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

Transcription

1 Pharma Session 4: Digital health your health on (the) line Monday, October :00-17:30

2 Niklas Mattsson, Awapatent (moderator) Leonore Ryan, formerly of CSIRO and Cardihab Jonathan C. Anderson, Eli Lilly Osamu Yamamoto, Yuasa & Hara 2

3 Introduction Niklas Mattsson, Awapatent 3

4 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

5 1. Established pharma company Two main scenarios 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

6 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

7 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

8 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

9 Digital health in practice Leonore Ryan, formerly of CSIRO and Cardihab 9

10 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,

11 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

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13 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, , 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. 13

14 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 16

15 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 17

16 Big pharma and U.S. IP law Jonathan C. Anderson, Eli Lilly 18

17 Digital Health/Connected Care in the U.S. Mobile Medical Apps Wearable Sensors Automated Dosing Systems (including control software) 19

18 IP Considerations in Digital Health U.S. patent eligibility for software/computer-based inventions 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 20

19 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? 21

20 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. 22

21 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 23

22 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? 24

23 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 25

24 Perspectives from Japan Osamu Yamamoto, Yuasa & Hara 26

25 Japan Election of House of Representatives October 22, 2017 Should the consumption tax rate be increased from 8% to 10%? 27

26 Japan Super-aging society Ratio of people aged 65 years or over to the total population reached a record 26.7% in Japanese government has adopted a number of measures aimed at promoting the development of digital health care. 28

27 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. 29

28 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. 30

29 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. Trade Secret The Unfair Competition Prevention Act (UCPA) regulates trade secret infringement, and a revised version UCPA was enacted in January 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. 31

30 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. 32

31 Patentable Subject Matter - Software-related inventions - 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. 33

32 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. 34

33 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. 35

34 Discussion Q & A 36

35 Thanks for your attention!