The Supreme Court Concludes That Prometheus' Medical Diagnostic Procedure Preempts a Law of Nature
The U.S. Supreme Court today held that claimed medical diagnostic processes that recite laws of nature are not patent eligible absent additional claimed features providing “practical assurance” that the processes are genuine applications of those laws, rather than clever drafting “designed to monopolize the correlations” (Mayo Collaborative Services et al. v. Prometheus Laboratories Inc., No. 10-1150, U.S. Sup.; See 12/19/11, Page 6).
The court unanimously overturned a 2010 ruling by the U.S. Court of Appeals for the Federal Circuit that Prometheus Laboratories Inc.’s medical treatment claims were patent eligible. The high court stated that “[t]he claims inform a relevant audience about certain laws of nature; any additional steps consist of well understood, routine, conventional activity already engaged in by the scientific community; and those steps, when viewed as a whole, add nothing significant beyond the sum of their parts taken separately. For these reasons we believe that the steps are not sufficient to transform unpatentable natural correlations into patentable applications of those regularities.” The court gave little weight to the fact that the ingested drug was transformed by the human body into a metabolite. Instead it treated the transformation of the ingested test drug as an insignificant data gathering step.
The patent-in-suit involved a method for determining the proper dosage of thiopurine drugs commonly used to treat gastrointestinal and autoimmune disorders.Thiopurine is potentially harmful when administered in large doses. Each individual taking the drug has a personal threshold for thiopurine tolerance. Prometheus sells a “Pro-Predict” test kit to detect metabolites that are produced when the drug is transformed by the human body.
At the Federal Circuit applied the machine-or-transformation test, under which a claimed process is patent eligible if it is tied to a particular machine or apparatus or if it transforms a particular article into a different state or thing. The court held that the administering and determining steps of the patents were transformative. Mayo filed a petition for writ of certiorari with the Supreme Court, and while the petition was pending, the Supreme Court decided Bilski v. Kappos (561 U.S. 130 S. Ct. 3218 [2010]; See 7/2/10, Page 4), in which it rejected the machine-or-transformation test as the sole method for determining patent eligibility under 35 U.S. Code Section 101.
In light of its ruling in Bilski, the Supreme Court in June 2010 vacated the Federal Circuit’s decision on Prometheus’ patents and remanded the case for further consideration. In its December 2010 ruling, the Federal Circuit again upheld the patentability of Prometheus’ medical treatment claims that include steps that are “part of a treatment protocol,” finding that such steps are transformative and not merely for the purpose of gathering data. The appellate panel concluded that the claims at issue were drawn to a particular practical application of a natural phenomenon, not the natural law itself. It further agreed with Prometheus that the claims involve a particular transformation of a patient's body and bodily sample and recite specific means of treating specific diseases with specific drugs.
In June 2011, Mayo’s second petition for certiorari was granted, and in December, oral arguments were held.
The court focused on the fact that the process tells doctors interested in the subject about the correlations that the researchers discovered. In doing so, it recites an ‘administering’ step, a ‘determining’ step, and a ‘wherein’ step. The court found that these additional steps are not themselves natural laws but neither are they sufficient to transform the nature of the claim.”
However, methods for determining metabolite levels were “well known” among those skilled in the art for “scientists routinely measured metabolites as part of their investigations into the relationships between metabolite levels and efficacy and toxicity of thiopurine compounds.”
“Thus, this step tells doctors to engage in well-understood, routine, conventional activity previously engaged in by scientists who work in the field. Purely ‘conventional or obvious’ ‘[pre]-solution activity’ is normally not sufficient to transform an unpatentable law of nature into a patent-eligible application of such a law,” the court said, citing Parker v. Flook (437 U.S. 584, 590 [1978]).
“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. . . . Anyone who wants to make use of these laws must first administer a thiopurine drug and measure the resulting metabolite concentrations, and so the combination amounts to nothing significantly more than an instruction to doctors to apply the applicable laws when treating their patients,” the high court concluded.
Later in the ruling, the court clarified that it would not decide whether, were the steps at issue “less conventional,” the features would prove sufficient for invalidation.
This is a disappointing decision for those working in the medical diagnostics field. Presumably, it is insufficient to create a novel pharmaceutical, then create a test to ensure that those patients taken the drug take it in a safe and effective manner. If the pharmaceutical composition is novel and non--obvious a new use of such drug should be patent eligible as well. See In re Ochiai.