Mayo Collaborative Services v. Prometheus Laboratories, Inc. (2012)

By Kwame Mensah --

In an opinion published earlier today, the Supreme Court unanimously held that claims directed to the relationship between the concentrations of blood metabolites and response to a therapeutic drug in two patents owned by Prometheus Laboratories, Inc. were unpatentable, stating that they "effectively claim the underlying laws of nature themselves."  This is a reversal of the Federal Circuit's decision, which held that the claims did indeed encompass patentable subject matter.

Prometheus Laboratories, Inc. (Prometheus) is the sole licensee of two patents (U.S. Patent Nos. 6,355,623 and 6,680,302) claiming methods for determining optimal dosages of thiopurine drugs used to treat gastrointestinal and non-gastrointestinal autoimmune diseases.  The patents generally claim methods reciting the steps of:  (a) administering a thiopurine drug to a subject, and (b) determining the levels of the drug or the drug's metabolites in red blood cells in the subject.  The measured metabolite levels are then compared to pre-determined metabolite levels, wherein measured metabolite levels in the patient that are outside the pre-determined range indicate a need to increase or decrease the level of drug to be administered so as to minimize toxicity and maximize treatment efficacy.

The Court sought to determine whether the claims did more than merely describe laws of nature.  It asked specifically, "do the patent claims add enough to their statements of the correlations to allow the processes they describe to qualify as patent-eligible processes that apply natural laws?"  The Court generally focused its analysis on two specific cases:  Diamond v. Diehr, 450 U.S. 175 (1981) (granting claims which encompassed natural phenomena) and Parker v. Flook, 437 U.S. 854 (1978) (invalidating claims encompassing natural phenomena).  In analogizing the Prometheus claims to those in Flook, the Court stated that the steps recited in the claimed method “add nothing specific to the laws of nature other than what is well-understood, routine, conventional activity, previously engaged in by those in the field" and thus, the claims encompassed non-patentable subject matter.

The general message conveyed by the Court seems to be two-fold.  First, if "the steps in claimed processes (apart from the natural laws themselves) involve well-understood, routine, conventional activity previously engaged in by researchers in the field," such claims likely encompass non-patentable subject matter.  And second, the Court demonstrated general concern that "upholding the patents would risk disproportionately tying up the use of the underlying natural laws, inhibiting their use in the making of further discoveries."  How this message affects the thousands of existing patents in the field of personal medicine remains to be seen.  However, going forward, patent practitioners would be wise to revisit this ruling when drafting claims to medical diagnostic methods.

Patent Docs will provide a more detailed analysis of this decision in a subsequent post.

Mayo Collaborative Services v. Prometheus Laboratories, Inc. (2012)
Opinion by Justice Breyer

Comments

[Geoff Karny]

The reasoning underlying this decision, if one can call it reasoning, is shockingly and abysmally flawed. It's the judicial equivalent of ruling that the earth is flat and the sun revolves around it.

The Court cites prior decisions which recognize that all inventions embody natural scientific principles and caution that applying the law of nature exclusionary principle too broadly could eviscerate the patent law. Then it proceeds to do just that.

The Court finds that the correlation between the level of 6-thioguanine in a patient's blood and the likelihood that such level will prove ineffective or cause harm to be a LAW OF NATURE, just like the law of gravity and Einstein's famous equation, which it also cites. Imagine that! Under the Court's rationale, every bit of scientific information rises to the level of a natural law! 230 pmol of 6-thioguanine per 8x108red blood cells is too little. Natural law! 400 pmol of 6-thioguanine per 8x108red blood cells is too much. Natural law! Between 230 pmol and 400 pmol is just right. Natural law! We better rewrite our science textbooks. There must be millions of these "natural laws" that we’re not teaching our children.

The Court also violates the first principle of claim analysis -- the claim must be analyzed as a whole. Instead, the Court breaks claim 1 of the patent into bite-size pieces, each of which it can easily dismiss as merely conventional or discover that it's yet another LAW OF NATURE.

Is there any patent that's safe from this analysis? Perhaps product patents are safe. But is there any process claim out there that can't be reformulated as a "law of nature?" And if you can't do this for the whole claim, then just pick it apart, take out the "conventional steps" and reformulate the rest as “laws of nature."

[Keep Your Eyes Open]

However, going forward, patent practitioners would be wise to revisit this ruling when drafting claims to medical diagnostic methods.

Going forward? People have been predicting this outcome since LabCorp. What planet have you been living on?