Prometheus Returns to the Supreme Court, Medical Method Patent Speculation Intensifies

While everyone has been busy speculating about whether the Supreme Court will ultimately take the Myriad case, the justices (at least four of them—see below) sprung a surprise this week by deciding to review the Federal Circuit’s decision in another biomedical patent case, Prometheus v. Mayo.

The patents at issue in Prometheus involve a method of administering a drug (specifically thiopurine drugs used to treat gastrointestinal and other autoimmune diseases), measuring the drug’s level in a patient’s body, and then adjusting the dosage of the drug. The Supreme Court will hear the case this fall and should (see below) issue a ruling by next summer, thus drawing to a close a legal journey that began more than three years ago in a California district court.

The Path of Prometheus. In March of 2008, a California district court invalidated a pair of patents (U.S. Patent No. 6,355,623 and No. 6,680,302) exclusively licensed to Prometheus Laboratories, holding that the claimed inventions were not patentable subject matter under Section 101 of the Patent Act. The district court’s ruling was overturned by the Federal Circuit on September 16, 2009. The Federal Circuit ruled that the claimed methods satisfied the machine-or-transformation (MoT) test used to decide whether particular methods qualify as patentable subject matter under Section 101.  The court held specifically that the administration and measurement steps worked a sufficient transformation of the body to satisfy the MoT test.

On the losing end of the Federal Circuit’s first decision, Mayo Medical Laboratories promptly applied to the Supreme Court for review (the technical term is a writ of certiorari). The Supreme Court took up the appropriateness of the MoT test for method patents in the summer of 2010 in Bilski v. Kappos. In Bilski, the Supreme Court issued a narrow opinion, holding that the MoT test was not the exclusive test for evaluating method patents but failing to issue any broader guidance, including for the biotechnology industry. Almost immediately thereafter, the Supreme Court granted certiorari in Prometheus, vacated (set aside) the Federal Circuit’s decision and ordered that the case be reconsidered by the Federal Circuit in light of Bilski (remand).

At the Supreme Court’s request, the Federal Circuit reconsidered Prometheus and, to nobody’s surprise, reached exactly the same result on December 17, 2010, upholding the ‘623 and ‘302 patents as valid under Section 101.

Prometheus, LabCorp and Personalized Medicine. The patents at issue in Prometheus are important in large part because they point to the very heart of the practice of personalized medicine. In many cases, patented diagnostic methods can play an essential role in delivering the appropriate treatment (in the appropriate dose or form) to a patient in the most efficient manner.

In each of its decisions, the Federal Circuit held that the patents at issue in Prometheus are valid because a method of treatment to “ameliorate the effects of an undesired condition” is “always transformative,” thus clearing the bar to patentability under Section 101.

As we commented following the Federal Circuit’s most recent ruling, the broad interpretation of the MoT test embodied by the Federal Circuit in Prometheus leaves:

a potentially enormous opening through which to push all manner of personalized medicine patents replete with diagnostic, measurement, correlation and other interpretive or mental steps, provided that the claim language can be framed as describing a “method of treatment.”

In its petition to the Supreme Court (pdf), Mayo struck a similar note, arguing that “the case concerns whether a patentee can monopolize basic, natural biological relationships.” It then presented this question to the Supreme Court for review:

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.

In making its case against the Prometheus patents, Mayo’s petition for certiorari places considerable emphasis on a 2006 Supreme Court dissent—Labcorp v.Metabolite (pdf)in which the Court granted certiorari and then “dismissed as improvidently granted” a case also involving patents claiming biomedical associations (in LapCorp, a process for diagnosing vitamin deficiencies).

LabCorp was dismissed on procedural grounds (the patents in question were not specifically examined by the lower courts for patentability under Section 101) over the vigorous dissent of three justices. The dissent was written by Justice Breyer (the only one of the three dissenting justices still on the Court, following the recent retirements of Justices Souter and Stevens), who argued that a “technical procedural objection” should not have prevented the Supreme Court from addressing a more fundamental question: do the patents at issue “amount to an invalid effort to patent a ‘phenomenon of nature’?”

Not only would the dissenting justices in LabCorp have answered that question, they would have answered it in the affirmative, finding that the patents describe “an unpatentable ‘natural phenomenon’” that, at most, “simply described the natural law at issue in the abstract patent language of a ‘process.’” Patents like those in LabCorp, argued the dissent, could “raise the cost of healthcare while inhibiting its effective delivery.”

Mayo focused heavily on LabCorp to no avail during each of its trips through the Federal Circuit, as well as in its previous certiorari petition to the Supreme Court. Will the Supreme Court prove a more receptive audience this time around?

The Significance of the Court’s Cert Grant. At this point we know only one thing for sure:  at least four justices (the minimum needed to take a case) are sufficiently interested in Prometheus to want to give the case a closer look.

Why? One explanation could be that the Court—which still includes the LabCorp dissent’s author, Justice Breyer—is ready to make a statement about the appropriate boundaries of biomedical method patents. (A possible signal: Justice Breyer referenced LabCorp while describing both the benefits and costs of patents in his dissent (joined by Justice Ginsburg) in the recent Supreme Court case Stanford v. Roche (pdf).) The emphasis on preemption in the statement of the question presented to the Supreme Court for review in Prometheus also tracks the Court’s major concern in the Bilski opinion, which worried that the business method claims at issue in that case would foreclose all uses of a basic process.

For those, including Mayo, who find the Prometheus claims to be overly broad, the case thus presents an obvious opportunity for the Supreme Court to extend its anti-preemption logic to biomedical claims. But the Court could easily reach the opposite result and uphold in full the Prometheus patents.

Either way, speculating on possible outcomes and effects is grossly premature. The Court granted review in LabCorp but, despite the emphasis Mayo and others place on Breyer’s dissent, never reached a decision. And the Court’s last opportunity to clarify the state of biomedical patents, Bilski, is regarded almost universally as a lost opportunity, a case that ended up producing more confusion than clarity.

In the end, a substantive decision of any sort would likely represent a step forward for the Court’s jurisprudence in the area of biomedical patents. The need for improved clarity, perhaps more than any other issue, was at the crux of the LabCorp dissent, where Justice Breyer wrote that any decision on the merits, irrespective of its substance, would “help diminish legal uncertainty” and “permit those in the medical profession better to understand the nature of their legal obligations.”

With the Supreme Court’s grant of certiorari in Prometheus it is clear that the opportunity is there for the Supreme Court and, for at least four justices, the interest as well. But whether the Court will ultimately clarify—let alone change—the law regarding biomedical method patents remains anyone’s guess.

What’s Next for Biomedical Patents? Finally, keep in mind that, when it comes to biomedical patents, the action is not only at the Supreme Court. The Federal Circuit heard oral argument in the Myriad gene patent litigation in April but has yet to release its highly-anticipated opinion. Nor has the Federal Circuit issued a decision in Prometheus’s sister case, Classen v. Biogen IDEC, which received identical grant, vacate and remand treatment from the Supreme Court following Bilski. And, of course, the possibility of Congressional patent reform remains on the table.

As we look to the future of biomedical patents, it is clear that myriad opportunities exist to evaluate, as Judge Breyer urged in LabCorp, “whether the patent system, as currently administered and enforced, adequately reflects the careful balance that the federal patent laws embody.”

Which leaves us with only one simple question: who will take up that challenge, when will they do so, and what decision will they reach? Stay tuned.