Mayo Collaborative Servs. v. Prometheus Labs., Inc.

• Decision Date: 20 March 2012
• Docket Number: No. 10–1150.,10–1150.
• Citation: 132 S.Ct. 1289,566 U.S. 66,182 L.Ed.2d 321
• Parties: MAYO COLLABORATIVE SERVICES, dba Mayo Medical Laboratories, et al., Petitioners v. PROMETHEUS LABORATORIES, INC.
• Court: U.S. Supreme Court

566 U.S. 66

132 S.Ct. 1289

182 L.Ed.2d 321

MAYO COLLABORATIVE SERVICES, dba Mayo Medical Laboratories, et al., Petitioners

v.PROMETHEUS LABORATORIES, INC.

No. 10–1150.

Supreme Court of the United States

Argued Dec. 7, 2011.

Decided March 20, 2012.

Stephen M. Shapiro, Los Angeles, CA, for Petitioners.

Donald B. Verrilli, Jr., Solicitor General, for the United States, as amicus curiae, by special leave of the Court.

Richard P. Bress for Respondent.

Jonathan Singer, John Dragseth, Deanna Reichel, Fish & Richardson P.C., Minneapolis, MN, Stephen M. Shapiro, Counsel of Record, Timothy S. Bishop, Jeffrey W. Sarles, Mayer Brown LLP, Chicago, IL, Eugene Volokh, Los Angeles, CA, Joseph M. Colaiano, James A. Rogers, III, Mayo Clinic, Rochester, MN, Charles Rothfeld, Mayer Brown LLP, Washington, D.C., for Petitioners.

Richard P. Bress, Counsel of Record, J. Scott Ballenger, Maximilian A. Grant, Matthew J. Moore, Gabriel K. Bell, Latham & Watkins LLP, Washington, DC, for Respondent.

Justice BREYER delivered the opinion of the Court.

Section 101 of the Patent Act defines patentable subject matter. It says:

"Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title." 35 U.S.C. § 101.

The Court has long held that this provision contains an important implicit exception. "[L]aws of nature, natural phenomena, and abstract ideas" are not patentable. Diamond v. Diehr, 450 U.S. 175, 185, 101 S.Ct. 1048, 67 L.Ed.2d 155 (1981) ; see also Bilski v. Kappos, 561 U.S. 593, ––––, 130 S.Ct. 3218, 3233–3234, 177 L.Ed.2d 792 (2010); Diamond v. Chakrabarty, 447 U.S. 303, 309, 100 S.Ct. 2204, 65 L.Ed.2d 144 (1980) ; Le Roy v. Tatham, 14 How. 156, 175, 14 L.Ed. 367 (1853) ; O'Reilly v. Morse, 15 How. 62, 112–120, 14 L.Ed. 601 (1854) ; cf. Neilson v. Harford, Webster's Patent Cases 295, 371 (1841) (English case discussing same). Thus, the Court has written that "a new mineral discovered in the earth or a new plant found in the wild is not patentable subject matter. Likewise, Einstein could not patent his celebrated law that E=mc ²; nor could Newton have patented the law of gravity. Such discoveries are ‘manifestations of ... nature, free to all men and reserved exclusively to none.’ " Chakrabarty, supra, at 309, 100 S.Ct. 2204 (quoting Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 130, 68 S.Ct. 440, 92 L.Ed. 588 (1948) ).

"Phenomena of nature, though just discovered, mental processes, and abstract intellectual concepts are not patentable, as they are the basic tools of scientific and technological work." Gottschalk v. Benson, 409 U.S. 63, 67, 93 S.Ct. 253, 34 L.Ed.2d 273 (1972). And monopolization of those tools through the grant of a patent might tend to impede innovation more than it would tend to promote it.

The Court has recognized, however, that too broad an interpretation of this exclusionary principle could eviscerate patent law. For all inventions at some level embody, use, reflect, rest upon, or apply laws of nature, natural phenomena, or abstract ideas. Thus, in Diehr the Court pointed out that " ‘a process is not unpatentable simply because it contains a law of nature or a mathematical algorithm.’ " 450 U.S., at 187, 101 S.Ct. 1048 (quoting Parker v. Flook, 437 U.S. 584, 590, 98 S.Ct. 2522, 57 L.Ed.2d 451 (1978) ). It added that "an application of a law of nature or mathematical formula to a known structure or process may well be deserving of patent protection." Diehr, supra, at 187, 101 S.Ct. 1048. And it emphasized Justice Stone's similar observation in Mackay Radio & Telegraph Co. v. Radio Corp. of America, 306 U.S. 86, 59 S.Ct. 427, 83 L.Ed. 506 (1939) :

" ‘While a scientific truth, or the mathematical expression of it, is not a patentable invention, a novel and useful structure created with the aid of knowledge of scientific truth may be.’ " 450 U.S., at 188, 101 S.Ct. 1048 (quoting Mackay Radio,supra, at 94, 59 S.Ct. 427).

See also Funk Brothers, supra, at 130, 68 S.Ct. 440 ("If there is to be invention from [a discovery of a law of nature], it must come from the application of the law of nature to a new and useful end").

Still, as the Court has also made clear, to transform an unpatentable law of nature into a patent-eligible application of such a law, one must do more than simply state the law of nature while adding the words "apply it." See, e.g., Benson, supra, at 71–72, 93 S.Ct. 253.

The case before us lies at the intersection of these basic principles. It concerns patent claims covering processes that help doctors who use thiopurine drugs to treat patients with autoimmune diseases determine whether a given dosage level is too low or too high. The claims purport to apply natural laws describing the relationships between the concentration in the blood of certain thiopurine metabolites and the likelihood that the drug dosage will be ineffective or induce harmful side-effects. We must determine whether the claimed processes have transformed these unpatentable natural laws into patent-eligible applications of those laws. We conclude that they have not done so and that therefore the processes are not patentable.

Our conclusion rests upon an examination of the particular claims before us in light of the Court's precedents. Those cases warn us against interpreting patent statutes in ways that make patent eligibility "depend simply on the draftsman's art" without reference to the "principles underlying the prohibition against patents for [natural laws]." Flook,supra, at 593, 98 S.Ct. 2522. They warn us against upholding patents that claim processes that too broadly preempt the use of a natural law. Morse, supra, at 112–120; Benson, supra, at 71–72, 93 S.Ct. 253. And they insist that a process that focuses upon the use of a natural law also contain other elements or a combination of elements, sometimes referred to as an "inventive concept," sufficient to ensure that the patent in practice amounts to significantly more than a patent upon the natural law itself. Flook, supra, at 594, 98 S.Ct. 2522; see also Bilski,supra, at 3218, 130 S.Ct. at 3230 ("[T]he prohibition against patenting abstract ideas ‘cannot be circumvented by attempting to limit the use of the formula to a particular technological environment’ or adding ‘insignificant postsolution activity’ " (quoting Diehr, supra, at 191–192, 101 S.Ct. 1048) ).

We find that the process claims at issue here do not satisfy these conditions. In particular, the steps in the claimed processes (apart from the natural laws themselves) involve well-understood, routine, conventional activity previously engaged in by researchers in the field. At the same time, upholding the patents would risk disproportionately tying up the use of the underlying natural laws, inhibiting their use in the making of further discoveries.

I

A

The patents before us concern the use of thiopurine drugs in the treatment of autoimmune diseases, such as Crohn's disease and ulcerative colitis. When a patient ingests a thiopurine compound, his body metabolizes the drug, causing metabolites to form in his bloodstream. Because the way in which people metabolize thiopurine compounds varies, the same dose of a thiopurine drug affects different people differently, and it has been difficult for doctors to determine whether for a particular patient a given dose is too high, risking harmful side effects, or too low, and so likely ineffective.

At the time the discoveries embodied in the patents were made, scientists already understood that the levels in a patient's blood of certain metabolites, including, in particular, 6–thioguanine and its nucleotides (6–TG) and 6–methyl–mercaptopurine (6–MMP), were correlated with the likelihood that a particular dosage of a thiopurine drug could cause harm or prove ineffective. See U.S. Patent No. 6,355,623, col.8, ll.37–40, 2 App. 10. ("Previous studies suggested that measurement of 6–MP metabolite levels can be used to predict clinical efficacy and tolerance to azathioprine or 6–MP" (citing Cuffari, Théorêt, Latour, & Seidman, 6–Mercaptopurine Metabolism in Crohn's Disease : Correlation with Efficacy and Toxicity, 39 Gut 401 (1996))). But those in the field did not know the precise correlations between metabolite levels and likely harm or ineffectiveness. The patent claims at issue here set forth processes embodying researchers' findings that identified these correlations with some precision.

More specifically, the patents— U.S. Patent No. 6,355,623 ('623 patent) and U.S. Patent No. 6,680,302 ('302 patent) —embody findings that concentrations in a patient's blood of 6–TG or of 6–MMP metabolite beyond a certain level (400 and 7000 picomoles per 8x10 ⁸ red blood cells, respectively) indicate that the dosage is likely too high for the patient, while concentrations in the blood of 6–TG metabolite lower than a certain level (about 230 picomoles per 8x10 ⁸ red blood cells) indicate that the dosage is likely too low to be effective.

The patent claims seek to embody this research in a set of processes. Like the Federal Circuit we take as typical claim 1 of the '623 Patent, which describes one of the claimed processes as follows:

"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

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