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.

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4 Responses to Can AMP v. Myriad Revive Diagnostic Method Claims?

  1. EG says:

    Hey Warren,

    May be Claim 2 of the ‘857 patent should be reconsidered by this Federal Circuit panel in view of the decision handed down by the Supreme Court per the statement (no. 2 of the 3) which were not at issue in the Supreme Court’s decision.

  2. Karen Canady says:

    Warren,
    Doesn’t this seem consistent with their unanimous decision in Mayo? Claim 4 recites (quite a number of) assays by which the detection is achieved — presumably what Mayo requires to limit the claim to an *application* of the principle and get beyond merely reciting mental steps. Claim 3 of the ‘857 patent is particularly interesting, as it only adds “wherein an alteration is detected in a regulatory region of the BRCA2 gene” to claim 2. This does not recite any assay, but it does require that some actual detection take place. Is “detecting” better than “comparing”? There may be limits to the conclusions we can draw, but clues likely reside in the difference between the challenged claims and the unchallenged claims, particularly when viewed in light of Mayo.

  3. Nice list of do’s and Don’ts. It will help newbies as well as experience designers and through this they can came to know about which points they have to consider and which are ignored.

  4. To the extent that modern sequencing technologies require the synthesis of replicates of the native sequence, doesn’t a claim to a ‘recombinant’ or ‘synthetic’ nuceic acid comprising a particular sequence variation catch any sequencing assay for that allele? Maybe the cDNA exception is a place to hang our hats. This doesn’t catch the act of diagnosis, but that seems to be off the table already. There will also be thorny novelty issues, but fragment length limitations might work to address that issue.

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