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U.S. Supreme Court issues decision on patents involving "Laws of Nature"

Posted: 04/05/2012
Industries: Life Sciences

By William C. Baton and Sarah A. Sullivan


The Supreme Court has held that processes applying laws of nature are not patent-eligible if the patent claims simply describe the natural law and incorporate routine steps already engaged in by the scientific community which, when viewed as a whole, add nothing significant beyond their individual parts.

In Mayo Collaborative Services, et al. v. Prometheus Laboratories, Inc., 566 U.S. ___ (2012), the U.S. Supreme Court unanimously held that Prometheus' patents claiming a method for determining the effective dosage of a drug were invalid as an improper attempt to patent a "law of nature," which is not generally patentable. The patents-in-suit involved the use of thiopurine drugs to treat autoimmune diseases, such as Crohn's disease and colitis. Because thiopurine metabolizes differently in each patient, the patents-in-suit covered a method for administering the drug, testing for the level of the drug after a certain period of time, and adjusting the dosage accordingly to prescribe an effective amount.

The Court asserted that Prometheus' patents set forth a "law of nature — namely the relationship between concentrations of certain metabolites in the blood and the likelihood that a dosage of a thiopurine drug will prove ineffective or cause harm." Accordingly, the critical question for the Court was "whether the claims dosignificantly more than simply describe these natural relations. To put the matter more precisely, do the patent claims add enough to their statements of the correlations to allow the processes they describe to qualify as patent-eligible processes that apply natural laws?" (emphasis added.)

In making its determination as to when a patent that applies a law of nature will be valid, the Court considered two previous cases: Diamond v. Diehr, 450 U.S. 175 (1981) and Parker v. Flook, 437 U.S. 584, 590 (1978). The Diehr case involved a patent that set forth a process for molding rubber that used a known mathematical equation. The Court had found that, while the mathematical equation was not patentable, the overall process was patentable because the other steps "added to the formula something that in terms of patent law's objectives had significance — they transformed the process into an inventive application of the formula."

By contrast, in Flook, which also involved a patent that incorporated a mathematical equation, the Court invalidated the patent. Flook involved a patent that used a formula to adjust certain "alarm limits" in the catalytic conversion of hydrocarbons. However, because the other steps described in the process did not limit the formula to a specific application, the Court had held that there was no "inventive concept" associated with the application of the formula.

In comparing the Mayo case with Flook and Diehr, the Court found that the case for patentability was "weaker than the (patent-eligible) claim in Diehr and no stronger than the (unpatentable) claim in Flook." The Court held:

Beyond picking out the relevant audience, namely those who administer doses of thiopurine drugs, the claim simply tells doctors to: (1) measure (somehow) the current level of the relevant metabolite, (2) use particular (unpatentable) laws of nature (which the claim sets forth) to calculate the current toxicity/inefficacy limits, and (3) reconsider the drug dosage in light of the law. These instructions 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. And since they are steps that must be taken in order to apply the laws in question, the effect is simply to tell doctors to apply the law somehow when treating their patients.

Notably, following the issuance of the Court's opinion, the United States Patent and Trademark Office immediately instructed its examiners that the Mayo ruling requires them to reject applications that incorporate natural phenomena unless the application demonstrates that the claimed invention would disclose "significantly more" than a law of nature. Further, following its ruling in Mayo, the Court vacated a Federal Circuit decision regarding Myriad Genetics Inc.'s patents on human genes, where the appellate court had rejected arguments that the patents impermissibly sought to patent products of nature. The Court has therefore remanded that case for further consideration in light of the Mayo ruling.

The Mayo opinion restates the Court's holding in Diehr that "laws of nature, natural phenomena, and abstract ideas are not patentable subject matter under §101 of the Patent Act." However, the Court's analysis seems to focus, not on the "usefulness" requirement of §101, but rather, on issues of novelty (§102) and non-obviousness (§103) in its rejection of the Prometheus patents:

To put the matter more succinctly, 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.

Therefore, it remains to be seen exactly how the Court's "significantly more" standard articulated in Mayo will be applied by patent examiners and the lower courts. In the meantime, as an attempt to meet the "significantly more" standard articulated in Mayo, it would be prudent when drafting claim language that involves a "law of nature" to include novel and inventive (i.e., non-routine) steps which, when viewed as a whole, do something significantly more than their individual parts.