 Priority Date by Year:...468 Figure 6.12 - Abbott Overall Patent Portfolio by Priority Year...468 Published Date by Year:... 469 Figure 6.13 Abbott Overall Patent Portfolio by Published Year...469 xvii

Table of Contents Diabetes Landscape: Source Jurisdiction:... 469 Figure 6.14 Abbott Overall Patent Portfolio by Source Jurisdiction...469 Abbott Patents Specific to This Study...470 Figure 6.15 Abbott Diabetes Patents by Technology Group... 470 Priority Date by Year:... 471 Figure 6.16 - Abbott Diabetes Patents by Priority Year... 471 Publication Date by Year:... 472 Figure 6.17 Abbott Diabetes Patents by Published Year... 472 IPC Analysis Top 10 Codes:... 473 Figure 6.18 Abbott Diabetes Patents by IPC Code... 473 USPC Analysis Top 10 Codes:...474 Figure 6.19 Abbott Diabetes Patents by USPC Code... 474 Source Jurisdiction:... 475 Figure 6.20 Abbott Diabetes Patents by Source Jurisdiction... 475 6.3 Roche Holding Ltd... 476 Roche Overall Patent Portfolio...476 Priority Date by Year:... 476 Figure 6.21 Roche Overall Patent Portfolio by Priority Year... 476 Published Date by Year:... 477 Figure 6.22 - Roche Overall Patent Portfolio by Published Year... 477 Source Jurisdiction:... 477 Figure 6.23 - Roche Overall Patent Portfolio by Source Jurisdiction... 477 Roche Patents Specific to This Study...478 Figure 6.24 Roche Diabetes Patents by Technology Group... 478 Priority Date by Year:... 479 Figure 6.25 - Roche Diabetes Patents by Priority Year... 479 Publication Date by Year:...480 Figure 6.26 - Roche Diabetes Patents by Published Year...480 IPC Analysis Top 10 Codes:... 481 Figure 6.27 - Roche Diabetes Patents by IPC Code...481 USPC Analysis Top 10 Codes:... 482 Figure 6.28 - Roche Diabetes Patents by USPC Code...482 Source Jurisdiction:... 483 Figure 6.29 Roche Diabetes Patents by Source Jurisdiction...483 6.4 Medtronic Inc...484 Medtronic Overall Patent Portfolio... 484 Priority Date by Year:...484 Figure 6.30 - Medtronic Overall Patent Portfolio by Priority Year...484 Published Date by Year:... 485 Figure 6.31 - Medtronic Overall Patent Portfolio by Published Year...485 Source Jurisdiction:... 485 Figure 6.32 Medtronic Overall Patent Portfolio by Source Jurisdiction...485 Medtronic Patents Specific to This Study... 486 Figure 6.33 Medtronic Diabetes Patents by Technology Group...486 Priority Date by Year:... 487 Figure 6.34 - Medtronic Diabetes Patents by Priority Year...487 Publication Date by Year:...488 Figure 6.35 - Medtronic Diabetes Patents by Published Year...488 IPC Analysis - Top 10 Codes:... 489 Figure 6.36 - Medtronic Diabetes Patents by IPC Code...489 USPC Analysis- Top 10 Codes:... 490 Figure 6.37 - Medtronic Diabetes Patents by USPC Code...490 Source Jurisdiction:... 491 Figure 6.38 Medtronic Diabetes Patents by Source Jurisdiction... 491 6.5 Becton, Dickinson and Co... 492 xviii

Diabetes Landscape: Table of Contents Becton, Dickinson and Co Overall Patent Portfolio...492 Priority Date by Year:... 492 Figure 6.39 Becton, Dickinson and Co Overall Patent Portfolio by Priority Year... 492 Published Date by Year:... 493 Figure 6.40 Becton, Dickinson and Co Overall Patent Portfolio by Published Year... 493 Source Jurisdiction:... 493 Figure 6.41 Becton, Dickinson and Co Overall Patent Portfolio by Source Jurisdiction... 493 Becton, Dickinson and Co Patents Specific to This Study... 494 Figure 6.42 Becton, Dickinson and Co Diabetes Patents by Technology Group...494 Priority Date by Year:... 495 Figure 6.43 Becton, Dickinson and Co Diabetes Patents by Priority Year...495 Publication Date by Year:... 496 Figure 6.44 Becton, Dickinson and Co Diabetes Patents by Published Year...496 IPC Analysis Top 10 Codes:... 497 Figure 6.45 Becton, Dickinson and Co Diabetes Patents by IPC Code... 497 USPC Analysis Top 10 Codes:... 498 Figure 6.46 Becton, Dickinson and Co Diabetes Patents by USPC Code...498 Source Jurisdiction:... 499 Figure 6.47 Becton, Dickinson and Co Diabetes Patents by Source Jurisdiction...499 6.6 Dexcom INC...500 Dexcom Overall Patent Portfolio... 500 Priority Date by Year:... 500 Figure 6.48 - Dexcom Overall Patent Portfolio by Priority Year...500 Published Date by Year:... 501 Figure 6.49 - Dexcom Overall Patent Portfolio by Published Year... 501 Source Jurisdiction:... 501 Figure 6.50 - Dexcom Overall Patent Portfolio by Source Jurisdiction... 501 Dexcom Patents Specific to This Study... 502 Figure 6.51 Dexcom Diabetes Patents by Technology Group...502 Priority Date by Year:... 503 Figure 6.52 - Dexcom Diabetes Patents by Priority Year... 503 Publication Date by Year:... 504 Figure 6.53 Dexcom Diabetes Patents by Published Year...504 IPC Analysis Top 10 Codes:... 505 Figure 6.54 Dexcom Diabetes Patents by IPC Code...505 USPC Analysis Top 10 Codes:... 506 Figure 6.55 Dexcom Diabetes Patents by USPC Code...506 Source Jurisdiction:... 507 Figure 6.56 Dexcom Diabetes Patents by Source Jurisdiction... 507 6.7 Novo Nordisk A/S...508 Novo Nordisk Overall Patent Portfolio... 508 Priority Date by Year:... 508 Figure 6.57 - Novo Nordisk Overall Patent Portfolio by Priority Year...508 Published Date by Year:... 509 Figure 6.58 - Novo Nordisk Overall Patent Portfolio by Published Year...509 Source Jurisdiction:... 509 Figure 6.59 - Novo Nordisk Overall Patent Portfolio by Source Jurisdiction...509 Novo Nordisk Patents Specific to This Study...510 Figure 6.60 Novo Nordisk Diabetes Patents by Technology Group... 510 Priority Date by Year:...511 Figure 6.61 - Novo Nordisk Diabetes Patents by Priority Year... 511 Publication Date by Year:...512 Figure 6.62 - Novo Nordisk Diabetes Patents by Published Year... 512 IPC Analysis Top 10: Codes...513 Figure 6.63 - Novo Nordisk Diabetes Patents by IPC Code... 513 xix

Table of Contents Diabetes Landscape: USPC Analysis Top 10 Codes:...514 Figure 6.64 - Novo Nordisk Diabetes Patents by USPC Code... 514 Source Jurisdiction:...515 Figure 6.65 Novo Nordisk Diabetes Patents by Source Jurisdiction... 515 6.8 Bayer AG... 516 Bayer Overall Patent Portfolio...516 Priority Date by Year:...516 Figure 6.66 - Bayer Overall Patent Portfolio by Priority Year... 516 Published Date by Year:...517 Figure 6.67 - Bayer Overall Patent Portfolio by Published Year... 517 Source Jurisdiction:...517 Figure 6.68 - Bayer Overall Patent Portfolio by Source Jurisdiction... 517 Bayer Patents Specific to This Study...518 Figure 6.69 Bayer Diabetes Patents by Technology Group... 518 Priority Date by Year:...519 Figure 6.70 - Bayer Diabetes Patents by Priority Year... 519 Publication Date by Year:... 520 Figure 6.71 - Bayer Diabetes Patents by Published Year... 520 IPC Analysis Top 10 Codes:... 521 Figure 6.72 - Bayer Diabetes Patents by IPC Code... 521 USPC Analysis Top 10 Codes:... 522 Figure 6.73 - Bayer Diabetes Patents by USPC Code... 522 Source Jurisdiction:... 523 Figure 6.74 Bayer Diabetes Patents by Source Jurisdiction... 523 6.9 Insulet Corporation... 524 Insulet Overall Patent Portfolio...524 Priority Date by Year:... 524 Figure 6.75 - Insulet Overall Patent Portfolio by Priority Year... 524 Published Date by Year:... 525 Figure 6.76 Insulet Overall Patent Portfolio by Published Year... 525 Source Jurisdiction:... 525 Figure 6.77 Insulet Overall Patent Portfolio by Source Jurisdiction... 525 Insulet Patents Specific to This Study...526 Figure 6.78 Insulet Diabetes Patents by Technology Group... 526 Priority Date by Year:... 527 Figure 6.79 - Insulet Diabetes Patents by Priority Year... 527 Publication Date by Year:... 528 Figure 6.80 Insulet Diabetes Patents by Published Year... 528 IPC Analysis Top 10 Codes:... 529 Figure 6.81 Insulet Diabetes Patents by IPC Code... 529 USPC Analysis Top 10 Codes:... 530 Figure 6.82 Insulet Diabetes Patents by USPC Code... 530 Source Jurisdiction:... 531 Figure 6.83 Insulet Diabetes Patents by Source Jurisdiction... 531 6.10 Nipro Diagnostic... 532 Nipro Overall Patent Portfolio...532 Priority Date by Year:... 532 Figure 6.84 Nipro Overall Patent Portfolio by Priority Year... 532 Published Date by Year:... 533 Figure 6.85 Nipro Overall Patent Portfolio by Published Year... 533 Source Jurisdiction:... 533 Figure 6.86 Nipro Overall Patent Portfolio by Source Jurisdiction... 533 Nipro Patents Specific to This Study... 534 Figure 6.87 Nipro Diabetes Patents by Technology Group... 534 Priority Date by Year:... 535 xx

Diabetes Landscape: Table of Contents Figure 6.88 - Nipro Diabetes Patents by Priority Year... 535 Publication Date by Year:... 536 Figure 6.89 Nipro Diabetes Patents by Published Year... 536 IPC Analysis Top 10 Codes:... 537 Figure 6.90 Nipro Diabetes Patents by IPC Code... 537 USPC Codes Top 10 Codes:... 538 Figure 6.91 Nipro Diabetes Patents by USPC Code... 538 Source Jurisdiction:... 539 Figure 6.92 Nipro Diabetes Patents by Source Jurisdiction... 539 6.11 Arkray Inc...540 Arkray Overall Patent Portfolio... 540 Priority Date by Year:... 540 Figure 6.93 Arkray Overall Patent Portfolio by Priority Year...540 Published Date by Year:... 541 Figure 6.94 Arkray Overall Patent Portfolio by Published Year... 541 Source Jurisdiction:... 541 Figure 6.95 Arkray Overall Patent Portfolio by Source Jurisdiction... 541 Arkray Patents Specific to This Study... 542 Figure 6.96 Arkray Diabetes Patents by Technology Group... 542 Priority Date by Year:... 543 Figure 6.97 - Arkray Diabetes Patents by Priority Year... 543 Publication Date by Year:...544 Figure 6.98 Arkray Diabetes Patents by Published Year...544 IPC Analysis Top 10 Codes:... 545 Figure 6.99 Arkray Diabetes Patents by IPC Code...545 USPC Analysis Top 10 Codes:... 546 Figure 6.100 Arkray Diabetes Patents by USPC Code...546 Source Jurisdiction:... 547 Figure 6.101 Arkray Diabetes Patents by Source Jurisdiction... 547 6.12 Sanofi Aventis SA...548 Sanofi-Aventis Overall Patent Portfolio... 548 Priority Date by Year:... 548 Figure 6.102 - Sanofi-Aventis Overall Patent Portfolio by Priority Year...548 Published Date by Year:... 549 Figure 6.103 - Sanofi-Aventis Overall Patent Portfolio by Published Year...549 Source Jurisdiction:... 549 Figure 6.104 - Sanofi-Aventis Overall Patent Portfolio by Source Jurisdiction...549 Sanofi-Aventis Patents Specific to Diabetes Project... 550 Figure 6.105 Sanofi-Aventis Diabetes Patents by Technology Group... 550 Priority Date by Year:... 551 Figure 6.106 - Sanofi-Aventis Diabetes Patents by Priority Year... 551 Published Date by Year:... 552 Figure 6.107 - Sanofi-Aventis Diabetes Patents by Published Year... 552 IPC Analysis Top 10 Codes:... 553 Figure 6.108 - Sanofi-Aventis Diabetes Patents by IPC Code... 553 USPC Analysis Top 10 Codes:... 554 Figure 6.109 - Sanofi-Aventis Diabetes Patents by USPC Code... 554 Source Jurisdiction:... 555 Figure 6.110 Sanofi-Aventis Diabetes Patents by Source Jurisdiction... 555 7.0 SUMMARY OF PATENT AND PRODUCT POSITIONS OF TOP DIABETES DEVICE COMPANIES... 556 Table 7.1 Table of Highlighted Companies and Technologies... 556 8.0 APPENDIX A - ASSUMPTIONS... 557 Patent...557 Current Assignee vs. Ultimate Parent...557 xxi