High Court Sides With Petitioner In Patent Dispute Over Treatment Protocols

WASHINGTON, D.C. - (Mealey's) The U.S. Supreme Court on March 20 held that processes claimed by a patent that recites laws of nature are not patentable absent additional features providing "practical assurance" that the processes are genuine applications of those laws, rather than a drafting effort "designed to monopolize the correlations" (Mayo Collaborative Services et al. v. Prometheus Laboratories Inc., No. 10-1150, U.S. Sup.). 

(Decision. Document #16-120402-005Z.)

Justice Stephen Breyer, writing for the unanimous court, reversed a 2010 ruling by the Federal Circuit U.S. Court of Appeals that respondent Prometheus Laboratories Inc.'s medical treatment claims are patentable, siding instead with petitioners Mayo Collaborative Services and Mayo Medical Laboratories (Mayo, collectively). 

"The 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 high court concluded. 

At issue in the dispute between Mayo and Prometheus is a patented method for determining the proper dosage of thiopurine drugs commonly used to treat gastrointestinal and autoimmune disorders.  Because thiopurine is potentially harmful when administered in large doses and because each individual possesses a unique threshold for thiopurine exposure, patent licensee Prometheus sells a "Pro-Predict" test kit to measure metabolites that naturally occur when the drug is internally converted by a patient's chemistry.

The Mayo parties purchased and used Pro-Predict before announcing in 2004 their intent to sell a competing test.  Prometheus responded by filing the instant lawsuit in the U.S. District Court for the Southern District of California, and Mayo counterclaimed for declaratory relief of noninfringement and patent invalidity.  On cross-motions for summary judgment, the District Court granted Mayo's motion to invalidate the patents under 35 U.S. Code Section 101.  The District Court held that Mayo's test literally infringed but that the patents' steps of administering the drug and measuring the metabolite levels impermissibly claim natural phenomena - the correlation between thiopurine drug metabolite levels and efficacy and toxicity that resulted from a natural body process.

 On appeal, the Federal Circuit reversed the ruling after applying 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]) [enhanced version available to lexis.com subscribers], 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 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 high court said as an initial matter that a patent "could not simply recite a law of nature and then add the instruction 'apply the law'" and expect federal protection.   

"Einstein, we assume, could not have patented his famous law by claiming a process consisting of simply telling linear accelerator operators to refer to the law to determine how much energy an amount of mass has produced (or vice versa).  Nor could Archimedes have secured a patent for his famous principle of flotation by claiming a process consisting of simply telling boat builders to refer to that principle in order to determine whether an object will float," the court continued. 

"What else is there in the claims before us?  The process that each claim recites 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.  These additional steps are not themselves natural laws but neither are they sufficient to transform the nature of the claim," the high court held. 

Addressing each step in detail, the Supreme Court deemed the administering step a reference to the relevant audience - doctors who treat patients with diseases requiring thiopurine drug therapy.  The wherein step "simply tells the doctor about the relevant natural laws," according to the court, while the determining step tells the doctor to determine the level of the relevant metabolites in the blood.  However, methods for determining metabolite levels were "well known" among those skilled in the art, the high court noted, 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]) [enhanced version]. 

"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.   

"The presence here of the basic underlying concern that these patents tie up too much future use of laws of nature simply reinforces our conclusion that the processes described in the patents are not patent eligible, while eliminating any temptation to depart from case law precedent," it said. 

The Mayo parties are represented by Stephen M. Shapiro, Timothy S. Bishop and Jeffrey W. Sarles of Mayer Brown in Chicago; Charles Rothfeld of Mayer Brown in Washington; Jonathan Singer, John Dragseth and Deanna Reichel of Fish & Richardson in Minneapolis; Eugene Volokh in Los Angeles; and Joseph M. Colaiano and James A. Rogers III of Mayo Clinic in Rochester, Minn.  Richard P. Bress, J. Scott Ballenger, Maximilian A. Grant, Matthew J. Moore and Gabriel K. Bell of Latham & Watkins in Washington represent Prometheus. 

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