Medical Method Claims Recite Patentable Subject Matter, Prometheus Notwithstanding

By Charles Bieneman

Categories: Patent Eligibility

Patent claims directed to a method for choosing an immunization schedule recite patentable subject matter even in light of the Supreme Court’s decision in Mayo Collaborative Services v. Prometheus Labs, 132 S. Ct. 1289 (2012), according to the District Court in Classen Immunotherapies, Inc. v. Biogen Idec, No. WDQ-04-2607 (D. Md. Aug. 9, 2012).  The District Court had previously declined to consider the issue of patentability on a motion to dismiss for failure to state a claim, and had stated that additional briefing in light of the Prometheus decision would not be helpful.  However, in this opinion, the court agreed to reconsider its earlier decision, which it then upheld.

Although the patents at issue in this case were in the medical field, the decision here is clearly of interest to those of us who practice in the software arena.  In discussing 35 U.S.C. § 101, the court acknowledged that an abstract idea was not made patentable by the addition of “token post-solution components.”  However, the court distinguished Classen’s claims from the claims at issue in Prometheus.  There, test results within a certain range indicated a recommended dosage level of a drug, but the claims recited no more than reaching a conclusion with respect to the recommended dosage level, and did not positively recite taking any action.

In this case, prior to the Supreme Court’s Prometheus decision, the Federal Circuit had held that claims of two of the three patents-in-suit recited more than mere post-solution activity because they positively recited the physical step of immunization. Now, considering Prometheus, the court stated that the steps at issue there recited well-known activities that could not be taken into the realm of patentability by the application of a natural law.  Here, where it was considering a motion to dismiss for failure to state a claim, the court lacked any evidence on which it could “conclude that the Classen patent claims involve ‘well-understood, routine, [or] conventional activity.’”  Thus, the court thought that “[t]he patents at issue here include the mandatory application step that was missing in the Prometheus claims.”

Taken with the two recent Federal Circuit decisions first finding patentable subject matter in, and then holding unpatentable, patent claims directed to financial processes, this case, if nothing else, teaches that conducting a patentable subject matter analysis remains a foggy exercise.