Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. __ (2012)

It’s not that I despise mayonnaise or fear saturated fat; I just like less of the white goo than most teenage burger jockeys like to apply.  I must admit, however, that the Supreme Court’s sticky ruling in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. __ (2012), gave me indigestion.

In Greek mythology, Prometheus, brother of Atlas and champion of mankind, stole fire from Zeus and gave it to the mortals.  For this, Zeus punished Prometheus by binding him to a boulder and commanding an eagle to devour his liver.  Each day, the liver grew back, and each day, the eagle returned for another meal.  The haunting image is preserved in Jacob Jordaens’s seventeenth century painting.  Hmm . . .  Compared with raw liver, the burgers with mayo don’t seem so bad.

The Supreme Court’s punishment of Prometheus Laboratories (and fans of personalized medicine everywhere), though somewhat less spectacular than the one dished out by Zeus, hardly seems like just desserts.  On March 20, the Court ruled unanimously that Prometheus’s patent claims to a diagnostic method for determining how best to administer a thiopurine drug to treat an autoimmune disease fails to claim patent-eligible subject matter under 35 U.S.C. § 101.  According to the Court, Prometheus’s claim is an attempt to pre-empt “laws of nature,” which Section 101 excludes from its ambit.  Thus, for example, we all learned that Newton could not patent gravity, and Einstein (despite being a former patent examiner) could not patent E=mc2.

Justice Breyer wrote that the relationships between concentrations of certain metabolites in the blood and the likelihood that a thiopurine drug dosage will prove ineffective or harmful are essentially “laws of nature.”  For Prometheus’s claimed process to be patentable, “additional features that provide practical assurance that the processes are genuine applications of those laws rather than drafting efforts designed to monopolize the correlations” are needed.  The Court analyzed each step of the claimed process and concluded that each was insufficient to “transform the nature of the claims” from merely reciting natural laws.

The Court assured us that controlling precedents reinforce its conclusion.  Thus, in Diamond v. Diehr, 450 U.S. 175 (1981), the claim was patentable because of additional steps that integrated the otherwise unpatentable Arrhenius equation into a process for molding uncured rubber.  In Parker v. Flook, 437 U.S. 584 (1978), an algorithm was used to recalculate alarm limits for temperature, pressure, or flow rates in a hydrocarbon conversion process.  Finding no “inventive concept,” the Court wrote in Flook that “post-solution activity” that is conventional or obvious will not “transform an unpatentable priniciple into a patentable process.”  The Court concluded that Prometheus’s claim more closely fit the facts of Flook.

While the Supreme Court acknowledged that the “laws of nature at issue here are narrow laws that may have limited applications,” it worried that patent law might “inhibit further discovery by improperly tying up the future use of laws of nature.”  It perceived an “acute” danger when a patented process “amounts to no more than an instruction to ‘apply the natural law,’ or otherwise forecloses more future invention than the underlying discovery could reasonably justify.”  Prometheus wept.  So did the Federal Circuit.

The Supreme Court afforded little deference to the patent law experts at the Federal Circuit (CAFC), which had reversed a district court’s grant of summary judgment in favor of Mayo.  Earlier, the CAFC held that the Prometheus patents satisfied its “machine or transformation” (MOT) test.  The Supreme Court vacated the judgment and remanded to the CAFC to reconsider in light of Bilski v. Kappos, 561 U.S. __ (2010), which limited the MOT test.  On remand, the CAFC reaffirmed its earlier view, deciding that the claims did not “encompass laws of nature or preempt natural correlations.”  The CAFC held that the Prometheus patents were valid because a method of treatment to “ameliorate the effects of an undesired condition” is “always transformative.”  However, the Supreme Court disagreed–again.

Perhaps the most troubling aspect of the Supreme Court’s latest reversal is its apparent rejection of the idea that Section 101 is “only a threshold test.”  In Bilski, Justice Kennedy wrote:

Even if an invention qualifies as a process, machine, manufacture, or composition of matter, in order to receive the Patent Act’s protection the claimed invention must also satisfy the “conditions and requirements of this title.”  § 101.  Those requirements include that the invention must be novel, see § 102, nonobvious, see § 103, and fully and particularly described, see § 112.

What could be clearer?  In recent decisions, the CAFC amplified the distinction between § 101, a “coarse eligibility filter” that identifies broad categories of potentially patentable subject matter, and §§ 102, 103, and 112, which deal with substantive patentability (see Classen Immunotherapies, Inc. v. Biogen IDEC, Fed. Cir., 2011; Ultramercial, LLC v. Hulu, LLC, Fed. Cir., 2011; and Research Corp. Techs, Inc. v. Microsoft Corp., Fed. Cir., 2010).

The Mayo opinion brims with concerns that are the proper purview of Sections 102 or 103.  Some examples:  Introduction, p. 4: “In particular, the steps in the claimed processes (apart from the natural laws themselves) involve well-understood, routine, conventional activity previously engaged in by researchers in the field.”  Take your pick: it’s at least a 103 problem, maybe a 102.  Part IA, p. 4: “At the time the discoveries embodied in the patents were made, scientists already understood that the levels in a patient’s blood of certain metabolites . . . were correlated with the likelihood that a particular dosage of a thiopurine drug would cause harm or prove ineffective.”  Still a 102/103 issue?  Part B1, p. 13:  “The claim before us presents a case for patentability that is weaker than the (patent-eligible) claim in Diehr and no stronger than the (unpatentable) claim in Flook.”  Sounds like Section 102/103 analysis to me.  In Section IIA, the Court strips out the “law of nature” contained in the Prometheus claim and disses the leftovers (“What else is there in the claims before us?”)  In short, the Court criticizes the substantive patentable merit of the Prometheus claims.  While that may well have been justified, the analysis belongs in a Section 102 or 103 case.  (Of course, if the issue here was “merely” Section 103, the Court wouldn’t have considered the case interesting enough to grant cert.)

How many dozens of similar patents have been granted where the case for substantive patentability under Sections 102 and 103 was stronger?  How many licensees of those patents will demand to renegotiate more favorable terms or challenge licensed patents based on invalidity under Section 101?  How many other fact patterns will now support an invalidity argument based on a “law of nature” usurpation theory?  Many reactions in organic chemistry utilize Coulomb’s Law (opposite charges attract).  Do I risk unwittingly tying up this natural law when I claim, e.g., a process in which a Grignard reagent adds to a ketone?  Shouldn’t we be concerned, given the unanimous holding in Mayo, that (to quote the Court) “too broad an interpretation of this exclusionary principle could eviscerate patent law”?  Only time will tell what damage the Court hath wrought.  For now at least, and until further notice, I’m avoiding raw meat and holding the mayo.


 -Jon Schuchardt

This article is for informational purposes, is not intended to constitute legal advice, and may be considered advertising under applicable state laws.  The opinions expressed in this article are those of the author only and are not necessarily shared by Dilworth IP, its other attorneys, agents, or staff, or its clients.