United States: Patent Eligibility May Not Be Settled for Diagnostic and Personalized Medicine Method Claims

On the heels of its decision in Bilski v. Kappos, the Supreme Court resolved the pending petition seeking review of the Federal Circuit's decision in Prometheus Laboratories, Inc. v. Mayo Collaborative Services, 581 F.3d 1336 (Fed. Cir. 2009). Rather than review this case on its merits, the Court granted certiorari, vacated the Federal Circuit's decision, and remanded the case back to the Federal Circuit for reconsideration in view of Bilski. (Among Supreme Court practitioners, this resolution is referred to as a GVR.)

This turn of events is somewhat unexpected because the Federal Circuit upheld the patent eligibility of Prometheus' method claims under the machine-or-transformation test. Although the majority opinion in Bilski held that the test is not the "only" way to evaluate compliance with § 101, the Court validated the test as a useful "tool." Moreover, in pronouncing its broad interpretation of the statute, the Court did not indicate that diagnostic or personalized medicine methods cannot be patented. Thus, the Federal Circuit's Prometheus decision appears to be wholly consistent with the Supreme Court's decision in Bilski.

Representative claims at issue in Prometheus relate to methods of optimizing the therapeutic efficacy of treatment of an immune-mediated gastrointestinal disorder that involves (a) administering a drug providing 6-thioguanine to a subject and (b) determining a level of 6-thioguanine in the subject, where the determined level is indicative of a need to increase or decrease dosing. Other claims do not recite the administering step.

In its original decision, the Federal Circuit held that the method claims met the "transformation" prong of the machine-or-transformation test. As noted by the court, the "asserted claims are in effect claims to methods of treatment, which are always transformative when a defined group of drugs is administered to the body to ameliorate the effects of an undesired condition." The Federal Circuit also held that determining metabolite levels "necessarily involves transformation" because such levels "cannot be determined by mere inspection."

The GVR could signal to the Federal Circuit that it should give more consideration to whether Prometheus' methods might fall under one of the three "exceptions" to the Supreme Court's broad interpretation of § 101 such as being an unpatentable "natural phenomenon" or "abstract idea." Indeed, Justice Breyer raised this issue in his 2006 dissent to the Court's order dismissing Laboratory Corp. of America Holdings v. Metabolite Laboratories, Inc., 548 U.S. 124 (2006), because certiorari was improvidently granted. In other words, by vacating and remanding Prometheus, the Supreme Court may be deliberately pointing the Federal Circuit toward directly addressing certain issues before the Supreme Court decides whether to weigh in.

The Supreme Court also issued a GVR in Classen Immunotherapies, Inc. v. Biogen Idec, 304 Fed. App'x 866 (Fed. Cir. 2008), where the Federal Circuit summarily held (in an unpublished decision) that claims directed to methods of evaluating and improving the safety of immunization schedules were invalid under § 101 because they did not satisfy either prong of the machine-or-transformation test. This remand is not surprising, because Bilski provides that methods that do not pass this test may nonetheless satisfy § 101.

With the controversial ACLU v. Myriad (BRAC I) case, also pending at the Federal Circuit, the Court will have an opportunity to address and decide many important issues surrounding the patent eligibility of diagnostic and personalized medicine methods.

Review our previous Legal News Alert, "Patent Eligibility of Personalized Medicine Method Claims Confirmed by Federal Circuit in Prometheus Labs., Inc. v. Mayo" at http://www.foley.com/publications/pub_detail.aspx?pubid=6435.

Foley will be discussing the implications of Bilski during a Web conference on June 30, 2010 (see http://www.foley.com/news/event_detail.aspx?eventid=3361).

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