To many, digital health is a relatively novel industry that has emerged at the hazy pharma-tech interface. However, as its boundaries and benefits become more apparent, investment and regulatory activity are becoming increasingly supportive, and in favour of its evolution. Unsurprisingly, these ratifications combined with the fast evolving nature of digital health and its ambition to set itself apart, has set precedence for aggressive competition within the industry. Navigating regulatory pathways and establishing reimbursement routes are hot topics among industry leaders with regard to ensuring speed-to-market and broad user reach. But we rarely hear them discuss the importance of protecting the novelty of these innovations. Is diverted focus one of the reasons why we are beginning to witness a burgeoning medtech rivalry ?
The year 2020 alone saw a number of IP-based legal battles including the long-awaited eruption between telehealth giants Teladoc and Amwell. Last autumn Teladoc filed a lawsuit against its competitor Amwell on the back of a patent infringement accusation. Teladoc claimed that Amwells products including some of its telehealth carts, a digital scope and stethoscope infringed on patents that it acquired following the acquisition of InTouch Health earlier in the year. In response, Teladoc began seeking unspecified monetary and injunctive relief under patent law. The year came to a close marked by contention between Apple and AliveCor. A lawsuit filed by AliveCor detailed that the tools included in the Apple Watch Series 4 and later devices infringed on three patents held by AliveCor, all of which focus on cardiac arrhythmia. A year prior to the unveiling of the Apple Watch's ECG, AliveCor had launched an Apple Watch strap with a built-in ECG sensor called the KardiaBand but ended sales to focus on its six-lead smartphone ECG screening device.
The evidence is rife; digital health is one of those industries destined for IP rivalry. Experts in the industry report that medical device litigation is probably the most contentious with competitor litigations going more frequently to trial than in many other industries. The solution to this is undeniable. IP protection should assume a critical component of a company’s overarching digital health strategy. But how is IP protection in digital health achieved?
Digital health solutions can be protected from IP theft by one or more of several ways depending on the individual component of interest i.e hardware, software, associated data analytics. The channels of IP that may be used to grant such protection are myriad and include:
Trademarks and design
A carefully selected and preserved trademark is a valuable asset for digital health innovators protecting against the registration of confusingly similar marks. Engaging with an IP attorney early on is imperative to ensuring the smooth sailing of solution naming and clearance. While trademark protection is a crucial part of a company’s underlying IP strategy, it is important to remember that while it protects the name, it does not prevent competitors from copying the function of a medical device. Design rights are another important consideration that impart protection against aspects of a product's appearance; factors which are often definitive to consumer uptake and HCP adoption.
Including details such as algorithms, or manufacturing secrets in standard operating procedures (SOPs), or marketing materials can inadvertently put companies at risk of IP theft. However, trade secret protection can be achieved by educating employees on keeping information confidential and implementing programs to preserve innovation seclusion. Trade secret law often appeals more to companies as courts in general are more willing to issue injunctions under trade secret litigation in comparison to the more complex patent litigation.
Components of digital health that may be patentable include mechanical, chemical and electrical, as well as associated methods and protocols. Protection can also be sought for user interfaces by means of utility or design patent applications. Pretty straight forward, right? But for computer-based elements, and abstract ideas things get a little bit murky. Case law developments have made it difficult for software or technology built on abstract ideas to get patent protection, and most jurisdictions require that these components can demonstrate real life outcomes. reSET®, the first FDA-approved software-only prescription digital therapeutic is one example where patent protection options wane. The software-based CBT product for substance use disorder which established efficacy in a 12-week clinical trial lists several trademarks but has no associated patents or patent applications.
Obtaining a patent can be a long and expensive process. In the US the process involves submitting a patent application to the US Patent and Trademark Office (USPTO). Preparing the submission can take anywhere in and around the 4-8 week mark. Not so bad eh? But after the application is filed, it can take an average of 2-3 years for examination prior to the issuance of an enforceable patent. Nevertheless, patents confer several advantages for inventors in that they offer the strongest form of IP protection and allow a monopoly over an invention for a fixed period. They are often considered currency to secure financing through venture capital or private equity investments. In addition to discouraging competitors and attracting investments, patents also bolster a company’s reputation for originality in its field, which helps attract top talent.
The top 100 Global Digital Health Patents for 2018-2020 illustrated that patenting is the still one of the most sought after channels for protecting innovation. China's Ping An topped the IP charts leading with 1,074 patent patent filings during the time period, followed closely in line by Philips (1,021 applications) and Johnson & Johnson (535 applications). So far this year we have seen continued patent activity with Voluntis receiving a patent for its intelligent insulin titration support as part of its Theraxium Digital Therapeutic Platform, and Neurosigma expanding its patent portfolio to covering the use of trigeminal nerve stimulation (TNS) in the treatment of neurological and neuropsychiatric disorders. Mydecine also made headlines last month when it filed a provisional patent for its technology combining a digital mental health programme and the world’s first telehealth platform for psychedelic integration.
Product life cycle opportunities
One reason why companies initially lean towards digital solutions is to reinforce their IP portfolios and product commercialisation strategies. Patents for pharmaceutical drugs typically confer 20 years protection but once a patent expires and generics begin to hit the market it is estimated that sales of the originator drops by a whopping 80 percent. Prior to the digital revolution, drug product developments and iterations typically involved tweaks in formulations, routes of administration, expansion of indications or development of drug-drug combinations. The inception of the digital health era has, however, created myriad opportunities to strengthen and diversify a drug patent portfolio by means of combination product approaches, or device differentiation. One example of this is the teaming up of Otsuka and Proteus to develop Abilify MyCite®. The prescription digital medicine combines the blockbuster antipsychotic Abilify® and embedded microsensors for digitally tracking drug ingestion and has shown to improve clinical outcomes compared to Abilify® creating a novel opportunity for extending the product life cycle.
Proteus’s patents covering innovations in Abilify MyCite® expire after those of Otsuka’s for Abilify®.
In the US, patent extension is classified under FDA (505-B) and provides pharma an opportunity and incentive for iterative product development. The Otsuka and Proteus partnership is testament to the fact that combining digital health solutions with conventional drugs can be leveraged to extend patent lifespans, allowing greater return on investment and invigorated product life cycles.
………... but what about all that data?
It goes without saying that digital health products collect an abundance of data, typically stored in designated databases. While the data itself may not be protected by copyright, the database or data collection may be protected if it is considered sufficiently avant-garde.
Building a successful digital health IP Strategy
IP is a key driver of innovation in the digital health industry and investing in its protection will reap enormous reward and diversity of solutions in the future. One crucial consideration to bear in mind is that product life cycles in the digital health industry are typically much shorter than other healthcare industries, putting added pressure on digital health manufacturers to regularly revise and update their IP strategy. Furthermore, considering the patentable exclusion criteria which pertains to the likes of mathematical methods and algorithms, players in the digital health field rely more heavily on streams of auxiliary protection such as copyright and trade secrets.
IP has facilitated cutting-edge collaborations between the medtech, healthcare and pharmaceutical industries and nurturing an ecosystem that appropriately balances innovation with IP challenges is imperative to ensuring continued industry growth and timely access by patients to innovative healthcare solutions worldwide. Every single solution on the digital health market today is a by-product of some individual's incipient idea. How would you protect the transformation of your own ideas into assets?