Today the Supreme Court granted cert in Prometheus Labs v. Mayo (captioned Mayo Collaborative Services v. Prometheus Laboratories, Inc. at the Supreme Court).
By way of background, the case involves the issue of whether an invention is eligible for a patent under 35 U.S.C. §101. In a case called In re Bilski, the Federal Circuit had adopted a "machine-or-transformation test" to judge patentability: a patent applicant "may show that a process claim satisfies § 101 either by showing that his claim is tied to a particular machine, or by showing that his claim transforms an article." The Supreme Court granted review of this case, and in Bilski v. Kappos, held that the Federal Circuit test was too strict, making it easier to obtain patents and finding that §101 was less restrictive than the Federal Circuit's view.
By way of background, the case involves the issue of whether an invention is eligible for a patent under 35 U.S.C. §101. In a case called In re Bilski, the Federal Circuit had adopted a "machine-or-transformation test" to judge patentability: a patent applicant "may show that a process claim satisfies § 101 either by showing that his claim is tied to a particular machine, or by showing that his claim transforms an article." The Supreme Court granted review of this case, and in Bilski v. Kappos, held that the Federal Circuit test was too strict, making it easier to obtain patents and finding that §101 was less restrictive than the Federal Circuit's view.
The Federal Circuit had twice held that Prometheus' asserted medical treatment claims were patentable subject matter in view of both Bilski decisions. After the first Federal Circuit decision so held, the Supreme Court had previously granted cert, and vacated and remanded so the Federal Circuit could reconsider the case in view of the Supreme Court's Bilski opinion. The Federal Circuit then held the claims patentable again.
Putting aside any personal views about what the scope of 35 U.S.C. §101 should be, I had thought that (1) the Federal Circuit having initially ruled the Prometheus claims patentable in view of its strict Bilski test, there was no reason for the Supreme Court to grant cert and remand; (2) in view of the Supreme Court's less strict Bilski test (that is, a much more expansive view of patentable subject matter than the Federal Circuit test), it was a foregone conclusion that the Federal Circuit would again find the claims patentable, which it did; and (3) there was therefore no need for the Supreme Court to grant cert.
However, now the Supreme Court will review this case on the merits. Are they going to revisit Bilski?
Here is a representative claim of the Prometheus patents:
Putting aside any personal views about what the scope of 35 U.S.C. §101 should be, I had thought that (1) the Federal Circuit having initially ruled the Prometheus claims patentable in view of its strict Bilski test, there was no reason for the Supreme Court to grant cert and remand; (2) in view of the Supreme Court's less strict Bilski test (that is, a much more expansive view of patentable subject matter than the Federal Circuit test), it was a foregone conclusion that the Federal Circuit would again find the claims patentable, which it did; and (3) there was therefore no need for the Supreme Court to grant cert.
However, now the Supreme Court will review this case on the merits. Are they going to revisit Bilski?
Here is a representative claim of the Prometheus patents:
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 8x10^8 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 8x10^8 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.
The issue presented in the case is as follows:
Whether 35 U.S.C. § 101 is satisfied by a patent claim that covers observed correlations between blood test results and patient health, so that the claim effectively preempts all uses of the naturally occurring correlations, simply because well-known methods used to administer prescription drugs and test blood may involve “transformations” of body chemistry.
Granting cert in this case will mean, if nothing else, that the Justices will have to get off the fence and perhaps make the patent-eligible-subject-matter determination that they strenuously avoided making in the Bilski decision.
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