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The IP Behind Software-as-a-Drug

When it comes to emerging health technology, securing the necessary IP protections means facing some pretty interesting challenges, including the task of educating patent examiners about an entirely new class of technology.

With healthcare startups and mobile health apps proliferating, a new category of digital healthcare has emerged: digital therapeutics. Also known as “software-as-a-drug,” digital therapeutics use Internet-based technology to help patients change a specific behavior. In fact, studies have shown the technology to be promising for treating a variety of medical and psychological conditions. 

Recently, the FDA approved the country’s first digital therapeutic: reSET, an app developed by Pear Therapeutics that’s being used to help treat substance use disorders. Pear’s patent attorney, Scott Barnett of intellectual property law firm Harness Dickey, recently sat down with Inside Counsel to discuss the importance of IP to healthcare startups and this emerging category of digital therapeutics.

Today, digital therapeutics refer to treatments or therapies utilizing digital health technologies to treat medical or psychological conditions. In some instances, according to Barnett, digital therapeutics may be used in place of traditional pharmaceuticals, such as pills, while in other cases digital therapeutics may be used in conjunction with traditional pharmaceutics to improve patient outcomes. Pear’s digital therapeutics are unique in that they are clinician prescribed, clinically validated, and in some cases, FDA-cleared. Pear has designed a suite of digital therapeutic offerings, each one succinctly tailored to treat a specific disease or disorder.  

“One challenge associated with securing IP protection in a completely new field of technology is educating patent examiners about the technology,” he explained. “Patent examiners are organized according to very specific technology sectors and are accustomed to reviewing very similar types of technology on a day-to-day basis. So, when presenting patent examiners with an outside the box innovation, it becomes critical to supply the context and background information necessary to facilitate an informed decision.”

Healthcare technology, perhaps more so than other areas, has always been high-risk, high-reward. IP protection is essential to ensure adequate return on investment. While IP is useful for carving out exclusive rights in any market, it is even more important in healthcare where the stakes tend to be much higher.

“Analysis of IP rights is always a major step in any pre-investment due diligence. Understandably, investors want assurances that the companies they invest with—including Pear—have a competitive edge in the market,” said Barnett. “Exclusive IP rights frequently provide, or enhance, that competitive edge. Pear’s strong IP rights have been a key factor in attracting substantial investment.”

These days, strong IP rights help create a cyclical path to growth, whereby existing IP rights carve out market share, spurring increased revenue. That increased revenue may, in turn, be poured back into the development of new product lines. 

Contributing Author

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Amanda Ciccatelli

Amanda G. Ciccatelli is a Freelance Journalist for InsideCounsel, where she covers intellectual property, legal technology, patent litigation, cybersecurity, innovation, and more. She earned a B.A....

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