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« Court Report | Main | White House Unveils BRAIN Initiative »

April 08, 2013

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Don,

Once more, Professor Holman exposes the malarkey about gene patenting. Again, you need to know the law in addition to the science, and Professor Holman knows both well.

Thanks Don. Any idea why was this Mason ignoramus was not cross-examined when the case was before the District Court, so as to thoroughly discredited as an "expert" opining on something about which he knows nothing?

"1. An isolated DNA coding for a BRCA1 polypeptide, said polypeptide having the amino acid sequence set forth in SEQ ID NO:2."

Don, would you like to construe this claim for us? What exactly does it cover and what does it not cover, and why? Does the term "isolation" require that no other DNA sequences be present in the composition? Does it mean 95% pure relative to other DNA sequences? Does it includes sequences greater than 100 kb in length? 500kb?

Thanks.

As you know, many of Myriad's claims (including the claim above) are breathtakingly broad and are almost certainly invalid under one or more patent statutes (besides 101). That issue should have been highlighted (here, by you guys) from the beginning of this controversy and repeated, over and over again, without ambiguity.

"While the authors' analysis may be relevant to claims directed to 15mers"

Is the analysis "relevant" or not? Why not just say so, unequivocally?

Bryan,
what "exactly" a patent claim covers in the abstract is not a realistic exercise. It's much easier to sit down, look at what it is one wants to do, and then decide whether the claim covers the intended activity.

For example, if the polypeptide of SEQ ID NO:2 is the wild-type BRCA1 protein and you want to provide a "second opinion" for a patient having a deleterious mutation that results in a truncated BRCA1 protein - well, in that case there's little risk that you'll be infringing that claim. The encoded protein just doesn't have SEQ ID NO:2.

That said, there's little risk you'll be infringing that claim through any kind of sequencing anyway. The claim requires an 'isolated' DNA of at least 5.5 kb or thereabouts. Sanger sequencing works with shorter fragments. Now, it would be different if you wanted to go into the business of recombinant production of BRCA1 protein. For that, you would need to make/use a full-length sequence, like the one claimed. Actually, I would think that recombinant expression (not diagnostic testing) was what they had in mind with that claim.

I don't think that claim is necessarily invalid for other patentability reasons. It's "breathtakingly broad" only in the sense that it covers any DNA that encodes that very specific AA sequence. Change just one codon from CTT to GTT (valine to leucine) and the encoding DNA sequence is outside the scope of the claim.

Your beef is probably with Myriad's "any fragment 15 bp or longer" claim. That claim is a very uncommon type of claim, and it has patentability problems other than 101, as you point out. Notably, that kind of claim is *not* what Rosenfeld and Mason used for their analysis, maybe because it's so uncommon. The Rosenfeld paper instead identified patents on methods for predicting the juiciness and marbling of beef steaks, and I have yet to figure out what such patents have to do with this debate.

Moocow: It's "breathtakingly broad" only in the sense that it covers any DNA that encodes that very specific AA sequence.

To some extent this is true of all claims written using "comprising" language. But in this case where the only known utility of the sequence at the time of filing was (1) as a probe and (2) as a tool for further research (since when is that a substantial utility?), the breadth is particularly absurd. Quadzillions of different nucleotides of different lengths are covered and only a microscopically tiny fraction were enabled for anything useful as of the filing date.

My comments are certainly more relevant to the shorter claims but they also apply to the claim I recited. You write:

"there's little risk you'll be infringing that claim through any kind of sequencing anyway. The claim requires an 'isolated' DNA of at least 5.5 kb or thereabouts."

But that's the question. What does "isolated" mean? We know from the prosecution history that it doesnt refer to the gene as it exists in the chromosome in the cell. What about when a fragment of the chromosome comprising that sequence is taken out of the cell? Is that fragment "isolated"? When does such a fragment become "isolated"? It's somewhat conspicuous that this obvious question is constantly swatted away with a glib "don't worry about it" by those who seem most invested (emotionally or financially) in the continued eligiblity and/or patentability of Myriad's claims.

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