Supreme Court Orders Federal Circuit to Reconsider Patent-Eligibility of GenesMarch 30, 2012

Just six days after it handed down its decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc., the Supreme Court vacated the Federal Circuit’s decision in Association for Molecular Pathology v. United States Patent and Trademark Office, ordering the appellate court to reconsider the case in light of the Prometheus decision. Order granting cert., vacating judgment, and remanding for further reconsideration, Assn. for Molecular Pathology v. Myriad Genetics, No. 11-725 (March 26, 2012). The Federal Circuit’s decision in Myriad upheld the patentability of isolated genes as compositions of matter, finding that such isolated genes were sufficiently distinct from their naturally occurring counterparts to warrant protection. Ass'n for Molecular Pathology v. United States PTO, 653 F.3d 1329, 1351 (Fed. Cir. 2011). The Federal Circuit also held that method claims for screening potential cancer therapeutics via changes in cell growth rates were patentable, but method claims for comparing or analyzing gene sequences were unpatentable. Id. at 1357–58.

The Court in Prometheus held that unpatentable laws of nature could not be rendered patentable by simply adding steps consisting of “well-understood, routine, conventional activity already engaged in by the scientific community.” 566 U.S. ___, No. 10-1150 at 11. Rather, the Court held that something significant must be added, but did not specify what would constitute such significance. The law of nature in question in Prometheus was the relationship between concentrations of metabolites in the blood of patients and the effective dose of a drug. The Court held that the additional steps recited in the patent—an “administering” step, a “determining” step” and a “wherein” step—did not rise to the level of “something substantial,” and as a result the claimed subject matter as a whole was unpatentable. Thus, the clear take-away from Prometheus was that method claims based on a law of nature needed to do more than add well-understood, routine, or conventional steps to be patentable.

However, the Court’s decision did signal that the holding may be more broadly applicable, stating “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. The Court has apparently followed through on this forewarning by vacating the Federal Circuit’s decision in Myriad, but it is not entirely clear how Prometheus will affect the Federal Circuit’s decision in Myriad.

With respect to the method claims involved in the Myriad case, the holding of Prometheus appears to be readily applicable. The Federal Circuit’s conclusion that methods for comparing or analyzing gene sequences are not patentable is underscored by Prometheus’ requirement for “something substantial.” The Federal Circuit’s conclusion regarding method claims for screening potential cancer therapeutics presents a much closer question after Prometheus. The appellate court’s conclusion that such method claims were patent-eligible rested on the inclusion of “growing” and “determining” steps. Ass'n for Molecular Pathology, 653 F.3d at 1357–58 (Fed. Cir. 2011). Given that these “growing” and “determining” steps were well known in the prior art, it is unlikely they would constitute anything more than “simply appending conventional steps, specified at a high level of generality, to . . . abstract ideas.” Prometheus, No. 10-1150 at 10–11.

The more complicated question for the Federal Circuit on remand is whether Prometheus disturbs the conclusion that isolated genes are patentable. On one hand, Prometheus can be read to apply only to claims that involve appending steps to otherwise unpatentable subject matter. Under such a view, Prometheus would not disturb the Federal Circuit’s conclusion because the court’s decision was based on the nature of the isolated genes themselves, not on the inclusion of any other subject matter. Since the court concluded isolated genes were sufficiently distinct from their naturally occurring counterparts, and thus were not exempted from patentability as “natural phenomena,” nothing more is required to render them patent eligible.

On the other hand, Prometheus could be read more broadly to preclude patent-eligibility for any subject matter that involves nothing more than natural phenomena altered or modified using routine or conventional techniques, particularly where such techniques are themselves natural phenomena. Under such a broad view, isolated genes may not constitute patent-eligible subject matter. The Federal Circuit may be reluctant to take such a broad view of Prometheus. As stated by Judge Moore in her concurrence in the Myriad decision, “I believe we must be particularly wary of expanding the judicial exception to patentable subject matter where both settled expectations and extensive property rights are involved. Combined with my belief that we should defer to Congress, these settled expectations tip the scale in favor of patentability.” Ass’n for Molecular Pathology, 653 F.3d at 1367 (Moore, J. concurring).

Depending on how the Federal Circuit addresses Prometheus in its reconsideration of Myriad, and how the Supreme Court views the Federal Circuit’s reconsideration, there may be much more to come with respect to patent-eligibility of genes.