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The Internet Of Medical Things – Food, Drugs, Healthcare, Life Sciences | #itsecurity | #infosec | #cybersecurity | #infosecurity | #hacker



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Exploring the growth of patents for connected medical devices,
and how best to protect them.

The Internet of Things (IoT) is expected to change our lives by
creating a connected world with billions of devices with embedded
sensors and transmission capability exchanging data with other
devices and systems over the Internet. Whilst the IoT is
well-established in the consumer market, this concept is also
frequently employed in medical devices for use in healthcare
systems. This trend, known as the Internet of Medical Things, is
leading to a paradigm shift in ways of treating some of the harder
to reach and pervasive medical problems. Patient access to
treatment is improved, regardless of their location.

Growth of IP directed to connected medical devices

The digital health industry has expanded exponentially in recent
years with the market for medical devices having functionality to
enable the exchange of data over the Internet (i.e. “connected
medical devices”) predicted to reach USD 52.2 billion in
20221. Common applications of such devices include
remote health monitoring and emergency medical notification
systems. In order to supplement the increasing desire for domestic
healthcare solutions to support aging global populations, demand
for wearable medical devices and mobile health monitoring
technologies is likely to increase. The use of these devices will
be further sustained through enhanced communications technology,
including the uptake of 5G mobile networks. Whereas earlier
generation mobile networks were limited to the mobile phone
industry, 5G is more broadly applicable to other industries,
including healthcare. The use of 5G is expected to improve the
speed and reliability of data transmission from wearable medical
devices, which promises to open up further opportunities to
introduce new innovative services.

The emergence of the Internet of Medical Things within the
healthcare field has prompted considerable R&D investment in a
race to gain market dominance, resulting in a high degree of
innovation across various technology sectors. This rapid growth in
R&D investment is closely shadowed by the growth in patent
applications filed in recent years directed to connected medical
devices. The graph below shows approximately a 100-fold increase in
patent filings in this field over a 20-year period. This trend
appears set to continue. Within this technology field, the top five
patent applicants are: Medtronic, Philips, Olympus, Fujifilm and
Konica Minolta.

What can be protected?

Consideration of a patent filing strategy should begin with
protection for the connected medical device itself, with claims
targeting unique features of the device per se. Many connected
medical devices are associated with wearable monitoring systems
that have data collection, storage, processing and transmission
capabilities. Such devices may include biocompatible sensors that
can provide real-time continuous measurement of physiological
parameters and communicate relevant information to the user,
physician or caregiver. Innovative means of forming or
incorporating the sensors within a wearable device is one such area
that has been subject to a series of patent filings: for instance,
the use of flexible substrates and sensor arrays embedded in
surgical implants and wound dressings that are adapted to measure
and transmit patient specific parameters and biomarkers.

Patent applications may additionally include claims to cover
processes of manufacturing the device and methods relating to how
the medical device is used, including how data is communicated from
the medical device to another part of a system, perhaps for further
processing or analysis. The manner in which physiological data from
the user is obtained, processed and transmitted by the medical
device (or a connected part of the system) may also be protectable.
The emergence of Artificial Intelligence (AI) is one particular
advancement that has prompted the filing of numerous applications
in this domain. Patent protection for inventions implemented
through AI is a fast-evolving field. The European Patent Office
(EPO) is at the forefront of this trend. The EPO considers that
patents may be granted for the use of AI in connected medical
devices, for example, the use of a neural network in a
heart-monitoring apparatus to identify irregular
heartbeats2.

We also increasingly see patent applications directed to
communications security to ensure the protection of any patient
data stored, transmitted and/or received by the device. As for any
technology concerning the transmission of sensitive data across the
internet, privacy is critical. This has become especially important
in view of the prominence of General Data Protection Regulation
(GDPR) legislation in Europe3 and the Health Insurance
Portability and Accountability (HIPAA) standards adopted in the
US4.

How best to secure patent protection?

In order to secure coverage for different aspects of a connected
medical device, a single patent application may include a variety
of claim types directed to the apparatus itself, how it is made and
used, and the manner in which data generated by the device is
processed and used. Although patents may be obtained across a broad
range of technology sectors, a number of jurisdictions include
exclusions that are intended to restrain the grant of patent rights
in certain fields of application.

In Europe, a European patent cannot be granted in respect of
methods of treatment of the human or animal body, either by surgery
or therapy5. The rationale for this patentability
exclusion is to provide medical and veterinary practitioners the
freedom to use the best available treatments without being
inhibited by a worry that such a treatment might be covered by a
patent. The law in Europe further stipulates that this exception to
patentability does not apply to products for use in such methods.
Claims directed to features of a connected medical device would not
typically be caught by this exclusion. However, care must be taken
where the medical device as claimed is only complete and configured
during or after surgical implantation, particularly wherein the
device is defined functionally and that function is only
configured in vivo. This may be achieved when
drafting patent claims by avoiding claiming elements in a manner
that would require a surgical or therapeutic step to elicit the
function of the device within the body.

Further, in Europe the same provision also excludes diagnostic
methods practised on the body. A connected medical device may well
generate data suitable for diagnosing a pathological state and may
well be positioned on (or in) a patient’s body. Care may need
to be taken to avoid falling within this exclusion. For instance,
in some circumstances a connected medical device may operate to
collect clinical data that could be of diagnostic relevance but
could equally be used in some other way, so that the final
deductive step of diagnosing a condition is not an essential
feature of the invention and method of using the device may be
patentable.

As for any invention, a patenting strategy for a connected
medical device should consider the range of potential infringers of
the patent. A claim directed to the connected medical device, and
its manufacture, is likely to be the focus to target rival
manufacturers and potentially resellers. While it is unlikely that
end users of a connected medical device (patients, physicians and
caregivers) are to be targeted, a method of use claim may still
have value, for instance where the focus is the transmission of
data from the device for processing elsewhere, and that processing
could be performed by a commercial organisation. This may be
particularly true where the value of the invention lies in the
generated clinical data, more than the sensing technology.

Where protection is sought for the transmission of data from a
connected medical device, it is desirable to separate the
transmission of data from the device, and the reception of that
data (and its processing) by a separate apparatus in order to avoid
ending up with a claim that can only be directly infringed by
multiple parties acting in concert. Further, the two ends of the
data transmission may potentially be in different jurisdictions,
leading to difficulties in establishing where the infringement
takes place that are best avoided.

Typically the inventive part of a connected medical device will
be partly or fully implemented in software. In Europe patent
protection is excluded for a program for a computer, to the extent
that the invention relates to a program for a computer “as
such”7. However, any computer program (including
where embedded in a connected medical device) having a technical
effect moving the invention away from a purely abstract concept
could be patentable. The identification of irregular heartbeats
discussed above is an example of such a technical effect. Returning
to inventions utilising AI, both the use of training data to create
a trained AI model, and the application of that model to process
data from a connected medical device to generate new insights from
physiological data may be protected.

Conclusion

Given the size of the market for connected medical devices, the
investment required to bring products to market and the relative
ease with which many products can be copied, patent protection
should be sought. While there are traps for the unwary, valuable
protection is available for different aspects of connected medical
devices and how they are used.

Footnotes

1 https://www2.deloitte.com/global/en/pages/life-sciences-and-healthcare/articles/medtech-internet-of-medical-things.html

2 https://www.epo.org/news-events/in-focus/ict/artificial-intelligence.html

3 https://ico.org.uk/for-organisations/in-your-sector/health/health-uk-gdpr-faqs/

4 https://campaigns.hgf.com/healthcare-scanner/issue-1/article-3/

5 https://www.epo.org/law-practice/legal-texts/html/epc/2016/e/ar53.html

6 https://www.epo.org/law-practice/legal-texts/html/guidelines/e/g_ii_4_2_1_3.htm

7 https://www.epo.org/law-practice/legal-texts/html/epc/2016/e/ar52.html

The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.



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