Pharma Session 4: Digital health – your health on (the) line

Monday, October 16 2017

16:00-17:30

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• Niklas Mattsson, Awapatent (moderator)

• Leonore Ryan, formerly of CSIRO and Cardihab

• Jonathan C. Anderson, Eli Lilly

• Osamu Yamamoto, Yuasa & Hara

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Introduction

Niklas Mattsson, Awapatent

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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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Digital health in practice

Leonore Ryan, formerly of CSIRO and Cardihab

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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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Big pharma and U.S. IP law

Jonathan C. Anderson, Eli Lilly

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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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Perspectives from Japan

Osamu Yamamoto, Yuasa & Hara

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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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Discussion

Q & A

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Thanks for your attention!

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