WASHINGTON, D.C.—In a case that is likely to have importantramifications for companion diagnostics and personalized medicine, the U.S.Supreme Court on Dec. 7 is set to hear oral arguments in the case of MayoCollaborative Services v. Prometheus Laboratories.
The high-profile dispute centers on the question of whetherlaws of nature and/or abstract ideas can be patented. At issue in this matteris a Prometheus patent on a method that assists doctors in figuring outeffective dosing of immunosuppressive drugs for patients based on varyinglevels of the drug's metabolic products as confirmed by tests with a Prometheuspatented kit. Prometheus has sued Mayo for infringement of this patent, andMayo has claimed that the patents involve a natural occurring phenomenon—thebody's reaction to dosing levels—and should therefore be nullified.
In its appeal, Mayo states that no patent should be issuedon observations of how varying a dosage of a medicine alters a patient'ssubjective reactions. Those kinds of observations are what doctors doroutinely, the Mayo group has contended, and bottling up that process insomeone's exclusive patent rights would stifle normal medical practice, andforce doctors to spend time looking in legal files to see if they are infringing.
Prometheus sued the Mayo Clinic and its affiliates,contending they were using the kits in violation of Prometheus' patent rights.Mayo at one point had a plan to produce its own kits, but after being sued forinfringement, it held off. Prometheus ultimately won in the Circuit Court, in afinding that the company's invention had satisfied that court's "machine ortransformation" test for patent eligibility. The Mayo group failed in thatcourt on its argument that the test was nothing more than observing a naturalphenomenon—something that ordinarily is not patentable.
In Bilski, et al., v. Kappos, the Supreme Court affirmed the use of the Federal Circuit Court's"machine-or-transformation" test as one test for patentability ofprocesses, but held that it is not the only test for patentability under 35U.S.C. §101. The term "process" was intended to be broadly defined with only alimited number of exceptions, such as the laws of nature, physical phenomena,and abstract ideas. While acknowledging that the"machine-or-transformation" test is a valid test for determiningwhether processes are patentable subject matter under §101, the court left openthe possibility for new tests to be defined to determine whether businessmethods and other processes are patentable.
While other processes such as proprietary software,analytical techniques and the like were not covered by the court's decision,these processes will presumably be subjected to the"machine-or-transformation" test or others that the court may decideto use to determine patentability.
After Mayo had lost to Prometheus in a closely similardispute in the Federal Circuit in 2009, it took its case to the Supreme Court.After the Court ruled in Bilski v. Kappos inJune last year, overturning the Circuit Court's singular reliance on themachine-or-transformation test of patent eligibility, the justices sent theMayo case back to that tribunal for a second look and the Circuit Court onceagain upheld Prometheus's patents saying that the patents were valid as a formof transformation, since the test measured the change in the body chemistry ofa patient after being given varying dosages of immune-suppressing drugs.
Dr. Michael Shuster, co-chair of the life sciences group atthe law firm Fenwick & West, has filed an amicus curiae brief on behalf of the National Venture CapitalAssociation in support of Prometheus' claims. He notes that the patent claimsare "very specific, not preemptive." In other words, no generalized ruling issought that might apply to other, similar patent claims. From an economicperspective, Shuster points out that a ruling in favor of Mayo would put allcompanion diagnostics in danger, setting off a chain reaction that mightplausibly result in the movement of such testing offshore and a loss ofcompetitiveness for the United States.
In its brief, the American Civil Liberties Union (ACLU)predictably takes the opposite tack. Noting that Prometheus' patent is based onthe correlation between drug dosage and metabolite blood levels, the ACLUargues that this correlation is not patentable because it represents anabstract idea and, further, that the First Amendment would prohibit the patentclaim because it attempts to license pure thought.
Soon enough, the Supreme Court will let us know which sidewill prevail.