AIPPI Congress Report 10: Digital Health

The AmeriKat facing her own digit-al health 
issues...

In an invigorating panel discussion featuring experts from Australia, the US and Japan, the fourth and final pharma session of the AIPPI World Congress explored the IP challenges for digital healthcare businesses.  James Ellsmore (KWM) reports:   

"The key message from the panel, chaired by Niklas Mattsson of Awapatent, was that any IP strategy must align with, and support, the business’ overall commercial goals.  This was the case regardless of the type of business – whether an established pharmaceutical or medical devices company, university spinout or independent start-up. 

From an IP perspective, some of the major challenges identified by the panel included the difficult environment for patenting computer-implemented inventions in jurisdictions like the US and Australia, the need to work effectively with third party partners, and the inherent differences between traditional modes of IP protection, which evolve slowly and offer protection over the long term, and alternative methods of protecting IP in the digital health industry where product life cycles are much shorter.  

What does this mean for businesses looking to play in the digital health space?  First, digital health businesses need to develop (and regularly revise) their IP strategy.  What may have worked in the past, such as filing a patent for a key aspect of the new technology, may not work so well for a digital health technology.  Secondly, businesses should ensure that robust practices and procedures are put in place when working with any third party partners.  And finally, businesses should not be afraid to consider what other (non-traditional) modes of IP protection might support those businesses’ overall strategy and commercial goals. 

The first panellist spoke of her first-hand experience with Cardihab to develop a digital cardiac rehabilitation service.  Leonore Ryan, formerly of the Commonwealth Scientific and Industrial Research Organisation (CSIRO) (Australia’s leading government research body) and Cardihab, provided attendees with an insight into the constraints that digital health start-ups face when bringing a new digital health technology to market.  In Cardihab’s case, it was a 2-person start-up with $50,000 in the kitty.  It needed to get to market quickly and faced difficult choices about how to achieve this with a limited budget.  While it had an IP strategy, Leonore explained that it did not focus on traditional forms of IP protection.  Instead, Cardihab looked to gain a competitive edge through being first to market, enhancing user experience and developing robust clinical trial data to support its technology platform.  In Cardihab’s case, the ability to provide proof of clinical efficacy based on robust clinical trial data was more important than pursuing traditional forms of IP protection.  Leonore’s presentation echoed some of the key themes of an earlier presentation of Jane Perrier the previous day about venturing with IP.  As Jane explained, and which Leonore emphasized, the business must consider its IP strategy and how any IP can be used to achieve the business’ strategic objectives. 

The second panelist, Jonathon Anderson, patent counsel with Eli Lilly, then addressed the session on some specific IP considerations for digital health businesses, considered particularly from the perspective of an established pharmaceutical/medical devices company.  Jonathon expanded on challenges such as patent eligibility for computer-implemented inventions following the US Supreme Court’s decision in Alice, the significance of shorter product lifecycles for digital health products as opposed to pharmaceutical products, and discussed the different types of protection available for graphical user interfaces in the US and their value (or perhaps lack thereof).  Jonathon also canvassed some of the challenges for digital health collaborations between pharmaceutical and medical device companies on the one hand, and universities, research organisations and start-ups on the other.  He offered some ‘tips and tricks’ for overcoming some of these challenges.  A key message of Jonathon’s was that an established business moving into the digital health space needs to be aware of “culture clash” – there are different lifecycle management techniques for digital health products and that what has worked successfully in the past for traditional medical devices or pharmaceuticals may not necessarily work with a new product offering in the digital health space." 

Finally, Osamu Yamamoto of Yusua & Hara spoke of the Japanese experience with digital health technology.  Unlike Australia and the US, Osamu-san pointed out that some of the challenges in those jurisdictions – such as patenting computer-implemented inventions and isolated genomic DNA sequences – do not necessarily apply in Japan.  A key take away from Osamu-san’s presentation was the importance of knowing the market in which the business intends to develop its digital health product or service.  Given Japan’s “super-aging” society, the Japanese government has adopted a number of measures aimed at promoting the development of digital healthcare.  One of these measures was the liberalisation of remote medical treatment, which has led to a number of new applications and systems for the provision of remote medical care.  Other measures have included reforms to laws to protect personal information and to enhance trade secrets protection.  These reforms have significantly changed the landscape for offering digital health products and services in Japan, demonstrating the importance of customising a strategy to the specific market in which the product or service will be developed. 

While cats might have nine lives, digital health businesses only get one shot at success.  The panel session establishes that having an appropriately tailored IP strategy, investing in smart partnerships and being open to non-traditional forms of IP protection might significantly extend a business’ chance of success."