Supreme Court Decision on Scope of Patent Protection - Sullivan ...

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BACKGROUND Under U.S. patent law, four independent categories of inventions or discoveries are eligible for patent protection: “process[es],” “machine[s],” “manufacture[s],” and “composition[s] of matter.” 35 U.S.C. § 101. The scope of these expansive terms is limited by the long-standing rule excluding from patentability “laws of nature, physical phenomena, and abstract ideas.” Diamond v. Chakrabarty, 447 U.S. 303 (1980). “Phenomena of nature, though just discovered . . . are not patentable, as they are the basic tools of scientific and technological work.” Gottschalk v. Benson, 409 U.S. 63, 67 (1972). In Mayo, the patents at issue claimed methods for treating autoimmune diseases with a class of drugs that had been used in that role for many years. Because patients metabolize these drugs at different rates, the same dosage can be too potent in one patient, risking harmful side effects, and too weak in another patient, rendering it ineffective. The patents at issue claimed steps of (1) “administering” the drugs, and (2) “determining” the levels of drug-related metabolic byproducts in the patient’s body, (3) “wherein,” according to a physiological correlation that exists naturally and was disclosed in the patent, certain levels indicate a need to increase or decrease the dosage for subsequent administration. Prometheus, the sole licensee of the patents, sells a diagnostic test that incorporates the patents. The Mayo Clinic purchased Prometheus’s test for a period of time, but then began using its own test that employed similar treatment guidelines based upon the same naturally existing correlation. Prometheus then sued the Mayo Clinic for patent infringement. The district court granted summary judgment to the Mayo Clinic based on § 101. The Federal Circuit reversed, twice, holding that the patent was valid under § 101. It found that the claims passed the machine-or-transformation test because the administration and metabolism of the drug “transformed” the body of the patient to whom it was administered, and the chemical testing required to determine metabolite levels in blood samples “transformed” those samples. THE SUPREME COURT’S DECISION The <strong>Supreme</strong> <strong>Court</strong> first concluded that the patents in fact claimed laws of nature. The <strong>Court</strong> explained that, “[w]hile it takes a human action . . . to trigger a manifestation of this relation in a particular person, the relation itself [between drug metabolites and clinical efficacy] exists in principle apart from any human action.” The <strong>Court</strong> then articulated the broad exclusionary principle that “[i]f a law of nature is not patentable, then neither is a process reciting a law of nature.” Nevertheless, the <strong>Court</strong> recognized tension between this principle and the purposes of the Patent Act, in that “too broad an interpretation of this exclusionary principle” would preclude patenting anything, because “all inventions at some level embody, use, reflect, rest upon, or apply laws of nature.” Addressing this, the <strong>Court</strong> looked to its decisions in Diamond v. Diehr, 450 U.S. 175 (1981), and Parker v. Flook, 437 U.S. 584 (1978), both of which concerned patenting laws of nature. The <strong>Court</strong> noted that -2- <strong>Supreme</strong> <strong>Court</strong> <strong>Decision</strong> on Scope of Patent Protection March 22, 2012
those cases reached different outcomes because the method claimed in Diehr included steps — in addition to the law of nature — that “transformed the process into an inventive application of the formula,” while the claims in Flook included “no ‘inventive concept’” beyond the natural law. The <strong>Court</strong> explained that the “danger . . . of patents that tie up” laws of nature is “acute” in two circumstances: first, when patents claim nothing “more than an instruction to ‘apply the natural law,’” and second, when a patent “forecloses more future invention than the underlying discovery could reasonably justify.” Thus, patents that specifically invoke a law of nature need to present “additional features that provide practical assurance that the process is more than a drafting effort designed to monopolize the law of nature itself.” The breadth or narrowness of the “law of nature” encompassed by a patent does not matter, because “even a narrow law of nature . . . can inhibit future research,” and “judges are not institutionally well suited to . . . distinguish[ing] among different laws of nature.” In rejecting the claims at issue, the <strong>Court</strong> concluded that, beyond a law of nature, the claims described only a “well-understood, routine, conventional activity, previously engaged in by those in the field.” The drugs at issue had been used to treat these same conditions for decades, and scientists “routinely measured metabolites” when assessing their efficacy. Moreover, because these well-understood steps were necessary for any person to apply the natural laws in question, “the effect is simply to tell doctors to apply the law somehow when treating their patients,” using routine steps that were not improved upon by the patent. In short, the claims were not patentable because they encompassed a law of nature, and the additional steps were not sufficiently inventive to impart patentability. While rejecting the Federal Circuit’s application of the machine or transformation test, the <strong>Supreme</strong> <strong>Court</strong> nevertheless appeared to preserve that test as “an important and useful clue.” It held that the Federal Circuit applied the test incorrectly because the particular transformations on which the Federal Circuit relied were either “irrelevant” or not required. IMPLICATIONS The decision in Mayo may well have broad implications in a variety of fields because, as the <strong>Court</strong> noted, all patented inventions in some sense rest on or apply laws of nature. The decision may, in particular, implicate many existing patents in the biotech, medical diagnostics and pharmaceutical fields. However, the precise effect will depend on a close reading of the Mayo decision and a detailed examination of the particular claims. Claim analysis will be required to determine, among other things, whether the steps of the claim beyond any law of nature are sufficiently “inventive” to impart patentability under § 101. The Mayo decision also suggests an answer to a question raised by conflicting decisions in the Federal Circuit: should analysis of subject matter eligibility under § 101 precede other conditions of patentability such as novelty or obviousness contained in other provisions of the patent statutes (e.g., §§ 102, 103)? Compare Dealertrack v. Huber, Nos. 09-1566, 09-1588, 2012 WL 164439 (Fed. Cir. Jan. 20, 2012) -3- <strong>Supreme</strong> <strong>Court</strong> <strong>Decision</strong> on Scope of Patent Protection March 22, 2012
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