The Association for Molecular Pathology (AMP) has petitioned the Supreme Court to review the Fed. Cir.’s opinion of July 29th, that isolated BRCA DNA sequences are patentable subject matter. Its brief (a copy available at the end of this post) contains little that is new in the way of argumentation, and relies heavily on the “rule” it found in Chakrabarty that a composition of matter must possess markedly new characteristics upon isolation, as compared to its naturally-occurring state, in order to be patent eligible.
But as the year closes, let’s take a minute to mourn what was lost in July. As I noted in my July 31st post on the decision, “The one hundred plus pages of opinion spent only about five pages on the ‘diagnostic’ method claims….Judge Lourie took care to distinguish the transformative elements of the claims at issue in the Prometheus decision from the minimalist Myriad method claims.” In fact, Judge Lourie found that the method claims which only involve “comparing” and “analyzing” DNA sequences fail the M&T test and are no more than abstract ideas. However, in re-reading the opinion, I was surprised to note that at least one “diagnostic method” claim was also found patent-ineligible. Claim 2 of the ‘857 patent reads:
“A method for diagnosing a predisposition for breast cancer in a human subject which comprises comparing the germline sequence of the BRCA2 gene or the sequence of its mRNA in a tissue sample from said subject with the germline sequence of the wild-type BRCA2 gene or the sequence of its mRNA wherein an alteration in the germline sequence of the BRCA2 gene or the sequence of its mRNA indicates a predisposition to said cancer.”
This claim goes beyond simply comparing a patient sequence with a reference sequence to see if there are differences – it requires the “comparer” to draw a conclusion from the comparison, and a rather important one at that. The train of logic that might have, but did not, lead Judge Lourie to a conclusion that this claim is sufficiently concrete to be patent-eligible begins at page 50 of the slip opinion:
“Limiting the comparison to just the BRCA genes or…to just the identification of particular alterations, fails to render the claimed process patent eligible. As the Supreme Court has held, ‘the prohibition against patenting abstract ideas cannot be circumvented by attempting to limit the use of the formula to a particular technological environment’ [citing Bilski and Diehr, quoting Flook), Although the application of a formula or abstract idea in a process may be patentable subject matter…Myriad’s claims do not apply the step of comparing two nucleotide sequences in a process. Rather, the step of comparing two DNA sequences is the entire process claimed [then going on to reject the argument that the steps of extracting DNA and sequencing it are inherently present in the claims].”
But look how this analysis goes off the rails. It is simply not the case that claim 2 does not “apply the step of comparing two nucleotide sequences in a process,” whether or not obtaining and sequencing the patient’s DNA is a step of the process. The claim is to a method of making a diagnosis. It goes beyond “mere data gathering steps.” There is absolutely no prohibition to including a “thinking step” in a method claim. It could be that the panel did not address this claim specifically because Myriad did not argue its concreteness separately from its other arguments. It may prove the most significant loss to the biotechnology industry and to “personalized medicine” in recent years. Worse yet, coupled with Cybersource v. Retail Decisions (processes that can be carried out entirely mentally are patent-ineligible), it grades the bumpy road for the Supreme Court to eventually hold – the question is not presented in Prometheus – that patents on diagnostic methods using single, or few, biomarkers are patent ineligible. Myriad should be petitioning for cert.