Bilski Follow-up, the Supreme Court addresses Patentable Subject Matter Again
Following the Bilski decision last summer, the Supremes still seem to have patentable subject matter on their radar. This time the focus is on the question of patentable subject matter in medical procedures where the human element of a doctor's procedures are involved, the U.S. Supreme Court today issued its decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc, which will have implications beyond medical devices given the broad reach of the decision. In a unanimous decision, the Supreme Court held that method claims that involved administering a drug to a patient and determining the effect were not patentable subject matter. The Court held that the correlation between the drug being administered and the concentrations of certain metabolites in the blood of the patient was not itself patentable as a "law of nature," and the claimed processes, while not natural laws themselves, did not sufficiently transform the nature of the claims.
Prometheus Laboratories is the exclusive licensee of two patents claiming the use of thiopurine drugs to treat autoimmune diseases. When ingested, the drugs are metabolized and produce metabolites in the bloodstream of the patient. The claims are directed to processes that identify correlations between metabolite levels and likely harm or ineffectiveness of the drug with regard to that patient. The claims each recite an administering step (the physician administers the drug to the patient), a determining step (the physician measures the resulting metabolite levels), and a "wherein" step describing the metabolite concentrations above which there is a likelihood of harmful side effects, and below which there is a likelihood of ineffectiveness. The physician is informed that concentrations above or below either threshold indicate a need to decrease or increase the drug dosage.
Mayo announced that it intended to sell and market a similar diagnostic test. Prometheus sued Mayo for patent infringement, and Mayo challenged the validity of the claims. The District Court found that the claims effectively claimed natural laws or phenomena, and declared the claims invalid. On appeal, the Federal Circuit Court of Appeals initially reversed, holding that the claims met the "transformation" element of the machine-or-transformation test which had been developed as a means for testing patent eligibility. The case was remanded by the Supreme Court for further consideration in light of its Bilski decision, and the Federal Circuit reaffirmed its earlier conclusion. In its decision today, the Supreme Court reversed.
The Court's starting point was that the relationship between the metabolite concentrations and the likelihood that the thiopurine drug dosage would be harmful or ineffective is a "law of nature," and thus not patentable. The claimed processes were applications of a law of nature, and would not be patentable unless they have additional features that provide practical assurance that the processes are genuine applications of those laws, rather than an attempt to monopolize the correlations. In this case, the Court determined that none of the steps of the method claims met this standard. In its analysis, the Supremes seem to have merged the concepts of 35 USC 101, 102 and 103, by requiring questions of patentable subject matter with anticipation and obviousness. This follows a similar confusing approach from the Federal Circuit in other cases, such as Cybersource v. Retain Decisions, where Judge Patel also seems to have confused these concepts. In that case, the following observations are apparent:
According to the Federal Circuit:
- Steps that can be performed entirely by a human mind are not patentable – even when they are embodied in computer-readable storage media (i.e., "Beauregard" claims) – because the "application of [only] human intelligence to the solution of practical problems is no more than a claim to a fundamental principle." (Citing the Federal Circuit's own language in its previous Bilski decision.)
- Adding data-gathering steps does not make an otherwise nonstatutory claim statutory.
- Courts look to the underlying invention even if the preamble is directed to a statutory class other than a method.
- Although adding software to a general-purpose computer makes the computer a special-purpose computer, simply reciting the use of a computer to execute an algorithm that can be performed entirely in the human mind does not make the algorithm patentable.
- The patent applicant has the burden of demonstrating that claims drawn to a specific apparatus are distinct from other apparatuses capable of performing identical functions.
- The "mere manipulation or reorganization of data" does not satisfy the transformation prong of the "machine-or-transformation" test.
- To satisfy the machine prong of the "machine-or-transformation" test, "the use of the machine 'must impose meaningful limits on the claim's scope.'" (Citing the Federal Circuit's language in Bilski.)
Observation in this case:
- Reciting steps to create the database of Internet addresses should have involved sufficient use of computers to overcome the 35 U.S.C. § 101 threshold.
- Reciting steps to sort, weigh, or draw conclusions from Internet transactions may have been useful to make the claims less "abstract," but it's unclear if doing so would have been sufficient to make the claims patentable given this decision.
The court also reiterated two of its prior decisions on patentable software that could serve as useful guidance:
- SiRF Tech. v. Int'L Trade Comm'n: a method for calculating an absolute position of a GPS receiver was patentable because the method could not be performed without the GPS receiver.
- Research Corp. Techs. v. Microsoft Corp.: a method for rendering a halftone image of a digital image was patentable because the method (a) manipulated data structures; (b) output a modified data structure; and (c) could not be performed entirely mentally.
The Mayo decision also brings into question the validity of similar claims in many patents already issued, and will have an immediate impact on pending patent applications, and it further gives less confidence to the efficacy of software and biomedical claims in general. It also further may have some bearing on the issue of the patentability of parts of the human genome, an issue that the Supreme Court may consider this coming term in the Myriad Genetics case. It will be interesting to watch these cases unfold in further precedent setting cases that define and seem to be depleting the rights of patent holders in many industries.
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