To many following the application of 35 U.S.C. § 101 to diagnostic and personalized medicine method claims, the Federal Circuit’s decisions in Prometheus Laboratories, Inc. v. Mayo Collaborative Services seem to be at odds with Justice Breyer’s dissent from the dismissal of the grant of certiorari in Laboratory Corp. of America Holdings v. Metabolite Laboratories, Inc. In both of its decisions (before and after Bilski), the Federal Circuit addressed Metabolite only in a footnote, which makes me wonder whether the court is setting itself up for a confrontation with Justice Breyer. (Justices Stevens and Souter, who joined the dissent, have since retired from the Court.)
The claims at issue in Metabolite recited:
A method for detecting a deficiency of cobalamin or folate in warm-blooded animals comprising the steps of:
assaying a body fluid for an elevated level of total homocysteine; and
correlating an elevated level of total homocysteine in said body fluid with a deficiency of cobalamin or folate.There can be little doubt that the correlation between homocysteine and vitamin deficiency set forth in claim 13 is a “natural phenomenon.”
The patent-eligibility issue was not raised at the Federal Circuit, but was raised in the petition for certiorari that was granted and then dismissed as improvidently granted. It was in that context that Justice Breyer wrote his "Metabolite dissent."
Justice Breyer framed the issue that he would have liked the Court to address:
The researchers who obtained the present patent found that an elevated level of homocysteine in a warm-blooded animal is correlated with folate and cobalamin deficiencies. As construed by the Federal Circuit, claim 13 provides those researchers with control over doctors’ efforts to use that correlation to diagnose vitamin deficiencies in a patient. Does the law permit such protection or does claim 13, in the circumstances, amount to an invalid effort to patent a “phenomenon of nature”?
Factually, Justice Breyer found that "[t]here can be little doubt that the correlation between homocysteine and vitamin deficiency . . . is a ‘natural phenomenon.’" He rejected Metabolite’s arguments that the method claims nonetheless were patentable because they "recite a ‘process’ for detecting vitamin deficiency, with discrete testing and correlating steps."
Justice Breyer summed up the claimed methods as involving only
- obtaining test results and
- thinking about them.
He opined that the claims “embody only the correlation between homocysteine and vitamin deficiency that the researchers uncovered. In my view, that correlation is an unpatentable ‘natural phenomenon.’”
The claims at issue in Prometheus recited:
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.
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.
The First Prometheus Decision
In its 2009 pre-Bilski decision, the Federal Circuit upheld Prometheus’s claims under the machine-or-transformation test. It addressed Justice Breyer’s Metabolite dissent in a brief footnote:
In reaching its conclusion, the district court relied heavily on the opinion of three justices dissenting from the dismissal of the grant of certiorari in Laboratory Corp. of America Holdings v. Metabolite Laboratories, Inc., 548 U.S. 124 (2006) (Breyer, J., dissenting). See Invalidity Opinion, 2008 WL 878910, at *8 (discussing the dissent in Laboratory Corp. at length and stating that although the dissent “does not have precedential value, the Court finds Justice Breyer’s reasoning persuasive”). That dissent is not controlling law and also involved different claims from the ones at issue here.
The Second Prometheus Decision
In its recent 2010 post-Bilski decision (which I wrote about in more detail here) the Federal Circuit again upheld Prometheus’s claims, reiterating its machine-or-transformation analysis and explaining that the claimed methods “recite a patent-eligible application of naturally occurring correlations."
Metabolite was once again relegated to a footnote:
Mayo, as did the district court, points to the opinion of three Justices dissenting from the dismissal of the grant of certiorari in Lab. Corp., 548 U.S. 124 (Breyer, J., dissenting from dismissal of certiorari as improvidently granted). See Invalidity Opinion, 2008 WL 878910, at *8 (discussing the dissent in Lab. Corp. at length and finding Justice Breyer’s reasoning persuasive). Again, with respect, we decline to discuss a dissent; it is not controlling law, and it involved different claims from the ones at issue here. Mayo further claims that five Justices in two concurrences cited Lab. Corp. with approval in Bilski, but such citations fail to transform a dissent into controlling law. Moreover, one concurrence cites Lab. Corp. for the proposition that “too much patent protection can impede rather than ‘promote the Progress of . . . useful Arts,’” in arguing for a categorical rule that business method patents do not qualify as patent-eligible processes under § 101. Bilski, 130 S. Ct. at 3255 (Stevens, J., concurring). But this case does not involve business method patents.
Setting Up A Supreme Confrontation?
Mayo has until mid-March to file a petition for certiorari at the Supreme Court, and is expected to do so. After all, the Supreme Court granted certiorari after the 2009 Federal Circuit decision, and Justice Breyer’s Metabolite dissent outlines potentially useful arguments.
While the footnote in the 2010 Federal Circuit decision makes it look like the court again did not address Justice Breyer’s concerns head on, the court did provide an analysis that in essence rebuts Justice Breyer’s views. The court explained how Prometheus’s claims satisfied § 101 under the difficult patchwork of Supreme Court precedent, related to a patent-eligible, specific application of a natural phenomenon, and passed the machine-or-transformation test that the Supreme Court itself recently affirmed in Bilski as a useful tool for applying § 101.
If the Supreme Court grants certiorari this time around, I’m sure there will be speculation that the Court disagrees with the Federal Circuit’s analysis. Only time will tell if Justice Breyer will reach a different decision in a case where the issue is fully briefed and illuminated by the Federal Circuit’s analysis.