Supreme Court Clarifies Patentability of Medical TreatmentsMarch 21, 2012

The Supreme Court recently handed down its unanimous decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc., No. 10-1150, slip op. (March 20, 2012). The Court specifically considered the patentability of a method for determining the effective levels of a drug to be administered to a patient, and found the claims in question to be unpatentable as “laws of nature.” Although some may view the holding to be fairly limited in its scope—resting “upon an examination of the particular claims before [the Court] in light of the Court’s precedents”, id. at 3,—the conclusions may have more far-reaching implications both for process patents and for patent-eligibility in general.

This decision is the most recent in a number of cases taken up by the Court to clarify patent eligibility under 35 U.S.C. § 101. The Court focused on the long standing exceptions to patent-eligibility—abstract ideas, natural phenomena, and specifically laws of nature—and the Court’s precedent in applying those exceptions. Of apparent overriding concern to the Court was “that patent law not inhibit further discovery by improperly tying up the future use of laws of nature.” Id.at 16. To this end, the Court looked to its holdings in Diamond v. Diehr, 450 U.S. 175 (1981), and Parker v. Flook, 437 U.S. 584 (1978), as a kind of litmus test for what constitutes a patentable process where a law of nature is involved. The Court concluded that “instructions [that] add nothing specific to the laws of nature other than what is well-understood, routine, conventional activity, previously engaged in by those in the field” were more akin to the unpatentable claim in Flook than the patentable claim in Diehr, and found the claims at issue here presented just such a case. Prometheus, slip op. at 13.

Specifically, the Court held that the patents-in-suit were nothing more than embodiments of laws of nature, and the recited “administering,” “determining,” and “wherein” steps were insufficient “to transform the nature of the claim,” even when the steps were considered as an ordered combination. Id.at 9–10. Thus, the Court concluded “the claims inform a relevant audience about certain laws of nature; any additional steps consist of well-understood, routine, conventional activity already engaged in by the scientific community; and those steps, when viewed as a whole, add nothing significant beyond the sum of their parts taken separately.” Id. at 11. Thus, the patents were invalid as “a drafting effort designed to monopolize the law of nature itself.” Id. at 9.

The Court’s decision does provide some limited guidance regarding the criteria for determining patent eligibility in the wake of its recent decision in Bilski v. Kappos, 130 S. Ct. 3218 (2010). The Court made clear that “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.’” Prometheus, slip op. at 3. The Court alluded to the “machine-or-transformation” (MOT) test—and reaffirmed that MOT is not the determinative test, “but only an important and useful clue”—but did not provide an alternative test. Id. at 7. Indeed, whereas the Federal Circuit had determined the patents at issue were patentable because “[i]t thought that the ‘machine-or-transformation test,’ understood merely as an important and useful clue, nonetheless led to the ‘clear and compelling conclusion . . . that the . . . claims . . . do not encompass laws of nature of preempt natural correlations,’” the Court clearly concluded otherwise. Id. at 7­–8. The Court determined that the Federal Circuit had misapplied the MOT because no relevant transformations are required by the claims. Specifically, the step of administering the drug to patients did nothing more than identify the relevant audience, and the step of analyzing the blood could, at least in theory, be carried out without physically transforming the blood. The Court did note that although “the ‘machine-or-transformation’ test is an ‘important and useful clue’ to patentability, [the Court has] neither said nor implied that the test trumps the ‘law of nature’ exclusion.” Id.at 19.

The Court did go a step further, and articulated a somewhat ambiguous standard for patentability of processes involving otherwise patent-ineligible subject matter. Specifically, the Court emphasized that “simply appending conventional steps, specified at a high level of generality, to laws of nature, natural phenomena, and abstract ideas cannot make those laws, phenomena, and ideas patentable.” Id. at 14. Thus, to clear the § 101 threshold, method claims must add something significant to the natural law itself. What remains unclear in light of the Courts holding is precisely what, and how significant, that “something” needs to be.

This most recent patentability decision appears to again rebuke the Federal Circuit’s approach to § 101 patent-eligibility, and may have substantial implications for a number of cases wending their way through the federal courts. See, e.g., Ass'n for Molecular Pathology v. United States PTO, 653 F.3d 1329 (Fed. Cir. 2011), reh’g denied 2011 U.S. App. LEXIS 21927 (holding patents for isolated genes and methods for detecting gene mutations patentable). The Court’s emphasis on—and potential broadening of—the long-standing exceptions to patent eligibility may signal a constriction of precisely what subject matter is eligible for patent protection. Clearly the Court is requiring process claims to do more than simply state the law of nature while adding the words “apply it,” but it is not yet clear how much more is required.