For the second time in less than two years, the Supreme Court will decide on the patent eligibility of method claims. In June of this year, the Court granted Mayo’s petition for certiorari in Prometheus Laboratories, Inc. v. Mayo Collaborative Services. Oral arguments before the Court are scheduled for December 7, 2011. The case involves the patent eligibility of personalized medicine (PM) technologies. PM refers to the customization of health care for an individual patient. PM can take into account a patient’s genetics and other individualized information to optimize therapeutic and preventive care in accordance with the patient’s specific biology and medical conditions. Examples of PM include genetic screening, engineering of a drug’s molecular structure, or dosage as a function of patient biomarkers. Given the significant current and future potential benefits of PM, as well as the large capital requirements for medical research, the Court’s ultimate holding will have far-reaching consequences.
The case involves method claims in two issued patents: U.S. Patent No. 6,355,623 and U.S. Patent No. 6,680,302. Prometheus holds exclusive licenses for both patents. The patents cover methods for determining optimal dosage, individualized to a particular patient, of a drug used to treat stomach disease. Claim 1 in the ‘623 patent recites a method for optimizing therapeutic efficacy for treatment comprising (a) administering a drug to a subject and (b) determining levels of metabolites present in the subject. The determined levels of metabolites correlate with the drug’s toxicity to the subject. The claim further recites, using a wherein clause, to either increase or decrease the amount of administered drug as a function of the determined levels of metabolites. Other claims in the patent cover similar, albeit different, methods.
In 2008, a federal district court found that the claims covered ineligible subject matter under 35 U.S.C. §101. In 2010, the Court of Appeals for the Federal Circuit (CAFC) reversed the lower court’s findings and reinstated the method claims. Mayo successfully petitioned the Supreme Court after the CAFC ruling.
Mayo argues that the method claims extend protection to natural phenomena. Although not prohibited by statute, federal courts have consistently denied patent protection to natural phenomena and laws of nature. Mayo claims that the correlation between metabolite level and toxicity is a natural phenomenon, and that the issued method claims grant protection to this correlation.
Specific applications of natural phenomena or laws of nature are proper patent subject matter. Thus, one who invents a useful, novel, and non-obvious application of a natural phenomenon may be entitled to a patent. However, federal courts have placed limits on the patentability of an application of natural phenomena. For instance, one is not entitled to a patent if the claimed application of natural phenomenon preempts all other uses of the natural phenomenon. In addition, one is not entitled to a patent if the claimed application of natural phenomenon involves merely mental steps.
Mayo argues that the “administering” and “determining” steps of the method claims are merely necessary data-gathering steps and that the claims, as recited, preempt all uses of the naturally occurring correlation. In support of this argument, Mayo claims that doctors will not be able to employ their patient’s unique biological information when giving care without risking patent infringement. Mayo also argues that the wherein clauses in the methods are purely mental steps.
The CAFC did not agree with Mayo’s arguments. Instead, the court found the claims to cover only a specific application of the correlation through the recitation of the “administering” and “determining” steps. The court held that the claims do not preempt all uses of the correlation. While applying Bilski’s “machine or transformation” test, the court stated that the “administering” and “determining” steps were not merely data gathering steps, but were “transformative” in nature because the steps were part of a treatment regime. The CAFC did acknowledge that the wherein clauses were mental steps, but found that other limitations of the claims were not mental steps. The court’s analysis indicated that the existence of mental steps in conjunction with steps that are not merely mental is not a per se bar to patentability.
The Supreme Court’s ultimate ruling will have far-reaching consequences beyond genetic testing technologies and other applications of PM. Many health care providers, medical researchers, technologists, investors, and patent practitioners are closely monitoring developments in the case. Most hope that the Court will provide further guidance on issues of patentable subject matter and further clarification of the “machine or transformation” test.