Post-Bilski: Federal Circuit to reconsider diagnostic testing and medical methods

In its recent Bilski v. Kappos decision, the U.S. Supreme Court held that business methods are patentable, and the Court refused to accept the Federal Circuit’s “machine or transformation” test as the sole test for determining whether a process is patent-eligible.  In a quiet counterpart to this decision, on the same day the Court also remanded two cases involving medical methods — Prometheus Laboratories, Inc. v. Mayo Collaborative Services and Classen Immunotherapies, Inc. v. Biogen Idec — to the Federal Circuit to reconsider the cases in light of the Bilski decision. 

In Prometheus Laboratories, the Federal Circuit originally found the following claim to be patentable under the pre-Bilski “machine or transformation” test:

A method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder, comprising:

(a)  adminstering a drug providing a 6-thioguanine to a subject having said immune-mediated gastrointestinal disorder; and

(b)  determining a level of 6-thioguanine in said subject having said immune-mediated gastrointestinal disorder;

wherein the level of 6-thioguanine less than about 230 pmol per 8×108 red blood cells indicates a need to increase the amount of said drug subsequently adminstered to said subject and

wherein the level of 6-thioguanine greater than about 400 pmol per 8×108 indicates a need to decrease the amount of said drug subsequently adminstered to said subject.

After the Federal Circuit found claims such as the one above patentable, Mayo appealed to the U.S. Supreme Court.  After receiving the case on remand, the Federal Circuit will now have to review the case under the broader standard for patentable subject matter that the Supreme Court established in Bilski.

In contrast, in Classen, the Federal Circuit found that claims such as the following one did not satisfy the machine-or-transformation test:

A method of determining whether an immunization schedule affects the incidence or severity of a chronic immune-mediated disorder in a treatment group of mammals, relative to a control group of mammals, which comprises:

immunizing mammals in the treatment group of mammals with one or more doses of one or more immunogens, according to said immunization schedule, and

comparing the incidence, prevalence, frequency or severity of said chronic immune-mediated disorder or the level of a marker of such a disorder, in the treatment group, with that in the control group.

In Classen, the Federal Circuit will now need to determine whether claims such as this cover an “abstract idea”.  Alternatively, the Federal Circuit may develop a new test that is not strictly tied to the machine or transformation test. 

These cases show that medical methods and diagnostic testing are setting the stage for the next round of patent subject matter-eligibility caselaw.

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