Microbial infection Point-of-care diagnostics

Microbial infection:
Point-of-care
diagnostics

Microbial infection: Point-of-care diagnostics 2
Contents
Foreword 3
Introduction 4
Overall filing trends (five years from 2009) 5
Geographic distribution of patent filings 7
Top applicants in each entity type 8
Technology: assay vs. device 11
Type of pathogen 12
Methodology 15
Contacts 16

Foreword
Geoff Mulgan
Chief Executive of Nesta
Longitude Prize committee member
Nearly 90 years have passed since Alexander Fleming discovered the first
antibiotic – penicillin. Since then, antibiotics and other antimicrobial drugs
have revolutionised every aspect of modern medicine. Without antimicrobials,
current routine surgery and common infections could be fatal.
As the use of antimicrobials has increased, so too has microbial resistance
to these drugs. Fleming, himself, predicted the rise of resistance in his 1945
Nobel lecture and, today, politicians to researchers warn that we are rapidly
approaching a “post-antibiotic era” – an era in which a common infection can
once again kill. This is an urgent global issue.
Blame for the development of antimicrobial resistance can be pointed at the
overuse of and overreliance on broad spectrum antimicrobials. In a sense,
antimicrobials are a victim of their own success; they are so effective that
clinicians and patients alike have become too dependent on their function.
With limited development of new antimicrobials, as was recently discussed in
the UK Government’s report, Securing new drugs for future generations: the
antibiotics pipeline, and the constant ability of microbes to evolve, we need a
new solution. This requires intelligent use of current antimicrobials and more
effective prevention to stop antimicrobial resistance from developing further.
It is now a year since the British public voted to make antibiotic resistance
the subject of the Longitude Prize. Since then, the issue of antibiotic
resistance has moved closer to the top of the global health agenda, and
a coalition is taking shape to galvanise action. Pharmaceutical companies
are beginning to pledge money towards new antibiotic R&D; many groups
are working to study resistance; big livestock producers are phasing out
wide antibiotic use in farming; and a lot more money is being pumped into
research. A useful input is the series of reports published by the
UK Government’s AMR Review, headed by Jim O’Neill, which have
shown the potential cost of antibiotic resistance could be as high as 300
million deaths and $100 trillion by 2050.
The Longitude Prize is just one part of this picture – but a crucial one.
We have focused the prize on point-of-care (POC) diagnostics to reduce
dependence on antibiotics as a means of tackling infections. At the moment,
it is difficult for doctors to identify quickly which antibiotics are needed to
treat an infection. If anyone can develop an easy and quick way to tell what
infection a patient has and whether antibiotics are even needed (infections
caused by a virus will not be affected by antibiotics, which will kill only
bacteria), this would lead to much more targeted use of antibiotics and a
much reduced threat from resistant strains.
We are grateful to CPA Global, Landon IP and Marks & Clerk for their
support of the Longitude Prize. The patent landscape study presented in
this report will be a very valuable tool for the judging panel when considering
submissions.

Marks & Clerk, CPA Global and Landon IP are proud to support the
Longitude Prize and the important quest to find a solution for one of the
greatest modern-day risks affecting people across the world: the rise of
antimicrobial resistance.
Although this issue has been attracting headlines for some years now, we
still face a serious threat from microbial resistance to drugs, compounded
by misprescription of antimicrobials.
Our research into patent filings in the area of POC diagnostic tests gives
an indication not only of the levels of research into such tests and the
types of organisations applying for patents in this area, but also the focus
of recent research. We analysed worldwide patent filings since 2009 in
order to draw out key trends.
This is a critical time for investment into and the development and
patenting of new POC technologies. Although our research revealed an
overall decrease in annual numbers of patent filings for POC diagnostic
tests in recent years, we hope that media and public awareness of
the importance of POC diagnostics in the fight against antimicrobial
resistance, a stronger focus and increased research investment by
governments (especially in the UK and USA), together with initiatives like
the Longitude Prize, will see an acceleration in patent filings in this area.
The picture emerging from our study shows the USA to be the clear
leader in research into POC diagnostic tests, followed by the UK. Over
half of all patent filings relating to POC diagnostics around the world were
by private companies. While Abbott, the global healthcare company, is
the leading individual filer of patent applications in this area, small to mid-
sized entities (SMEs) represent 70 per cent of patent filings by private
companies.
Over the past few months, the Nesta Longitude team has been
encouraging submissions from around the world. Events across the USA,
China, India, Europe and South America have attracted registrations from
many different types of organisations worldwide. With innovators now
able to submit their ideas to the Longitude Prize judging panel, we are
excited at the prospect of finding an accurate, rapid, affordable, easy-to-
use POC test that will be available to anyone, anywhere in the world.
Introduction
Dr Paul Chapman
Partner, European Patent Attorney
Marks & Clerk
Longitude Prize advisory panel member
Tim Griffiths
Chief Executive Officer
CPA Global
Dr Paul Chapman
Tim Griffiths

Microbial infection: Point-of-care diagnostics Microbial infection: Point-of-care diagnostics5 6
Fig. 1a
Patent applications (families
and individual) for point-of-
care diagnostics inventions
by year*
*2013 data not complete
The past five years have seen upwards
and downwards movement in the number
of patent filings for POC diagnostic tests
in the field of antimicrobial-resistant
organisms. While the number of patent
families initially increased from 90 in 2009
to 100 in 2010, subsequent years have
seen a reduction in filings (Fig.1). It is likely
that the global financial crisis was at least
partly accountable for the dip, having led to
a reduction in research and development
budgets and funding available for private
and public sector research.
However, the trend of decreased patent
filings is expected to reverse over the
next few years. The media and general
public have become increasingly aware of
antimicrobial resistance, to the extent that
it was ranked in a public vote as one of
the greatest modern-day risks, leading to
the search for a POC diagnostic solution
becoming the focus for the Longitude Prize.
This will likely act as a stimulus for research,
innovation and, consequently, patent filings
in the area. The relatively limited number of
recent POC diagnostic test patent filings,
together with initiatives like the Longitude
Prize, may lead innovators to the view that
now is an opportune time for investment
into, and the development and patenting of
new POC technologies.
A more noticeable decrease in filings has
been observed for individual applications
(Fig. 1a). This suggests that applicants are
adopting a more restricted filing strategy,
with more recent applications limited to a
smaller number of countries compared to
previous years.
At present, the USA leads the way as the
jurisdiction in which applicants file the
first patent application in any given POC
patent family, with 78 percent of all first
patents filed there (Fig. 2). It is no surprise
that the USA, home to the world’s largest
economy, is the destination of choice for
first filing, both for US entities and many
foreign entities. This is the case not only
in POC diagnostics, but also in the wider
biotechnology field and, in fact, across
most technologies.
Second only to the USA, the UK has been
the destination for a significant number
of first filings (26). Other developed
countries show lower levels of activity, with
Singapore, Germany, Australia, and South
Korea following behind the UK and the USA
as destinations for first filing.
A review of the POC test patent
applications first filed in the UK highlighted
a number of trends. Unlike some US
applications, patent applications first
filed in the UK appear to be primarily
directed towards devices or a method in
combination with a device. In particular, a
number of UK first-filed applications are
related to disposable assay cartridges,
where a biological sample can be placed
directly into the cartridge for subsequent
assessment before disposal. This
disposable feature is important for clinicians
when requiring a quick and sterile change-
over of equipment at the point of care
between patient samples. Many of the
UK patent applications do not relate to
a particular pathogen, but are, instead,
purposefully broad in order to cover a
device that could diagnose any number
of infections. The UK patent applications
that are more specific are directed towards
the diagnosis of bacterial rather than viral
infection.
Overall filing trends (five years from 2009)
Philippines
Switzerland
Netherlands
Spain
Japan
South Africa
Chile
India
Canada
China
USA
UK
Singapore
Germany
Australia
Korea
Denmark
Finland
3
21
258 (78%)
26 (8%)
4
6
3
90
100
61 64
16
2009 2010 2011 2012 2013
NumberofPatentFamilies
18-monthpublicationdelay
Fig. 1
Patent applications (families)
for point-of-care diagnostics
inventions by year*
Filings in 2009 and 2010 were high but
dropped in the subsequent years
*2013 data not complete
Fig. 2
Patent applications (families) for
point-of-care diagnostic inventions
by geography of first filing
The USA dominates as the destination for first filings,
followed by the UK.
Numbers indicate numbers of patent families
applied for between 2009 and 2013
Data incomplete for 2013 due to 18-month
publication lag
2009 2010 2011 2012 2013
434
360
238
113
6590 100
61 64
16
Total patent applications
Patent families
18-monthpublicationdelay

27%
330
US
UK
Singapore
Taiwan
Australia
China
Korea
Europe (EPO)
PCTs
India
Other
Japan
Mexico
Canada
25%
312
11%
139
7%
89
5%
62
5%
57
5%
56
3%
31
2%
29
2%
29
4%
48
1% 10
1% 10
1% 9
While research into POC tests appears to
be mostly limited to a few countries – as
indicated by the countries of first filing – a
different picture emerges when analysing
the geographical distribution of total patent
filings. Although the USA again leads with
a total of 330 patent applications since
2009, Europe also features strongly, with
139 patent applications in the same period.
A significant number of patent applications
have also been filed in China (89) and India
(29) (Fig. 3).
Geographic distribution of patent filings
Fig. 3
Total patent applications for point-of-care
diagnostic inventions by geography
The USA and Europe are the two most significant markets where
entities are seeking protection. Among the BRIC countries, most
filings are taking place in China and India.
27%
330
US
UK
Singapore
Taiwan
Australia
China
Korea
Europe (EPO)
PCTs
India
Other
Japan
Mexico
Canada
25%
312
11%
139
7%
89
5%
62
5%
57
5%
56
3%
31
2%
29
2%
29
4%
48
1% 10
1% 10
1% 9
Numbers indicate total numbers of patents applied
for between 2009 and 2013 (multiple entries per
patent family)
publication lag

Top applicants in each entity type
Like in many other biotechnology sub-
fields, private companies and academia are
driving the innovation of POC diagnostic
tests (Fig. 4). Of the applications from
private companies in this field, over 70
percent of patent filings (121 patent families
out of 170 from private companies) are from
small to mid-size entities (SMEs – Fig. 5).
However, universities follow closely behind
with 118 families.
To take a few examples, the University
of California has filed eight patent
applications since 2009 (Table 2). In the
same period, Harvard University filed
four patent applications. Brigham and
Women’s Hospital and Massachusetts
General Hospital, both affiliates of Harvard
Medical School, have filed four and
three applications, respectively (Table 3).
Combined with the four applications in
Harvard University’s own name, this makes
the Massachusetts-based university a key
player in the field.
No one SME dominates the field, with
individual SMEs filing three patent
applications, at most, since 2009. Most
SMEs filed one patent application each in
the same period.
Of the 14 SMEs that have applied for two or
three patent applications, two specialise in
technology transfer. Another five are owned
or controlled by larger entities.
In addition, government agencies from the
USA, Singapore, and the UK have carried
out research in this area, leading to a
number of patent filings (Table 4), indicating
that antimicrobial resistance is a key area of
concern at government level.
The most prominent player by far across
the whole field is Abbott, which has filed
26 patent applications in the area of POC
diagnostics since 2009, more than three
times the amount of any other applicant.
The majority of Abbott’s recent filings
have focused on immunoassays and viral
detection.
One example of an entity already making
an impact in the POC diagnostic test field
is Alere. Alere recently announced that
it has won FDA approval for its i Strep
A test, the first molecular test to detect
Group A Streptococcus bacteria in throat
swab specimens in around eight minutes.
This technology is already in use in its
corresponding influenza A and B test.
Current pending applications by Alere focus
upon the improvement of test devices
generally (application WO2014/13996, for
example) rather than a particular test or
device. >
Innovation coming from
US hospitals
A number of the filings by Brigham and
Women’s Hospital relate to methods
for use with portable systems and
devices. For example, application
US2014/0242612 relates to a method
for analysing the level of biomarker
expression by using a microchip
coupled to an imaging device such as
a mobile phone. This system can be
directed towards the detection of a
number of different biomarkers.
In contrast, Massachusetts General
Hospital’s applications appear to be
directed towards the detection of
drug-resistant or particular species
of microorganisms. Application
US2013/0190196 relates to a method
for determining the drug sensitivity
of a pathogen, while application WO
2014/028726 is directed towards
methods for the diagnosis of infection
by a bacterium belonging to the
Borrelia burdorferi sensu lato complex.
Microchip device coupled to a
mobile phone, as featured in patent
application US2014/0242612 by
Brigham and Women’s Hospital.
118
36%
170
51%
9
11
10
14
Private companies
Individual inventors
Government agencies
Universities
Public/private collaborations
Hospitals
Fig. 4
Patent applications for
point-of-care diagnostic
inventions by applicant type
AbbottUS HHS
US DOE
UK Defra
Singapore-A*STAR
UK HPA (now PHE)
4
2
1
1
1
Table 4
Government agency applicants for patents
on point-of-care diagnostic inventions
Brigham & Women’s
Massachusetts General
Houston Methodist
Children’s Medical Center (Boston)
Montefiore Medical Centre
4
3
2
1
1
3
Table 3
Hospital applicants for patents on
point-of-care diagnostic inventions
Brigham and Women’s Hospital and Massachusetts
General Hospital are Harvard Medical School’s
largest teaching affiliates. These relationships make
Harvard an important entity.
U. California
U. Florida
Harvard U.
Yale U.
U. Michigan State
Burnet Institute
U. Boston
U. Nevada
8
4
4
3
3
3
3
3
Table 2
Top 8 university and research institute
applicants for patents on point-of-care
diagnostic inventions
Total=118
Abbott
Siemens
Becton Dickinson
DST Diagnostische
LG Electronics
Meso Scale
Cellestis (Qiagen)
Q Chip (Midatech Pharma)
26
5
4
3
3
3
3
3
Table 1
Top 8 private company applicants for
patents on point-of-care diagnostic
inventions
Abbott is leading by a big margin in patent filing in
point-of-care diagnostics.
Total=170
Numbers indicate numbers of patent families applied for between
2009 and 2013
Data incomplete for 2013 due to 18-month publication lag

71%
121
29%
49
Fig. 5
Patent applications for
point-of-care diagnostic
inventions by private
companies
Most filings in the private sector are
by mid-size or small companies.
Mid-size or small companies
Large companies
Innovation coming from
SMEs
Nexus DX Inc, a company specialising
in POC diagnostics, has filed two patent
applications since 2009. One of these,
application US2010/0323343, relates to
methods and devices for the detection
of analytes, such as influenza virus. The
method in this application is described
as utilising a sample collection device
and a test strip, where readable lines will
form if the patient is infected.
Similarly, Cellestis Ltd. (a top SME filer
acquired by Qiagen N.V. in 2011) has
filed a number of applications describing
methods for measuring cell-mediated
immune responsiveness in blood, which
can be used to indicate if an individual is
infected by a particular pathogen. These
applications appear to be directed
towards the further development of their
QuantiFERON®
technology, currently
available as diagnostic tests for TB or
CMV infection.
Fio Corp, an independent SME, has
filed two patent applications since
2009. Application WO2010/099607
is directed towards a diagnostic test
for the detection of malaria and severe
bacterial infections. In particular, this test
can distinguish between different strains
of malaria and so is able to diagnose
the resulting severity of the disease. Fio
Corp’s key product is the Deki Reader,
an in vitro diagnostic device for use with
rapid diagnostic tests in order to deliver
quality control and an objective analysis
of results. This can be combined
with Fionet mobile phone software to
facilitate remote oversight.
Many entities are seeking to develop
smartphone-like diagnostic devices.
One SME, QuantuMDx, has developed
a handheld DNA analyser (Q-POCTM
),
which uses disease-specific cartridges
to provide a molecular diagnostic result
in 10 –15 minutes. Tests are currently
being developed for malaria, multi-
drug-resistant tuberculosis and sexually
transmitted infections.
Not surprisingly, two of the largest
antibiotic manufacturers, AstraZeneca
and GlaxoSmithKline, are looking to enter
the POC test area. However, at present,
this is not reflected in our data set. In
2012, these two companies launched
an alliance geared towards pioneering
a new approach to antibiotic research
in Europe. Since then, the alliance has
expanded to include the molecular
diagnostic companies Cepheid and
Cubist Pharmaceutical. Incorporating
smaller companies into such alliances
suggests the need for small and large
entities to cooperate in the area; while the
majority of filings originate from SMEs, an
alliance with a larger company provides
the resources to help facilitate product
development. This alliance approach is
expected to continue and expand over the
next five years.

While certain entities in the POC test area
are looking to develop a methodology and/
or service – “the assay” – others focus
more on the development of a platform
technology in the form of a device or kit
to be used in the field. However, there
are a significant number of applications
incorporating both an assay and a device.
Analysis of the technology in patent family
filings since 2009 indicates that assays are
the primary focus of many researchers, with
51 percent of patent families (170 in total)
filed relating exclusively to assays (Fig. 6).
Of patent families filed, 32 percent (107 in
total) were directed to technology for an
assay and a device, with the remaining
17 percent of patent families (55 in total)
relating to apparatus device technology
only. Within assay filings, 93 were nucleic
acid-based and 82 were immunoassay-
based (Fig. 7). The most popular device
and apparatus filings were directed to
microarrays (52), with 28 patent families
related to biosensors or biowires (Fig. 8).
With devices and assays often going hand
in hand, collaborations between assay and
device developers can be beneficial to both
parties and may increase in the future.
Technology: assay vs. device
Numbers indicate numbers of patent families
applied for between 2009 and 2013
publication lag
Both
32%
107
Device
17%
55
Assay
51%
170
Immunoassay
Cartridge/cassette
Nucleicacid-based
Biomarkerassay
Lateralflow
Other
Microarray
Biosensororbiowire
Hand-heldormobile
Highthroughput
Computersystem
Fig. 6
Patent applications for point-of-care diagnostic
inventions by technology type
Fig. 7
Patent applications (families)
for assay technologies
Fig. 8
Patent applications
(families) for device or
apparatus technologies

Tuberculosis – still a killer
The position of TB at the top of bacterial POC
diagnostic applications is due to the global
TB epidemic in low- and middle-income
countries, combined with a steady increase in
antibiotic-resistant TB over the past 12 years.
TB is the second leading cause of death from
a single infectious agent, and nine million
people worldwide fell ill from TB in 2013.
Although access to TB care has improved
dramatically since 2000, this has unfortunately
coincided with a rise in antibiotic-resistant TB,
with an estimated 480,000 people worldwide
developing multidrug-resistant TB (MDR-TB)
in 2013. Of those, nearly half died of MDR-TB.
With the WHO aiming to expand rapid testing
and detection of drug-resistant TB cases,
there has been a clear push by the authorities
to develop such diagnostic technology, which
is reflected in patent filings.
TB is a complex disease with a number of
different stages. Some patients progress
through each stage quickly. Other patients
possess a latent and asymptomatic form of
the disease, where bacilli remain in a cavity
without spreading for a number of years.
In treating TB, it is particularly important to
be able to distinguish between MDR-TB and
non-MDR-TB. Such a diagnostic test would
provide a real benefit to patients, enabling
clinicians to quickly and effectively administer
appropriate treatment to the individual, which
could potentially prevent the progression of
disease in MDR-TB patients.
Type of pathogen
To date, the majority of applications in the
POC test area have focused on bacterial
or viral infection, with only 3 percent of
applications directed towards the diagnosis
of parasitic infections, and even fewer (2
percent) directed towards fungal infection
(Fig. 9). Given that parasitic infections are of
most concern in the developing world, it is
perhaps unsurprising, although unfortunate
that more is not being done in this area of
detection.
Within bacterial infections, antibiotic-
resistant tuberculosis (TB) has been a
major target, with 28 filings in the past
five years (Fig. 10). A number of other
applications were directed towards MRSA
(8) or C.difficile (8). Reflecting the large
variety of antibiotic-resistant bacteria, other
applications have also been directed to
Salmonella (3), Enterococcus (3), Borrelia
(2), Strep A (1), Klebsiella (1), Pseudomonas
(1), and Treponema (1).
In its report, Antimicrobial resistance: global
report on surveillance 2014, the World
Health Organization (WHO) identified three
bacteria with very high rates of resistance in
all WHO regions: Escherichia coli, Klebsiella
pneumoniae, and Staphyloccocus aureus.
However, relatively few of the current POC
diagnostic patent applications are directed
towards E. coli or K. pneumoniae. These
may well become a target for research into
diagnostic tests over the next five years.
Given the media attention surrounding
MRSA, it is unsurprising that the second-
highest number of patent applications
for bacterial POC diagnostic tests is
directed towards this infection. Mostly a
hospital-acquired infection, MRSA can
be life-threatening if the bacteria gets into
the body. Notoriously difficult to eradicate,
MRSA has subsequently become a major
concern for patients following surgery or the
insertion of an intravenous drip. >
Tb bacilli
TB bacilli are inhaled and rapidly
pass into the terminal bronchioli
and alveoli of the lung.
Inhalation of TB bacilli
Macrophage
Tb bacilli
Ingested bacteria
The bacillus gets picked
up by immune cells called
macrophages, which sit within
the tissue of the alveoli.
Macrophage ingests bacillus
The bacilli reproduces quickly in
the macrophage leading to the
destruction of the macrophage
and the infection of nearby
macrophages that swallow
emerging TB bacilli.
Bacilli reproduces Cavity formation & symptoms
A cavity is formed in the tissue
where the body’s immune system
cannot reach them. The TB bacilli
spread and the patient develops
symptoms of active TB e.g.
coughing.
Dead macrophages
releasing bacteria
Formation of a complex
The TB bacilli and macrophages
that swallowed them form a
fibrous granulomatous circular
complex with TB bacilli and
infected macrophages in the
middle (Ghon complex).
Fig. 11
virus-related point-of-care diagnostic
inventions by virus type
0
5
10
15
20
HIV
HPV
Herpes
Influenza
DengueFever
Hepatitis
0
5
10
15
20
MycobacteriumTuberculosis
MRSA
C.Difficile
Other*
2009 and 2013
Only patents specifying viruses are counted
Fig. 10
bacteria-related point-of-care diagnostic
inventions by bacteria
0
5
10
15
20
HIV
HPV
Herpes
Influenza
DengueFever
Hepatitis
0
5
10
15
20
MycobacteriumTuberculosis
MRSA
C.Difficile
Other*
*Enterococcus, Pseudomonas, Legionella, Klebsiella, Salmonella
2009 and 2013
Only patents specifying bacteria are counted
Bacteria
Virus
Parasite
Fungus
134
114
7
5
Fig. 9
Patent applications (families) for point-of-care diagnostic
inventions by pathogen type
Numbers indicate numbers of patent families applied for
between 2009 and 2013
Only patents specifying pathogens are counted
How TB infects a
patient
Diagram created with reference to:
www.tbonline.info/
posts/2011/5/31/how-tb-infects-
body-tubercle/
www.healthandfitnesstalk.com/
tag/tuberculosis/

To reduce the chance of developing
infection, many National Health Service
(NHS) hospitals in the UK now screen
patients for MRSA prior to a planned
procedure. However, this is time and labour-
intensive. It generally involves obtaining
a sample from the patient, then growing
the sample for a period of time to assess
bacterial growth. Results typically take three
to five days. A number of patent filings have
consequently focused on the development
of faster POC diagnostics for MRSA, thus
reducing time and cost for the healthcare
provider.
Within applications focused on the
diagnosis of viral infections, POC tests
directed to drug-resistant HIV are the most
numerous, with nine applications filed in
the past five years (Fig. 11). According to
the WHO, by the end of 2013 an estimated
35 million people were living with HIV
worldwide. The world’s leading infectious
killer, HIV can be prevented from multiplying
if patients take combination antiretroviral
therapy (ART). Importantly, if a patient is on
ART, their chance of transmitting HIV to a
partner or their child dramatically decreases.
However, the WHO estimates that around
10 percent of patients are ART-resistant, a
percentage that is increasing over time.
The majority of current patent filings have
focused on the detection of one single
microbe. Whilst it is important to detect
specific infections, there is a desire for a
POC diagnostic test that can detect multiple
infectious agents, or more broadly, diagnose
whether an infection is viral or bacterial.
A product that can establish whether an
infection is bacterial or viral would be of
great benefit in preventing the misuse of
antibiotics for viral infections.
It is clear that the emergence of
antimicrobial-resistant microorganisms is
of increasing concern to authorities across
the world. One example being closely
monitored is carbapenem-resistance.
Considered a last resort of treatment,
carbapenem is a powerful antibiotic
prescribed to treat Enterobacteriaceae
infections, which cause bladder, lung,
and blood infections. Left untreated,
these infections can progress into life-
threatening septic shock. Once a patient
has a carbepenem-resistant infection, few
antimicrobial treatments remain.
Looking ahead
We envisage that the next few years will see
a reemergence of antimicrobial research in
combination with the development of POC
diagnostic tests. Together, the discovery
of new antibiotics with the development of
POC diagnostic tests will be fundamental for
the safeguarding of the effective treatment
of common infections for years to come.

The patent filing data analysed in this report was provided by Landon IP,
the specialist patent analytics and consulting arm of CPA Global.
Patent landscaping was carried out for patent applications filed around
the world from the earliest priority date after 1 January 2009. During the
search, USPTO, International Patent Classification (IPC), and Cooperative
Patent Classification (CPC) codes with direct relevance to point-of-care
(POC) diagnostics were combined with keywords related to infectious
diseases. The keywords covered the most significant human pathogens
identified by the US National Institutes of Health (NIH) and Centers for
Disease Control and Prevention (CDC) as having potential for developing
resistance. Companies with known history of developing POC diagnostic
tests were also searched. The landscape search was conducted in late
October 2014 using PatBase.
The results from the search queries were analysed by a Landon IP
technical expert with an advanced degree in biotechnology, who
manually screened the patent applications for relevancy. Patents deemed
not relevant were removed from the final result set. The technical expert
further categorised all the relevant patent families based on a custom-
built taxonomy covering assays, devices, types of pathogens and
advantages.
Methodology

Contacts
Joshua Ryan-Saha
Longitude Prize Assistant Manager
Nesta
e: joshua.ryan-saha@nesta.org.uk
Joshua is the Assistant Manager of the Longitude Prize. Prior to joining
Nesta in October 2013, he worked as a consultant in Bosnia-Herzegovina
working with a range of international organisations developing and delivering
projects related to constitutional reform and reconciliation as well as working
with smaller NGOs to improve their presentation skills. Joshua started his
career in local government as a participant in the sector’s National Graduate
Development Programme, working for the London Borough of Newham
on a number of transformative projects across a range of service areas
including education, social care, housing, and crime reduction.
Dr Paul Chapman
Partner, European Patent Attorney
Marks Clerk
e: pchapman@marks-clerk.com
Paul is a Chartered and European Patent Attorney, with almost 20 years of
experience in the IP profession. Before entering the patent profession, Paul
studied microbiology at university and also carried out his PhD in relation
to antibiotic producing bacteria. Paul’s clients range from universities and
SMEs to large multinational companies particularly in the biotechnology,
chemistry and pharmaceutical fields. He has significant expertise in biologics
including antibody, technology, stem cells, RNAi and vaccines. He has
experience of European Opposition and Appeal procedures, in particular, in
the areas of biotechnology, molecular biology and chemistry. Paul also has
experience of filing and prosecuting SPC applications throughout Europe.
As well as prosecution and opposition work, Paul provides strategic advice
to ensure that his clients get the best out of their IP. He is a member of the
Longitude Prize advisory panel.
Haydn Evans
Vice President, IP Solutions
CPA Global
e: hevans@cpaglobal.com
Haydn works with CPA Global’s corporate and law firm clients across a
range of industry sectors – including technology and telecommunications,
electronics, chemical, pharmaceuticals, and biotechnology – helping to
develop software and service solutions to meet their IP objectives and
challenges. He also served as a key advisor on the patent landscape study
for the Longitude Prize. Previously, Haydn was a Senior Analyst and IP
Strategy Manager for GE Healthcare, where he worked in areas such as
diagnostics, medical imaging and bioscience technology, and was also
closely involved in corporate portfolio strategy and the alignment of GE’s IP
and business processes.
If you would like more information about this report,
please contact the contributors to this report:
The contributors are grateful to Laura Carney of Marks Clerk for her assistance in drafting
written analysis of the data.
Potential Longitude Prize competitors should review Nesta’s FAQs for queries about their own intellectual property
and responsibility to consider patentability and freedom-to-operate issues before entering the Prize. Professional
advice should also be sought, where appropriate.
Dr Terrence Joyce
Technical Consultant, Analytics and Technology Consulting Group
Landon IP
e: tjoyce@landon-ip.com
Terrence is the main author and contributor for the patent landscape study
for the Longitude Prize. A technical expert in biotechnology, he has served
as an advisor to numerous US government agencies and authored several
scientific research papers. His extensive experience in IP includes IP strategy
development, portfolio analysis, licensing, and patent searching. He has
worked with entrepreneurs and start-up companies in life sciences, helping
them obtain funding, manage portfolios, and commercialise IP assets.
Terrence is a graduate of Dartmouth Medical School and Franklin Pierce
Law Center where he obtained a Doctorate in Medicine and a Master of
Intellectual Property, Commerce and Technology (MIP) degree respectively.
Pramitha Krishnamurthyprakash
Analytics Group Manager, USA, Analytics and Technology
Consulting Group
Landon IP
e: pkrishnamurthyprakash@landon-ip.com
Pramitha was project manager for the patent landscape study for the
Longitude Prize. Previously, she has worked on patent analytics and
consulting projects in computing, electronics and electrical engineering, and
has particular expertise in financial services. In her consulting role, Pramitha
has helped clients address their needs across the patent lifecycle, including
RD decisions, assessing freedom-to-operate risks and the competitive
landscape, portfolio management and optimisation, patent-product
mapping, and devising patent monetisation strategies. She holds a Masters
in Intellectual Property from University of New Hampshire School of Law,
and Bachelors in Computer Science and Engineering from The National
Institute of Engineering.
Haopeng Wang
Technical consultant, Analytics and Technology Consulting Group
Landon IP
e: hwang@landon-ip.com
Haopeng has extensive experience in conducting patent analytics and
consulting projects in chemistry, chemical engineering, biotechnologies
and healthcare; and was responsible for developing the framework for the
patent landscape study for the Longitude Prize. He is also experienced in
interacting with Chinese multinational corporations and SMEs regarding
their IP requirements and research needs. Haopeng holds a Ph.D. in
Macromolecular Science and is a United States Patent and Trademark
Office (USPTO) patent agent. Prior to joining Landon IP in 2012, he was a
staff scientist at global life sciences company Life Technologies.

About the Longitude Prize
The Longitude Prize is a challenge with a £10 million prize fund to help solve
the problem of global antibiotic resistance. It is developed and run by Nesta,
the innovation charity. The Prize was announced by British Prime Minister David
Cameron at G8 2013 and is being supported by Innovate UK (formerly the
Technology Strategy Board) as funding partner. The Prize commemorates the
300th anniversary of the Longitude Act (1714) when the British government threw
down the gauntlet to solve one of the great scientific challenges of that century:
how to pinpoint a ship’s location at sea by knowing its longitude. The British
public voted for antibiotic resistance to be the focus of the Longitude Prize. For
further information, please visit: www.longitudeprize.org.
About Marks Clerk
Marks Clerk is recognised as a world leader in intellectual property and is
proud to be a supporter of the Longitude Prize. Our patent attorneys, trade
mark attorneys, solicitors and consultants offer a comprehensive range of
services – covering patents, trademarks, designs, domain names and copyright.
This includes protection worldwide, portfolio management, IP strategy,
commercialisation, licensing, enforcement, due diligence, litigation and valuation.
The extent of our resources means we are able to offer expertise covering an
exceptionally diverse range of technologies and commercial sectors. Healthcare
inventions are one of our key specialisms. Our international network of 17
offices – in the UK, France, Luxembourg, Canada, China, Hong Kong, Malaysia,
Singapore and Australia – and unrivalled IP connections around the world, enable
us to provide single point access to a consistently high-quality and cost-effective
service both locally and globally.
For further information, please visit: www.marks-clerk.com.
About CPA Global
CPA Global is the world's leading provider of intellectual property (IP) management
services and software. With offices across Europe, the United States and Asia
Pacific, CPA Global supports many of the world’s best known corporations and
law firms with a range of IP and broader legal services, helping them manage
risk, cost and capacity. CPA Global assists corporates and law firms in managing
valuable IP rights, such as patents and trademarks, ensuring that IP portfolios
are protected, maintained and regularly reviewed to optimise value. Working
closely with its clients, CPA Global ensures they have the best information on
which to base IP decisions, and the best support in terms of helping implement
those decisions. Founded in Jersey, Channel Islands in 1969, CPA Global today
employs some 2,000 people, serving clients’ needs in 200 jurisdictions through its
own offices and an extensive agent network.
For further information, please visit: www.cpaglobal.com.
About Landon IP
As the specialist patent analytics and consulting arm of CPA Global, Landon IP
is a leading global provider of professional business support services throughout
the intellectual property lifecycle and across all technologies. Landon IP’s primary
services include patent searching, technical literature searching, analytics and
technology consulting, global IP information research and retrieval, and patent,
legal, and technical translations. The company’s activities cover every possible
type of search, including: patentability, innovation screening or accelerated
examination; freedom-to-operate, product clearance or infringement detection;
invalidity, opposition, post-grant proceedings or strength testing; and state of
the art or collection. The company also provides advanced training in patent
searching worldwide through Patent Resources Group (PRG), a wholly-owned
subsidiary. The patent landscape study for the Longitude Prize that forms the
basis of the Microbial infection: Point-of-care diagnostics report was undertaken
by Landon IP’s Analytics and Technology Consulting Group.
For further information, please visit: www.landon-ip.com.

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