Supreme Court Reverses In Prometheus v. Mayo!

In a decision dated March 20, 2012, Justice Breyer writing for a unanimous court, held that claims to administering a drug, followed by measuring the levels of metabolites of the drug, in order to optimize the amount administered, are not patent eligible, because they are attempts to monopolize naturally-occurring correlations. (A copy of the decision is also found at the end of this post.)

The steps that the Fed. Cir. found transformative, namely the “administering step” of the drug and the “determining step” wherein the metabolite levels are measured, were disregarded as “simply telling doctors to engage in a well-understood, routine, conventional activity previously engaged in by scientists in the field,” citing Parker v. Flook. Citing Bilski, Benson and O’Reilly v Morse, the Court concluded:

“Further support for the view that simply appending conventional steps, specified at a high level of generality, to laws of nature, natural phenomena and abstract ideas cannot make those laws, phenomena and ideas patentable.”

The Court bought the argument that patent law can inhibit future discovery by improperly “tying up the use of laws of nature and the like.” Mayo had argued that the claims at issue inhibited research that would improve the assay, e.g., by refining the recited ranges of metabolite levels. But the Court apparently completely ignored those ranges as claim limitations –  and, without the high/low ranges, the claim would likely never have been allowed.

I have not had the time to read the entire text of the decision at this point, and these comments are based on the Syllabus, but the entire patent bar will be left to wonder what, if any, medical diagnostic claims will be patent-eligible in the future. In the Metabolite dissent, Justice Breyer and two other Justices would have invalidated a claim to measuring the level of homocystine in a fluid of a patient and arriving at a diagnosis of colbalamin deficiency, based on comparison of the homocystine level with a benchmark “normal” level.

It is hard to think of a diagnostic assay that does not either detect the +/- presence of a marker (like anti-HIV antibodies) or involve the comparison of the level of a marker of some sort (like homocystine or PSA) with a normal benchmark level. But now, all of these assays seem to have been converted into no more than the discovery of laws of nature. The key phrase in the decision may be “specified at a high level of generality” but I am too shocked by this decision to find any comfort in this “guidance.”


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8 Responses to Supreme Court Reverses In Prometheus v. Mayo!

  1. Robin says:

    The Court used section 103 to make a section 101 ruling.

  2. Pingback: - USSC on unpatentable subject matter

  3. Despondent in Canada says:

    Wow, just wow! Next thing you know they will decide corporations are people and money is speech. Oh wait a second…

  4. Rodney says:

    What Robin said. Not only will this put into question many/all diagnostic claims, it will probably bleed over into nucleic acid claims and possibly proteins, as well as into certain treatments using these types of molecules. Methods for regulating (inhibit or stimulate) a molecule or a metabolic or signal transduction pathway now appear to be closer to falling under the umbrella of natural laws or phenomena.

  5. Pingback: Myriad Revisited – The Consequences of Prometheus Unbound | Biotechnology Patent Law Blog | Patents4Life by Warren Woessner

  6. Robin says:

    I thought restraint was wise until the shock wore off. But the shock is not wearing off, and I think Depondent had it right – WHAT WAS THE S.CT. THINKING! They seem to be trying to ‘fix’ things but they they have no idea of the consequences. Maybe they should take note of precedent before wildly carreening into areas they apparently do not understand.

  7. Donna Ferber says:

    Haven’t read the whole thing or the file history — was that critical range of compound in the red cells a new and nonobvious aspect of the claimed invention? or was the claimed invention really just about the measuring and adjusting dose to stay in a known range?

  8. EG says:

    SCOTUS didn’t even read (or chose to ignore) the binding precedent, Robin. The following quote is taken directly from Diamond v. Diehr. Breyer’s opinion should be “hung, drawn, and quartered” for it does exactly what this quote from Diehr says not to do in an analysis under section 101:

    “In determining the eligibility of respondents’ claimed process for patent protection under 101, their claims must be considered as a whole. It is inappropriate to dissect the claims into old and new elements and then to ignore the presence of the old elements in the analysis. This is particularly true in a process claim because a new combination of steps in a process may be patentable even though all the constituents of the combination were well known and in common use before the combination was made. The ‘novelty’ of any element or steps in a process, or even of the process itself, is of no relevance in determining whether the subject matter of a claim falls within the 101 categories of possibly patentable subject matter.”

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