The substantial investment in digital health by corporations and universities has led to renewed interest in how to protect these investments. This is particularly challenging since much of the intellectual property associated with digital health products and services is readily discernible from inspection, thus obviating many trade secret strategies. It is made even more challenging given the current legal climate in the United States and elsewhere in which many traditionally patentable types of innovations are being denied patent protection on the basis that they are deemed abstract or otherwise not patentable. Digital health organizations are taking a number of legal strategies to protect their digital health intellectual property in the face of this legal climate.
FIRST, WHAT IS DIGITAL HEALTH?
Digital health is technology addressing the health problems and challenges faced by health care practitioners and their patients. It encompasses mobile health, health and wellness applications, big data, telehealth, electronic medical records, personal genomics, diagnostics, medical imaging and related industries.
Digital health is a growing industry. Investment in digital health companies has increased rapidly over the past five years, and several digital health companies have made initial public offerings in 2015, according to StartUp Health Insights’ midyear report. These companies are seeking patent protection in spite of the current patent climate making it more difficult for companies to acquire intellectual property.
THE CURRENT PATENT CLIMATE
The far-reaching impact of the recent U. S. Supreme Court holding in Alice v. CLS Bank International, 134 S.Ct. 2347 (2014), has affected the digital health industry. Alice held certain patents invalid because the claims were drawn to a judicial exception to patentability— an abstract idea. Recitation of standard computer components within the claims of the invalidated patents was not enough to take the claims outside the judicial exception. Alice has been broadly interpreted as a decision impacting software patents, resulting in declines in business method and software patent issuances and invalidating many existing software patents challenged in federal court or post-grant proceedings. Alice has made digital health companies think more strategically about how to acquire patent protection. Alice is the latest in a line of cases restricting the breadth of patentable subject matter. Recent Supreme Court decisions, including Mayo Collaborative Services v.
Prometheus Laboratories, 132 S.Ct. 1289 (2012); Association for Molecular Pathology v. Myriad Genetics, 133 S. Ct. 2107 (2013); and, most recently, Ariosa Diagnostics v. Sequenom, 788 F.3d 1371 (Fed. Cir. 2015), have limited the scope of what biologic matter may be patentable. These cases all impact digital health companies as they pursue patent protection.
IP PROCUREMENT STRATEGIES
Below, we highlight the diverse IP procurement strategies of three representative digital health companies. These case studies show that digital health companies continue to pursue patents despite the current legal climate.
• IMS Health
IMS Health provides information technology services for health care industry clients using an end-to-end cloud-based platform that provides insight into diseases, treatments, costs and outcomes by tapping into a vast proprietary health care database. They have obtained approximately 230 patents encompassing a wide variety of technology.These include software patents, methods of analyzing data, and systems to analyze data. Representative of their portfolio is U.S. Patent No 8,666,798, “Method and System for Rapidly Projecting and Forecasting Pharmaceutical Market Information.”
Mindbody provides business management software to the “wellness service industry,” including fitness clubs, personal service salons and skin care service providers. Mindbody primarily relies on a single published patent family titled “Systems and methods for wellness programs,” which is currently facing issues in the United States under Alice for being abstract. Mindbody completed a $100 million IPO in June. It provides integrated cloud-based business management software and mobile applications that simplify the way subscribers run their businesses, including automated appointment scheduling, business staffing, client data management, and payroll services, among other things.
Imprivata provides authentication and access management technology solutions, including their single sign-on product, which allows doctors and patients to use one username and password across multiple platforms. They own approximately 55 patents related to software and health information technology. Representative of their portfolio is U.S. Patent No. 8,973,091, directed to secure authentication using a mobile device.
Lessons learned from these patent procurement case studies and our own experience is to address Alice rejections by arguing that the rejected claims are directed to substantially more than a judicial exception (abstract idea) because they provide improvements to another technical field, include unconventional steps that confine the claim to a particular useful application, and have other meaningful limitations beyond generally linking the use of the judicial exception to a particular technological environment. Further, it is useful to argue for patentability by drawing comparisons between the rejected claims and those that have been allowed under Alice in prominent proceedings, including Google v. Simpleair, CBM 2014-00170 (P.T.A.B. Jan. 22, 2015), and DDR Holdings v. Hotels.com, 773 F.3d 1245 (Fed. Cir. 2014). Also, for rejected patent applications, a review of the examiner’s recently allowed patents provides clues as to what the examiner considers to be patentable under Alice. Just as the courts have been uneven in determining patentability under Alice, so have patent examiners.
DIGITAL HEALTH IP ENFORCEMENT
Apart from examining the IP procurement strategy of representative organizations in the digital health space, it is also instructive to examine IP enforcement strategies. A case in point is American Well, which facilitates the practice of medicine between doctors and patients by videoconference. American Well recently brought suit against Teledoc, one of the largest telemedicine providers, for infringement of American Well’s U. S. Patent No. 7,590,550, in American Well v. Teledoc, No. 1:15-cv-12274 (D.Mass. Jun. 8, 2015). This patent is directed to the algorithms American Well uses to match patients with health care providers in their telemedicine platform.
To counter the American Well lawsuit, Teledoc initiated inter partes review of the ’550 patent with the U.S. Patent and Trademark Office, seeking to invalidate the patent on the basis of obviousness, in Teledoc v. American Well, IPR2015-00924 (P.T.A.B. Mar. 24, 2015). In the review, Teledoc argued that the asserted patent is overbroad because it encompasses the fundamental concept of telemedicine, in which a consumer first requests medical service provider consultation, and a computer then identifies an available provider and establishes a real-time communication channel between the consumer and provider. Teledoc further contends the patent is obvious in view of prior art. The inter partes review is currently pending.
As digital health companies continue to achieve commercial success, patent litigation battles such as the American Well litigation are a foreseeable eventuality.
The digital health space is experiencing rapid growth. While the current climate for obtaining patents remains uncertain, many successful digital health companies are managing to secure patent protection for their inventions and pursuing enforcement of these patents.