pharma session 4: digital health your health on (the)...
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Pharma Session 4: Digital health – your health on (the) line
Monday, October 16 2017
16:00-17:30
www.aippi.orgg
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• Niklas Mattsson, Awapatent (moderator)
• Leonore Ryan, formerly of CSIRO and Cardihab
• Jonathan C. Anderson, Eli Lilly
• Osamu Yamamoto, Yuasa & Hara
Definition – one of many
“The broad scope of digital health includes categories such as mobile health (mHealth), health information technology (IT), wearable devices, telehealth and telemedicine, and personalized medicine”
- U.S. FDA website
Two main scenarios
1. Established pharma company
• Accustomed to long development times
• Experience in patenting of pharma/biotech/med tech
• Protects platform technologies, product pipelines
• Competitive edge through expertise and high quality
• Looking to broaden their offering through digital products/services
2. Established or start-up tech company
• Skilled at getting to market quickly
• Different focus on intellectual property rights – “more patents quicker”
• Alternative ways to exclusivity; e.g. GUI, brand, user experience, logistics and creative use of data
• Looking to exploit their solutions in the health space
Adapting established IP strategies
1. Established pharma company
• Digital solutions have (way) shorter generation cycles than pharmaceuticals
• One or a few key patents are rarely suitable
• More patents and quicker – ”fail fast” is more OK, but requires back-up
• Start looking at options to accelerate prosecution
2. Tech company
• Look for solutions that can be protected over the long term
• Central ideas may have a ”therapeutic” or ”diagnostic” benefit – generalize and attempt to protect!
• Do not rush decisions to accelerate and/or abandon prosecution
• Both: Revise existing strategies and make sure that IP follows the business
Legal challenges
• Patenting of computer implemented inventions is restricted, as is medical and biotech inventions
• Goes for many countries, but with specific & different implications
• Legal practice and case law evolves slowly, technology quickly
• Achieving granted exclusive rights can take a long time
• You will have to live with a substantial degree of uncertainty
Take home messages
Do you want to explore the digital health space?
• You may need to revise your IP strategies
• File more IPR applications?
• Start using available tools to accelerate prosecution?
• There are technology-specific criteria for patenting
• Make sure to understand the relevant limitations and requirements
• …in order to properly appraise the value and potential of your IP protection
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Australia
• Australia’s healthcare system ranks among the best in the world in almost
every quality indicator.
• However, costs are rising at rates well ahead of inflation, putting significant
pressure on providers to find new and better ways to keep Australians
healthy.
• While quality of care is high, Australia has fallen well behind in its adoption of
new technologies and processes that promise not just further improvements
in patient outcomes, but significant gains in efficiency as well.
• Australian healthcare could be more efficient and more effective if it took up
the international trend to digital transformation.
• Source: “Australia can see further by standing on the shoulders of giants- Driving digital transformation by adopting
‘Meaningful Use’ legislation” pwc, 2016 http://www.pwc.com.au/publications/pdf/digital-hospital-2016.pdf
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Australia
• The majority of Australians are digitally connected, and make everyday use
of digital services across a range of industries including travel, banking,
education and government services.
• Almost 80% of Australians have a smartphone, which (as of 2015) they
collectively glance at 440 million times a day.
• In terms of digital technology and health, most (77%) Australians would like
their doctor to suggest health information websites and 73% have already
used the internet to research a health issue. However, only a small
proportion of the population (6%) manage to find an online health source that
they trust.
• Of all Australian Google searches, one in 20 are health related.
• 69% of Australians aged 65 and over have used the internet to look up
health information.
• Source: Australian’s National Digital Health Strategy 2017 https://www.digitalhealth.gov.au/australias-national-
digital-health-strategy
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What is ‘Digital Health’? - Wikipedia• Digital health is the convergence of digital and genomic technologies with health,
healthcare, living, and society to enhance the efficiency of healthcare delivery and make medicines more personalized and precise.
• It involves the use of information and communication technologies to help address the health problems and challenges faced by patients.
• It includes both hardware and software solutions and services, including telemedicine, web-based analysis, email, mobile phones and applications, text messages, and clinic or remote monitoring sensors.
• Generally, digital health is concerned about the development of interconnected health systems to improve the use of computational technologies, smart devices, computational analysis techniques and communication media to aid healthcare professionals and patients manage illnesses and health risks, as well as promote health and wellbeing.
• Digital health is a multi-disciplinary domain which involves many stakeholders, including clinicians, researchers and scientists with a wide range of expertise in healthcare, engineering, social sciences, public health, health economics and management.
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Business Models• Established pharma or medical device company
– Accustomed to long development times
– Experience in patenting of pharma/biotech/med tech
– Protects platform technologies, product pipelines
– Competitive edge through expertise and high quality
– Looking to broaden their offering through digital products/services
• Established or start-up tech company
– Skilled at getting to market quickly
– Rarely focused on intellectual property rights
– Competitive edge through e.g. GUI, brand, user experience, logistics and creative use of data
– Looking to exploit their solutions in the health space
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Digital Health – my experience
• came from a research organisation with a strong patenting culture, CSIRO
– Accustomed to long development times
– Experience in patenting, IP strategy
– Protects platform technologies
– Competitive edge through expertise and high quality
• to in a 2 person start up with $50k in the bank and a licence to the IP
– An IT response to a healthcare issue
– Need to get to market quickly – hot space, need revenue
– Focus on intellectual property rights?
– Competitive edge through ‘novelty’ – first to market, user experience, clinical trial outcomes, research pedigree
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Digital Health/Connected Care in the U.S.
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Mobile Medical Apps
Automated Dosing Systems (including control software)
Wearable Sensors
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IP Considerations in Digital Health
U.S. patent eligibility for software/computer-based inventions
- 2014 Supreme Court decision in Alice
- Lower court trends since Alice
- Best practices
Divided infringement considerations
Shorter product life cycles as compared to pharma
Graphical User Interfaces (GUIs)
- Types of protection available and value
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Patent Eligible Subject Matter in the U.S.
35 U.S.C.§101: process, machine, manufacture, composition of
matter
Judicially created exceptions: abstract ideas, laws of nature,
natural phenomena
Mayo (2012) – established a two-step framework for determining patent
eligibility as related to natural phenomena
Alice (2014) – computer implementation of abstract idea not patent
eligible; extended Mayo’s two-step framework to analysis of abstract
ideas
Test: (1) abstract idea? If yes, (2) claim significantly more?
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Post-Alice: Where do we stand?
Lower courts broad application of Alice
Federal Circuit trends – “safe harbor” if invention provides a
technological improvement
USPTO guidelines on patent eligibility
New USPTO Director
Legislative update?
Software patents are not dead in the U.S.
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Software Patent Drafting/Claiming Strategies
Federal Circuit and USPTO have given some hints
Technological improvement as “safe harbor”
Add physical structure to the claims other than general
computer/processor
Tell a story in the specification
Describe and illustrate algorithms in painful detail
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GUIs in Digital Health
Available IP protection:
Copyright
Trade dress
Design patent - visual aspects that capture user experience
(overall layout; icons; fonts)
Utility patent?
Is it worth the investment in GUI IP?
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Collaborations in Digital Health
Many collaborations occurring between drug companies, universities,
tech companies, and startups in the digital health space
Drug companies often lack technical expertise or resources to
implement connected care solutions alone
Collaborations can lead to competing ownership disputes over
innovations and know-how
Other challenges and considerations with collaborations
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Japan
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Election of House of Representatives
October 22, 2017
Should the consumption tax rate be increased from 8% to 10%?
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Japan
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Super-aging society
Ratio of people aged 65 years or over to the total population reached a
record 26.7% in 2015.
Japanese government has adopted a number of measures aimed at
promoting the development of digital health care.
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Japan
Big pharmaceutical companies are keen to participate in the digital
health field, recognizing that digital health impacts drug discovery,
clinical development, and commercialization.
As a result of collaboration with other companies, including a variety of
start-up companies specializing in different technical fields the role of
existing players will begin to change, while that of new players in the
field will increase in importance.
By tailoring health care to individual needs, a quality of care provided
increases while the cost of providing health care reduces. Careful
utilization of ‘Big data’ inherent in existing health records holds
tremendous potential for the improvement of digital health care.
Since digital Health care is a new area of technology, and it is highly
important to adopt optimal IP practices to properly appraise value.
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Remote medical treatment
In Japan, remote health care has until recently essentially been
prohibited. However, in 2015 the Ministry of Health, Labor and Welfare
substantially liberalized this area of health care.
It is now possible to receive some medical services without any need to
visit a hospital, regardless of whether the hospital is geographically
proximate.
Acquisition of vital data, such as a heart rate and blood glucose levels,
via wearable devices is now possible.
Multiple IT ventures announced new applications and systems for the
provision of remote medical care.
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Protection of Personal Information
The revised Act on the Protection of Personal Information was enacted
in May 2017, and under the revised act what constitutes personal
information is clearly defined.
Anonymized and statistically processed data can be used for improving
service provision and the creation of new businesses.
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Trade Secret
The Unfair Competition Prevention Act (UCPA) regulates trade secret
infringement, and a revised version UCPA was enacted in January 2016.
Three key components :
the act of keeping a thing secret,
the object of secrecy consists of valuable information, and
the object of secrecy has not been publicly disclosed.
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Patentable Subject Matter- Biotech inventions -
It is possible to obtain a patent for an invention directed to diagnostics
simply by employing careful claim drafting techniques; for example,
“A method for providing an indicator to diagnose lung cancer, which
comprising a step of measuring - - -” is patentable in Japan.
Isolated genomic DNA is patentable.
Even where a thing exists in nature but a need exists to artificially
isolate that thing from its surroundings by use of a particular technique,
such things are deemed to be creations.
A potential exists under this system for ownership of diagnostic gene
patents to become fragmented.
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Under Japanese Patent Law, an “Invention” is defined as a “creation of
a technical idea at a high level which utilizes a law of nature.”
Software-related inventions can be patent protected both as methods
and things, so long as information processing by software is concretely
realized by using hardware resources.
Regarding IoT related technology, in order to improve predictability for
obtaining patents, the JPO released a revised examination handbook
that provides new case examples of patent examination of IoT related
technology in September 2016, with a supplemental version having
been released in March this year.
http://www.jpo.go.jp/tetuzuki_e/t_tokkyo_e/files_handbook_sinsa_e/app_z_e.pdf
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Patentable Subject Matter- Software-related inventions -
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Personalized medicine
Thanks to the great progress that has been made in next generation
gene sequencer and AI, personalized medicine is now a “hot’ area within
digital health; particularly in cancer.
“SCRUM-Japan” is the first industry-academia collaboration undertaken
in cooperation to conduct nation-wide genome screenings. The aims are
to develop new drugs and diagnostic techniques, to match a variety of
genetic defects that exist in common among Japanese cancer patients.
For new sub-group of patients:
Such inventions may face difficulties relating to support and enablement
requirements, particularly where it comes to obtaining a broad or even
reasonable scope of invention.
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Patent infringement by multiple parties
The problem of patent infringement by multiple parties is likely to
become more obvious with the progress of digital health technologies.
The legal issues raised by such infringement can be roughly divided into
two general categories: direct infringement and indirect infringement.
No theories or judicial precedents have been established with regard to
whether existence of direct infringement as a prerequisite is necessary
for establishing indirect infringement. This tends to be judged on a
case-by-case basis.
Under Japanese Patent Law, there is no stipulation corresponding to
“induced infringement.”
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