On Tuesday March 20, the US Supreme Court did the truly unexpected in Mayo Collaborative Services v. Prometheus Laboratories, Inc. The Court unanimously held that a method of optimizing drug treatment, based on a discovered correlation between measured levels of human metabolites of synthetic drugs and their safety and efficacy, was not eligible to be patented. In doing so, the Court made very clear that it will enforce limits on what can be considered a patentable "invention" even for medical advances with important social benefits. The Court has drawn its differences even more sharply with the US Court of Appeals for the Federal Circuit, which was established to consolidate patent appeals in a single court with patent expertise and which (along with its predecessor, the Court of Claims and Patent Appeals) sought to expand the scope of the patent system into ever more areas of life. The Supreme Court has thus struck another powerful blow in the culture war between many patent law practitioners who think the patent system should have no limits (even if many specific claims of invention should not be patented because not new or obvious) and many in the medical, scientific, software and other communities which think that important natural and theoretical discoveries should remain free from private ownership (even if some practical claims of invention, such as synthetic drugs with significant new uses, should be patentable).
Justice Breyer, who authored the opinion, finally reached the issues he had previewed in his dissent from the dismissal in Laboratory Corporation of America Holdings v. Metabolite Laboratories, Inc. The opinion conveys a utilitarian concern that too much patent protection can impede innovation more than promote it, and thus our patent system has historically excluded from its scope three forms of preexisting things and basic information: (1) laws of nature; (2) physical phenomena; and (3) abstract ideas. Justice Breyer quoted the 1972 case of Gottschalk v. Benson, stating that excluded phenomena of nature, mental processes and abstract intellectual concepts are the basic tools of scientific and technological work. The rest of the work of the Mayo decision goes into explaining (1) why the particular claim at issue added nothing of significance beyond an instruction to doctors to apply the "law of nature" (a discovered medical fact induced by human activity of synthetic drug administration) and thus why the claim remained overbroad from an innovation policy perspective; (2) how the Court's approach is justified in light of its earlier precedents (and how those precedents should be viewed); and (3) why counterarguments regarding eligibility of the claims fail and why alternative approaches to restricting the reach of the patent system are inadequate (including relying on patentability standards such as novelty, non-obviousness and adequacy of disclosure). The Court's decision, along with its earlier business method decision in Bilski v. Kappos should but will not put to rest efforts to eliminate reliance on the eligibility doctrine of 35 USC § 101 to draw fences around the patent system. It will certainly encourage more litigation over eligibility under what remain unclear standards for determining the significance of limitations in claims applying new discoveries (particularly as at one point Justice Breyer's opinion conflates significance of the limitations of the claimed application of the discovery with the breadth of those limitations).
More importantly, the case illustrates the continuing importance of morality to patent law. As I have argued, Justice Breyer's history is wrong given that the exclusions for "laws of nature" were adopted in large part based on religious views that God-given nature and the principles on which it operates should neither be privately owned nor treated as if human inventions. These religious views also required treating the natural discovery (once freely disclosed in order to seek patent rights) as if it were already known (i.e., as the public's communal property). The consequence of this prior art treatment is to require, for a patent eligible human invention to exist, that the human creativity reside in the application of the discovery itself and not from merely applying the discovery. Although I made this point to the Court in an amicus brief [PDF] on behalf of nine law professors, and although Justice Breyer's opinion reiterated the requirement for the claimed invention to reflect an "inventive concept" that is more than mere application of the discovery (as Justice Breyer put it, "one must do more than simply state the law of nature while adding the words 'apply it'"), Justice Breyer ultimately fell back on older case law that required evaluating whether the claim limitations added only "conventional or obvious" "[pre]-solution activity" or restricted "the use of the [discovery] to a particular technological environment." Because conventionality of the restriction does not match the utilitarian concerns, the decision unremarkably provides insufficient guidance for drawing lines although it makes progress by using "or obvious" (which assumes the prior art status). Justice Breyer does explicitly refer to prior art status of the excluded discovery when rejecting arguments to rely on 35 USC § 102 (novelty) and § 103 (obviousness) rather than § 101 to police the scope of the patent system (given that those sections are limited to prior art as defined in § 102, although Justice Breyer does not make that point explicit).
Ultimately, even if Justice Breyer were right about the origins of the laws of nature (and other two) exclusions, the different legal and social communities tend to view ownership of nature with a religious fervor hard to find for other intellectual property doctrines. Accordingly, we should expect continued strong views on the propriety (or perversity) of the Mayo opinion, of its effects on innovation, and of its ultimate morality (using any given utilitarian metric or deontological standard).
Joshua Sarnoff is an Associate Professor of Law at DePaul University College of Law, where he teaches patent law and other related courses. He has written numerous articles and book chapters on patent law, has submitted testimony on domestic patent law reform bills, has filed numerous amicus briefs in the US Supreme Court and in the US Court of Appeals for the Federal Circuit on important patent law issues. He has also been a pro bono mediator for the Federal Circuit, and has been a consultant to the UN Conference on Trade and Development on international intellectual property, trade and environmental issues.
Suggested citation: Joshua Sarnoff, Patents and Innovation After the Mayo Ruling, JURIST - Forum, Mar. 26, 2012, http://jurist.org/forum/2012/03/joshua-sarnoff-patents-mayo.php.
This article was prepared for publication by Ben Klaber, a senior editor for JURIST's academic commentary service. Please direct any questions or comments to him at email@example.com