On Monday, June 28, 2010, the last day of its 2009 term, the Supreme Court finally issued its decision in Bilski v. Kappos. While the case directly addresses the patent-eligibility of “business method patents,” many in the biotech and pharmaceutical industries were concerned that the Court might take this opportunity to limit the circumstances under which diagnostic methods or methods pertaining to personalized medicine are eligible for patent protection. Those of us working in this field breathed a collective sigh of relief that the Court—at least for now—has left this subject matter unscathed.  Our relief was short-lived, however, because the next day the Court vacated and remanded Mayo Collaborative Servs. v. Prometheus Labs., Inc., re-opening the question as it applies specifically to pharmaceutical fields.

The Bilski Majority Opinion

The Court affirmed the Federal Circuit’s decision that Bilski’s methods for hedging risk in the field of commodity trading are not patentable subject matter under 35 U.S.C. § 101. The Court determined that the “machine or transformation test” applied by the Federal Circuit, while a useful “tool,” is not the “only” test for satisfying the statute. Still, the Court agreed that the methods were unpatentable as an “abstract idea.”

Diagnostic and Personalized Medicine Methods Remain Vulnerable

In reaching its decision, the Court recognized only “three exceptions” to the seemingly broad plain, language of the statute: (1) laws of nature; (2) physical phenomena; and (3) abstract ideas.

It is these exceptions, rather than future tests that may be developed to address the patent-eligibility of other business methods, that are most likely to be used to limit the patent protection available to certain diagnostic and personalized medicine methods. Indeed, it is on these grounds that Justices Breyer, Stevens and Souter would have invalidated the diagnostic method claims at issue in Laboratory Corp. of America Holdings v. Metabolite Labs., Inc.

Punt to Prometheus 

Shortly after deciding Bilski, the Court granted certiorari, vacated and remanded Mayo Collaborative Servs. v. Prometheus Labs., Inc. and Classen Immunotherapies, Inc. v. Biogen Idec. The Federal Circuit had applied the machine or transformation test in both cases, upholding Prometheus’ claims to personalized methods of optimizing dosage based on metabolite levels for a specific prodrug-metabolite combination, while invalidating Classen’s claims to methods of evaluating and improving the safety of immunization schedules. On remand, the Federal Circuit is likely to decide whether these types of methods cannot be patented because they claim a phenomenon of nature or abstract idea.  In doing so, the court may formulate a new test for the patent-eligibility of diagnostic and personalized medicine methods.

Stakeholders in these fields should study these cases, and consider filing amicus briefs to inform the Federal Circuit’s decisions.  Until these issues are resolved, we will be holding our breath once again.