March 26, 2012
LES Insights
Authored by Erika Harmon Arner, D. Brian Kacedon, and John C. Paul
In Mayo Collaborative Services v. Prometheus Laboratories, Inc.,1 decided March 20, 2012, the Supreme Court ruled unanimously that the claimed methods for optimizing the dosage of medication based on a body's reaction to the drug were unpatentable under section 101 of the Patent Act. In particular, the Court ruled that the patent claims covered "natural phenomena," which cannot be patented because they are the fundamental building blocks of science.
U.S. patent law lists four categories of subject matter that can be patented: machines, compositions of matter, manufactures, and processes. An invention that falls within one of these categories may not be patented, however, if it claims only a fundamental principle, i.e., an abstract idea, a law of nature, or a natural phenomenon. These fundamental principles may not be patented on their own because they are the building blocks of science and must be available for all to use. Only an invention that includes a particular, practical application of such principles may be patented. Courts have struggled for decades, even centuries, to identify the proper boundary between an unpatentable fundamental principle and a patentable, practical application of the principle.
The Mayo v. Prometheus case is the latest in a long line of recent cases demonstrating just how difficult it can be to identify patentable subject matter, particularly for "process" patents. In this case, the Supreme Court considered whether a process for optimizing the efficacy of a drug was patentable subject matter under section 101. In particular, the patents at issue claimed a process including the steps of: (a) administering a thiopurine drug to a patient with a certain gastrointestinal disorder; and (b) determining how the patient's body responded by measuring thiopurine metabolites in the patient. The level of thiopurine metabolites would indicate a need to increase or decrease the amount of the drug for the patient.
The patents were granted by the United States Patent and Trademark Office and subsequently enforced by Prometheus, the sole licensee of the patents, against diagnostic tests sold by Mayo that allegedly infringed the patents. At the district court, Mayo argued that the patents were invalid because they merely claimed the natural correlation between thiopurine metabolite levels in a patient and the toxicity and efficacy of thiopurine drugs. The district court agreed, granting summary judgment in Mayo's favor. Thus began a lengthy appeals process that would twice land the case before both the Court of Appeals for the Federal Circuit and Supreme Court.
The Federal Circuit decided this case twice, once before the Supreme Court's landmark decision in Bilski v. Kappos, and again afterwards. Both times, the Federal Circuit ruled that the treatment method was patent-eligible because it is "a series of transformative steps that optimizes efficacy and reduces toxicity of a method of treatment for particular diseases using particular drugs." To the extent that the claims involved a natural phenomenon, the Federal Circuit reasoned that the claimed method practically applied the natural phenomenon, making it a patentable process under section 101. First, the Federal Circuit explained that the step of administering the drug to the patient transformed the patient's body because the drug did not simply pass through the body unchanged. Second, the court found that the determination of metabolite levels required transformative testing and could not be performed by mere inspection.
Mayo asked the Supreme Court to review the first Federal Circuit decision. At the same time, the Supreme Court was considering the issue of patentable processes in another case, Bilski v. Kappos, ultimately ruling that a process did not have to be tied to a particular machine or transform articles (the so-called "machine or transformation" test) in order to satisfy section 101. After deciding Bilski, the Supreme Court granted Mayo's review request for the limited purpose of vacating the first Federal Circuit decision and remanding the case back to the Federal Circuit for consideration in light of Bilski. The Federal Circuit again found that the Prometheus methods were patent-eligible, and Mayo again asked the Supreme Court to intervene, which it did.
All nine justices of the Supreme Court agreed that the Prometheus claims were invalid because they claimed natural phenomena. Justice Breyer, writing for a unanimous Court, stated that this case "lies at the intersection" of the basic principles that laws of nature, natural phenomena, and abstract ideas are not patentable, but practical applications of one of these may be patentable.
The Court explained that "to transform an unpatentable law of nature into a patent-eligible application of such a law, one must do more than simply state the law of nature while adding the words ‘apply it.'" The Court dismissed the "administering" and "determining" steps relied upon by the Federal Circuit as insufficient to constitute a practical application of the underlying natural phenomenon. In particular, Justice Breyer reasoned that these amounted only to instructing doctors to measure thiopurine levels, which can be done using well-known testing methods, and using the unpatentable laws of nature to calculate toxicity and efficacy.
The Court reaffirmed its holding in Bilski that the Federal Circuit's "machine or transformation" test for processes is an "important and useful clue" to patentability, but explained that the test does not trump the "law of nature" exclusion and that it does not decide this case. The Court also dismissed arguments that its reliance on "well-known" and "routine" subject matter confused the subject matter analysis with the separate requirement of novelty. Rather, wrote Justice Breyer, partitioning the patentability requirements in this way would create "significantly greater" legal uncertainty. The Court was also not swayed by arguments that denying patent protection to diagnostic methods like this one would inhibit future medical research and the burgeoning field of personalized medicine. Instead, policy decisions like this are better left for Congress, wrote Justice Breyer.
The Mayo v. Prometheus decision demonstrates a departure from the Supreme Court's usual stance that the scope of patentable subject matter is extremely broad. Rather than emphasizing, as it usually does, that Congress intended the scope of patent protection to be as broad as possible, the Mayo Court focuses on the judge-made exclusions from patentable subject matter, reasoning that narrower patent protection may better promote innovation.
The Court's focus on the "natural phenomenon" exception to patentable subject matter may blunt the impact of the decision on other technology areas, such as computer software and signal processing. The Court's reasoning will likely add, however, to the uncertainty in the law of patentable subject matter. In particular, the Court based its decision on the subjective inquiry of whether "enough" or "sufficient" subject matter has been added to an unpatentable natural phenomenon to create a patentable "inventive concept." Lower courts and the Patent Office will likely struggle with the question of what is "enough" added subject matter.
1 The Mayo v. Prometheus decision: http://www.supremecourt.gov/opinions/11pdf/10-1150.pdf.
Copyright © Finnegan, Henderson, Farabow, Garrett & Dunner, LLP. This article is for informational purposes, is not intended to constitute legal advice, and may be considered advertising under applicable state laws. This article is only the opinion of the authors and is not attributable to Finnegan, Henderson, Farabow, Garrett & Dunner, LLP, or the firm’s clients.
Copyright © Finnegan, Henderson, Farabow, Garrett & Dunner, LLP. This article is for informational purposes, is not intended to constitute legal advice, and may be considered advertising under applicable state laws. This article is only the opinion of the authors and is not attributable to Finnegan, Henderson, Farabow, Garrett & Dunner, LLP, or the firm’s clients.
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