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INTELLECTUAL PROPERTYCONSULTING & BROKERAGE FIRM

An International

Patent Landscape Report

HOME HEALTH DIAGNOSTICSMICROFLUIDICS & IP

© Copyright ClearViewIP 2015. All rights reserved.

About ClearViewIPClearViewIP is an Intellectual Property Consultancy providing a comprehensive range of services to high-tech markets. Using our proven international commercial experience, we help our clients develop their IP strategy, establish effective processes and realise value from their intellectual property.

Founded in 2007, the experience of our directors, consultants and analysts provides a unique blend of commercial and IP experience that carries with it a highly competitive track record of delivering value to businesses.

ClearViewIP have experience of working with FTSE and Fortune 500 companies, as well as smaller enterprises, across a range of industry sectors including, but not exclusive to: telecoms, computing, silicon, medical devices, satellite, consumer electronics, automotive and manufacturing.

Our services are bespoke dependent on client’s requirements but can include: investment due diligence, IP strategy, competitive intelligence, IP discovery and capture, patent landscaping, patent searching, IP acquisition, commercialisation and coaching.

Robin has experience working with clients throughout the IP lifecycle – from managing innovation capture processes, to delivering detailed patent landscapes/competitive analysis reports and assessing IP monetisation options. He also undertakes a number of other consulting roles at ClearViewIP including: patent mining strategy

for acquisition, identifying licensing opportunities, IP due diligence and patent valuation. Robin advises clients on IP matters in a range of high-tech fields including: audio/video streaming, telecoms, consumer electronics, mobile apps, mHealth/telehealth and medical devices.

Robin has a first class honours degree in Biomedical Materials from Nottingham University (BSc), a doctorate in Biomaterials from Oxford University (DPhil) and holds the Postgraduate Certificate in Intellectual Property Law from Brunel University (PGCert IP). Robin is also a Certified Patent Valuation Analyst (CPVA).

His published articles include peer-reviewed academic research and patent review papers on collagen-based medical devices/implants, as well as editorial for Managing Intellectual Property Magazine.

Robin WaltonIP ConsultantClearViewIP

HOME HEALTH DIAGNOSTICS MICROFLUIDICS & IP This report is based on data from 2012 and was prepared as part of a home health diagnostics patent landscape.

2015 Update: Since 2012, the size of the market for home health diagnostics technologies has increased significantly from around $5bn in 2012 to a projected $12bn in 2018 – a driving factor being insurance providers and national health services looking to decrease doctors’ visits and reduce costs. One of the predominant overall trends in home health diagnostics, from a technology standpoint, has been convergence. Home health products have become richer in features – in particular, fitness trackers/smartwatches (wearables) have really taken off, with a large emphasis being on health monitoring features. The wearables market in 2015 is estimated to be worth over 7 times what it was in 2012 ($7bn vs. $1bn), with the relatively new Apple Watch having approximately 50% of the smartwatch market. The 2 major players in fitness trackers, Fitbit and Jawbone, have been involved in intense technology-related litigation in recent years over trade secrets and patent infringement – showing the struggle for market dominance in this space. In terms of next-generation home testing devices, the microfluidic chip revolution is still yet to be realised in the market, however, patent filings from key assignees and fundamental academic research continues in this space.

About the Author

© Copyright ClearViewIP 2015. All rights reserved. © Copyright ClearViewIP 2015. All rights reserved.

Consumer-Driven Healthcare

The concept of self-conducted diagnostic tests, administered by patients in their own home, would likely have been thought completely preposterous 100 years ago – conjuring-up images of an array of test-tubes, flasks and Bunsen burners. Today however, home diagnostics (HD) are one of the fastest growing categories of what has been termed consumer-driven healthcare.1 Although there are certain self-administered tests that have been used for decades, such as the home pregnancy test, consumers have been attracted to the convenience, privacy, time, and cost-benefits of the latest home-testing kits, when compared to visiting a primary care physician. This shift has largely been driven by continued technological advances that have brought the testing methods out of the lab and into small, inexpensively-produced, and easily-operated medical devices.

Traditionally, there are three main areas for these devices:1. Electronic devices (usually reusable e.g. blood pressure

monitor/pulse oximeter)2. Chemical or Bio-marker assay devices (usually single use,

e.g. urine-test paper-strips)3. Sample collection devices (the user collects the sample at

home then sends it to a lab for testing)

Because of the falling price of simple electronic components, there are increasingly more examples of chemical or bio-marker tests which include an electronic readout such as the Quick Check home diagnostic device (www.quickcheckhealth.com) in Figure 1. In terms of patents, this is a rather complex area, as much of the early patented technologies, covering many of the standard physical/chemical/biological assays used in these devices, have long expired. Consequently, many home-diagnostic related patents tend to disclose an implementation of a standard testing method in an overall “package” which may be used/interfaced with various technologies such as the internet (‘telemedicine”) or mobile devices, (known as “mHealth,”- see Figure 2). The strongest patents with relevance to HD however, are those which claim a fundamentally new type of sensor or testing means.

1 https://www.bioiq.com/press/consumer_diagnostics_poised_for_growth.pdf

Miniaturisation and Microfluidics Advances Driving Change

New types of bodily-fluid diagnostic tests are usually first implemented clinically in the laboratory, often taking many years of technological advances for miniaturisation into a cost effective home-testing device — miniaturisation is desirable so only small quantities of expensive testing materials are needed. Recently, it is becoming more and more apparent that the fast-developing field known as microfluidics (MF) is going to play a key role in realising the miniaturization process more rapidly by enabling extremely small volumes of bodily fluid samples to be examined within so-called “lab-on-a-chip” miniature testing components.23

IBM has created their own concept of an “ideal home diagnostic device4,” which incorporates a disposable “microfluidic chip”. From this concept it is evident that new developments in materials, microfluidics, sensor/receptors and electronic components will be essential for the realisation of these types of devices. It is possible then, that the forthcoming high-tech, multi-component HD devices will go the way of mobile phone handsets where hundreds of patents can be associated with each device, often from many different companies under specific license agreements – this patent model for HD is in-line with the current trend towards “open innovation5 in the medical device sector6.”

A History of Patent Filings in the HD & MF Space

The graphs depicted in Figure 3 show the filing timelines of both HD patents (left) and microfluidics (right). The blue lines indicate the total number of patent documents that have been published worldwide, while the red lines indicate the number of separate, unique inventions. What these graphs show is that since the mid-90s there has been a steady rise in patented technology in these areas (note: the severe tail-off from 2008 onwards is an artefact due to patent documents still awaiting publication).

2 http://www.nanowerk.com/news/newsid=15949.php3 http://www.sciencedaily.com/releaes/2011/03/110324104410.htm4 http://www.nanowerk.com/spotlight/spotid=21383.php5 http://en.wikipedia.org/wiki/Open_innovation6 http://bloinc.ninesigma.com/post/2011/02/09/title.aspx

Figure 2. m-Health example - Withings blood pressure monitor connected to an iPhone

Quick Check

Blood Pressure Monitor Connected to iPhone

Figure 1. Home diagnostic device


Microfluidics Patent Assignees

HD Technologies & Jurisdictions Important to Top Assignees

To investigate the HD IP landscape, a patent dataset was collected based on the identification of patents which explicitly state that the device/method can be self-administered or is suitable for home testing – this was to exclude diagnostic methods which can only be conducted in a laboratory. Based on this search criterion, Figure 4 below shows the Top 10 patent assignees with their associated jurisdiction coverage – Japan notably being a key territory in this field.

Philips appears to dominate the IP landscape in terms of volume of patents, with a relatively equal spread across jurisdictions. Other key players are Roche, Medtronic and Panasonic. Panasonic and Toshiba’s HD patent portfolios are notably weighted towards coverage in Japan, with considerably less filings in EP and US territories.

Some of the key diagnostic areas in terms of the volume patents appear to be: heart conditions, diabetes, sleep disorders, blood coagulation and cholesterol. Figure 4 (bottom) shows the proportion of the HD portfolios of these top 10 assignees that are focussed on these key diagnostic areas (note: some patents appear in more than one of these diagnostic categories). Patents that do not fall into these categories are often telemedicine related or describe non-specific “health monitoring” devices where the novelty focus lies within other, non-health related technological attributes. Philips, Medtronic and Cardiac Pacemakers are the key players in the heart condition field. While Roche, Abbot and Medtronic have significant proportions of their HD portfolios related to diabetes care. Home cholesterol monitoring is a smaller area in terms of IP – Roche, Abbot and Medtronic being the Top 3 patent assignees. The major focus of Cordis’ portfolio appears to be blood clotting, while Roche and Siemens also have some IP in this area. Toshiba’s HD patents lie outside the 5 key diagnostic areas and, on further investigation, appear to be primarily telemedicine-related.

The Landscape for Microfluidics

Figure 5 shows the Top 10 microfluidics/lab-on-a-chip patent assignees. Unsurprisingly, there is a mix of electronic goods manufacturers and biotech/life science companies; three American universities also feature in the Top 10. Caliper Life Sciences dominates this space, in terms of patent portfolio size, and is actively licensing their technologies to companies such as Aglient, Canon Life Sciences and Affymetrix7. Indeed, their

7 http://www.caliperls.com/about/business-development-and-partner-ship-opportunities/licensing-opportunities.htm

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1990 1995 2000 2005 2010

Number ofpatentdocuments

Number ofuniquepatentfamilies

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1990 1995 2000 2005 2010

Number ofpatentdocuments

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HD Patents Microfluidics

Figure 3. Filing timeline of home diagnostics patents and microfluidics, based on priority date

Figure 4. Home diagnostics patent filings from top 10 assignees with jurisdiction (top) and showing the technology spread across common diagnostic categories (bottom)

Patent Assignees by Jurisdiction

Patent Assignees by Diagnostic Categories

PHILIPS CORP

ROCHE DIAGNOSTICS

MEDTRONIC INC

PANASONIC CORP

ABBOTT INC

SIEMENS

TOSHIBA CORP

CORDIS CORP

BECTON DICKINSON CO

CARDIAC PACEMAKERS INC

USEPGBJPWO

0 50 100 150 200 250 300 350

PHILIPS CORP

ROCHE DIAGNOSTICS

MEDTRONIC INC

PANASONIC CORP

ABBOTT INC

SIEMENS

TOSHIBA CORP

CORDIS CORP

BECTON DICKINSON CO

CARDIAC PACEMAKERS INC

Diabetes

Sleep Disorders

Cholesterol

General Health /Telemedicine / Other

0 50 100 150 200 250 300 350

CALIPER LIFE SCIENCES

UNIV CALIFORNIA

GENEASYS PTY LTD

CAL TECH

SAMSUNG ELECTRONICS CO LTD

PHILIPS CORP

AGILENT TECHNOLOGIES INC

3M

HARVARD COLLEGE

CORNING INC

USEPGBJPWO

0 100 200 300 400 500

Figure 5. Top 10 microfluidics/lab-on-chip patent assignees with jurisdiction


extensive MF-related patent portfolio has been ranked second best for its technological strength in the MIT Technology Review Patent Scorecard8. The University of California and Caltech also have a large number of MF patents which they licence out or use to form spin-outs e.g. Fluidigm9, an MF company using technology licensed from Stanford University and Caltech.

In terms of jurisdiction coverage, microfluidics appears to be quite a US-driven innovation area, thus the filings have been predominantly in the US, with Japan being notably less prevalent a territory than for home diagnostic patents.

An important observation from Figures 4 & 5 is that Philips is the only company to feature in the Top 10 of both HD & MF patents. Figure 6 puts their position in these areas into context with some other prominent HD/MF patent assignees. The diagram shows that Philips has a comparatively large and evenly spread HD + MF portfolio with a 53/47% split of patents, respectively. This puts them in a strategically strong position for the continued development of MF-chip-based HD devices.

Roche and Siemens also appear to be in excellent strategic positions for the development of MF-chip HD devices, with Roche slightly leaning towards HD patents at 61% dominance, and Siemens slightly leaning towards MF patents at 58% dominance. Assignees with extremely MF-heavy portfolios include Caliper, Geneasys, Samsung and The University of California. Whereas, Medtronic, Panasonic and Abbot have HD-heavy portfolios – the latter less so having an 85/15% split.

Due to the strong MF portfolios of companies such as Caliper, HD developers with virtually no MF patents, such as Panasonic, may find themselves needing to license technologies from these MF companies, should they shift their commercial focus to MF-chip HD products in the future. Indeed, Panasonic appears to

8 http://www.technologyreview.com/magazine/25/9 http://www.fluidigm.com/

be playing catch-up, having partnered with IMEC in 200810 with whom they have jointly developed various critical components of a biomedical lab-on-chip sensor11.

Citations as an Indicator of Technological Importance

Patent citation analysis is a useful method to see which patents stand out and act as key reference points for forthcoming research and development. Figure 7 shows the Top 10 cited patent assignees pre-2000 left and the Top 10 cited patent assignees post-2000 on the right. The picture is quite different pre/post 2000, with Medtronic and Siemens being the only assignees to have continually high citation levels. Pre-2000, the most highly cited patent documents from these top cited assignees are all from the 1990’s, except one from inventor E. Ellinwood in 1977 – “Self-powered implanted programmable medication system and method”, which appears to have introduced some key concepts for implantable medication delivery devices.

10 http://www2.imec.be/be_en/press/imec-news/archive-2008/im-ec-and-panasonic-sign-comprehensive-joint-research-contract.html

11 http://www.sciencedaily.com/releases/2010/12/101210075918.htm

Figure 6. Distribution of HD/MF patents in combined HD + MF portfolios of key assignees

HD/MF Patent PortfoliosSigni nt HD & MFpo osHD-heavy po os

MF-heavy por olios

CALIPERGENEASYS

SAMSUNGUNIVCALIFORNIA

SIEMENS

PHILIPS

ROCHE

ABBOTT

MEDTRONIC/ PANASONIC

Bubble size = combined sizeo f HD + MF patent p io

% Home diagnostic patents

% M

icro

fl uid

ics

pate

nts

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Figure 7. Top 10 HD patent citations by assignee pre/post-2000 (top/bottom), also indicating assignees’ most cited patent with (application year and #of citations)

Patent Citations Post 2000

HEALTH HERO NETWORK INC

MEDTRONIC INC

FUTREX INC

ELLINWOOD EVERETT H JR

ORATEC INTERVENTIONS INC

VISIONARY MED PROD INC

SIEMENS

BRIGHAM & WOMENS HOSPITAL

NOKIA CORP

UNIV COLUMBIA

US5840020A (1997) [266]

US5778882A (1995) [221]

US5855601A (1996) [508]

US5375604A (1992) [193]

US5593390A (1995) [235]

US6073051A (1997) [226]

US4146029A (1977) [352]

US5028787A (1989) [255]

US6248080B1 (1999) [126]

US6248080B1 (1999) [126]

Patent Citations Pre 20000 500 1000 1500 2000 2500 3000 3500 4000 4500

PHILIPS CORP

ROCHE DIAGNOSTICS

MEDTRONIC INC

ABBOTT INC

PANASONIC CORP

SIEMENS

CORDIS CORP

LIFESCAN CORP

MASIMO CORP

CARDIAC PACEMAKERS INC US7433853B2 (2004) [13]

US7289835B2 (2005) [44]

US6612111B1 (2000) [66]

US7252086B2 (2004) [26]

EP1101437A1 (2000) [24]

US6885196B2 (2002) [73]

US20030212316A1 (2002) [53]

US6895263B2 (2002) [161]

US20050004494A1 (2004) [92]

US6611206B2 (2001) [64]

0 50 100 150 200 250 300 350 400 450 500


Interestingly, pre-2000, Nokia have some very highly cited patent documents in the 1990’s relating to diabetes monitoring equipment used in conjunction with a mobile phone: this strongly relates to the core concepts of the upcoming field of mHealth. Post-2000, Roche have a key, highly cited patent application from 2004 (granted in 2010), which covers a device for sampling body fluid and a means for measuring the body fluid (e.g. porous test strips, electronic testing, optical/reflectance testing or visual inspection). Many of the assignees with the highest post-2000 citation levels also appear in the Top 10 patent assignees, as seen in Figures 4 and 5. This indicates that the new players in this area are now dominating the field in terms of patent volumes and the technological significance of their patents.

Summary and Conclusions

Looking at the whole home diagnostics patent landscape, there is a clear split between companies developing diagnostic technologies which do not require a sample of bodily fluid and those that do. Companies such as Panasonic, Medtronic, Toshiba and Cardiac Pacemakers have their IP aligned with devices in categories that do not require a sample and as such have not developed a microfluidics patent portfolio to date. Conversely, it is also evident that the key companies that have at least some devices that do require a sample, such as Siemens, Philips and Roche, have developed significant microfluidics patent portfolios.

If IBM’s ideal bodily-fluid home diagnostic device is to be realised, the key question is whether it will be through open innovation or a significant player using IP to dominate the field though rigorous enforcement of their patents. The first sign of this was seen in 2007 when Roche sued Home Diagnostics Inc. for patent infringement relating to a home-testing glucometer12: could this be a warning sign of things to come? The fact is that there are only a handful of very large corporations with the resources and the necessary volume, type and technological quality of patents to go it alone without adhering to the open innovation model.

The telemedicine and mHealth fields continue to grow in terms of products; although patents seem to feature less in these areas as the majority of embodiments to date often rely on older fundamental testing principles (e.g. Figure 2). Nevertheless, this is a rapidly expanding field with mobile phone manufacturers eager to show off innovation in this area, as demonstrated at the Mobile World Congress 201213. It is quite likely that in the future, there will be technological convergence between mHealth/telemedicine and microfluidic-chip diagnostics devices. With this convergence of products will come a whole host of IP issues – this could well become a future focus of the Smartphone/Tablet Patent Wars14.

12 http://www.patentdocs.org/2007/03/roche_diagnosti.html13 http://www.mobileworldcongress.com/mobile-health.html14 http://www.ambercite.com/downloads/The%20Smartphone%20Pat-ent%20Wars%20whitepaper_March%202011.pdf


Roche holds the most highly cited patent for a device used to sample and measure

Philips, Medtronics & Cardiac Pacemakers dominate patents relating to heart conditions

Roche, Abbott, and Medtronic have

of their HD patent portfolios relating to diabetes

Cordis’ patent portfolio focuses on blood clotting (Roche & Siemens also show interest)

Roche, Abbott and Medtronic are the top assignees for home cholesterol monitoring

Japan dominates health diagnostics

The US dominates

Heart Conditions

Diabetes

Cholesterol

Sleep Disorders

Blood Coagulation

Medtronic and Siemens have high patent citation levels

Philips, Roche and Siemens have

portfolios and are all in a good position to

Health Diagnostic devices

Toshiba’s patents primarily relate to general telemedicine systems and devices

PhilipsRoche DiagnosticsMedtronicPanasonicAbbotSiemensToshibaCordisBecton DickinsonCardiac Pacemakers

Top Players in HHD

123456789

10

Caiper Life Sciences Uni. of CaliforniaGeneasysCal TechSamsungPhilipsAgilent Technologies3mHarvard CollegeCorning

Top Players in Mf

123456789

10

Since the mid 90s, there has been a steady rise in patents relating to health diagnostics &

AnalysisBased on the industry trends and patent landscape, we expect mHealth/telemedicine &

diagnostics will be combined in future products

1990s: Most highly cited patents for using diabetes monitoring equipment with mobile phones belonged to Nokia

Early patents on standard elements in common home health devices have expired

In 2007, Roche sued Home Diagnostics Inc. for patent infringement relating to a home-testing glucometer

1990 2000 2010 2020

Home Health Diagnostics, Microfluids & IP

Patents Relating to Key Diagnostic Areas


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