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Prometheus v. Mayo and Classen v. Biogen Sent Back to Federal Circuit


Not unexpectedly, today the Supreme Court granted cert. in Prometheus v. Mayo, (09-490) vacated, and remanded to the Fed. Cir. for reconsideration in view of Bilski v. Kappos, decided yesterday. While this clears the Court’s collective desk, I don’t see anything in Bilski that would either cause the Fed. Cir. to reverse its original decision or cause the Supreme Court to reverse an affirmance.  As you will recall, the claims in Prometheus were directed to a method of administering an immunosuppressive drug and monitoring the level of its metabolites to determine the appropriate dosage. While the Fed. Cir. found that certain of the steps were “mental steps,” the panel both found the administration steps and the sampling steps to be transformative, and strongly reaffirmed that methods of medical treatment were patentable methods or processes under s. 101. Given that the M or T test is still viable and given that even the Justices who sided with Justice Stevens should find that these claims are not directed to a business method and involve more than simply organizing human activity, it is hard to envision what circumstances would cause any of the Justices to reverse a decision below that the claims are patentable subject matter.

The Supreme Court also granted cert., vacated and remanded Classen Immunotherapeutics Inc. v. Biogen IDEC (08-1509) for reconsideration in view of Bilski. The Fed. Cir. summary affirmance of the district court’s holding that the claims of US Pat No 5,723,283 are invalid as failing the M or T test was the subject of one of my first posts on this blog in March 2009. The claims were directed to determining whether or not an immunization schedule is effective in treating a chronic immune-related disorder. Claim 1 contains the steps of immunizing mammals with dose(s) of immunogens according to the schedule and comparing the results with that of a control group. The district court found that the claims were invalid; an attempt to patent a natural phenomenon. The Fed. Cir. affirmed on the basis that the claims fail the M or T test. I argued at the time that immunization transforms the immune system. The immunization schedule can, in some cases, ameliorate the symptoms of the disorder. Regardless of whether or not the Fed. Cir. reapplies the M or T test, this claim is not directed to an abstract idea or a law of nature. The Fed. Cir. got it wrong the first time, even if it were proper to use the M or T test as the sole test to evaluate whether this method is patentable subject matter (which we now know it is not). The Bilski decision gives the court a rare opportunity to change its mind.

As I have noted in earlier posts, more problematic are certain of the diagnostic or “screening” method claims the Fed. Cir. will be required to consider after the Ass’n of Molecular Pathology (read “ACLU”) vs. USPTO and Myriad district court decision crosses their threshold.  The ultimate decision in this case will not turn on whether or not a diagnostic method is a business method, since none of the parties ever urged that it is. (Query: Is a surgical method a business method? What about a chiropractic technique?)

“Abstract idea” was also not defined by the Court’s opinion, and since this exception to patentable subject matter sealed Bilski’s fate, should we now be asking: “Can diagnostic methods be so technologically disembodied that they are ‘abstract ideas’”?  Judge Sweet found that the “analyzing” and “comparing” steps in Myriad’s screening claims were abstract mental processes that failed the M or T test.  Of course, post-Bilski, the Fed. Cir. has more to work with than just the M or T test – too bad we don’t know how much more!

Appeal Summary Disposition


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