On September 16, 2009, the Federal Circuit reversed the holding of the district court that a process for monitoring and adjusting a method of medical treatment was unpatentable as attempting to claim non-statutory subject matter (Prometheus Labs., Inc. v. Mayo Collaborative Services, Appeal No. 2008-1403 (Fed. Cir. Sept. 16, 2009)). (A copy of the decision is available at the end of this post.) The patent’s claims at issue recited (a) administering a drug such as AZA that provides 6-TG metabolites to a subject and (b) determining the levels of the metabolites. The measured metabolite levels are then compared to pre-determined metabolite levels and may “indicate a need” (e.g., provide a warning to the doctor) to increase or decrease the amount of drug that is administered so as to maximize efficacy of treatment. Claim 1 of U.S. Pat. No. 6,355,623 begins: “A method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder, comprising (a)….”
Applying the transformation test set forth in Bilski, Judge Lourie, writing for the panel, considered almost every aspect of the “natural phenomena” debate surrounding the patent-eligibility of methods of medical treatment and diagnosis. The court found that both the administering steps and the determining steps are “transformative.” Judge Lourie wrote:
“The asserted claims are in effect claims to methods of treatment, which are always transformative when a defined group of drugs is administered to the body to ameliorate the effects of an undesired condition….The transformation here…is the result of the physical administration of a drug to a subject to transform–i.e., treat–the subject, which is itself not a natural process.”
The court also found that the determining step is also transformative and central to the claimed methods, since “[d]etermining the levels of [the metabolites] in a subject necessarily involves a transformation … it is necessary to extract the metabolites from a bodily sample and determine their concentration…this transformation [of clinical samples] is central to the purpose of the claims…Measuring the levels of [the metabolites] is what enables possible adjustments [in the administered drug].”
The court went on the hold that the administering and determining steps are not merely “insignificant extra-solution activity” but “[i]stead the administering and determining steps are part of a treatment protocol, and they are transformative….the claims are therefore not drawn merely to correlations between metabolite levels and toxicity or efficacy.”
The court went further to clarify that the presence of mental steps, e.g., recognition that a dose modification may be needed, does not detract from patentability. While the court agreed that the “wherein” clauses are mental steps and not patent-eligible per se, it stated that “the final step of providing a warning based on the results of the prior steps does not detract from the patentability of the … claimed methods as a whole…The addition of the mental steps to the claimed methods thus does not remove the prior two [administering and determining steps] from the [the realm of patentable subject matter].” (citing with approval In re Abele, 684 F.2d 902 (CCPA 1982.)) At least the court did not agree that the correlating steps are themselves natural phenomena, which was part of the district court’s opinion.
Furthermore (and importantly), the court held that the claims do not wholly preempt use of correlations between metabolite levels and efficacy or toxicity of the administered immunosuppressive drug: “As discussed above, the claims are to transformative methods of treatment, not correlations…Moreover the claims do not preempt natural processes; they utilize them in a series of specific steps…because the claims meet the machine-or-transformation test, they do not preempt a fundamental principle.” (This is an interesting “rule” that perhaps was developed to show the utility of the Bilski M or T test. It also can easily be extended to rebut Justice Breyer’s dissent in Lab. Corp., 548 U.S. 124 (2006) in which the dissenters argued that a diagnostic method that recited an analyte-determining step and a correlating step simply was an attempt to claim a natural phenomenon.) Earlier in the opinion, Judge Lourie reiterated the rule that “the patent eligibility of a claim as a whole should not be based on whether selected limitations constitute patent-eligible subject matter (citing Diehr and Parker v. Flook).
Finally, and this is my opinion, the next action of the Federal Circuit should be to reconsider and withdraw its summary affirmance in Classen v. Biogen IDEC, supposedly compelled by Bilski, of a district court ruling that a claim to a method of evaluating a treatment method that involves a vaccination protocol was not-patent eligible. As discussed in my March 2009 post in this blog on Classen (2008 WL 5273107 Fed. Cir. 2008). There is no question that a vaccination method that is, in effect, a method of treatment of an immune-mediated disorder, is transformative of the vaccinated subject.