Supreme Court Accepts Appeal on Patented Medical Diagnostics

U.S. Supreme Court Building, Washington, D.C.

Earlier today the United States Supreme Court granted certiorari in Mayo Collaborative Services v. Prometheus Laboratories, Inc., which sets up another foray into the patent eligible subject matter waters for the Supreme Court in the October 2011 term.  This appeal by Mayo will challenge the December 17, 2010 decision of the United States Court of Appeals for the Federal Circuit, one of the first patentable subject matter cases for the Federal Circuit in the wake of the Supreme Court’s decision in Bilski v. Kappos.  In fact, this case was returned from the Supreme Court to the Federal Circuit for further consideration in light of the Supreme Court ruling in Bilski v. Kappos.

This case first reached the Federal Circuit on an appeal brought by Prometheus, challenging the final judgment of the United States District Court for the Southern District of California. The district court had granted summary judgment of invalidity of U.S. Patents 6,355,623 and 6,680,302 under 35 U.S.C. § 101. In the original case the Federal Circuit held that the district court erred as a matter of law in finding Prometheus’s asserted medical treatment claims to be drawn to non-statutory subject matter under the machine-or-transformation test, which at the time was the definitive test for determining the patent eligibility of a process under § 101.

In Bilski, however, the Supreme Court held that the machine-or-transformation test, although “a useful and important clue,” was not the sole test for determining the patent eligibility of process claims. The Supreme Court vacated and remanded the Prometheus case for further consideration in light of Bilski v. Kappos. On remand, once again, the Federal Circuit held (per Judge Lourie with Chief Judge Rader and Judge Bryson) that Prometheus’s asserted method claims are drawn to statutory subject matter, reversing for the second time the district court’s grant of summary judgment of invalidity under § 101.

The Question Presented by Mayo’s petition to the Supreme Court for certiorari was:

This case concerns whether a patentee can monopolize basic, natural biological relationships. The Court has twice granted certiorari on the question presented, without yet resolving the issue. Last year, it granted certiorari, vacated, and remanded in this case to allow the Federal Circuit to reconsider this question in light of Bilski v. Kappos, 130 S. Ct. 3218 (2010). And seven years ago it granted certiorari but dismissed the writ as improvidently granted in Laboratory Corp. of America Holdings v. Metabolite Laboratories, Inc., 548 U.S. 124, 135 (2006), because petitioner there had not adequately preserved the question.

The question presented is:

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.

On of the central contentions of Mayo, if not the central contention, is that “Prometheus’s broad patent claims attempt to turn a physician’s thought processes into infringement.”

Claim 1 of the ’623 patent, which is representative of the independent claims asserted by Prometheus in this case, reads:

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 8×108 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 8×108 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.

Claim 1 of the ’302 patent is substantially the same.

Claim 46 of the ’623 patent dispenses with the “administering” step and claims only the “determining” step:

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 8×108 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 8×108 red blood cells or a level of 6-methylmercaptopurine greater than about 7000 pmol per 8×108 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.

At the Federal Circuit Prometheus argued that its asserted claims not only satisfy the machine-or-transformation test, but also are not drawn to mere abstractions. Specifically, Prometheus argued that its asserted claims involve a particular transformation of a patient’s body and bodily sample and use particular machines to determine metabolite concentrations in a bodily sample (e.g., via high pressure liquid chromatography), thus satisfying either prong of the machine-or-transformation test. Prometheus further argues that its claims also involve an application of a law of nature, not the law itself, because they recite specific means of treating specific diseases using specific drugs, and therefore do not preempt the abstract idea of calibrating drug dosages to treat disease.

At the Federal Circuit Mayo argued that the Supreme Court in Bilski reaffirmed that preemption is the controlling standard for § 101 under the Court’s Benson, Flook, and Diehr precedents and made clear that while a machine-or-transformation test may inform the analysis, that test is not outcome determinative. And, according to Mayo, under the governing preemption standard, Prometheus’s claims are invalid because they preempt all practical use of naturally occurring correlations between metabolite levels and drug efficacy and any machine or transformation present in the claims is merely insignificant post-solution activity.

The Federal Circuit explained:

[T]he claims recite specific treatment steps, not just the correlations themselves. And the steps involve a particular application of the natural correlations: the treatment of a specific disease by administering specific drugs and measuring specific metabolites. As such, and contrary to Mayo’s assertions, the claims do not preempt all uses of the natural correlations; they utilize them in a series of specific steps… The inventive nature of the claimed methods stems not from preemption of all use of these natural processes, but from the application of a natural phenomenon in a series of steps comprising particular methods of treatment. Other drugs might be administered to optimize the therapeutic efficacy of the claimed treatment.

We similarly reaffirm that the treatment methods claimed in Prometheus’s patents in suit satisfy the transformation prong of the machine-or-transformation test, as they “transform an article into a different state or thing,” and this transformation is “central to the purpose of the claimed process.”

Throughout its petition for certiorari Mayo continually cites to Laboratory Corporation of America v. Metabolite Laboratories, 548 U.S. 124, 135 (2006), which is a dissent by three Justices in a case without a decision.  The real story behind Laboratory Corporation of America v. Metabolife Laboratories is that the Supreme Court did decide to hear the case, but notwithstanding the fact that it was fully briefed by both sides, the Court, without explanation, issued an order explaining that no decision would be forthcoming because the appeal was improvidently granted.  Justice Breyer wrote a dissent and was joined by Justices Stevens and Souter.  With only Justice Breyer remaining on the Court it seems a bit odd to rely so heavily on a dissent in a case not heard, particularly when those who voted to dismiss the case as improvidently granted still remain on the Court.

Notwithstanding, the Supreme Court has decided to hear the Mayo challenge, which will drudge up the Lab Corp. issues no doubt.  It seems unlikely to me that the Supreme Court will overrule the Federal Circuit in this case, but predicting the Supreme Court is far more an art than a science.

It seems unlikely that the Supreme Court will say that the Prometheus patent claims cover an invention that does not satisfy the machine-or-transformation test.  If that is, in fact, the case then Mayo must argue that even when an invention satisfies the machine-or-transformation test it could still, nevertheless, be unpatentable.  To accomplish this Mayo is placing its hopes on a preemption argument, saying that the claims totally preempt, and as a result must therefore cover nothing more than an abstract idea.  This argument will likely face an uphill climb for at least two reasons.  First, the Federal Circuit has found that there is not preemption in total.  Second, the very nature of a patent right is to preempt.

For the Supreme Court to rule in favor of Mayo, the Court will need to define the concept of an “abstract idea” to cover something that is tangible and manifested, but that is simply too broad to warrant patent protection.  Frankly, denying a patent because it is too broad in and of itself is ridiculous.  Mayo might as well be arguing that the Prometheus patent claims cover an invention so foundational and fundamentally important that it would be unjust to award a patent.  But isn’t that the exact type of innovations that we want?  Isn’t that the exact type of innovation that the Supreme Court in KSR v. Teleflex sought to elevate and distinguish from the mere trivial, common sense inventions that are not deserving of a patent?