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« SAP America, Inc. v. Versata Development Group, Inc. (PTAB 2013) | Main | Novo Nordisk A/S v. Caraco Pharmaceutical Laboratories, Ltd. (Fed. Cir. 2013) »

June 19, 2013

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Listed below are links to weblogs that reference Does the Myriad Decision Presage a Golden Age of Patent-Free Personalized Medicine?:

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When I read "and no less a legal luminary than Nina Totenberg" I immediately become...

Kevin,

Nice article. A Pyrrhic victory indeed! Maybe those media pundits, as well as the ACLU/PubPat should stop "crowing" about how they "won" in the Myriad decision.

Not so fast.

These claims are indeed specific and might well withstand the new post-Mayo, post-Myriad jurisprudence (who knows?). But see below.

Who knows if Myriad will sue, but deep-sequencing of multiple genes can be done many ways. Let's see how folks do their tests before deciding they're going to be infringing. No one is going to do a multi-gene deep sequencing test using Sanger or hybridization, and you don't do BRCA genotyping of patient samples on tumors (and several claims you cited are for tumor samples, see below).

Claim 4 of '857 would cover Sanger, but not NGS since NGS does not entail electrophoresis (step a).

Did you stitch together two claims in your editing of claim 9 of '441? One refers to genomic the other to tumor. The first half suffers the same fate as the claims invalidated by CAFC in its first (and affirmed in its second) ruling (the invalidated claims also included the language about sample origin--not sure why you italicized it). The second half (seemingly a different claim) is for tumor, and not relevant to Dx genotyping of a person.

Claims 3 and 4 from the '999 patent are method-specific and not infringed by NGS. One is hybridization; the other has amplification step and electrophoresis.

And claim 10 of '001 is for a tumor sample, again not genomic from a person's blood or cheek swab.

I don't think you've made your case. Or maybe I've missed something.

My sense of a subtractive algorithm: If it entails electrophoresis, can be worked around easily. If it involves tumor sample, not relevant for testing genomic DNA from an individual. If it involves hybridization, easy to work around.

It's gonna depend a lot on details of the methods. And here's a general heuristic. If the claims are so broad they cover NGS sequencing, they are likely to be so broad they fall afoul of Mayo, because no one foresaw NGS until recently. There may be an NGS-infringed claim on non-tumor BRCA testing, but I don't see it here.

Some of the later method claims might survive, but they will be to very specific mutations (check out the claims in US 7,993,835). I can't tell if that survives Mayo or not. But if so, it would be for one rare BRCA2 deletion and surely not gonna command an injunction, and damages would be restricted to hits on a very rare mutation so tiny percent of tests.

BCD

"When I read "and no less a legal luminary than Nina Totenberg" I immediately become..." Skeptical

As do I, Skeptical.

Yes, claim 9 in '441 is incorrectly transcribed. The correct version doesn't have any tumor language:

1. A method for screening germline of a human subject for an alteration of a BRCA1 gene which comprises comparing germline sequence of a BRCA1 gene or BRCA1 RNA from a tissue sample from said subject or a sequence of BRCA1 cDNA made from mRNA from said sample with germline sequences of wild-type BRCA1 gene, wild-type BRCA1 RNA or wild-type BRCA1 cDNA, wherein a difference in the sequence of the BRCA1 gene, BRCA1 RNA or BRCA1 cDNA of the subject from wild-type indicates an alteration in the BRCA1 gene in said subject.
9. The method of claim 1 wherein a germline nucleic acid sequence is compared by amplifying all or part of a BRCA1 gene using a primer specific for a specific BRCA1 mutant allele and detecting the presence of an amplified product, wherein the presence of said product indicates the presence of said specific allele.

This seems like the broadest protection Myriad has left, except that I'm not sure we know what cDNA means anymore. If cDNA can only be defined the way it is in the opinion: ~composite DNA with the introns removed, it's hardly useful in an assay that identifies fragments, since there are no introns to remove. The assays wouldn't use RNA in any case.

An excellent and interesting post, as always, Kevin--thanks. I am however wondering whether these claims would indeed be limited to covering only the particular mutations disclosed, as the plain language of, e.g., '441 claim 9 does not recite the names of the mutations. While Myriad might lose if trying to assert such a claim against a screen for a 'new' mutation for lack of enablement or written description, it also seems possible that they would win by virtue of having met those requirements by describing a sufficient number of examples. However, I have not looked at the prosecution history, so perhaps something in there is limiting.

BCD, I don't think Kevin was making the case that the announced BRCA testing would inevitably infringe Myriad's remaining claims. My takeaway is that the Supreme Court decision didn't really change what Myriad's competitors are free to do or not. In my opinion, the ACLU won the case when the Federal Circuit struck down Myriad's broad "comparing" method claims. The ACLU could have stopped there because the rest of the challenged claims are irrelevant to its case. Why they persisted in challenging, for example, methods of drug screening when Harry Ostrer never expressed any interest in screening drugs is beyond me. Myriad's other claims, to full-length genomic sequences, can easily be designed around and we can assume that Myriad's competitors knew that all along. The upheld cDNA claims are likewise already being laughed off as irrelevant. And the fragment claims, under a PTO "broadest reasonable claim construction" are invalid anyway for other reasons and could have been wiped out in a simple ex parte reexamination.
So I think this whole Supreme Court appeal, from the ACLU's perspective, was just gravy. In the meantime there are companies that work in beverage manufacturing or industrial microbiology whose claims were just sacrificed by the hundreds, and who don't quite know what to think about the "we won!" banners that went up at Cardozo Law School.

I think Moocow is mostly right here.

On the other hand, I do wonder about claims 1 and 9 of the '441. Here's claim 1 with the "or" clauses removed.

"1. A method for screening germline of a human subject for an alteration of a BRCA1 gene which comprises comparing germline sequence of a BRCA1 gene ... with germline sequences of wild-type BRCA1 gene ... wherein a difference in the sequence of the BRCA1 gene ... from wild-type indicates an alteration in the BRCA1 gene in said subject."

I don't think that's an enforceable claim, for the same reasons that claim 1 of the '857 went down.

All claim 9 does is generically describe an old method for obtaining the sequence. That's not going to save it from ineligibility.

I'm curious as to whether anyone has thoughts about the eligibility of mixtures consisting only of individually ineligible polynucleotides (say, a new mixture of two ineligible primers). Does Myriad/Funk nix all such claims or ...?

Dear Bob:

I am not saying that third parties will inevitably infringe any of these claims. Just that it is not the case that they inevitably will not. We shall see, but Moocow is correct that access to this technology for third party providers (as opposed to patients) was achieved when the broad method claims were invalidated. For the same reasons that these claims should remain patent eligible they are also easier to design around.

Thanks for the comment.

Shrivan - to state it in a way Justice Thomas would understand: "Primer 1 is ineligible, primer 2 is ineligible, and primer 3 is also ineligible. Put them all in a vial, and they're all ineligible together."
Don't overanalyze the opinion. Just by asking your question you've probably expended more mental effort than what went into the decision :)

"Under circumstances where asserting their patent rights throughout this case put the patent rights of many biotechnology companies at risk for patents Myriad itself admitted were not critically important to protect their commercial interests, it would be regrettable if Myriad did not defend their remaining method claims with the same vigor and tenacity."

Regrettable? Are you sure you didn't mean "refreshing"?

Kevin, I have been in the trenches of attempting to obtain diagnostics methods claims since Prometheus. And I can tell you that it is unlikely that the USPTO would issue any of those methods claims noted above now. Currently, they are requiring a method of treatment step to follow the diagnosis step, even where the correlation is novel. I have tried to get claims directed to once the correlation is found, additional testing is performed, but USPTO will not allow those, I've found. They've very broadly construed Prometheus. Not that this matters all that much for the eventual Fed Circuit weigh-in of the Myriad diagnostics methods claims, but just thought I'd mention it. I guess my take on this is that the 101 eligibility of the Myriad-type diagnostics methods claims (where the correlation is actually novel)in the absence of a treatment step, really haven't been decided yet.

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