Within the past year, the FDA has launched a provider pre-certification program as a pilot to manage the expansion of “digiceuticals” or digital therapeutics that produce clinical benefits for patients via interaction with a software application or mobile app. This innovative regulatory approach seeks to provide discipline around clinical utility with the iterative improvements enabled by software versus standard manufactured medicines. Given the near-instant worldwide distribution platforms of mobile apps, the technology enables fundamental changes in managing interactions with patients to understand and treat disease, with clear collaboration benefits between biopharma and digital therapy providers.
Exploring this new frontier was a panel on Day 2 of the 2018 BIO Investor Forum. Moderated by Ruchita Sinha of Sanofi Ventures, the panelists included:
- Jeffrey Abraham, Akili Interactive
- David Klein, Click Therapeutics, Inc.
- Antoun Nabhan, Pear Therapeutics
- Lucia Savage, Omada Health
One question several audience members raised was on the issue of intellectual property (IP) protections for digital therapeutics. What aspects may be patented, what kind of IP can be built in this space, and how much of a differentiator are strong IP assets?
Pear Therapeutic’s Antoun Nabhan noted that software has long been patentable so long as the methodology that is enabled by a machine – a so-called machine patent. “That’s been available to us the whole way through and that is clearly one of the pillars of an IP strategy in this space. There are also method claims that you can obtain – and we have a fair portfolio of this – around “how to treat diseases,” specific techniques, how you implement those specific techniques in software. The third pillar of the strategy is around specific implementation aspects and architectural aspects. These are more what you might think of as method claims, but they are method claims around how you construct the software, how you pass data around, how you enable cybersecurity, how you enable HIPPAA compliance. There is certainly a tradition in the patent space for how you do that generally… So three pillars on the patent side, and quite a bit of copyright that you can take advantage of, and in the U.S., that’s even longer than patent life.”
Click Therapeutic’s David Klein also weighed in to note that unfounded concerns around IP protections were a pervasive myth in the digital therapeutics space. “I’d say from our perspective… IP would be the first layer of protection. In our view, and I think if I spent enough time with anyone in this room who is more of a “composition of matter” mindset… not only can we prove, outright prove, that there’s really not an ability even from an IP perspective to go out and make a generic version of one of Clikc’s programs, but I think we could take it a step further and make a pretty convincing argument that not only are we protected from an IP perspective, but that there’s a pretty reasonable chance that we could have perpetual exclusivity on these programs. By the time someone copied one of these programs, the algorithms inside and trade secrets have already advance the program 2-3 years beyond where that copy ends up. So I think we’re in a very beneficial position there, and I think in general pharma companies who have done their research in this space get over that hump very quickly.”
Access business panels, therapeutic sessions, and fireside chats from the 2018 Investor Forum by purchasing a Virtual Attendee Package here.