indispensable tool enabling them to protect their investments in new drugs.
Most approved drugs are covered by a number of patents, which cover
different aspects of the drug at issue.
18 Core patents typically claim the drug
compound itself while secondary patents may cover methods of treatment
that use the drug, particular formulations of the drug, or the process of making
Recent developments in patent law have made it far more difficult for
mobile health app developers to achieve the same levels of patent protection
that exist in the pharmaceutical context.
20 Specifically, in a series of cases
over the past few years, the Supreme Court limited the types of technologies
eligible for patent protection under 35 U.S. C. § 101,
21 most recently deciding
Alice Corporation, Ltd. v. CLS Bank International.
22 CLS Bank had sought
a declaratory judgment that several of Alice’s patents, directed toward
methods of mitigating settlement risk using computers,
23 were invalid under
Justice Thomas’ majority opinion agreed that Alice’s specific method
claims were invalid.
25 More important, though, was the way Justice Thomas
crystallized a two-step process for deciding § 101 cases. The process asks
first whether “the claims at issue are directed to [a] patent-ineligible
17. Stuart J.H. Graham et. al., High Technology Entrepreneurs and the Patent System:
Results of the 2008 Berkeley Patent Survey, 24 BERKELEY TECH. L.J. 1255, 1286 (2009);
Wesley Cohen et al., Protecting Their Intellectual Assets: Appropriability Conditions and Why
U.S. Manufacturing Firms Patent (Or Not) 2, 12 (Nat’l Bureau of Econ. Research, Working
Paper No. 7552, 2000).
18. Lisa Larrimore Ouellette, How Many Patents Does It Take to Make A Drug? Follow-on Pharmaceutical Patents and University Licensing, 17 MICH. TELECOMM. & TECH. L. REV.
299, 300–01 (2010).
19. Amy Kapczynski, Chan Park, & Bhaven Sampat, Polymorphs and Prodrugs and Salts
(Oh My!): An Empirical Analysis of “Secondary” Pharmaceutical Patents, 7 PLOS ONE 1, 1
20. See infra notes 21–22 and accompanying text.
21. 35 U.S. C. § 101 (2012) (“Whoever invents or discovers any new and useful process,
machine, manufacture, or composition of matter, or any new and useful improvement thereof,
may obtain a patent therefor, subject to the conditions and requirements of this title.”). The
Supreme Court has articulated a number of specific exceptions to the broad text of § 101:
“[l]aws of nature, natural phenomena, and abstract ideas” are not eligible for patent protection.
See Alice Corp. Pty. v. CLS Bank Int’l, 134 S. Ct. 2347, 2354 (2014); see also Mayo
Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289, 1293 (2012); Diamond v.
Chakrabarty, 447 U.S. 303, 309 (1980).
22. CLS Bank Int’l v. Alice Corp. Pty., 717 F.3d 1269, 1274 (Fed. Cir. 2013) (en banc)
(Lourie, J., concurring) (per curiam).
24. Id. at 1273–74 (discussing how the en banc Federal Circuit splintered badly, with ten
judges issuing seven opinions, none commanding a majority).
25. Id. at 2352 (holding further that “merely requiring generic computer implementation
fails to transform [Alice’s] abstract idea into a patent-eligible invention”).