Mayo Collaborative Services v. Prometheus Laboratories at the Supreme Court: Oral Argument Tomorrow

By Kevin E. Noonan --

Tomorrow, the U.S. Supreme Court will hear oral argument in Mayo Collaborative Services v. Prometheus Laboratories, Inc.  The case represents the "other side" of the current foment regarding patent eligibility for methods and reagents related to what can broadly be termed "life sciences" patenting (the other, of course, being the "Myriad gene patenting" case, AMP v. USPTO).  And at least some of the frisson that attends this case is the position taken by Justice Breyer (joined by departed Justices Stephens and Souter) in yet another case, Laboratory Corp. of America Holdings ("LabCorp") v. Metabolite Laboratories, Inc., that indicated a disquiet with patent claims that impinge those Justices' concept of medical practice.

As a reminder, the case involves claims directed to methods for determining whether an effective amount of a drug is being administered to a patient.  The claims of the patents-in-suit (U.S. Patent Nos. 6,355,623 and 6,680,302) were held invalid by the District Court as being outside the scope of patent-eligible subject matter under 35 U.S.C. § 101, based on its application of the "machine or transformation" test enunciated in In re Bilski.  These claims included claims that affirmatively recited an "administrative" step, exemplified by Claim 1 of the '623 patent:

1.  A method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder, comprising:
    (a)  administering a drug providing 6-thioguanine to a subject having said immune-mediated gastrointestinal disorder; and

    (b)  determining the level of 6-thioguanine in said subject having said immune-mediated gastrointestinal disorder,

    wherein the level of 6-thioguanine less than about 230 pmol per 8x10⁸ red blood cells indicates a need to increase the amount of said drug subsequently administered to said subject and

    wherein the level of 6-thioguanine greater than about 400 pmol per 8x10⁸ red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.

and claims that did not recite such a step, exemplified by Claim 46 of the '302 patent:

46.  A method of optimizing therapeutic efficacy and reducing toxicity associated with treatment of an immune-mediated gastrointestinal disorder, comprising:
    (a)  determining the level of 6-thioguanine or 6-methylmercaptopurine in a subject administered a drug selected from the group consisting of 6-mercaptopurine, azathiop[u]rine, 6-thioguanine, and 6-methyl-mercaptoriboside, said subject having said immune-mediated gastrointestinal disorder,
    wherein the level of 6-thioguanine less than about 230 pmol per 8x10⁸ red blood cells indicates a need to increase the[] amount of said drug subsequently administered to said subject, and
    wherein the level of 6-thioguanine greater than about 400 pmol per 8x10⁸ red blood cells or a level of 6-methylmercaptopurine greater than about 7000 pmol per 8x10⁸ red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.

The Federal Circuit reversed, in turn this decision being reversed on petition for certiorari and remanded from the Supreme Court for consideration in view of the Supreme Court's intervening decision in Bilski v. Kappos.  The Federal Circuit again reversed the District Court, finding that the claims recited sufficiently transformative steps that they satisfied the Bilski "machine or transformation" test.  The Court rejected the District Court's characterization that the claims consisted of three steps:  (1) administering the drug to a subject, (2) determining metabolite levels, and (3) being warned that an adjustment in dosage may be required, wherein the first two steps were "data-gathering," leaving the third step as merely an unpatentable mental step, comprising the correlation, because no step requiring a change in administered dose.  The Court agreed that the last (comparison) step was a mental step, but maintained (as it had in the original opinion) that this by itself cannot provide legitimate grounds for invalidating the claims (because the claims must be considered in their entirety).

Review by the Supreme Court will test the panel's understanding of Bilski to have rejected the machine-or-transformation test as the "sole, definitive test," and to have "declined to adopt any categorical rules outside the well-established exceptions for laws of nature, physical phenomena, and abstract ideas, and resolved the case based on its decisions in Gottschalk v. Benson, 409 U.S. 63 (1972), Parker v. Flook, 437 U.S. 584 (1978), and Diamond v. Diehr, 450 U.S. 175 (1981)."  The Federal Circuit interpreted the entirety of Supreme Court precedent on patent eligibility to construe patent-eligibility broadly, limiting eligibility to exclude only laws of nature, physical phenomena, and abstract idea (based, the panel suggested, on historical precedent extending back to the 19th century; Le Roy v. Tatham, 55 U.S. (14 How.) 156, 174-75 (1853), continuing in the Court's most recent opinion on this issue (Bilski).  The panel also distinguished between finding patent eligible laws of nature, physical phenomena, and abstract ideas with finding specific applications thereof.  The Federal Circuit put this dichotomy expressly: do the Prometheus claims recite and preempt a natural phenomenon, alá Benson and Flook, or are they merely a particular application thereof, alá Diehr?  The Supreme Court's answer to this question should help flesh out the extent to which the Court is willing to permit the Federal Citcuit to interpret its precedent (as opposed to slavishly following it).

Of course, it is just as likely that the Court's attention will be distracted by the "practice of medicine" argument.  There is precedent for letting the political branch, Congress, make this decision:  almost a generation ago, 35 U.S.C. § 287(c) exempted from infringement liability the practice of surgical methods by doctors.  This remedy may be less apt in this instance, however, since the practice of many such methods is performed not by doctors but by medical laboratories (which are expressly exempted from the scope of § 287(c)).

Patent Docs will report on oral argument, and on selective portions of the parties' briefs and amici, in later posts.

Comments

[EG]

Kevin,

What will be interesting at the oral argument tomorrow is whether the Justices (other than Breyer) give any credance to Breyer's dissent in LabCorps v. Metabolite. In my opinion, Mayo and the other "naysayers" are putting way too much emphasis on that dissent (given that two of the Justices who joined that dissent are no longer with the Supreme Court). But we'll see what happens tomorrow, as we wait anxiously to see if we get "clarity" (like in Diamond v. Chakrabarty) as opposed to "fuzziness" (like in Bilski v. Kappos) on the standard for patent-eligibility

[JV]

"almost a generation ago, 35 U.S.C. § 287(c) exempted from infringement the practice of surgical methods by doctors."

If I read this section correctly, the law does not "exempt from infringement" but blocks one from pursuing a remedy, injunction, damages and attorney fees. The medical practitioner could still be infringing.

Nevertheless, we await clarity on patent-eligibility.

[step back]

argument transcript:
http://www.supremecourt.gov/oral_arguments/argument_transcripts/10-1150.pdf