In its recent landmark Bilski non-decision, the Supreme Court held that the now-famous “machine-or-transformation test” (MOTT), although “a useful and important clue,” is not the sole test for determining the patentability of process claims. Fortunately for the legion of lawyers who will now earn vast sums of money litigating the question, the Court did not indicate what other test might apply. Well, to the chagrin of the lawyers, the Court Of Appeals For The Federal Circuit (CAFC) has now stepped in to fill the vacuum.
(Prometheus Laboratories, Inc. v. Mayo Collaborative Services (d/b/a Mayo Medical Laboratories) et al.)
Prometheus sued Mayo for infringement of two patents directed to methods for determining the optimal dosage of drugs used to treat certain autoimmune diseases. Mayo moved for a summary judgment of invalidity, arguing that the patents-in-suit were directed to non-statutory subject matter. The trial court granted this motion and Prometheus appealed.
The CAFC reversed, holding the claims valid under what was then its “definitive test” for determining whether a process is patentable subject matter, namely the “machine or transformation test.” Prometheus petitioned for a writ of certiorari, which was granted. The Supreme Court, having already handed down its Bilski non-decision, reversed the reversal and remanded the case back to the CAFC for reconsideration, bringing us to the present decision.
Essentially, the asserted claims recite: a) administering a drug; and b) determining the level of one of the drug’s components in the patient, “wherein” a level of the said component in one range indicated a need to increase the amount of the drug subsequently administered to the patient, and a level of the component above a certain point indicated a need to decrease the amount of the drug to be subsequently administered.
Mayo had argued – successfully at the trial court level – that the patents impermissibly claimed natural phenomena, namely “the correlations between, on the one hand, [the drug component] levels and, on the other hand, efficacy and toxicity – and that the claims wholly preempt[ed] use of the natural phenomena.” The court agreed, finding “that the ‘administering’ and ‘determining’ steps are merely necessary data-gathering steps for any use of the correlations … and that the [“wherein” clause] … is only a mental step.”
The CAFC had, of course, disagreed, holding that “both the ‘administering’ and ‘determining’ steps were transformative and not merely data-gathering steps under the second [transformation] prong of the test, and as such the claims did not wholly preempt the use of the recited correlations between [drug] levels and drug efficacy or toxicity.”
Now that the matter was again before the CAFC, with a gentle hint from the Supreme Court to conform with the Bilski indecision, the CAFC took great pains to remind everyone – including the Supreme Nine – that they (the Nine) had “consistently construed [the standard for patentability] broadly” and that “Congress took this permissive approach to patent eligibility to ensure that ‘ingenuity should receive a liberal encouragement.’” Also, as the Nine had previously held, “an application of a law of nature or mathematical formula to a known structure or process may well be deserving of patent protection.” Thus, the question to be answered, by the remand, was “whether the claims are drawn only to a particular application of that phenomenon.”
After this fine introduction, the CAFC went on to repeat its earlier decision. “The Supreme Court’s decision in Bilski did not undermine our … analysis of Prometheus’s claims and it rejected the machine-or-transformation test only as a definitive test.”
Having thus covered its judicial behind and paid lip service to the Supreme Court, the CAFC FINALLY explained its application of the MOTT to the subject claims. “The transformation is of the human body and of its components following the administration of a specific class of drugs, and the various chemical and physical changes of the drugs’ [component] that enable their concentrations to be determined … The asserted claims are in effect claims to methods of treatment which are always transformative when one of a defined group of drugs is administered to the body to ameliorate the effects of an undesired condition … The administering step, therefore, is not merely data-gathering, but a significant transformative element …”
Just to avoid any questions, the CAFC went on, “we also hold that the determining step … is transformative as [s]ome form of manipulation … is necessary to extract the [drug component] from a bodily sample and determine their concentration … the determining step, by working a chemical and physical transformation on physical substances, likewise sufficiently confines the patent monopoly, as required by the machine-or-transformation test.”
In closing, the CAFC seized the opportunity to quote its own earlier Bilski decision, “it is inappropriate to determine the patent eligibility of a claim as a whole based on whether selected limitations constitute patent-eligible subject matter … it is irrelevant that any individual step or limitation of such processes by itself would be unpatentable …”
So there it is – the latest word on MOTT. We hope that makes it clear!
THE LESSON TO BE LEARNED: Sometimes it’s the CAFC, not the Supreme Court, that gets the last word.
I've long thought that the "transformation is of the human body" angle is a rather weak argument. Judging from its decision to remand, possibly the SCOTUS itself thought so too. However, if the Court really wanted to rid the world of such method patents, then it certainly didn't serve its own purposes by issuing the weak decision (or, as you say, "non-decision") that it did in Bilski.