In March 2012, the US Supreme Court issued its decision in the case of Mayo Collaborative Services v. Prometheus Laboratories, Inc. The Court unanimously held that the claims of the patents-in-suit were not directed to patent eligible subject matter, as defined by 35 USC § 101, and therefore invalid. While the claims at issue were in the field of personalized medicine, the Court's decision has broad implications for patent stakeholders in all areas of innovative technologies.
The Prometheus claims covered methods for treating a disease by administering a drug to a patient, monitoring the patient's blood levels of the drug's breakdown products, and indicating when dosages of the drug should be changed to optimize the therapeutic effect of the drug and minimize side effects. A truncated version of the exemplary claim is as follows:
A method of optimizing therapeutic efficacy for treatment of anThe Court began its opinion by acknowledging that 35 USC § 101 broadly defines patent eligible subject matter as "any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof." Although judicial limitations have excluded laws of nature, natural phenomena and abstract ideas from patent eligibility, the application of such laws, phenomena or ideas may satisfy the statutory requirements. The Court noted that the "[t]he claims purport to apply natural laws describing the relationships between the concentration in the blood of certain thiopurine metabolites and the likelihood that the drug dosage will be ineffective or induce harmful side-effects." The Court then framed its task as determining "whether the claimed processes have transformed these unpatentable natural laws [the relation between the concentration of a chemical in the blood and treatment efficacy] into patent eligible applications of those laws."
immune-mediated gastrointestinal disorder, comprising:
(a) administering a [thiopurine] drug ... and (b) determining the level of [a metabolite of the drug] ... wherein the level [of the metabolite below or above given thresholds indicates a need to increase or decrease the amount of drug subsequently administered].
The Court conducted a piecemeal analysis of the claim, dissecting it into discrete steps, blurring the lines between analyzing patentable subject matter under 35 USC § 101, novelty under 35 USC § 102 and obviousness under 35 USC § 103. The Court opined that the "wherein" clauses "simply tell a doctor about the relevant natural laws, at most adding a suggestion that he should take those laws into account when treating his patient," and that the "determining" step tells the doctor to "determine the level of the relevant metabolites in the blood, through whatever process the doctor or laboratory wishes to use." The Court further added that methods for determining these metabolite levels were conventional and routinely used.
Typically when analyzing a claim for patentability, the claim "as a whole" should be examined. The Court did purport to consider the claim as a whole; however, it decided that: "to consider the three steps as an ordered combination adds nothing to the laws of nature that is not already present when the steps are considered separately." Interestingly, the Court quoted an earlier case which held that the claimed process was patent eligible subject matter, Diamond v. Diehr to support its analysis: "[A] new combination of steps in a process may be patentable even though all the constituents of the combination were well known and in common use before the combination was made." But in contrast to Diehr, the Supreme Court decided that the combination claimed "amounts to nothing significantly more than an instruction to doctors to apply the applicable laws when treating their patients" and that "the steps are not sufficient to transform unpatentable natural correlations into patentable applications of those regularities."
The court also dismissed the position of the US government as proposed in their amicus brief [PDF], that other statutory provisions, such as novelty under § 102, obviousness under § 103, or written description/enablement under 35 USC § 112 can perform screening functions for patentability rather than narrowly interpreting patent eligible subject matter under § 101. The court flatly stated that "[t]his approach, however, would make the 'law of nature' exception to § 101 a dead letter." And "to shift the patent-eligibility inquiry entirely to these later sections risks creating significantly greater legal uncertainty, while assuming that those sections can do the work that they are not equipped to do."
But instead of certainty, many stakeholders believe that this decision creates more uncertainty for innovators trying to protect their inventions, with little practical guidance on how to analyze patent-eligible subject matter. The Court stated that they were not opining as to whether "less conventional" steps would avoid the same decision reached here, leaving open the possibility that, for example, unconventional steps could rescue otherwise unpatentable methods. The Court also indicated that it was troubled that the claims "tie up the doctor's subsequent treatment decision whether that treatment does, or does not, change in light of the inference he has drawn using the correlations." Since the Court was troubled by the fact that the claim captures situations where the caregiver's treatment does not change, methods that expressly require a specific change in treatment based on the test results might be patent-eligible. Another approach may be to use a claim preamble that is more "active" i.e., a method of treatment, or a method of diagnosis, as opposed to arguably more abstract ideas such as "a method of optimizing therapeutic efficacy."
As technology advances, the courts will continue to struggle to redefine the scope of statutory subject matter while following the constitutional mandate to promote the progress of the arts and sciences. The court acknowledged such policy issues in Prometheus, stating a "basic underlying concern that these patents tie up too much future use of laws of nature." But innovative technology-based companies rely on their patents to attract investors. If it becomes more difficult to obtain patents, some companies could lose investors, or they may seek alternative avenues to protect their inventions, such as trade secret. The decision, however, may also stimulate companies to develop more specific, patent-protectable products rather than try to patent their early-stage inventions. The Supreme Court's ruling in Prometheus will certainly cause technology-driven companies to rethink their patent strategies to protect their innovations.
Doreen Hogle is a principal at Hamilton Brook Smith Reyonlds. She has practiced law in the Intellectual Property field for over 20 years, counseling universities, biotechnology companies and research institutions. She was a past president of the Boston Patent Law Association (BPLA) and has been voted a Massachusetts/New England Super Lawyer numerous times. As a member of the BPLA Amicus Committee, she has co-written an amicus brief to the US Supreme Court.
Suggested citation: Doreen Hogle, Supreme Court Ruling Will Cause Patent Strategy Shift, JURIST - Sidebar, May 10, 2012, http://jurist.org/sidebar/2012/05/doreen-hogle-prometheus-patents.php
This article was prepared for publication by Jordan Barry, an assistant editor for JURIST's professional commentary service. Please direct any questions or comments to him at email@example.com