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DIABETES LANDSCAPE Market, Technology and Intellectual Property A Joint Research Report from Espicom and UBM TechInsights. May 2012

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DIABETES LANDSCAPE

Market, Technology and

Intellectual Property

A Joint Research Report from

Espicom and UBM TechInsights.

May 2012

Diabetes Landscape: Market, Technology and Intellectual Property

May 2012

© 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.

May 2012ii © Espicom Business Intelligence © 2012 UBM Semiconductor Insights

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

Table of Contents

CONTENTSEXECUTIVE SUMMARY

Volume I ................................................................................................................................................................................... 1Current Technologies ............................................................................................................................................................................... 2Geographic Trends .................................................................................................................................................................................... 2Volume II .................................................................................................................................................................................. 2Intellectual Property Trends ................................................................................................................................................................... 3Technology Trends .................................................................................................................................................................................... 3

VOLUME I DIABETES INDUSTRY ANALYSIS

1.0 MARKET OVERVIEW .....................................................................................................................................71.1 BACKGROUND ............................................................................................................................................................................7

1.1.1 Diagnosis and Management of Diabetes ..................................................................................................................... 8Insulin-Dependant Diabetes Patients ................................................................................................................................................... 9Current Trends in Diabetes Care ............................................................................................................................................................. 9

1.2 THE GLOBAL DIABETES BURDEN ...........................................................................................................................................101.2.1 Diabetes Prevalence .................................................................................................................................................... 10Fig.1.0: Diabetes Prevalence by Geographic Region, 2011-2030 ...................................................................................................................................................................11Diabetes Prevalence for the Top 10 Countries, 2011-2030 (million) ..............................................................................................................................................................11Burden of Metabolic Risk Factors of Chronic Diseases Collaborating Group Study ................................................................... 121.2.2 Mortality ...................................................................................................................................................................... 121.2.3 Diabetes Complications ............................................................................................................................................. 131.2.4 The Cost of Diabetes .................................................................................................................................................... 14

1.3 THE DIABETES DEVICE MARKET ............................................................................................................................................151.3.1 Product Segments ....................................................................................................................................................... 16Fig.1.2: Diabetes Device Market by Major Product Category, 2011 ...............................................................................................................................................................16Fig.1.3: Percentage of US Diabetes Patients by Treatment Type, 2007-2009 ................................................................................................................................................17Fig.1.4: Diabetes Device Market by Product Type, 2011 .................................................................................................................................................................................181.3.2 Current Market Trends ............................................................................................................................................... 19Fig.1.5: Global Diabetes Device Market, 2011 (US$ billion) ...........................................................................................................................................................................19Global Diabetes Market by Product Type, 2005-2011 (US$ million) .............................................................................................................................................................20Fig.1.6: Global Diabetes Market By Product Type, 2005-2011 (US$ billion) ..................................................................................................................................................20Global Diabetes Market Growth Rates by Product Type, 2006-2011 (%) .....................................................................................................................................................21Fig.1.7: Global Diabetes Device Market Growth Rates, 2006-2011 (%) ........................................................................................................................................................211.3.3 Regional Perspective .................................................................................................................................................. 21Fig.1.8: Global Diabetes Device Market by Region, 2011 ...............................................................................................................................................................................22Fig.1.9: US Market by Product Type, 2011 ......................................................................................................................................................................................................22Fig.1.10: European Market by Product Type, 2011 ........................................................................................................................................................................................23Fig.1.11: Other Regions by Product Type, 2011 ..............................................................................................................................................................................................23

1.4 COMPETITIVE ENVIRONMENT ...............................................................................................................................................24Fig.1.12: Diabetes Device Market Share by Company, 2011 ...........................................................................................................................................................................25Key Companies’ Diabetes Care Sales, 2005-2011 (US$ million) ....................................................................................................................................................................25Non-US Companies’ Diabetes Sales in Reported Currency, 2005-2011 (million) ..........................................................................................................................................25Leading Companies’ International Diabetes Care Sales, 2005-2011 (US$ million) .......................................................................................................................................26Leading Companies’ US Diabetes Care Sales, 2005-2011 (US$ million) ........................................................................................................................................................261.4.1 New Market Entrants ...................................................................................................................................................261.4.2 Market Withdrawals ....................................................................................................................................................271.4.3 Rounding Out Product Portfolios ..............................................................................................................................28Key Companies: Market Presence & Position by Product Area ......................................................................................................................................................................28Key Companies: Current & Future Potential Market Presence by Product Area ............................................................................................................................................291.4.4 Market Consolidation .................................................................................................................................................29

1.5 GROWTH DRIVERS, RESTRAINTS AND FUTURE OPPORTUNITIES ....................................................................................301.5.1 Regulatory and Reimbursement Environment ........................................................................................................ 31

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1.5.2 Connectivity and Data Integration ............................................................................................................................32The Role of Telemonitoring in Diabetes Care ....................................................................................................................................32Safety Issues .............................................................................................................................................................................................331.5.3 Emerging Technologies ..............................................................................................................................................34New-Generation Insulin Delivery Devices ......................................................................................................................................... 34Development of a Closed-Loop System ..............................................................................................................................................35Rival Technologies ..................................................................................................................................................................................35

1.6 MARKET EXPECTATIONS ........................................................................................................................................................ 38Fig.1.13: Global Diabetes Device Market, 2011-2017E (US$ billion) ..............................................................................................................................................................38Global Diabetes Market Forecast by Product Type, 2011-2017E (US$ million) ............................................................................................................................................. 39Global Diabetes Market Forecast Growth Rates by Product, 2011-2017E (%) ............................................................................................................................................. 39Fig.1.14: Global Monitoring Market Forecast, 2011-2017E (US$ billion) ....................................................................................................................................................... 39Fig.1.15: Global Insulin Delivery Market Forecast, 2011-2017(E) (US$ billion) .............................................................................................................................................40Fig.1.16: Diabetes Device Market by Product, 2017E ....................................................................................................................................................................................40

2.0 DIABETES MONITORING PRODUCTS .......................................................................................................41Overview: Glucose Monitoring Products ...........................................................................................................................42

2.1 MARKET DYNAMICS ............................................................................................................................................................... 44Fig.2.1: Global Glucose Monitoring Market, 2005-2011 (US$ billion)...........................................................................................................................................................44Fig.2.2: Global Blood Monitoring Market Growth, 2005-2011 (%) .............................................................................................................................................................44Fig.2.3: Glucose Monitoring Market by Product Type, 2011 ......................................................................................................................................................................... 45Fig.2.4: Blood Glucose Testing Market by Geographic Region, 2011 ............................................................................................................................................................ 45Public Companies’ Glucose Monitoring Sales, 2005-2011 (US$ million) ...................................................................................................................................................... 45Fig.2.5: Glucose Monitoring Market Shares by Company, 2011 ...................................................................................................................................................................46

2.2 MANUAL SELF-MONITORING BLOOD GLUCOSE PRODUCTS .......................................................................................... 47Fig.2.6: Example of a Classic BGM & Test Strip: Bayer’s Contour Meter .......................................................................................................................................................482.2.1 Current Market Environment .................................................................................................................................... 48Fig.2.7: Global SMBG Market, 2005-2011 (US$ million) ...............................................................................................................................................................................49Fig.2.8: Global SMBG Market Growth Rates, 2005-2011 (%) ......................................................................................................................................................................49Fig.2.9: SMBG Market by Product Type, 2011 ...............................................................................................................................................................................................49Regional Markets and Reimbursement ............................................................................................................................................. 50Fig.2.10: SMBG Market by Region, 2011 .......................................................................................................................................................................................................50Market Developments ............................................................................................................................................................................51Fig.2.11: Mendor’s Discreet (left) & Roche’s Accu-Check Mobile with Attached Lancing Device (right) ....................................................................................................... 51Fig.2.12: BodyTel Europe’s GlucoTel BGM ...................................................................................................................................................................................................... 51Fig.2.13: Medisana’s GlucoDock Attached to an Apple iPhone ................................................................................................................................................................... 52Accuracy Standards ................................................................................................................................................................................53Market Forecast ...................................................................................................................................................................................... 54Summary: SMBG Growth Drivers, Restraints & Opportunities .................................................................................................................................................................... 55Fig.2.14: Global SMBG Market, 2011-2017E (US$ billion) ............................................................................................................................................................................. 55Fig.2.15: Global SMBG Market Growth Rates, 2012-2017E (%) ....................................................................................................................................................................562.2.2 Competitive Environment ..........................................................................................................................................56Public Companies’ BGM Sales, 2005-2011 (US$ million) .............................................................................................................................................................................57Fig.2.16: SMBG Market Share by Company, 2011 .........................................................................................................................................................................................57Fig.2.17: United States SMBG Market Share by Company, 2011 ...................................................................................................................................................................58Fig.2.18: SMBG International Market Share by Company, 2011 ..................................................................................................................................................................582.2.3 Market-Leading Self-Testing Blood Glucose Meters ...............................................................................................591. Abbott’s Blood Glucose Monitors ....................................................................................................................................................592. Arkray’s Glucocard Products ............................................................................................................................................................ 603. Bayer’s Blood Glucose Monitoring Systems ...................................................................................................................................614. Contour USB ........................................................................................................................................................................................ 625. Contour, Contour TS, Contour Link and Breeze 2 ......................................................................................................................... 626. DIDGET Meter ..................................................................................................................................................................................... 637. Elite and Elite XL .................................................................................................................................................................................. 63LifeScan OneTouch Products ................................................................................................................................................................ 63

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Nipro Diagnostics’ TRUE Products ...................................................................................................................................................... 66Roche Diabetes Care’s Products ...........................................................................................................................................................672.2.4 Other Market Participants ..........................................................................................................................................68Competing Self-Testing Blood Glucose Monitoring Products .......................................................................................................................................................................68Product Highlights ..................................................................................................................................................................................712.2.5 Products in Development ...........................................................................................................................................77Intuity Medical’s POGO Blood Glucose Monitoring System ........................................................................................................... 77Pepex Biomedical’s Trio Products ....................................................................................................................................................... 77

2.3 CONTINUOUS GLUCOSE MONITORING .............................................................................................................................. 78Fig.2.19: Example of a CGM: Medtronic’s Guardian REAL-Time System .......................................................................................................................................................782.3.1 The Benefits of CGM ....................................................................................................................................................782.3.2 Barriers to Adoption ...................................................................................................................................................79The Cost of CGM ...................................................................................................................................................................................... 792.3.3 Clinical Trial Results - Highlighting Benefits and Drawbacks .................................................................................792.3.4 The TD1 Exchange: User Experiences of CGM ...........................................................................................................812.3.5 CGM Market Trends and Opportunities ....................................................................................................................82Fig.2.20: Global CGM Market, 2006-2011 (US$ million) ..............................................................................................................................................................................82Fig.2.21: Percentage of CGM Sales Volumes by Hardware & Consumables, 2011 ........................................................................................................................................82Regional Adoption Rates, Regulatory and Reimbursement Environment ................................................................................. 83Fig.2.22: CGM Market by Region, 2011 .........................................................................................................................................................................................................83Future Prospects..................................................................................................................................................................................... 84Fig.2.23: Global CGM Market Forecast, 2011-2017E (US$ million)................................................................................................................................................................85Fig.2.24: Global CGM Market Forecast Growth Rates, 2011-2017E (%) .......................................................................................................................................................86Summary: CGM Benefits, Challenges & Opportunities ................................................................................................................................................................................862.3.6 Competitive Environment ..........................................................................................................................................87Leading Companies’ Reported CGM Sales, 2006-2011 (US$ million) ........................................................................................................................................................... 87Fig.2.25: Global CGM Market Shares by Company, 2011 ..............................................................................................................................................................................88Fig.2.26: US CGM Market Shares by Company, 2011 ....................................................................................................................................................................................88Fig.2.27: International CGM Market Shares by Company, 2011 ...................................................................................................................................................................892.3.7 Currently-Available Products .....................................................................................................................................89Medtronic’s Guardian REAL-Time CGM System ............................................................................................................................... 89DexCom’s CGMs ...................................................................................................................................................................................... 90Abbott’s FreeStyle Navigator ...............................................................................................................................................................91A Menarini Diagnostics’ GlucoDay S ....................................................................................................................................................922.3.8 Products in Development ...........................................................................................................................................92Abbott’s Navigator II ...............................................................................................................................................................................92DexCom’s Research and Development ...............................................................................................................................................92New-Generation Implantable CGM Sensors ......................................................................................................................................93Minimally-Invasive CGM in Development ......................................................................................................................................... 95

2.4 NON-INVASIVE GLUCOSE MONITORING ...........................................................................................................................1002.4.1 Competitive Environment ....................................................................................................................................... 1002.4.2 AIMEDICS’ HypoMon ................................................................................................................................................1012.4.3 Biosign Technologies’ UFIT TEN-20 Non-Invasive Blood Pressure and Glucose Meter 1012.3.4 Biovotion’s Multisensor Glucose Monitoring System ............................................................................................1022.3.5 Integrity Applications’ GlucoTrack ..........................................................................................................................103Clinical Study Results ........................................................................................................................................................................... 1032.3.6 Optical Technologies.................................................................................................................................................105C8 MediSensors Optical Glucose Monitor ....................................................................................................................................... 105EyeSense’s Optical Sensor .................................................................................................................................................................. 105Freedom Meditech’s I-SugarX Glucose Monitoring System ......................................................................................................... 106Grove Instruments’ Grove Glucometer ............................................................................................................................................ 106Lein Applied Diagnostics .................................................................................................................................................................... 107LighTouch Medical’s Non-Invasive Glucose Monitor ..................................................................................................................... 107Massachusetts Institute of Technology’s Raman Spectroscopy System ................................................................................... 108Medtronic’s PreciSense Technology ................................................................................................................................................. 108

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OrSense’s NBM-200G Non-Invasive Blood Glucose Meter ........................................................................................................... 108St Louis Medical Devices Near-Infrared Light-Based System ....................................................................................................... 109Smart Tattoos ........................................................................................................................................................................................ 1092.3.7 Tear Fluid Glucose Sensors .......................................................................................................................................110Mayo Clinic, Arizona State University and BioAccel ........................................................................................................................110University of Washington and Microsoft Research ........................................................................................................................111The University of Western Ontario’s Glucose Monitoring Contact Lenses .................................................................................1112.3.8 Breath-Based Glucose Monitoring .........................................................................................................................112PositiveID’s EasyChek ...........................................................................................................................................................................112Xhale’s Breath-Based Glucose Monitor .............................................................................................................................................112Brown University and Saliva-Based Glucose Testing .....................................................................................................................112

3.0 INSULIN DELIVERY PRODUCTS ...............................................................................................................1143.1 ADDRESSABLE PATIENT POPULATION ...............................................................................................................................116

Fig.3.1: Percentage of US Diabetes Patients by Treatment Type, 2007-2009 ............................................................................................................................................. 1163.2 MARKET TRENDS ...................................................................................................................................................................117

Insulin Delivery Market by Product Type 2005-2011 (US$ million) .............................................................................................................................................................117Fig.3.2: Global Insulin Delivery Market, 2005-2011 (US$ billion) ...............................................................................................................................................................117Fig.3.3: Global Insulin Delivery Market Growth Rates, 2006-2011 (%) ..................................................................................................................................................... 118Fig.3.4: Percentage of Insulin Delivery Market by Product Type, 2011 ....................................................................................................................................................... 118Fig.3.5: Insulin Delivery Market by Geographic Region, 2011 .................................................................................................................................................................... 1193.2.1 Competitive Environment ........................................................................................................................................120Key Companies’ Insulin Delivery Sales, 2006-2011 (US$ million) .............................................................................................................................................................. 120Fig.3.6: Insulin Delivery Market Share by Company, 2011 ......................................................................................................................................................................... 120

3.3 FUTURE MARKET PROSPECTS ............................................................................................................................................ 121Summary: Insulin Delivery Market Growth Drivers, Restraints & Opportunities ...................................................................................................................................... 121Insulin Delivery Market Forecast by Product Type 2011-2017E (US$ million) ............................................................................................................................................. 122Fig.3.7: Global Insulin Delivery Market Forecast, 2011-2017 (US$ billion) ................................................................................................................................................. 122Fig.3.8: Global Insulin Delivery Market Estimated Growth Rates, 2012-2017 (%) .................................................................................................................................... 122Fig.3.9: Estimated Insulin Delivery Market by Product Type, 2017 ............................................................................................................................................................. 123

3.4 MANUAL INSULIN INJECTION PRODUCTS ........................................................................................................................ 124Fig.3.10: Manual Insulin Delivery Method by Product Type, 2011 ............................................................................................................................................................. 124Fig.3.11: Percentage of Novo Nordisk Insulin Sold in Pens by Region, 2011 ............................................................................................................................................... 125Fig.3.12: Manual Insulin Delivery Market by Geographic Region, 2011 ..................................................................................................................................................... 1253.4.1 Insulin Pens ................................................................................................................................................................126Fig.3.13: Example Insulin Pen: Novo Nordisk’s NovoPen 4 ......................................................................................................................................................................... 126Fig.3.14: Global Insulin Pen Market: Disposable vs Reusable Pens, 2011 ................................................................................................................................................... 126Competitive Environment ..................................................................................................................................................................127Fig.3.15: Insulin Pen Use by Manufacturer, 2011 ........................................................................................................................................................................................ 127Currently-Available Products ............................................................................................................................................................. 1283.4.2 Needles and Syringes ................................................................................................................................................130Fig.3.16: Insulin Needles & Syringes Market by Manufacturer, 2011 ......................................................................................................................................................... 131Pen Needles ............................................................................................................................................................................................131

3.5 INSULIN PUMPS .................................................................................................................................................................... 133Fig.3.17: Example Insulin Pump: Medtronic’s MiniMed Paradigm REAL-Time Revel ................................................................................................................................ 133Fig.3.18: Example Insulin Pump: Roche’s Accu-Check Spirit ...................................................................................................................................................................... 133Insulin Pump Market: Growth Drivers, Restraints & Opportunities ........................................................................................................................................................... 1343.5.1 The TD1 Exchange: User Experiences of CGM .........................................................................................................1353.5.2 Current Market Trends .............................................................................................................................................136Fig.3.19: Global Insulin Pump Market, 2005-2011 (US$ million) .............................................................................................................................................................. 136Fig.3.20: Global Insulin Pump Market Growth Rates, 2006-2011 (%) ...................................................................................................................................................... 136Fig.3.21: Insulin Pump Market by Product, 2011 ........................................................................................................................................................................................ 137Regional Perspective ............................................................................................................................................................................137Fig.3.22: Insulin Pump Market by Region, 2011 ......................................................................................................................................................................................... 137Fig.3.23: Insulin Pump Adoption Rates for Type 1 Diabetes Patients by Key Country, 2010 (%) ............................................................................................................... 138

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Regulatory Environment - FDA Infusion Pump Improvement Initiative ................................................................................... 139Negative Publicity and the Potential for Cyber Attacks ................................................................................................................ 140Market Outlook ......................................................................................................................................................................................141Fig.3.24: Global Insulin Pump Market Forecast, 2011-2017 (US$ million) ................................................................................................................................................. 141Fig.3.25: Global Insulin Pump Market Estimated Growth Rates, 2012-2017 (%) ..................................................................................................................................... 1413.5.3 Competitive Environment ........................................................................................................................................142Key Companies’ Insulin Pump Sales, 2005-2011 (US$ million) .................................................................................................................................................................. 142Fig.3.26: Insulin Pump Market Shares, 2011 .............................................................................................................................................................................................. 1433.5.4 Currently-Available Insulin Pumps .........................................................................................................................143Animas Insulin Pumps ......................................................................................................................................................................... 143Asante Solutions’ Pearl Insulin Pump ............................................................................................................................................... 144D Medical Industries’ Spring Pumps and Infusion Sets ................................................................................................................. 144Medtronic’s MiniMed Paradigm Revel Insulin Pump and Infusion Sets .................................................................................... 145Sooil Development’s Diabecare Insulin Pumps .............................................................................................................................. 146Roche Insulin Pumps ........................................................................................................................................................................... 146Tandem Diabetes Care’s t:slim Insulin Delivery System .................................................................................................................147Insulin Delivery Patch Pumps .............................................................................................................................................................1473.5.5 Products in Development .........................................................................................................................................150Becton Dickinson-JDRF Micro-Needle Technology ...................................................................................................................... 150CeQur’s Insulin Patch Infuser ............................................................................................................................................................. 150D Medical Industries’ Spring Hybrid Patch Pump .......................................................................................................................... 150Debiotech’s JewelPUMP .......................................................................................................................................................................151Insulet’s Second-Generation OmniPod ............................................................................................................................................151Insuline Medical’s InsuPatch and InsuPad ........................................................................................................................................151Roche’s SOLO Micropump .................................................................................................................................................................. 152

3.6 ALTERNATIVE INSULIN DELIVERY DEVICES....................................................................................................................... 1533.6.1 Generex Biotechnology’s Oral-lyn ...........................................................................................................................1533.6.2 Insulin Inhalers ..........................................................................................................................................................154Development Considerations ............................................................................................................................................................ 154Fig.3.27: MannKind’s Dreamboat (Gen2) Insulin Inhaler .......................................................................................................................................................................... 155

4.0 COMBINED CGMINSULIN PUMP SYSTEMS ...........................................................................................1574.1 CURRENTLY-AVAILABLE PRODUCTS ................................................................................................................................. 158

4.1.1 Medtronic’s Paradigm Integrated Diabetes Management Products ....................................................................158Paradigm REAL-Time Revel ................................................................................................................................................................ 158Fig.4.1: MiniMed Paradigm REAL-Time System .......................................................................................................................................................................................... 158Enlite CGM Sensor ................................................................................................................................................................................ 159Clinical Trials .......................................................................................................................................................................................... 159ONSET Study ......................................................................................................................................................................................... 160REAL Trend Study ................................................................................................................................................................................. 1604.1.2 Animas Vibe ...............................................................................................................................................................161

4.2 PRODUCTS IN DEVELOPMENT ............................................................................................................................................ 1624.2.1 D Medical Industries’ Combined CGM-Pump System ............................................................................................162

5.0 ARTIFICIAL PANCREAS TECHNOLOGY .................................................................................................. 1635.1 SEMI-CLOSED LOOP SYSTEMS ............................................................................................................................................ 165

5.1.2 Medtronic’s Paradigm Veo System with Low Glucose Suspend ............................................................................165Fig.5.1: Medtronic’s Paradigm Veo System with Low Glucose Suspend ..................................................................................................................................................... 165ASPIRE Study ........................................................................................................................................................................................ 166

5.2 RESEARCH & DEVELOPEMNT ............................................................................................................................................. 1675.2.1 FDA Artificial Pancreas Development Guidelines ..................................................................................................1675.2.2 Key Closed-Loop Development Projects .................................................................................................................168The Juvenile Diabetes Research Foundation’s Artificial Pancreas Project ............................................................................... 168Mayo Clinic ............................................................................................................................................................................................ 172UC Santa Barbara, Sansum Diabetes Research Institute, Mayo Clinic, Universities of Virginia & Padova 172AP@home Project ................................................................................................................................................................................. 172

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MD-Logic Artificial Pancreas System ................................................................................................................................................ 173Medtronic’s Closed-Loop System .......................................................................................................................................................174Rensselaer Polytechnic Institute .......................................................................................................................................................175

6.0 POC MANUFACTURERS ...........................................................................................................................1766.1 POC COMPANY DIRECTORY................................................................................................................................................. 1766.2 LEADING COMPANY PROFILES ...........................................................................................................................................184

6.2.1 Abbott Laboratories .................................................................................................................................................184Recent Key Events .......................................................................................................................................................................................................................................184Blood Glucose Monitors ..................................................................................................................................................................... 185In Development - Navigator II CGM System .................................................................................................................................... 186Alliance with Insulet............................................................................................................................................................................. 187Litigation ............................................................................................................................................................................................... 187Financial Performance ........................................................................................................................................................................ 188Abbott Diabetes Care Sales by Region, 2006-2011 (US$ million) ..............................................................................................................................................................188Fig.6.1: Percentage of Abbott Diabetes Care Revenue by Region, 2011 .....................................................................................................................................................1886.2.2 Arkray .........................................................................................................................................................................189Recent Key Events .......................................................................................................................................................................................................................................189Blood Glucose Self-Testing ................................................................................................................................................................. 189Current Alliances and Contracts .........................................................................................................................................................1916.2.3 Bayer ...........................................................................................................................................................................192Recent Key Events ....................................................................................................................................................................................................................................... 192Blood Glucose Monitoring Systems .................................................................................................................................................. 192Current Alliances .................................................................................................................................................................................. 194Litigation ................................................................................................................................................................................................ 195Financial Performance ........................................................................................................................................................................ 195Bayer Diabetes Care Revenue, 2005-2011 (EUR million) ............................................................................................................................................................................ 1956.2.4 Becton, Dickinson and Company .............................................................................................................................196Recent Key Events .......................................................................................................................................................................................................................................196BD Diabetes Care Products ................................................................................................................................................................. 196Collaboration with the JDRF .............................................................................................................................................................. 197Litigation with Insulet ......................................................................................................................................................................... 197Financial Performance ........................................................................................................................................................................ 197BD Diabetes Care Sales by Region, 2006-2011 (US$ million) .....................................................................................................................................................................198Fig.6.2: Percentage of BD Diabetes Care’s Revenue by Region, 2011 .........................................................................................................................................................1986.2.5 DexCom ......................................................................................................................................................................199Recent Key Events ....................................................................................................................................................................................................................................... 199SEVEN PLUS CGM System .................................................................................................................................................................... 200GlucoClear ............................................................................................................................................................................................. 201Research and Development ............................................................................................................................................................... 201SweetSpot Diabetes Care Acquisition ............................................................................................................................................. 201Current Alliances .................................................................................................................................................................................. 202Litigation with Abbott ........................................................................................................................................................................ 203Financial Performance ........................................................................................................................................................................ 204DexCom - Operating Results, 2007-2011 (US$ thousands) ........................................................................................................................................................................2056.2.6 Insulet ........................................................................................................................................................................ 206Recent Key Events .......................................................................................................................................................................................................................................207OmniPod Insulin Management System ........................................................................................................................................... 207Current Alliances .................................................................................................................................................................................. 208Acquisition of Neighborhood Diabetes ........................................................................................................................................... 209Litigation with Becton, Dickinson and Company .......................................................................................................................... 209Financial Performance ........................................................................................................................................................................ 209Insulet - Operating Results, 2007-2011 (US$ thousands) ........................................................................................................................................................................... 2106.2.7 Johnson & Johnson ...................................................................................................................................................211Recent Key Events ....................................................................................................................................................................................................................................... 211

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Animas Operations ...............................................................................................................................................................................212LifeScan Operations ..............................................................................................................................................................................214Financial Performance .........................................................................................................................................................................217J&J Diabetes Care Revenue, 2006-2011 (US$ million) ............................................................................................................................................................................... 218Fig.6.3: J&J Diabetes Care Sales by Region, 2011 ....................................................................................................................................................................................... 218Fig.6.4: J&J Diabetes Care Sales, 2004-2011 (US$ million) ........................................................................................................................................................................ 2186.2.8 Medtronic...................................................................................................................................................................219Recent Key Events ....................................................................................................................................................................................................................................... 219Integrated Diabetes Management Products .................................................................................................................................. 220Guardian REAL-Time CGM System .................................................................................................................................................... 221iPro Professional Use CGM Products ................................................................................................................................................. 222Enlite CGM Sensor ................................................................................................................................................................................ 222MiniMed Paradigm Revel Insulin Pump and Infusion Sets .......................................................................................................... 222CareLink Software ................................................................................................................................................................................ 223Blood Glucose Meters ......................................................................................................................................................................... 223Clinical Trials .......................................................................................................................................................................................... 224Research and Development ............................................................................................................................................................... 225Alliance with Bayer .............................................................................................................................................................................. 225Financial Performance ........................................................................................................................................................................ 226Fig.6.5: Medtronic Diabetes Revenue, 2005-2011 (US$ million) ................................................................................................................................................................226Medtronic - Diabetes Sales by Region, 2008-2011 (US$ million) ...............................................................................................................................................................227Fig.6.6: Medtronic Diabetes Revenue by Region, 2011 ..............................................................................................................................................................................227Fig.6.7: Medtronic Diabetes Revenue by Product Type, 2010* ...................................................................................................................................................................2276.2.9 Nipro Diagnostics .................................................................................................................................................... 229Recent Key Events .......................................................................................................................................................................................................................................229Blood Glucose Monitoring Products ................................................................................................................................................ 230Blood Glucose Monitors ...................................................................................................................................................................... 2306.2.10 Roche Diabetes Care ...............................................................................................................................................232Recent Key Events ....................................................................................................................................................................................................................................... 232Diabetes Care Products ....................................................................................................................................................................... 233Accu-Chek Combo BGM and Pump System .................................................................................................................................... 234Insulin Pumps ........................................................................................................................................................................................ 234Data Management Tools ..................................................................................................................................................................... 235In Development - SOLO Micropump ................................................................................................................................................. 235Current Alliances and Contracts ........................................................................................................................................................ 236Litigation ................................................................................................................................................................................................ 236Financial Performance ........................................................................................................................................................................ 237Roche Diabetes Care Sales by Product, 2010-2011 (SFr million) ................................................................................................................................................................ 237Roche Diabetes Care Sales by Region, 2006-2011 (SFr million) ................................................................................................................................................................. 237Fig.6.8: Roche Diabetes Care - Revenue by Product Line, 2011 ..................................................................................................................................................................238Fig.6.9: Roche Diabetes Care - Revenue by Region, 2011 ...........................................................................................................................................................................2386.2.11 Ypsomed .................................................................................................................................................................. 239Recent Key Events ....................................................................................................................................................................................................................................... 239mylife Diabetes Care Products .......................................................................................................................................................... 240Ypsomed Delivery Systems ................................................................................................................................................................ 240Acquisition of ICU Medical’s Orbit Infusion Set Business .............................................................................................................. 241Current Alliances .................................................................................................................................................................................. 241Financial Performance ........................................................................................................................................................................ 242Ypsomed - Operating Results, Y/E 31st March 2007-2011 (SFr millions) .................................................................................................................................................... 243Ypsomed - Results by Business Segment, Y/E 31st March 2009-2011 (SFr millions) .................................................................................................................................. 243Ypsomed - Revenue by Geographic Region, Y/E 31st March 2009-2011 (SFr millions) ..............................................................................................................................244Fig.6.10: Ypsomed - Revenue by Business Segment, Fiscal 2010 ...............................................................................................................................................................244Fig.6.11: Ypsomed - Revenue by Geographic Location, Fiscal 2010 ........................................................................................................................................................... 245

7.0 APPENDICES ............................................................................................................................................. 246

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7.1 LIST OF ABBREVIATIONS ......................................................................................................................................................2467.2 - REPORT METHODOLOGY .................................................................................................................................................. 247

Sources ................................................................................................................................................................................247Market forecasts ................................................................................................................................................................ 248

VOLUME II DIABETES TECHNOLOGY AND INTELLECTUAL PROPERTY ANALYSIS

1.0 SUMMARY ............................................................................................................................................... 251Figure 1.1 – Diabetes Landscape by Technology........................................................................................................................................................................................ 252Figure 1.2 – High Level Overview of Diabetes Patent Activity ...................................................................................................................................................................254Figure 1.3 – Bar Chart of Totals for each Technology Group ...................................................................................................................................................................... 255Figure 1.4 – Top 20 Assignees Patents from this Study ..............................................................................................................................................................................256Figure 1.5 - Blood Extraction by Priority Date by Assignee ........................................................................................................................................................................257Figure 1.6 – Number of Patents versus Revenue for Highlighted Companies ...........................................................................................................................................258Figure 1.7 – Litigation Analysis .................................................................................................................................................................................................................. 259Table 1.1 – Table of Highlighted Companies and Technologies .................................................................................................................................................................260

2.0 INTRODUCTION ...................................................................................................................................... 262

3.0 TECHNOLOGY ......................................................................................................................................... 264Figure 3.1 – Diabetes Landscape by Technology .......................................................................................................................................................................................265Figure 3.2 – Self Monitoring of Blood Glucose ...........................................................................................................................................................................................266Figure 3.3 – Blood Glucose Test Strip Operation ........................................................................................................................................................................................ 267Figure 3.4 – Continuous Glucose Monitoring (CGM) .................................................................................................................................................................................. 267Figure 3.5 – Artificial Pancreas Representative Diagram ..........................................................................................................................................................................269

4.0 OVERVIEW OF PATENT ACTIVITIES ....................................................................................................... 270Figure 4.1 – High Level Overview of Diabetes Patent Activity ................................................................................................................................................................... 271

4.1 Analysis of Patents Sorted by this Study ..........................................................................................................................273Figure 4.2 – Bar Chart of Totals for each Technology Group......................................................................................................................................................................273Figure 4.3 – Top 20 Assignees Patents from This Study ............................................................................................................................................................................. 274Figure 4.4 – Patents by Priority Date ......................................................................................................................................................................................................... 275Figure 4.5 – Priority Date by Top 5 Companies .......................................................................................................................................................................................... 276Figure 4.6 – Patents by Published Date .....................................................................................................................................................................................................277Figure 4.7 – Patents by Source Jurisdiction ...............................................................................................................................................................................................278Figure 4.8 – Top 10 IPC Codes from the Patents Analyzed ......................................................................................................................................................................... 279Figure 4.9 – Total U.S. Patents by Assignee ...............................................................................................................................................................................................280Figure 4.10 – USP Classification Analysis within the U.S. Dataset ............................................................................................................................................................. 281

5.0 PATENT ANALYSIS BY TECHNOLOGY SUBCATEGORY ......................................................................... 2825.1 Detection and Monitoring – Periodic – Invasive – Blood Extraction ..........................................................................283

Figure 5.1 – Blood Extraction – Top Assignees ..........................................................................................................................................................................................283Priority Date by Year and Source: ......................................................................................................................................................284Figure 5.2 - Blood Extraction by Priority Date ............................................................................................................................................................................................284Priority Date by Year by Top 5 Assignees within the Subcategory: ............................................................................................ 285Figure 5.3 - Blood Extraction by Priority Date by Assignee ........................................................................................................................................................................285Published Date by Year and Source: ................................................................................................................................................. 286Figure 5.4 - Blood Extraction by Published Date ........................................................................................................................................................................................286IPC Analysis – Top 10 Codes: ............................................................................................................................................................... 287Figure 5.5 - Blood Extraction by IPC Code ..................................................................................................................................................................................................287USPC Analysis – Top 10 Codes: ........................................................................................................................................................... 288Figure 5.6 - Blood Extraction by USPC Code ...............................................................................................................................................................................................288Figure 5.7 – Blood Extraction - Text Clustering Analysis ...........................................................................................................................................................................289Source Jurisdiction: .............................................................................................................................................................................. 290Figure 5.8 - Blood Extraction by Source Jurisdiction ..................................................................................................................................................................................290Top Patents ............................................................................................................................................................................................ 291Table 5.1 - Top Patents Identified in the Blood Extraction Group ............................................................................................................................................................... 291

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US6461496B1: Abbott Laboratories ................................................................................................................................292Figure 5.9 – Representative Image in US6461496 ..................................................................................................................................................................................... 292Figure 5.10 – Top 20 Companies Citing US6461496 .................................................................................................................................................................................. 293US5916230A: Bayer AG .................................................................................................................................................... 294Figure 5.11 – Representative Images of US5916230 ..................................................................................................................................................................................294Figure 5.12 – Top 20 Companies Citing US5916230 ...................................................................................................................................................................................295

5.2 Detection and Monitoring – Periodic – Invasive – Test Strips ......................................................................................296Figure 5.13 – Test Strips – Top Assignees ...................................................................................................................................................................................................296Priority Date by Year and Source: ...................................................................................................................................................... 297Figure 5.14 - Test Strips by Priority Date .....................................................................................................................................................................................................297Priority Date by Year by Assignee: .................................................................................................................................................... 297Figure 5.15 - Test Strips by Priority Date by Assignee .................................................................................................................................................................................297Published Date by Year: ...................................................................................................................................................................... 298Figure 5.16 - Test Strips by Published Date .................................................................................................................................................................................................298IPC Analysis – Top 10 Codes: ............................................................................................................................................................... 299Figure 5.17 - Test Strips by IPC Code ............................................................................................................................................................................................................299USPC Analysis – Top 10 Codes: ...........................................................................................................................................................300Figure 5.18 - Test Strips by USPC Code ........................................................................................................................................................................................................300Text Clustering Analysis: ..................................................................................................................................................................... 301Figure 5.19 – Test Strips - Text Clustering Analysis .....................................................................................................................................................................................301Source Jurisdiction: .............................................................................................................................................................................. 302Figure 5.20 - Test Strips by Source Jurisdiction ...........................................................................................................................................................................................302Top Patents ............................................................................................................................................................................................ 303Table 5.2 - Top Patents Identified in the Test Strips Group .........................................................................................................................................................................303US5496453A: Arkray, Inc. ................................................................................................................................................ 304Figure 5.21 – Representative Image in US5496453 ...................................................................................................................................................................................304Figure 5.22 – Top 20 Companies Citing US5496453 ..................................................................................................................................................................................305US5563042: Johnson & Johnson ...................................................................................................................................... 306Figure 5.23 – Representative Image in US5563042 ...................................................................................................................................................................................306Figure 5.24 – Top 20 Companies Citing US5563042 ..................................................................................................................................................................................307

5.3 Detection and Monitoring – Periodic – Invasive – Devices ..........................................................................................308Figure 5.25 – Devices – Top Assignees ......................................................................................................................................................................................................308Priority Date by Year: ........................................................................................................................................................................... 309Figure 5.26 - Devices by Priority Date .........................................................................................................................................................................................................309Priority Date by Year by Assignee: .................................................................................................................................................... 309Figure 5.27 - Devices by Priority Date by Assignee .....................................................................................................................................................................................309Published Date by Year and Source: ..................................................................................................................................................310Figure 5.28 - Devices by Published Date ..................................................................................................................................................................................................... 310IPC Analysis – Top 10 Codes: ................................................................................................................................................................311Figure 5.29 - Devices by IPC Code ................................................................................................................................................................................................................311USPC Analysis – Top 10 Codes: ............................................................................................................................................................312Figure 5.30 - Devices by USPC Code ............................................................................................................................................................................................................ 312Text Clustering Analysis: ......................................................................................................................................................................313Figure 5.31 – Devices - Text Clustering Analysis ......................................................................................................................................................................................... 313Source Jurisdiction: ...............................................................................................................................................................................314Figure 5.32 - Devices by Source Jurisdiction ............................................................................................................................................................................................... 314Top Patents .............................................................................................................................................................................................315Table 5.3 - Top Patents Identified in the Devices Group ............................................................................................................................................................................. 315US6233471: Johnson & Johnson ......................................................................................................................................316Figure 5.33 – Representative Image in US6233471 ................................................................................................................................................................................... 316Figure 5.34 – Top 20 Companies Citing US6233471 .................................................................................................................................................................................. 317

5.4 Detection and Monitoring – Periodic – Minimally Invasive – Interstitial Fluid ......................................................... 318Figure 5.35 – Interstitial Fluid – Top Assignees ......................................................................................................................................................................................... 318Priority Date by Year: ............................................................................................................................................................................319Figure 5.36 - Interstitial Fluid by Priority Date ........................................................................................................................................................................................... 319

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Priority Date by Year by Assignee: .....................................................................................................................................................319Figure 5.37 - Interstitial Fluid by Priority Date ........................................................................................................................................................................................... 319Published Date by Year: ...................................................................................................................................................................... 320Figure 5.38 - Interstitial Fluid by Published Date .......................................................................................................................................................................................320IPC Analysis - Top 10 Codes: ...............................................................................................................................................321Figure 5.39 - Interstitial Fluid by IPC Code .................................................................................................................................................................................................. 321USPC Analysis – Top 10 Codes: ........................................................................................................................................................... 322Figure 5.40 - Interstitial Fluid by USPC Code ............................................................................................................................................................................................... 322Text Clustering Analysis: ..................................................................................................................................................................... 323Figure 5.41 – Interstitial Fluid - Text Clustering Analysis ........................................................................................................................................................................... 323Source Jurisdiction: .............................................................................................................................................................................. 324Figure 5.42 - Interstitial Fluid by Source Jurisdiction .................................................................................................................................................................................. 324Top Patents ............................................................................................................................................................................................ 325Table 5.4 - Top Patents Identified in the Interstitial Fluid Group ................................................................................................................................................................ 325US5582184: Alere Incorporated ......................................................................................................................................326Figure 5.43 – Representative Image in US5582184 ................................................................................................................................................................................... 326Figure 5.44 – Top 20 Companies Citing US5582184 .................................................................................................................................................................................. 327

5.5 Detection and Monitoring – Periodic – Minimally Invasive – Skin Diffusion ............................................................328Figure 5.45 – Skin Diffusion – Top Assignees ............................................................................................................................................................................................ 328Priority Date by Year: ........................................................................................................................................................................... 329Figure 5.46 - Skin Diffusion by Priority Date .............................................................................................................................................................................................. 329Priority Date by Year by Assignee: .................................................................................................................................................... 329Figure 5.47 - Skin Diffusion by Priority Date by Assignee ........................................................................................................................................................................... 329Published Date by Year: ...................................................................................................................................................................... 330Figure 5.48 - Skin Diffusion by Published Date ..........................................................................................................................................................................................330IPC Analysis – Top 10 Codes: ............................................................................................................................................................... 331Figure 5.49 - Skin Diffusion by IPC Code ..................................................................................................................................................................................................... 331USPC Analysis – Top 10 Codes: ........................................................................................................................................................... 332Figure 5.50 - Skin Diffusion by USPC Code .................................................................................................................................................................................................. 332Text Clustering Analysis: ..................................................................................................................................................................... 333Figure 5.51 – Skin Diffusion - Text Clustering Analysis .............................................................................................................................................................................. 333Source Jurisdiction: .............................................................................................................................................................................. 334Figure 5.52 - Skin Diffusion by Source Jurisdiction ..................................................................................................................................................................................... 334Top Patents ............................................................................................................................................................................................ 334Table 5.5 - Top Patents Identified in the Skin Diffusion Group ................................................................................................................................................................... 334US6454710: Johnson & Johnson ......................................................................................................................................335Figure 5.53 – Representative Image in US6454710 ................................................................................................................................................................................... 335Figure 5.54 – Top 20 Companies Citing US6454710 .................................................................................................................................................................................. 336

5.6 Detection and Monitoring – Periodic – Non Invasive – Optical................................................................................... 337Figure 5.55 – Non Invasive - Optical – Top Assignees ............................................................................................................................................................................... 337Priority Date by Year: ........................................................................................................................................................................... 338Figure 5.56 - Non Invasive - Optical by Priority Date .................................................................................................................................................................................. 338Priority Date by Year by Assignee: .................................................................................................................................................... 338Figure 5.57 - Non Invasive - Optical by Priority Date .................................................................................................................................................................................. 338Published Date by Year: ...................................................................................................................................................................... 339Figure 5.58 - Non Invasive - Optical by Published Date .............................................................................................................................................................................. 339IPC Analysis – Top 10 Codes: ...............................................................................................................................................................340Figure 5.59 - Non Invasive - Optical by IPC Code ........................................................................................................................................................................................340USPC Analysis – Top 10 Codes: ........................................................................................................................................................... 341Figure 5.60 - Non Invasive - Optical by USP Class Code .............................................................................................................................................................................. 341Text Clustering Analysis: ..................................................................................................................................................................... 342Figure 5.61 – Non Invasive - Optical - Text Clustering Analysis .................................................................................................................................................................342Source Jurisdiction: .............................................................................................................................................................................. 343Figure 5.62 - Non Invasive - Optical by Source Jurisdiction ........................................................................................................................................................................ 343Top Patents ............................................................................................................................................................................................344

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Table 5.6- Top Patents Identified in the Non Invasive Optical Group .........................................................................................................................................................344US5743262: Masimo Corporation ................................................................................................................................... 345Figure 5.63 – Representative Image in US5743263 ...................................................................................................................................................................................345Figure 5.64 – Top 20 Companies Citing US5743263 ...................................................................................................................................................................................346US6040578: Sensys Medical Inc ........................................................................................................................................347Figure 5.65 – Patent Diagram of US6040578 ............................................................................................................................................................................................347Figure 5.66 – Top 20 Companies Citing US6040578 ..................................................................................................................................................................................348

5.7 Detection and Monitoring – Periodic – Non Invasive – Other .....................................................................................349Figure 5.67 – Non-Invasive Other – Top Assignees ...................................................................................................................................................................................349Priority Date by Year: ........................................................................................................................................................................... 350Figure 5.68 – Non-Invasive Other by Priority Date .................................................................................................................................................................................... 350Priority Date by Year by Assignee: .................................................................................................................................................... 350Figure 5.69 - Non-Invasive Other by Priority Date by Assignee.................................................................................................................................................................. 350Published Date by Year: ...................................................................................................................................................................... 351Figure 5.70 - Non-Invasive Other by Published Date ................................................................................................................................................................................. 351IPC Analysis – Top 10 Codes: ............................................................................................................................................................... 352Figure 5.71 - Non Invasive Other by IPC Code ............................................................................................................................................................................................. 352USPC Analysis – Top 10 Codes: ........................................................................................................................................................... 353Figure 5.72 - Non Invasive Other by USPC Code.......................................................................................................................................................................................... 353Text Clustering Analysis: ..................................................................................................................................................................... 354Figure 5.73 – Non Invasive Other - Text Clustering Analysis ......................................................................................................................................................................354Source Jurisdiction: .............................................................................................................................................................................. 355Figure 5.74 – Non-Invasive - Other by Source Jurisdiction ........................................................................................................................................................................ 355Top Patents ............................................................................................................................................................................................ 355Table 5.7 - Top Patents Identified in the Non Invasive – Other Group ....................................................................................................................................................... 355US6572542: Medtronic Inc ................................................................................................................................................356Figure 5.75 – Representative Image in US6572542 ................................................................................................................................................................................... 356Figure 5.76 – Top 20 Companies Citing US6572542 .................................................................................................................................................................................. 357

5.8 Detection and Monitoring – Continuous – Non-Implanted ........................................................................................358Figure 5.77 – Continuous Non-Implanted – Top Assignees ...................................................................................................................................................................... 358Priority Date by Year: ........................................................................................................................................................................... 359Figure 5.78 - Continuous Non-Implanted by Priority Date ........................................................................................................................................................................ 359Priority Date by Year by Assignee: .................................................................................................................................................... 359Figure 5.79 - Continuous Non-Implanted by Priority Date by Assignee .................................................................................................................................................... 359Published Date by Year: ...................................................................................................................................................................... 360Figure 5.80 - Continuous Non-Implanted by Published Date ....................................................................................................................................................................360IPC Analysis – Top 10 Codes: ............................................................................................................................................................... 361Figure 5.81 - Continuous Non-Implanted by IPC Code ............................................................................................................................................................................... 361USPC Analysis – Top 10 Codes: ........................................................................................................................................................... 362Figure 5.82 - Continuous Non-Implanted by USPC Code ...........................................................................................................................................................................362Figure 5.83 – Continuous Non-Implanted -Text Clustering Analysis .........................................................................................................................................................363Source Jurisdiction: ..............................................................................................................................................................................364Figure 5.84 - Continuous Non-Implanted by Source Jurisdiction ..............................................................................................................................................................364Top Patents ............................................................................................................................................................................................ 365Table 5.8 - Top Patents Identified in the Continuous Non-Implanted Group .............................................................................................................................................365US6931327: Dexcom, Inc. ................................................................................................................................................. 366Figure 5.85 – Representative Image in US6931327 ...................................................................................................................................................................................366Figure 5.86 – Top 20 Companies Citing US6931327 ...................................................................................................................................................................................367

5.9 Detection and Monitoring – Continuous – Implanted ..................................................................................................368Figure 5.87 – Continuous Implanted – Top Assignees ..............................................................................................................................................................................368Priority Date by Year: ........................................................................................................................................................................... 369Figure 5.88 - Continuous Implanted by Priority Date ................................................................................................................................................................................369Priority Date by Year by Assignee: .................................................................................................................................................... 369Figure 5.89 - Continuous Implanted by Priority Date by Assignee .............................................................................................................................................................369Published Date by Year: ...................................................................................................................................................................... 370

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Figure 5.90 - Continuous Implanted by Published Date............................................................................................................................................................................. 370IPC Analysis – Top 10 Codes: ............................................................................................................................................................... 371Figure 5.91 - Continuous Implanted by IPC Code ....................................................................................................................................................................................... 371USPC Analysis – Top 10 Codes: ........................................................................................................................................................... 372Figure 5.92 - Continuous Implanted by USPC Code .................................................................................................................................................................................... 372Text Clustering Analysis: ..................................................................................................................................................................... 373Figure 5.93 – Continuous Implanted - Text Clustering Analysis ................................................................................................................................................................ 373Source Jurisdiction: ...............................................................................................................................................................................374Figure 5.94 - Continuous Implanted by Source Jurisdiction ....................................................................................................................................................................... 374Top Patents ............................................................................................................................................................................................ 375Table 5.9 - Top Patents Identified in the Continuous Implanted Group ..................................................................................................................................................... 375Figure 5.95 – Representative Image in US6001067 ................................................................................................................................................................................... 376Figure 5.96 – Top 20 Companies Citing US6001067 .................................................................................................................................................................................. 377

5.10 Treatment – Manual – Syringe ........................................................................................................................................ 378Figure 5.97 – Syringe – Top Assignees....................................................................................................................................................................................................... 378Priority Date by Year: ........................................................................................................................................................................... 379Figure 5.98 - Syringe by Priority Date ......................................................................................................................................................................................................... 379Priority Date by Year by Assignee: .................................................................................................................................................... 379Figure 5.99 - Syringe by Priority Date by Assignee ..................................................................................................................................................................................... 379Published Date by Year: ...................................................................................................................................................................... 380Figure 5.100 - Syringe by Published Date ...................................................................................................................................................................................................380IPC Analysis – Top 10 Codes: ............................................................................................................................................................... 381Figure 5.101 - Syringe by IPC Code .............................................................................................................................................................................................................. 381USPC Analysis – Top 10 Codes: ........................................................................................................................................................... 382Figure 5.102 - Syringe by USPC Code ..........................................................................................................................................................................................................382Text Clustering Analysis: ..................................................................................................................................................................... 383Figure 5.103 – Syringe - Text Clustering Analysis .......................................................................................................................................................................................383Source Jurisdiction: ..............................................................................................................................................................................384Figure 5.104 - Syringe by Source Jurisdiction .............................................................................................................................................................................................384Top Patents ............................................................................................................................................................................................ 384Table 5.10 - Top Patents Identified in the Syringe Group ............................................................................................................................................................................384US6254586: Medtronic, Inc. ............................................................................................................................................ 385Figure 5.105 – Representative Image in US6254586 .................................................................................................................................................................................385Figure 5.106 – Top 20 Companies Citing US6254586 ................................................................................................................................................................................386

5.11 Treatment – Manual – Pen................................................................................................................................................387Figure 5.107 – Pen – Top Assignees ...........................................................................................................................................................................................................387Priority Date by Year: ........................................................................................................................................................................... 388Figure 5.108 - Pen by Priority Date .............................................................................................................................................................................................................388Priority Date by Year by Assignee: .................................................................................................................................................... 388Figure 5.109 - Pen by Priority Date by Assignee .........................................................................................................................................................................................388Published Date by Year: ...................................................................................................................................................................... 389Figure 5.110 - Pen by Published Date .........................................................................................................................................................................................................389IPC Analysis – Top 10 Codes: ............................................................................................................................................................... 390Figure 5.111 - Pen by IPC Code ....................................................................................................................................................................................................................390USPC Analysis – Top 10 Codes: ........................................................................................................................................................... 391Figure 5.112 - Pen by USPC Code ................................................................................................................................................................................................................. 391Text Clustering Analysis: ..................................................................................................................................................................... 392Figure 5.113 – Pen - Text Clustering Analysis ............................................................................................................................................................................................. 392Source Jurisdiction: .............................................................................................................................................................................. 393Figure 5.114 - Pen by Source Jurisdiction .................................................................................................................................................................................................... 393Top Patents ............................................................................................................................................................................................ 394Table 5.11 - Top Patents Identified in the Pen Group ..................................................................................................................................................................................394US6192891: Becton, Dickinson and Company ................................................................................................................395Figure 5.115 – Representative Image in US6192891 .................................................................................................................................................................................. 395Figure 5.116 – Top 20 Companies Citing US6192891 .................................................................................................................................................................................396

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US5514097: Roche Holding Ltd. .......................................................................................................................................397Figure 5.117 – Representative Image in US5514097 .................................................................................................................................................................................. 397Figure 5.118 – Top 20 Companies Citing US5514097 .................................................................................................................................................................................398

5.12 Treatment – Manual - Patch .............................................................................................................................................399Figure 5.119 – Patch – Top Assignees ........................................................................................................................................................................................................399Priority Date by Year: ...........................................................................................................................................................................400Figure 5.120 - Patch by Priority Date ..........................................................................................................................................................................................................400Priority Date by Year by Assignee: ....................................................................................................................................................400Figure 5.121 - Patch by Priority Date by Assignee ......................................................................................................................................................................................400Published Date by Year: ...................................................................................................................................................................... 401Figure 5.122 - Patch by Published Date ......................................................................................................................................................................................................401IPC Analysis– Top 10 Codes: .............................................................................................................................................. 402Figure 5.123 - Patch by IPC Code .................................................................................................................................................................................................................402USPC Analysis – Top 10 Codes: ........................................................................................................................................................... 403Figure 5.124 - Patch by USPC Code ..............................................................................................................................................................................................................403Text Clustering Analysis: .....................................................................................................................................................................404Figure 5.125 – Patch - Text Clustering Analysis ..........................................................................................................................................................................................404Source Jurisdiction: ..............................................................................................................................................................................405Figure 5.126 - Patch by Source Jurisdiction ................................................................................................................................................................................................405Top Patents ............................................................................................................................................................................................405Table 5.12 - Top Patents Identified in the Patch Group ...............................................................................................................................................................................405US6682757: Purdue Pharma LP ....................................................................................................................................... 406Figure 5.127 – Representative Image in US6682757 .................................................................................................................................................................................406Figure 5.128 – Top 20 Companies Citing US6682757 .................................................................................................................................................................................407

5.13 Treatment – Manual – Other ...........................................................................................................................................408Figure 5.129 – Treatment - Other – Top Assignees ....................................................................................................................................................................................408Priority Date by Year: ...........................................................................................................................................................................409Figure 5.130 – Treatment – Other by Priority Date ...................................................................................................................................................................................409Priority Date by Year by Assignee: ....................................................................................................................................................409Figure 5.131 – Treatment – Other by Priority Date by Assignee ................................................................................................................................................................409Published Date by Year: .......................................................................................................................................................................410Figure 5.132 - Treatment – Other by Published Date ................................................................................................................................................................................. 410IPC Analysis – Top 10 Codes: ................................................................................................................................................................411Figure 5.133 – Treatment – Other by IPC Code .......................................................................................................................................................................................... 411USPC Analysis – Top 10 Codes: ............................................................................................................................................................412Figure 5.134 – Treatment - Other by USPC Code ........................................................................................................................................................................................ 412Text Clustering Analysis: ......................................................................................................................................................................413Figure 5.135 – Treatment – Other - Text Clustering Analysis..................................................................................................................................................................... 413Source Jurisdiction: ...............................................................................................................................................................................414Figure 5.136 – Treatment - Other by Source Jurisdiction ........................................................................................................................................................................... 414Top Patents .............................................................................................................................................................................................414Table 5.13 - Top Patents Identified in the Treatment – Other Group ......................................................................................................................................................... 414US6313093: Novartis AG ...................................................................................................................................................415Figure 5.137 – Top 20 Companies Citing US6313093 ................................................................................................................................................................................. 415

5.14 Treatment – Automatic – External Pump ...................................................................................................................... 416Figure 5.138 – External Pump – Top Assignees ......................................................................................................................................................................................... 416Priority Date by Year: ............................................................................................................................................................................417Figure 5.139 - External Pump by Priority Date ........................................................................................................................................................................................... 417Priority Date by Year by Assignee: .....................................................................................................................................................417Figure 5.140 - External Pump by Priority Date by Assignee ....................................................................................................................................................................... 417Published Date by Year: .......................................................................................................................................................................418Figure 5.141 - External Pump by Published Date ....................................................................................................................................................................................... 418IPC Analysis – Top 10 Codes: ................................................................................................................................................................419Figure 5.142 - External Pump by IPC Code .................................................................................................................................................................................................. 419USPC Analysis – Top 10 Codes: ........................................................................................................................................................... 420

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Figure 5.143 - External Pump by USPC Code...............................................................................................................................................................................................420Text Clustering Analysis: ..................................................................................................................................................................... 421Figure 5.144 – External Pump - Text Clustering Analysis........................................................................................................................................................................... 421Source Jurisdiction: .............................................................................................................................................................................. 422Figure 5.145 - External Pump by Source Jurisdiction .................................................................................................................................................................................422Top Patents ............................................................................................................................................................................................ 422Table 5.14 - Top Patents Identified in the External Pump Group ................................................................................................................................................................422US6740059: Insulet Corporation Devices ....................................................................................................................... 423Figure 5.146 – Representative Image in US6740059 ................................................................................................................................................................................. 423Figure 5.147 – Top 20 Companies Citing US6740059 ................................................................................................................................................................................. 424

5.15 Treatment – Automatic – Implanted Pump ..................................................................................................................425Figure 5.148 – Implanted Pump – Top Assignees ..................................................................................................................................................................................... 425Priority Date by Year: ........................................................................................................................................................................... 426Figure 5.149 - Implanted Pump by Priority Date ........................................................................................................................................................................................ 426Priority Date by Year by Assignee: .................................................................................................................................................... 426Figure 5.150 - Implanted Pump by Priority Date by Assignee .................................................................................................................................................................... 426Published Date by Year: ...................................................................................................................................................................... 427Figure 5.151 - Implanted Pump by Published Date .................................................................................................................................................................................... 427IPC Analysis – Top 10 Codes: ............................................................................................................................................................... 428Figure 5.152 - Implanted Pump by IPC Code .............................................................................................................................................................................................. 428USPC Analysis– Top 10 Codes: .......................................................................................................................................... 429Figure 5.153 - Implanted Pump by USPC Code ........................................................................................................................................................................................... 429Text Clustering Analysis: ..................................................................................................................................................................... 430Figure 5.154 – Implanted Pump - Text Clustering Analysis .......................................................................................................................................................................430Source Jurisdiction: .............................................................................................................................................................................. 431Figure 5.155 - Implanted Pump by Source Jurisdiction .............................................................................................................................................................................. 431Top Patents ............................................................................................................................................................................................ 431Table 5.15 - Top Patents Identified in the Implanted Pump Group ............................................................................................................................................................ 431US5569186: Medtronic, Inc. ............................................................................................................................................. 432Figure 5.156 – Representative Image in US5569186.................................................................................................................................................................................. 432Figure 5.157 – Top 20 Companies Citing US5569186 ................................................................................................................................................................................. 433

5.16 Treatment – Automatic – SW and Algorithms ..............................................................................................................434Figure 5.158 – SW/Algorithm – Top Assignees ..........................................................................................................................................................................................434Priority Date by Year: ........................................................................................................................................................................... 435Figure 5.159 - SW/Algorithm by Priority Date ............................................................................................................................................................................................ 435Priority Date by Year by Assignee: .................................................................................................................................................... 435Figure 5.160 - SW/Algorithm by Priority Date by Assignee ........................................................................................................................................................................ 435Published Date by Year: ...................................................................................................................................................................... 436Figure 5.161 - SW/Algorithm by Published Date ........................................................................................................................................................................................ 436IPC Analysis – Top 10 Codes: ............................................................................................................................................................... 437Figure 5.162 - SW/Algorithm by IPC Code ................................................................................................................................................................................................... 437USPC Analysis – Top 10 Codes: ........................................................................................................................................................... 438Figure 5.163 - SW/Algorithm by USPC Code ...............................................................................................................................................................................................438Text Clustering Analysis: ..................................................................................................................................................................... 439Figure 5.164 – SW/Algorithm - Text Clustering Analysis ........................................................................................................................................................................... 439Source Jurisdiction: ..............................................................................................................................................................................440Figure 5.165 - SW/Algorithm by Source Jurisdiction ..................................................................................................................................................................................440Top Patents ............................................................................................................................................................................................ 441Table 5.16 - Top Patents Identified in the SW/Algorithms Group ...............................................................................................................................................................441US6168563: Robert Bosch GmbH ..................................................................................................................................... 442Figure 5.166 – Front Page Diagram of US6168573 ....................................................................................................................................................................................442Figure 5.167 – Top 20 Companies Citing US6168573 .................................................................................................................................................................................443US6809653: Medtronic, Inc. .............................................................................................................................................. 444Figure 5.168 – Representative Image in US6809653 .................................................................................................................................................................................444Figure 5.169 – Top 20 Companies Citing US6809653 ................................................................................................................................................................................445

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5.17 Artificial Pancreas ..............................................................................................................................................................446Figure 5.170 – Artificial Pancreas – Top Assignees ....................................................................................................................................................................................446Priority Date by Year: ........................................................................................................................................................................... 447Figure 5.171 - Artificial Pancreas by Priority Date ......................................................................................................................................................................................447Priority Date by Year by Assignee: .................................................................................................................................................... 447Figure 5.172 - Artificial Pancreas by Priority Date by Assignee ..................................................................................................................................................................447Published Date by Year: ......................................................................................................................................................................448Figure 5.173 - Artificial Pancreas by Published Date ..................................................................................................................................................................................448IPC Analysis– Top 10 Codes: .............................................................................................................................................. 449Figure 5.174 - Artificial Pancreas by IPC Code .............................................................................................................................................................................................449USPC Analysis– Top 10 Codes: .......................................................................................................................................... 450Figure 5.175 - Artificial Pancreas by USPC Code .........................................................................................................................................................................................450Text Clustering Analysis: ..................................................................................................................................................................... 451Figure 5.176 – Artificial Pancreas - Text Clustering Analysis ...................................................................................................................................................................... 451Source Jurisdiction: .............................................................................................................................................................................. 452Figure 5.177 - Artificial Pancreas by Source Jurisdiction ............................................................................................................................................................................ 452Top Patents ............................................................................................................................................................................................ 453Table 5.17 - Top Patents Identified in the Artificial Pancreas Group........................................................................................................................................................... 453US6175752: Abbott Laboratories .................................................................................................................................... 454Figure 5.178 – Representative Image in US6175752 ..................................................................................................................................................................................454Figure 5.179 – Top 20 Companies Citing US6175752 ................................................................................................................................................................................. 455US6122536: Johnson & Johnson ...................................................................................................................................... 456Figure 5.180 – Representative Image in US6122536 .................................................................................................................................................................................456Figure 5.181 – Top 20 Companies Citing US6122536 ................................................................................................................................................................................. 457

6.0 PATENT ANALYSIS BY KEY COMPANIES ............................................................................................... 458Figure 6.1 – Number of Patents versus Revenue for Highlighted Companies ........................................................................................................................................... 459Litigation ............................................................................................................................................................................ 460Figure 6.2 – Litigation Analysis .................................................................................................................................................................................................................460

6.1 Johnson & Johnson ..............................................................................................................................................................461Johnson & Johnson Overall Patent Portfolio ...................................................................................................................461Priority Date by Year: ........................................................................................................................................................................... 461Figure 6.3 – Johnson & Johnson Overall Patent Portfolio by Priority Year ................................................................................................................................................461Published Date by Year: ...................................................................................................................................................................... 462Figure 6.4 – Johnson & Johnson Overall Patent Portfolio by Published Year ............................................................................................................................................462Source Jurisdiction: .............................................................................................................................................................................. 462Figure 6.5 – Johnson & Johnson Overall Patent Portfolio Source Jurisdiction ...........................................................................................................................................462Johnson & Johnson Patents Specific to This Study ......................................................................................................... 463Figure 6.6 – Johnson & Johnson Diabetes Patents by Technology Group .................................................................................................................................................463Priority Date by Year: ...........................................................................................................................................................................464Figure 6.7 - Johnson & Johnson Diabetes Patents by Priority Year ............................................................................................................................................................464Publication Date by Year: .................................................................................................................................................. 464Figure 6.8 – Johnson & Johnson Diabetes Patents by Published Year.......................................................................................................................................................464IPC Analysis– Top 10 Codes: .............................................................................................................................................. 465Figure 6.9 – Johnson & Johnson Diabetes Patents by IPC Code .................................................................................................................................................................465USPC Analysis – Top 10 Codes: ...........................................................................................................................................................466Figure 6.10 – Johnson & Johnson Diabetes Patents by USPC Code ...........................................................................................................................................................466Source Jurisdiction: .............................................................................................................................................................................. 467Figure 6.11 – Johnson & Johnson Diabetes Patents by Source Jurisdiction ...............................................................................................................................................467

6.2 Abbott Laboratories............................................................................................................................................................468Abbott Overall Patent Portfolio ....................................................................................................................................... 468Priority Date by Year: ...........................................................................................................................................................................468Figure 6.12 - Abbott Overall Patent Portfolio by Priority Year ....................................................................................................................................................................468Published Date by Year: ...................................................................................................................................................................... 469Figure 6.13 – Abbott Overall Patent Portfolio by Published Year ..............................................................................................................................................................469

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Source Jurisdiction: .............................................................................................................................................................................. 469Figure 6.14 – Abbott Overall Patent Portfolio by Source Jurisdiction ........................................................................................................................................................469Abbott Patents Specific to This Study ...............................................................................................................................470Figure 6.15 – Abbott Diabetes Patents by Technology Group.................................................................................................................................................................... 470Priority Date by Year: ........................................................................................................................................................................... 471Figure 6.16 - Abbott Diabetes Patents by Priority Year .............................................................................................................................................................................. 471Publication Date by Year: .................................................................................................................................................................... 472Figure 6.17 – Abbott Diabetes Patents by Published Year ......................................................................................................................................................................... 472IPC Analysis– Top 10 Codes: ............................................................................................................................................................... 473Figure 6.18 – Abbott Diabetes Patents by IPC Code ................................................................................................................................................................................... 473USPC Analysis – Top 10 Codes: ............................................................................................................................................................474Figure 6.19 – Abbott Diabetes Patents by USPC Code ................................................................................................................................................................................ 474Source Jurisdiction: .............................................................................................................................................................................. 475Figure 6.20 – Abbott Diabetes Patents by Source Jurisdiction .................................................................................................................................................................. 475

6.3 Roche Holding Ltd ................................................................................................................................................................ 476Roche Overall Patent Portfolio ..........................................................................................................................................476Priority Date by Year: ........................................................................................................................................................................... 476Figure 6.21 – Roche Overall Patent Portfolio by Priority Year ................................................................................................................................................................... 476Published Date by Year: ...................................................................................................................................................................... 477Figure 6.22 - Roche Overall Patent Portfolio by Published Year.................................................................................................................................................................477Source Jurisdiction: .............................................................................................................................................................................. 477Figure 6.23 - Roche Overall Patent Portfolio by Source Jurisdiction...........................................................................................................................................................477Roche Patents Specific to This Study ................................................................................................................................478Figure 6.24 – Roche Diabetes Patents by Technology Group ..................................................................................................................................................................... 478Priority Date by Year: ........................................................................................................................................................................... 479Figure 6.25 - Roche Diabetes Patents by Priority Year ............................................................................................................................................................................... 479Publication Date by Year: ....................................................................................................................................................................480Figure 6.26 - Roche Diabetes Patents by Published Year ...........................................................................................................................................................................480IPC Analysis– Top 10 Codes: ............................................................................................................................................................... 481Figure 6.27 - Roche Diabetes Patents by IPC Code .....................................................................................................................................................................................481USPC Analysis – Top 10 Codes: ........................................................................................................................................................... 482Figure 6.28 - Roche Diabetes Patents by USPC Code ..................................................................................................................................................................................482Source Jurisdiction: .............................................................................................................................................................................. 483Figure 6.29 – Roche Diabetes Patents by Source Jurisdiction ....................................................................................................................................................................483

6.4 Medtronic Inc .......................................................................................................................................................................484Medtronic Overall Patent Portfolio ................................................................................................................................. 484Priority Date by Year: ...........................................................................................................................................................................484Figure 6.30 - Medtronic Overall Patent Portfolio by Priority Year ..............................................................................................................................................................484Published Date by Year: ...................................................................................................................................................................... 485Figure 6.31 - Medtronic Overall Patent Portfolio by Published Year ..........................................................................................................................................................485Source Jurisdiction: ..............................................................................................................................................................................485Figure 6.32 – Medtronic Overall Patent Portfolio by Source Jurisdiction ...................................................................................................................................................485Medtronic Patents Specific to This Study ........................................................................................................................ 486Figure 6.33 – Medtronic Diabetes Patents by Technology Group ..............................................................................................................................................................486Priority Date by Year: ........................................................................................................................................................................... 487Figure 6.34 - Medtronic Diabetes Patents by Priority Year ........................................................................................................................................................................487Publication Date by Year: ....................................................................................................................................................................488Figure 6.35 - Medtronic Diabetes Patents by Published Year .....................................................................................................................................................................488IPC Analysis - Top 10 Codes: ................................................................................................................................................................489Figure 6.36 - Medtronic Diabetes Patents by IPC Code ...............................................................................................................................................................................489USPC Analysis- Top 10 Codes: ............................................................................................................................................................. 490Figure 6.37 - Medtronic Diabetes Patents by USPC Code ............................................................................................................................................................................490Source Jurisdiction: .............................................................................................................................................................................. 491Figure 6.38 – Medtronic Diabetes Patents by Source Jurisdiction ............................................................................................................................................................. 491

6.5 Becton, Dickinson and Co .................................................................................................................................................. 492

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Becton, Dickinson and Co Overall Patent Portfolio .........................................................................................................492Priority Date by Year: ........................................................................................................................................................................... 492Figure 6.39 – Becton, Dickinson and Co Overall Patent Portfolio by Priority Year .....................................................................................................................................492Published Date by Year: ...................................................................................................................................................................... 493Figure 6.40 – Becton, Dickinson and Co Overall Patent Portfolio by Published Year ................................................................................................................................. 493Source Jurisdiction: .............................................................................................................................................................................. 493Figure 6.41 – Becton, Dickinson and Co Overall Patent Portfolio by Source Jurisdiction ........................................................................................................................... 493Becton, Dickinson and Co Patents Specific to This Study .............................................................................................. 494Figure 6.42 – Becton, Dickinson and Co Diabetes Patents by Technology Group ......................................................................................................................................494Priority Date by Year: ........................................................................................................................................................................... 495Figure 6.43 – Becton, Dickinson and Co Diabetes Patents by Priority Year................................................................................................................................................495Publication Date by Year: .................................................................................................................................................................... 496Figure 6.44 – Becton, Dickinson and Co Diabetes Patents by Published Year ...........................................................................................................................................496IPC Analysis – Top 10 Codes: ............................................................................................................................................................... 497Figure 6.45 – Becton, Dickinson and Co Diabetes Patents by IPC Code ......................................................................................................................................................497USPC Analysis – Top 10 Codes: ........................................................................................................................................................... 498Figure 6.46 – Becton, Dickinson and Co Diabetes Patents by USPC Code ..................................................................................................................................................498Source Jurisdiction: .............................................................................................................................................................................. 499Figure 6.47 – Becton, Dickinson and Co Diabetes Patents by Source Jurisdiction .....................................................................................................................................499

6.6 Dexcom INC ..........................................................................................................................................................................500Dexcom Overall Patent Portfolio ..................................................................................................................................... 500Priority Date by Year: ...........................................................................................................................................................................500Figure 6.48 - Dexcom Overall Patent Portfolio by Priority Year .................................................................................................................................................................500Published Date by Year: ...................................................................................................................................................................... 501Figure 6.49 - Dexcom Overall Patent Portfolio by Published Year .............................................................................................................................................................. 501Source Jurisdiction: .............................................................................................................................................................................. 501Figure 6.50 - Dexcom Overall Patent Portfolio by Source Jurisdiction ....................................................................................................................................................... 501Dexcom Patents Specific to This Study ............................................................................................................................ 502Figure 6.51 – Dexcom Diabetes Patents by Technology Group..................................................................................................................................................................502Priority Date by Year: ........................................................................................................................................................................... 503Figure 6.52 - Dexcom Diabetes Patents by Priority Year ............................................................................................................................................................................503Publication Date by Year: ....................................................................................................................................................................504Figure 6.53 – Dexcom Diabetes Patents by Published Year .......................................................................................................................................................................504IPC Analysis – Top 10 Codes: ............................................................................................................................................................... 505Figure 6.54 – Dexcom Diabetes Patents by IPC Code .................................................................................................................................................................................505USPC Analysis – Top 10 Codes: ........................................................................................................................................................... 506Figure 6.55 – Dexcom Diabetes Patents by USPC Code ..............................................................................................................................................................................506Source Jurisdiction: .............................................................................................................................................................................. 507Figure 6.56 – Dexcom Diabetes Patents by Source Jurisdiction .................................................................................................................................................................507

6.7 Novo Nordisk A/S .................................................................................................................................................................508Novo Nordisk Overall Patent Portfolio ............................................................................................................................ 508Priority Date by Year: ........................................................................................................................................................................... 508Figure 6.57 - Novo Nordisk Overall Patent Portfolio by Priority Year .........................................................................................................................................................508Published Date by Year: ...................................................................................................................................................................... 509Figure 6.58 - Novo Nordisk Overall Patent Portfolio by Published Year .....................................................................................................................................................509Source Jurisdiction: .............................................................................................................................................................................. 509Figure 6.59 - Novo Nordisk Overall Patent Portfolio by Source Jurisdiction ...............................................................................................................................................509Novo Nordisk Patents Specific to This Study....................................................................................................................510Figure 6.60 – Novo Nordisk Diabetes Patents by Technology Group ......................................................................................................................................................... 510Priority Date by Year: ............................................................................................................................................................................511Figure 6.61 - Novo Nordisk Diabetes Patents by Priority Year .................................................................................................................................................................... 511Publication Date by Year: .....................................................................................................................................................................512Figure 6.62 - Novo Nordisk Diabetes Patents by Published Year ................................................................................................................................................................ 512IPC Analysis – Top 10: Codes ................................................................................................................................................................513Figure 6.63 - Novo Nordisk Diabetes Patents by IPC Code .......................................................................................................................................................................... 513

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USPC Analysis– Top 10 Codes: .............................................................................................................................................................514Figure 6.64 - Novo Nordisk Diabetes Patents by USPC Code ...................................................................................................................................................................... 514Source Jurisdiction: ...............................................................................................................................................................................515Figure 6.65 – Novo Nordisk Diabetes Patents by Source Jurisdiction ........................................................................................................................................................ 515

6.8 Bayer AG ................................................................................................................................................................................ 516Bayer Overall Patent Portfolio ..........................................................................................................................................516Priority Date by Year: ...........................................................................................................................................................................516Figure 6.66 - Bayer Overall Patent Portfolio by Priority Year ..................................................................................................................................................................... 516Published Date by Year: .......................................................................................................................................................................517Figure 6.67 - Bayer Overall Patent Portfolio by Published Year ................................................................................................................................................................. 517Source Jurisdiction: ...............................................................................................................................................................................517Figure 6.68 - Bayer Overall Patent Portfolio by Source Jurisdiction ........................................................................................................................................................... 517Bayer Patents Specific to This Study .................................................................................................................................518Figure 6.69 – Bayer Diabetes Patents by Technology Group ..................................................................................................................................................................... 518Priority Date by Year: ............................................................................................................................................................................519Figure 6.70 - Bayer Diabetes Patents by Priority Year ................................................................................................................................................................................ 519Publication Date by Year: .................................................................................................................................................................... 520Figure 6.71 - Bayer Diabetes Patents by Published Year ............................................................................................................................................................................520IPC Analysis– Top 10 Codes: ............................................................................................................................................................... 521Figure 6.72 - Bayer Diabetes Patents by IPC Code ...................................................................................................................................................................................... 521USPC Analysis – Top 10 Codes: ........................................................................................................................................................... 522Figure 6.73 - Bayer Diabetes Patents by USPC Code ...................................................................................................................................................................................522Source Jurisdiction: .............................................................................................................................................................................. 523Figure 6.74 – Bayer Diabetes Patents by Source Jurisdiction ..................................................................................................................................................................... 523

6.9 Insulet Corporation ............................................................................................................................................................. 524Insulet Overall Patent Portfolio ........................................................................................................................................524Priority Date by Year: ........................................................................................................................................................................... 524Figure 6.75 - Insulet Overall Patent Portfolio by Priority Year .................................................................................................................................................................... 524Published Date by Year: ...................................................................................................................................................................... 525Figure 6.76 – Insulet Overall Patent Portfolio by Published Year .............................................................................................................................................................. 525Source Jurisdiction: .............................................................................................................................................................................. 525Figure 6.77 – Insulet Overall Patent Portfolio by Source Jurisdiction ........................................................................................................................................................ 525Insulet Patents Specific to This Study ...............................................................................................................................526Figure 6.78 – Insulet Diabetes Patents by Technology Group.................................................................................................................................................................... 526Priority Date by Year: ........................................................................................................................................................................... 527Figure 6.79 - Insulet Diabetes Patents by Priority Year .............................................................................................................................................................................. 527Publication Date by Year: .................................................................................................................................................................... 528Figure 6.80 – Insulet Diabetes Patents by Published Year ......................................................................................................................................................................... 528IPC Analysis – Top 10 Codes: ............................................................................................................................................................... 529Figure 6.81 – Insulet Diabetes Patents by IPC Code ................................................................................................................................................................................... 529USPC Analysis – Top 10 Codes: ........................................................................................................................................................... 530Figure 6.82 – Insulet Diabetes Patents by USPC Code ................................................................................................................................................................................530Source Jurisdiction: .............................................................................................................................................................................. 531Figure 6.83 – Insulet Diabetes Patents by Source Jurisdiction ................................................................................................................................................................... 531

6.10 Nipro Diagnostic ................................................................................................................................................................ 532Nipro Overall Patent Portfolio ...........................................................................................................................................532Priority Date by Year: ........................................................................................................................................................................... 532Figure 6.84 – Nipro Overall Patent Portfolio by Priority Year .................................................................................................................................................................... 532Published Date by Year: ...................................................................................................................................................................... 533Figure 6.85 – Nipro Overall Patent Portfolio by Published Year ................................................................................................................................................................ 533Source Jurisdiction: .............................................................................................................................................................................. 533Figure 6.86 – Nipro Overall Patent Portfolio by Source Jurisdiction .......................................................................................................................................................... 533Nipro Patents Specific to This Study ................................................................................................................................ 534Figure 6.87 – Nipro Diabetes Patents by Technology Group .....................................................................................................................................................................534Priority Date by Year: ........................................................................................................................................................................... 535

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Figure 6.88 - Nipro Diabetes Patents by Priority Year ................................................................................................................................................................................ 535Publication Date by Year: .................................................................................................................................................................... 536Figure 6.89 – Nipro Diabetes Patents by Published Year ...........................................................................................................................................................................536IPC Analysis – Top 10 Codes: ............................................................................................................................................................... 537Figure 6.90 – Nipro Diabetes Patents by IPC Code ..................................................................................................................................................................................... 537USPC Codes – Top 10 Codes: ............................................................................................................................................................... 538Figure 6.91 – Nipro Diabetes Patents by USPC Code ..................................................................................................................................................................................538Source Jurisdiction: .............................................................................................................................................................................. 539Figure 6.92 – Nipro Diabetes Patents by Source Jurisdiction ..................................................................................................................................................................... 539

6.11 Arkray Inc .............................................................................................................................................................................540Arkray Overall Patent Portfolio ........................................................................................................................................ 540Priority Date by Year: ...........................................................................................................................................................................540Figure 6.93 – Arkray Overall Patent Portfolio by Priority Year ...................................................................................................................................................................540Published Date by Year: ...................................................................................................................................................................... 541Figure 6.94 – Arkray Overall Patent Portfolio by Published Year .............................................................................................................................................................. 541Source Jurisdiction: .............................................................................................................................................................................. 541Figure 6.95 – Arkray Overall Patent Portfolio by Source Jurisdiction ........................................................................................................................................................ 541Arkray Patents Specific to This Study .............................................................................................................................. 542Figure 6.96 – Arkray Diabetes Patents by Technology Group ....................................................................................................................................................................542Priority Date by Year: ........................................................................................................................................................................... 543Figure 6.97 - Arkray Diabetes Patents by Priority Year ..............................................................................................................................................................................543Publication Date by Year: ....................................................................................................................................................................544Figure 6.98 – Arkray Diabetes Patents by Published Year .........................................................................................................................................................................544IPC Analysis – Top 10 Codes: ............................................................................................................................................................... 545Figure 6.99 – Arkray Diabetes Patents by IPC Code ...................................................................................................................................................................................545USPC Analysis – Top 10 Codes: ...........................................................................................................................................................546Figure 6.100 – Arkray Diabetes Patents by USPC Code ..............................................................................................................................................................................546Source Jurisdiction: .............................................................................................................................................................................. 547Figure 6.101 – Arkray Diabetes Patents by Source Jurisdiction .................................................................................................................................................................547

6.12 Sanofi – Aventis SA ............................................................................................................................................................548Sanofi-Aventis Overall Patent Portfolio .......................................................................................................................... 548Priority Date by Year: ...........................................................................................................................................................................548Figure 6.102 - Sanofi-Aventis Overall Patent Portfolio by Priority Year .....................................................................................................................................................548Published Date by Year: ...................................................................................................................................................................... 549Figure 6.103 - Sanofi-Aventis Overall Patent Portfolio by Published Year .................................................................................................................................................549Source Jurisdiction: .............................................................................................................................................................................. 549Figure 6.104 - Sanofi-Aventis Overall Patent Portfolio by Source Jurisdiction ...........................................................................................................................................549Sanofi-Aventis Patents Specific to Diabetes Project ...................................................................................................... 550Figure 6.105 – Sanofi-Aventis Diabetes Patents by Technology Group ..................................................................................................................................................... 550Priority Date by Year: ........................................................................................................................................................................... 551Figure 6.106 - Sanofi-Aventis Diabetes Patents by Priority Year ............................................................................................................................................................... 551Published Date by Year: ...................................................................................................................................................................... 552Figure 6.107 - Sanofi-Aventis Diabetes Patents by Published Year ............................................................................................................................................................ 552IPC Analysis – Top 10 Codes: ............................................................................................................................................................... 553Figure 6.108 - Sanofi-Aventis Diabetes Patents by IPC Code ...................................................................................................................................................................... 553USPC Analysis– Top 10 Codes: ............................................................................................................................................................ 554Figure 6.109 - Sanofi-Aventis Diabetes Patents by USPC Code .................................................................................................................................................................. 554Source Jurisdiction: .............................................................................................................................................................................. 555Figure 6.110 – Sanofi-Aventis Diabetes Patents by Source Jurisdiction..................................................................................................................................................... 555

7.0 SUMMARY OF PATENT AND PRODUCT POSITIONS OF TOP DIABETES DEVICE COMPANIES .............556Table 7.1 – Table of Highlighted Companies and Technologies ................................................................................................................................................................. 556

8.0 APPENDIX A ASSUMPTIONS ............................................................................................................... 557Patent ..................................................................................................................................................................................557Current Assignee vs. Ultimate Parent ...............................................................................................................................557

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9.0 APPENDIX B PATENT STRENGTH......................................................................................................... 558

10.0 APPENDIX C TEXT CLUSTERING ....................................................................................................... 559

GLOSSARY ...................................................................................................................................................... 560