CPLRG™ 0079 - Mayo Collaborative Services v. Prometheus Laboratories, Inc. - Mar. 20, 2012

Mayo Collaborative Services v. Prometheus Laboratories, Inc., 132 S. Ct. 1289 (2012) (Breyer, J. for unanimous Court).  For the slip opinion, click here: Mayo03202012.USSC

SUMMARY:  CLAIM TO “LAW OF NATURE”; PROCESS STEPS NOT SUFFICIENT TO TRANSFORM CLAIM INTO A PATENT-ELIGIBLE APPLICATION OF A LAW OF NATURE; WELL-UNDERSTOOD, ROUTINE, CONVENTIONAL STEPS PREVIOUSLY USED BY RESEARCHERS IN FIELD; CLAIM TYING UP USE OF UNDERLYING NATURAL LAW AND INHIBITING ITS USE FOR FURTHER DISCOVERY. A patent concerned thiopurine drugs, which are used to treat immune-mediated gastrointestinal disorders. When a thiopurine drug is administered to a patient with the disorder, the patient develops metabolites, including G-TG and 6-MMP. The patent reports the named inventors’ discovery of precise correlations between the level of the metabolites in the patient’s blood and the drug’s efficacy and toxicity. The correlations are useful to physicians for adjusting the drug dosage up or down for a particular patient. The claim at issue recites two steps: (1) administering the drug to a patient with an immune-mediated gastrointestinal disorder and (2) determining the level of the 6-TG metabolite, together with two “wherein” clauses, which recite that a concentration below one specified level (230 pmol) “indicate[s] a need to increase” drug dosage and a concentration above another level (400 pmol) indicates a need to decrease the dosage. A district court held the claim invalid as a “law of nature. The Federal Circuit reversed. HELD: the Federal Circuit erred. The claim is invalid as drawn to a “law of nature,” that is, the relationship between metabolite concentration in blood and thiopurine drug efficacy and toxicity. The recited steps of administering the drug, determining the metabolite level together with the “wherein” indications of a need for dosage adjustment, do not transform the claim into a patent-eligible application of a law of nature because (1) “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,” and (2) “upholding the patents would risk disproportionately tying up the use of the underlying natural laws, inhibiting their use in the making of further discoveries.”

COMMENTARY.  For a critical commentary on Mayo, see below.CRITIQUE: WEAK POINTS IN BASIC FRAMEWORK OF MAYO.

On reading the Mayo opinion, several “weak points” in the basic framework that it prescribes came immediately to my mind.

1.. Basic Framework:  Three Determinations to Implement a Principle
.   Mayo‘s basic framework for a Section 101 patent eligible subject matter analysis can be roughly described as involving three determinations that implement a basic principle.

The basic principle is that one cannot patent a “law of nature”, “natural phenomenon,” or “abstract idea”, as such, but one can patent such a law, phenomenon, or idea as applied.  The line to be drawn is at the point at which there is an “application” of the law, phenomenon or idea.  It is not enough to add to a claim to a law, phenomenon or idea the admonition: “apply it.” And the ban on patenting laws, phenomena, and ideas cannot be avoided by clever claim drafting.  Further, for policy reasons, one cannot claim applications of laws, phenomena and ideas so broadly as to unreasonably inhibit their subsequent development by others.

The three steps for implementing the principle are as follows.

*First, one determines whether a claim is drawn to a law of nature, natural phenomenon, or abstract idea.

*Second, one determines whether the claim adds steps that are more than “well-understood, routine, conventional activity previously engaged in by researchers in the field.”

*Third, one determines whether the claim “risk[s] disproportionately tying up the use of the underlying natural laws, inhibiting their use in the making of further discoveries.”

2. No Definition of “Law of Nature.” A glaring weak point in Mayo is the Court’s failure to define what constitutes a “law of nature.”  The absence of a definition is reflected in the Court’s rather summary determination that the claims at issue did involve such a “law of nature.”  The Court determined that the claimed correlations between the metabolites a human’s body produced in reaction to administration of a thiopurine drug and the drug’s effectiveness and toxicity were laws of nature because the correlations resulted from the way the body metabolizes the drugs.  However, the drugs themselves were, presumably, invented by humans and did not exist in nature.  Correspondingly, the specific metabolites presumably never existed in nature until the drugs were invented and administered to humans.

Although not an issue in the case, the continued, unanalyzed assumption that an “algorithm” is the same as a “law of nature” is analytically wrong and can lead to erroneous conclusions.  An algorithm, by proper definition, is the essence of a “process,” that is, a specific, step-by-step, repeatable series of steps that solves a problem.  Ironically, case law holds that in some instances a patent applicant must include an algorithm in order to provide specific “structure” to support computer-related claims drafted in function terms.  See, e.g., Rembrandt Data Technologies, LP v. AOL, LLC, 641 F.3d 1331 (Fed. Cir. 2011).

3.  What is “Conventional Activity”?  Standards of Novelty and Obviousness; Law or Fact?
Another weak point that many will identify in Mayo‘s analytic framework is the concept of  “well-understood, routine, conventional activity previously engaged in by researchers in the field.”  The argument will be that the Court inappropriately intermixes considerations of novelty and unobviousness over the prior art (Section 102 and Section 103) with the issue of patent eligible subject matter under Section 101.  However, in fairness to the Court, there can be a meaningful distinction between (1) added steps that are merely technically in the prior art for Section 102 and 103 purposes, and (2) added steps that are truly well-known, conventional, and routine.  The former might include a single description in an obscure prior art reference; the latter would not.

The Court did not address the extent to which the “conventional” step determination entails fact questions.  Case law has tended to treat Section 101 patent eligibility as purely a question of law.  In Mayo, the Court could avoid any issue whether added steps were conventional by pointing to statements in the patent itself.  In other situations, what is “well-known, conventional, and routine” will not be so clear, and, indeed, may be disputed by a patent owner or validity challenger, or, during examination, by an examiner.

4. How to Apply Third Determination, That is, Disproportionate Tying Up of Natural Law Inhibiting Innovation. A serious weak point resides in the Court’s apparent requirement that a claim may be patent ineligible if it is so broad as to “disproportionately tie up” (preempt) a natural law or idea so as to dampen further research, development and innovation.  The Court discusses policy considerations supporting such a requirement.  However, the requirement seemingly entails a court (or even a patent examiner) engaging in a subjective and imprecise value assessment of the contribution an inventor has made and then comparing that value to the scope of the claim (and its value).  This is the type of qualitative inquiry that patent law has, historically, avoided and for good reason: such an inquiry is subjective and overly dependent on the predispositions of particular decision makers (patent examiners and judges).  It adds unpredictability, which in turn taxes investment in innovation and in business generally.  Some predictability is inevitable in a complex system, such as that of patent law, but legal rules should be fastened with a sharp eye toward the question: can a proposed standard, test or rule be implemented by the necessary decision makers in a reasonably objective (and, therefore, predictable) fashion?  The Mayo “disproportionately tie up” requirement does not pass muster.

Here is the Court’s explanation:

“[E]ven though rewarding with patents those who discover new laws of nature and the like might well encourage their discovery, those laws and principles, considered generally, are `the basic tools of scientific and technological work.’ [Gottschalk v. Benson, 409 U.S. 63, 67 (1972)].  And so there is a danger that the grant of patents that tie up their use will inhibit future innovation premised upon them, a danger that becomes acute 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.”

How is a judge or an examiner to assess whether a “discovery” “reasonably justif[ies” a certain amount of “foreclosure” (that is, a claim for broad scope)?

The Court further confuses matters by specifically rejecting the patent owner’s argument that any concern with preemption is avoided when the “law of nature” and the claim at issue are narrow and specific, as were the claims at issue.  The Court rejects the patent owner’s argument because it would require the courts to “draw distinctions among laws of nature based on whether or not they will interfere significantly with innovation in other fields now or in the future.”  The Court notes that (1) “Courts and judges are not institutionally well suited to making the kinds of judgments needed to distinguish among different laws of nature,” and (2) “the cases have endorsed a bright-line prohibition against patenting laws of nature, mathematical formulas and the like, which serves as a somewhat more easily administered proxy for the underlying `building-block’ concern.”

The irony and inconsistency in the Court’s reasoning on this point is palpable.  It already directed an inquiry into matters such as what an “underlying discovery could reasonable justify.”  It then dismissed a quite similar inquiry into distinguishing broad and narrow “laws of nature” and claims as ones for which courts are “not institutionally well suited.”

Problems with the Court’s “disproportionate tie-up” analysis could be avoided by interpreting Mayo as requiring only an inquiry into whether added steps are “well-understood, routine, conventional activity.”  The “disproportionate tie-up” language in Mayo can be interpreted, in context, as only offering a policy rationale for the holding that conventional application steps do not rescue a claim otherwise unpatentable as drawn to a law of nature.  This interpretation is supported by the Court’s language, which assumes that the exceptions to Section 101 are a “bright-line prohibition.”

5. Effect on PTO and Examination.
Another weakpoint is the Supreme Court’s failure to consider seriously what its framework is practical and workable in the context of PTO examination.

In part out of concern about that question, the United States government in an amicus brief in Mayo urged that Section 101 be confined to claims that are to laws of nature as such and that further screening of broad claims be through application of the traditional standards of novelty (Section 102), obviousness (Section 103), and full disclosure (Section 112).  Those standards may be better understood by patent examiners.  Unfortunately, the Court rejected the argument.  The Court may not have sufficiently understood how Section 112 can be used to reject broad claims that are not sufficiently supported when it stated:

“Section 112 requires only a `written description of the invention … in such full, clear, concise, and exact terms as to enable any person skilled in the art … to make and use the same.’  It does not focus on the possibility that a law of nature (or its equivalent) that meets these conditions will nonetheless create the kind of risk that underlies the law of nature exception, namely the risk that a patent on the law would significantly impede future innovation.”

Indicative of the problems the PTO may face in having its examiners apply Mayo is a memorandum by the PTO’s Associate Commissioner for Patent Examination Policy issued the day after the decision, providing “preliminary guidance to the Patent Examining Corps. The memorandum noted:

“As part of a complete analysis under 35 U.S.C. § 101, examiners should continue to examine patent applications for compliance with section 101 using the existing Interim Bilski Guidance issued July 27, 2010, factoring in the additional considerations below. The Interim Bilski Guidance directs examiners to weigh factors in favor of and against eligibility and reminds examiners that, while the machine-or-transformation test is an investigative tool, it is not the sole or a determinative test for deciding whether an invention is patent-eligible.
“Examiners must continue to ensure that claims, particularly process claims, are not directed to an exception to eligibility such that the claim amounts to a monopoly on the law of nature, natural phenomenon, or abstract idea itself.  In addition, to be patent-eligible, a claim that includes an exception should include other elements or combination of elements such that, in practice, the claimed product or process amounts to significantly more than a law of nature, a natural phenomenon, or an abstract idea with conventional steps specified at a high level of generality appended thereto.
“If a claim is effectively directed to the exception itself (a law of nature, a natural phenomenon, or an abstract idea) and therefore does not meet the eligibility requirements, the examiner should reject the claim under section 101 as being directed to non-statutory subject matter. If a claim is rejected under section 101 on the basis that it is drawn to an exception, the applicant then has the opportunity to explain why the claim is not drawn solely to the exception and point to limitations in the claim that apply the law of nature, natural phenomena or abstract idea.
“The USPTO is continuing to study the decision in Mayo and the body of case law that has evolved since Bilski and is developing further detailed guidance on patent subject matter eligibility under 35 U.S.C. § 101.”  (Emphasis added).

More recently, in early July 2012, the PTO Director Kappos announced a “memorandum to all patent examiners “implementing a new procedure for examining process claims for subject matter eligibility in view of the Supreme Court decision Mayo v. Prometheus.”

“The memorandum explains that this new procedure is intended for analyzing process claims in which a law of nature, natural phenomenon, or naturally occurring relation or correlation is a limiting element or step. This procedure will assist examiners in making the determination of whether a claim is a patent-eligible practical application of a law of nature or whether the claim is effectively drawn to the law of nature itself, like the claims found ineligible by the Supreme Court in Mayo. Along with determining subject matter eligibility in accordance with this new procedure, examiners will complete a full examination of the claims to determine whether the additional patentability requirements are met, such as novelty and non-obviousness in view of the relevant prior art.
This memorandum is designed to focus on examination of claims most directly impacted by the Mayo decision while the courts continue to address eligibility questions in pending cases, such as Assn. for Molecular Pathology v. Myriad Genetics and WildTangent v. Ultramercial. The Office will continue to follow the guidance issued after Bilski v. Kappos for examination of other types of process claims for eligibility, and it is expected that additional guidance will be issued as these pending cases are decided.”

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