Tuesday, March 20, 2012

Supreme Court rejects patent by Prometheus Laboratories

The opinion written by Justice Stephen Breyer, for a unanimous court, said the Prometheus blood test used "unpatentable" natural laws.

From the decision:

Prometheus’ patents set forth laws of nature—namely, relationships between concentrations of certain metabo­ lites in the blood and the likelihood that a dosage of a thiopurine drug will prove ineffective or cause harm. Claim 1, for example, states that if the levels of 6–TG in the blood (of a patient who has taken a dose of a thiopu­ rine drug) exceed about 400 pmol per 8x108 red blood cells, then the administered dose is likely to produce toxic side effects. While it takes a human action (the administration of a thiopurine drug) to trigger a manifestation of this relation in a particular person, the relation itself exists in principle apart from any human action. The relation is a consequence of the ways in which thiopurine compounds are metabolized by the body—entirely natural processes. And so a patent that simply describes that relation sets forth a natural law.

The question before us is whether the claims do signifi­ cantly more than simply describe these natural relations. To put the matter more precisely, do the patent claims add enough to their statements of the correlations to allow the processes they describe to qualify as patent-eligible pro­ cesses that apply natural laws? We believe that the an­ swer to this question is no.

The name "Einstein" appears in the decision:

That is to say, these clauses tell the relevant audience about the laws while trusting them to use those laws appropriately where they are relevant to their decisionmaking (rather like Einstein telling linear accelerator operators about his basic law and then trusting them to use it where relevant).

The claims were "routine":

To put the matter more succinctly, the claims inform a relevant audience about certain laws of nature; any additional steps consist of well­ understood, routine, conventional activity already engaged in by the scientific community; and those steps, when viewed as a whole, add nothing significant beyond the sum of their parts taken separately. For these reasons we believe that the steps are not sufficient to transform un­ patentable natural correlations into patentable applica­ tions of those regularities.

As to previous decisions:

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.

As to the CAFC:

We have considered several further arguments in sup­ port of Prometheus’ position. But they do not lead us to adopt a different conclusion. First, the Federal Circuit, in upholding the patent eligibility of the claims before us, relied on this Court’s determination that “[t]ransformation and reduction of an article ‘to a different state or thing’ is the clue to the patentability of a process claim that does not include particular machines.” Benson, supra, at 70–71 (emphasis added); see also Bilski, supra, at ___ (slip op., at 6–7); Diehr, 450 U. S., at 184; Flook, supra, at 588, n. 9; Cochrane v. Deener, 94 U. S. 780, 788 (1877). It reasoned that the claimed processes are therefore patent eligible, since they involve transforming the human body by ad­ ministering a thiopurine drug and transforming the blood by analyzing it to determine metabolite levels. 628 F. 3d, at 1356–1357.

Lemley is mentioned [ based on whether or not they will interfere significantly with innovation in other fields now or in the future. Brief for Respondent 42–46; see also Lemley 1342–1344 (making similar argument). ] But the Supreme Court said Courts and judges are not institutionally well suited to making the kinds of judgments needed to distinguish among differ- ent laws of nature. And so 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.

Similarly, the government's position is rejected: This approach, however, would make the “law of nature” exception to §101 patentability a dead letter. The approach is therefore not consistent with prior law. The relevant cases rest their holdings upon section 101, not later sections. Bilski, 561 U. S. ___; Diehr, supra; Flook, supra; Benson, 409 U. S. 63. See also H. R. Rep. No. 1923, 82d Cong., 2d Sess., 6 (1952) (“A person may have ‘invent­ ed’ a machine or a manufacture, which may include any­ thing under the sun that is made by man, but it is not necessarily patentable under section 101 unless the condi­ tions of the title are fulfilled” (emphasis added)).


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