Initial Thoughts on Mayo v. Prometheus
Yesterday, the Supreme Court in Mayo Collaborative Services v. Prometheus Laboratories, Inc. decided that Prometheus’s claims to a therapeutic process—comprising the steps of (1) administering a thiopurine drug to a patient suffering from an autoimmune disease, (2) determining the level of a particular metabolite in the patient’s blood, and (3) adjusting the amount of the drug up or down based upon certain naturally-occurring correlations between metabolite levels and the need for a higher or lower dose of thiopurine—recited unpatentable subject matter. Specifically, the Court (in a 9-0 opinion authored by Justice Breyer) concluded that the process claims at issue were not meaningfully distinct from the underlying law of nature—the naturally-occurring correlation itself. In the Court’s view, the steps of administering the drug, determining the metabolite level, and adjusting the amount of the drug up or down in light of the correlation, did not “add enough . . . to allow the processes . . . to qualify as patent-eligible processes that apply natural laws” (emphasis in original). In reaching this conclusion, the Court reaffirmed that “[p]urely ‘conventional or obvious’ ‘[pre]-solution activity” is normally not sufficient to transform an unpatentable law of nature into a patent-eligible application of such a law”; and emphasized its “concern that patent law not inhibit further discovery by improperly tying up the future use of laws of nature.” Finally, the Court rejected the Federal Circuit’s view that the “transformations” that these processes cause within the human body satisfied the machine-or-transformation test (which test, the Court added , is merely a clue, not the clue, to patentability); the government’s view that the presence of even minimal steps beyond a statement of the law of nature is sufficient to satisfy § 101; and the views of some amici that a finding of unpatentability in this case would necessarily discourage medical research.
Here are some initial thoughts on the opinion and its significance.
1. I really didn’t know what to expect from the Court as a whole, but it is not surprising that Justice Breyer concluded that the processes at issue were unpatentable. The issue presented in the case is similar to the issue raised in the 2006 case of Laboratory Corp. of Am. Holdings v. Metabolite Laboratories, Inc., in which Justice Breyer (joined by Justices Stevens and Souter) filed an opinion (dissenting from the Court’s decision to dismiss the writ of certiorari as having been improvidently granted) expressing similar views. What is interesting is that a unanimous Court signed off on Justice Breyer’s approach.
2. The Mayo Court leaves open the question of what additional steps would suffice to transform an unpatentable law of nature into a patentable process. In this respect, the opinion resembles the Court’s 2010 decision in Bilski v. Kappos, which reiterated that abstract ideas are not patentable without, however, providing much guidance as to what distinguishes an abstract from a concrete idea. Presumably the answer to the question will evolve over time in both the USPTO and the courts.
3. The opinion is in some ways similar to the Court’s 2007 decision in KSR Int’l Co. v. Teleflex Inc., in which Justice Kennedy used the term “common sense” five times in the course of discussing the standard for determining whether an invention is sufficiently nonobvious to qualify for patent protection. I wouldn’t be surprised if the Court viewed Mayo as a sort of “common sense” opinion as well, to the extent the Court rejected arguments that even minimal steps in addition to the statement of the law of nature would suffice to render a process patent-eligible; indeed, Justice Breyer twice expressed concern that such a standard would merely induce creative claim drafting that would in effect monopolize laws of nature. Whether such “common sense” approaches are consistent with good innovation policy is a difficult question; one can easily see their appeal, though at the same time they risk introducing a certain “I know it when I see it” quality that can lead to unpredictability and inconsistency in application. The question I would now ask is whether this same approach will lead the Court to agree with the view, expressed in the district court opinion in Association for Molecular Pathology v. U. S. Patent & Trademark Office, 702 F. Supp. 2d 181, 185 (S.D.N.Y. 2010), rev’d, 653 F.3d 1329 (Fed. Cir. 2011), pet’n for cert. filed, 80 U.S.L.W. 3380 (Dec. 7, 2011), that distinguishing isolated gene sequences from naturally-occurring gene sequences is nothing more than “a lawyer’s trick”?
4. In my view, rules of patent law should be evaluated and adjusted in light of their consequences, particularly where (as here) the statutory text provides little or no explicit guidance. Ultimately, then, whether Mayo is a good or a bad decision depends on whether, as some of the amici predicted, the decision will on balance inhibit investments in developing new techniques of personalized medicine or (as other amici predicted) it will encourage such investments by ensuring that the essential building blocks of future innovation remain in the public domain, free for others to draw upon. In all honesty, neither I nor anyone else really knows what those consequences will be. We can speculate, given our understanding of the relative importance (or not) of the patent incentive in spurring innovation in this field, of the difficulties (or lack thereof) facing researchers who have to negotiate patent “thickets,” and the like. At the end of the day, I’m an optimist and I suspect that innovation will proceed apace; so perhaps the opinion reaches the right result as a matter of policy. I just wish I could be more confident in that expectation.