concept,” and then determines whether there is an “inventive concept” that
nonetheless transforms the patent-ineligible natural law into a patent-eligible
26 Applying this test to Alice’s claims, Justice Thomas
first found that they were directed to an abstract idea—the concept of
intermediated settlement, making it a patent-ineligible concept.
27 At step two,
Justice Thomas found that merely reciting the existence of a generic
computer was insufficient to convert Alice’s patent-ineligible abstract idea
into a patent-eligible invention.
Citing Alice, lower courts have invalidated patents in almost two hundred
and fifty cases since June 2014.29 Mobile health-related patents have been
among those struck down,
30 and lawyers have recognized the increased
difficulty of using patents to protect mobile health apps going forward.
Although manufacturers of more complex wearable technologies may find it
easier to protect aspects of their products, makers of mobile health
applications that work with existing phones, tablets, or other technologies
will find it difficult to achieve comprehensive patent protection in the way
that most drugs or medical devices have.
FDA Regulation. — For at least the last half century,
33 the FDA has played
a central role in the regulation of health technologies of all kinds.
regulation of pharmaceuticals is particularly rigorous, requiring companies
to obtain premarket approvals of their technologies by demonstrating both
safety and efficacy of the compound in question.
35 The FDA’s regulation of
26. Id. at 2355 (citations omitted).
27. Id. at 2356.
28. Id. at 2358.
29. Robert R. Sachs, AliceStorm Update for Fall 2016, BILSKIBLOG (Oct. 19, 2016),
30. See, e.g., MobiHealthNews, What Have We Learned from Four Years of Digital
Health Patent Fights?, MOBIHEALTHNEWS (Aug. 26, 2016),
31. See, e.g., Douglas H. Pearson et al., Are You Ready for Digital-Health Patent
Disputes?, JONES DAY DIGITAL HEALTH LAW UPDATE (Aug. 2015),
Digital%20Health%20Vol%20I%20Issue%204.pdf; Brian E. Ferguson & Anish R. Desai, The
Coming Patent War Over Wearable Technologies, WEIL GOTSHAL (Sept. 2, 2015),
32. Douglas H. Pearson et al., supra note 31 (“The [Alice] test has been applied with
devastating effect by district courts and the USPTO to invalidate patents or reject patent claims
on grounds that they claim no more than general computer implementations of abstract
33. Kefauver Harris Amendments of 1962, Pub. L. No. 87-781, 76 Stat. 780 (1962).
34. Cortez, Cohen & Kesselheim, supra note 9, at 372.