Today, in Prometheus Laboratories, Inc. v. Mayo Collaborative Services, No. 2008-1403 (Fed. Cir. 2010), the Federal Circuit affirmed that personalized medicine and medical diagnostic claims are not per se unpatentable for claiming natural phenomena. The Court’s opinion provides guidance on the post-Bilski application of patent-eligibility requirements to claims that define the relationship between a treatment or drug regimen to the presence or absence of a patient-specific clinical marker (in this case, a metabolite of the administered drug).
The patent-eligibility of such claims has been in question since the Supreme Court’s dismissal of the grant of certiorari in Laboratory Corp. of American Holdings v. Metabolite Labs., Inc., 548 U.S. 124 (2006). Supreme Court Justice Breyer dissented from the dismissal and wrote a non-binding opinion that “detecting” and “correlating” claims were not patent-eligible. More recently, the Supreme Court decision to vacate and remand the Federal Circuit’s 2009 Prometheus decision in view of its decision in Bilski v. Kappos, 130 S.Ct. 3218 (2010), fueled speculation that the patent-eligibility of such methods might not survive scrutiny under Bilski.
The Claims at Issue
Representative claims at issue in Prometheus relate to methods of optimizing the therapeutic efficacy of treatment of an immune-mediated gastrointestinal disorder that involves (a) administering a drug providing 6-thioguanine to a subject and (b) determining a level of 6-thioguanine in the subject, where the determined level is indicative of a need to increase or decrease dosing. Other claims do not recite the administering step, but still recite a determining step.
In its original 2009 decision, the Federal Circuit applied its machine-or-transformation test for patent-eligibility and held that the method claims satisfied § 101 by meeting the “transformation” prong of the test. As noted by the Federal Circuit, the “asserted claims are in effect claims to methods of treatment, which are always transformative when a defined group of drugs is administered to the body to ameliorate the effects of an undesired condition.” With regard to “determining” claims without a treatment step, the Federal Circuit held that methods of determining metabolite levels also are transformative because the levels “cannot be determined by mere inspection.”
The Second Time Around
In Bilski, the Supreme Court held that the machine-or-transformation test is not the “only” way to evaluate compliance with § 101, although it can be a useful clue or tool for analyzing § 101 compliance. On remand, Prometheus argued that its claims should be found to be patent-eligible because the Supreme Court did not invalidate the machine-or-transformation test, while Mayo argued that the claims do not satisfy § 101 because they preempt all practical uses of a natural phenomenon.
The Court began its analysis by noting that the Supreme Court has consistently construed § 101 broadly, in accord with congressional intent, as reflected in the “expansive terms” used in the statute. The Court nevertheless acknowledged that § 101 is not unlimited, because Supreme Court precedent provides three specific exceptions to § 101’s broad patent-eligibility principles: “laws of nature, physical phenomena, and abstract ideas.” Still, the Court explained, “an application of a law of nature or mathematical formula to a known structure or process may well be deserving of patent protection.” Against this background, the Federal Circuit characterized the issue on remand as “whether Prometheus’s asserted claims are drawn to a natural phenomenon, the patenting of which would entirely preempt its use … or … only to a particular application of that phenomenon,” which would be patent-eligible.
The Court rejected Mayo’s argument that the Supreme Court’s Bilksi decision or its remand of this case required a “wholly different analysis of a different result.” To the contrary, the Court stated that the Supreme Court’s Bilksi decision “did not undermine our preemption analysis” and “did not disavow the machine-or-transformation test.”
Thus, the Federal Circuit again upheld the claims, finding that they “recite a patent-eligible application of naturally occurring correlations between a metabolite levels and efficacy or toxicity, and thus do not wholly preempt all uses of the recited correlations.” The Court reasoned that claims relating to administering specific drugs and measuring specific metabolites do not preempt all uses of natural correlations, but rather utilize them in a series of specific steps relating to particular methods of treatment.
The Court pointed out that the purpose of the claims was to treat the human body (which was made clear in the specification and preambles of the asserted claims) and emphasized that the fact that the treatment relies on natural processes of the human body (e.g., conversion of the administered drug into a metabolite) does not disqualify the treatment step from patentability.
The Court separately addressed the “determining” claims that do not recite a treatment or administration step. The Court held that the omission of the treatment step does not diminish patentability because the determining step also is transformative because some form of manipulation of the patient sample is required. As the Court noted in its 2009 decision and stated again here, “at the end of the process, the human blood sample is no longer human blood; human tissue is no longer human tissue.”
Consistent with its 2009 decision, the Court explained that the “wherein” clauses of the claims are not fatal to patent-eligibility, even though they involve “a subsequent mental step.” To the contrary, the Court emphasized that, “when viewed in the proposer context the final step of providing a warning based on the results of the prior steps does not detract from the patentability of Prometheus’s claimed methods as a whole.”
The Court concluded by characterizing Prometheus’s invention as “a series of transformative steps that optimizes efficacy and reduces toxicity of a method of treatment for particular diseases using particular drugs.” As such, the claims “pass muster under § 101.”
No News Is Good News?
By standing by its original decision and analysis, the Federal Circuit returns a level of certainty to the field of personalized medicine and medical diagnostic claims that has been lacking since the Supreme Court vacated and remanded the 2009 Prometheus decision. Now, companies innovating and practicing in these fields know that patent claims are likely to be upheld against § 101 challenges if they satisfy the machine-or-transformation test and can be fairly characterized as being directed to a specific application of a naturally occurring correlation. This certainty may be short-lived, however, if Mayo decides to petition for rehearing or rehearing en banc, or petitions the Supreme Court for certiorari.
With the controversial ACLU v. Myriad (BRACA I) case also pending at the Federal Circuit, the Court will have another opportunity to address and decide many important issues surrounding the patent eligibility of diagnostic and personalized medicine methods.
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