Can AMP v. Myriad Revive Diagnostic Method Claims?
At the end of the Supreme Court’s Opinion, Justice Thomas makes it clear that the Court was impressed by Judge Byson’s dissents in the Fed. Cir. Myriad opinions. Although Judge Bryson was on the Intema panel that sank claims to pre-natal screening for Down’s syndrome, the Supreme Court’s opinion makes his position in Myriad sound like a progressive one that will lead the way to patent-eligible claims:
“Similarly, this case does not involve patents on new applications of knowledge about the BRCA1 and BRCA2 genes. Judge Bryson aptly noted that ‘[a]s the first party with knowledge of the [BRCA1 and BRCA2] sequences, Myriad was in an excellent position to claim applications of that knowledge. Many of its unchallenged claims are limited to such applications.’ 689 F.3d at 1349.”
Well, to what applications is Justice Thomas referring? Remember, Judge Bryson had no problem with Judge Lourie’s nearly summary disposal of the method claims that were on appeal. Also, in Intema, a panel that included Judge Bryson wrote: “The stricken [process] claims [in Myriad] are indistinguishable from those before us [in Intema]…The claims were not over an application of the mental process of comparing [a sequence in a tumor sample with one from a non-tumor sample]. ‘Rather, the step of comparing two DNA sequences [was] the entire process that [was] claimed. [citing to Myriad].’”
The emphasis above on applications is present in both “original” quotations. Would the Supreme Court have ruled differently if the method claims at issue in Myriad been appealed as well as the DNA claims? I went back and looked at the method claims considered by the Fed. Cir. in Myriad. There were only five.
Claim 1 of the ‘999 patent is directed to a method for detecting a germline alteration in a BRCA1 gene. The specific alterations were recited in the claim but that was it. There was no diagnostic conclusion based on the alterations.
Claim 1 of the ‘001 patent was directed to a method of screening a tumor sample …for a somatic alteration in a BRCA1 gene…which comprises comparing a first [BRCA1 gene sequence from the tumor sample…with a second sequence selected from the group consisting of a BRCA1 gene from a non-tumor sample…wherein a difference…. indicates a somatic alteration. Again, no diagnostic conclusion was recited.
Claim 1 of the ‘441 patent is directed to a method for screening germline of a human subject for an alteration of a BRCA1 gene which comprises comparing the sequence from a tissue sample with the sequence of the wild-type BRCA1 gene, wherein a sequence difference indicates an alteration in the BRCA1 gene of the subject. So far, so “good”, since no diagnosis is attained.
Claim 1 of the ‘857 patent continues this thread, claiming a method for identifying a mutant BRCA2 nucleotide sequence by comparing it with the wild-type BRCA2 nucleotide sequence, wherein a difference between them identifies a mutant BRCA2 mucleotide sequence. No diagnostic conclusion for you!
So I was feeling pretty good about the application of such comparisons to diagnose a real-world pathology, until I read claim 2 of the ‘857 patent:
“A method for diagnosing a predisposition for breast cancer in a human subject which comprises comparing the germline sequence of the BRCA2 gene …in a tissue sample from a subject…with the germline sequene of the wild-type BRCA2 gene…wherein an alteration in the germline sequence…indicates a predisposition to said cancer.”
Of course, my heart sank. Actually, the patent ship went down when the Fed. Cir. Myriad panel ruled that this claim was patent-ineligible (twice). Did the Judges –or their clerks just miss this claim? Why isn’t this just the sort of use or application of a naturally occurring DNA sequence that the Supreme Court suggested that they would endorse?
Claims 3 and 4 of the ‘857 patent depend from claim 2 and were not challenged. They are the only other “cancer diagnosis claims” in that patent. None of the unchallenged claims in the ‘001, ‘999 or ‘441 patents are directed to a diagnostic method. The ‘441 patent even has an independent kit claim but the kit is only recited to be useful to screen for an alteration in a BRCA1 gene in a human subject, not to screen for cancer.