Supreme Court Decision on Scope of Patent Protection

Transcription

1 Supreme Court Decision on Scope of Patent Protection Supreme Court Holds Pharmaceutical Treatment Method Without Inventive Insight Unpatentable as a Law of Nature SUMMARY In a decision that is likely to have significant implications across the healthcare spectrum, including biotech, diagnostics and medical devices, on March 20, 2012, the U.S. Supreme Court held that two patents claiming methods for optimizing the therapeutic efficacy of drugs by monitoring metabolized byproducts in a patient s bloodstream are ineligible for patent protection under 35 U.S.C. 101 because they seek to claim fundamental laws of nature. Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. (2012). In a unanimous decision, the Court continued the trend from its decision in Bilski v. Kappos, 130 S. Ct (2010), spurning the machine-or-transformation test, which was the pre-bilski standard for determining patentability under 101 and which the Federal Circuit had applied in Mayo both before and after the Bilski decision. Instead, the Supreme Court instructed 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. The Court held that a patentable process incorporating a natural law must also claim an inventive concept, sufficient to ensure that the patent in practice amounts to significantly more than a patent upon the natural law itself. Although the Court did not clearly articulate any new test in addition to the machine-or-transformation test, which it still declared useful, it concluded that the patents at issue overreached by claiming fundamental laws of nature and virtually any application of those laws, and that whatever the patents claimed beyond those fundamental laws was not sufficiently inventive to qualify them as eligible subject matter under 101. New York Washington, D.C. Los Angeles Palo Alto London Paris Frankfurt Tokyo Hong Kong Beijing Melbourne Sydney

2 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 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 Supreme Court first concluded that the patents in fact claimed laws of nature. The Court 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 Court 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 Court 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 Court 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 Court noted that -2-

3 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 Court 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 Court 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 Supreme Court 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 Court 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 , , 2012 WL (Fed. Cir. Jan. 20, 2012) -3-

4 (Linn, J.) (noting that 101 is a threshold inquiry (quoting Bilski), over dissent by Judge Plager), with MySpace, Inc. v. GraphOn Corp., No , 2012 WL (Fed. Cir. Mar. 2, 2012) (Plager, J.) ( [C]ourts should avoid reaching for interpretations of broad provisions, such as 101, when more specific statutes, such as 102, 103, and 112, can decide the case. ). In Mayo, the Supreme Court acknowledges that the 101 patent-eligibility inquiry... might sometimes overlap with other inquiries, but appears to favor addressing 101 first, because shifting the inquiry to later sections risks creating significantly greater legal uncertainty. * * * Copyright Sullivan & Cromwell LLP

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