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« USPTO Adopts New Measure of Patent Examination Quality | Main | Biotech/Pharma Docket »

October 13, 2010

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Kevin,

Very interesting article. Your point about the danger of "at-home" testing to assess for risks as serious (and as complex) as these is "spot on." In fact, the folks who wrote and published this article are at risk of more than inducing patent infringement. What if someone did this "at-home" testing and through ignorance missed a "warning sign" for either breast or ovarian cancer that Myriad's testing would have found? We're now talking about potential tort liability if that person later develops that cancer. Just some thinking out loud.

Huh? What does that tell us about the ACLU's assertion that patents on "isolated" or "purified" DNA molecules (like the BRCA sequences in the Myriad case) are impossible to design around?

That aside, I don't think there would ever be a realistic risk that even the broad and generalized method claims would be asserted against Dr. Salzberg or anyone else - because the described method simply doesn't interfere with Myriad's business. No patient, and no provider, would ever decide to perform a mastectomy, oophorectomy, or any other medical procedure on the basis of a computational at-home test alone, without the confirmation of a real CLIA-certified diagnostic test. If anything, Salzberg's method would generate more business for Myriad and other test providers.

We should keep in mind that taking one's temperature might require the use of a patented thermometer!

Inflammatory? "but because of gene patents, the act of reading one's own genome may require the permission of a private company."

Highly dependent on just how that act of reading was undertaken, and like myriads (pun intended) of other patented methods that may be done at home, just as protected.

Kevin,

Thanks for this analysis. I'm not so sure about the quick dismissal of the composition of matter claims in the '282 patent on BRCA1, and its equivalent claims on BRCA2. By my reading, those claims would arguably be infringed by any method that would be an input to the Salzberg process. Any way of determining a DNA sequence of which I am aware, including single-molecule methods and most certainly any first- or second-generation method that entails "DNA prep" before sequencing steps, is arguably creating "isolated" DNA. Any sequence would also generate sequences longer than the 15-mers claims for both genes (claims 5 and 6 of '282).

It turns out these claims are probably invalid based on novelty, but that has not been determined. None of us can know how courts will interpret scope of these claims until and unless a court makes such determination. To my knowledge there is zero case law on this, and even the AMP v USPTO case is now about section 101 patent-eligibility, not 103 novelty. Perhaps we will get to questions of novelty and enablement/written description in that case after appellate review, but we're not there now.

Your points about DIY diagnosis and caution are quite interesting and a vexing policy matter. But not about patents.

To my eyes, both the composition of matter claims and the method claims in these BRCA1 and 2 patents (and others like them on other genes) are quite broad and might well be deemed infringed; then we'll have to figure out if the claims infringed are valid. And then we can choose sides about whether granting patents with such claims in them is a good idea or not as a policy matter.

Dear Bob:

I confess that it has been a long time since I left the lab, but I don't think the kind of whole genome sequencing discussed in the paper would infringe any of the composition of matter claims. But I have been a patent attorney long enough to know it could be raised; I just don't think very successfully. And remember: a broad claim is not necessarily a good thing, since it provides a bigger target for invalidity.

Thanks for the comment.

Dear Moo:

I wrestled with writing "de minimis non curat lex" in the post, but I agree with you - while probably providing a frisson of "taking it to the Man" in the authors, I don't think such "at-home" tests will supplant CLIA-verified testing labs. But I do think the sentiments expressed by the authors reveal the danger that public opinion has been swayed to the view that there is something "wrong" with permitting companies like Myriad from making such tests available to the public, and that the at-home version is a viable alternative.

Thanks for the comment.

Funny how exactly the thing I brought up a few months ago has now become a reality.

It's like every other comment I make on your blog foretells the future Kev.

"patented thermometer!"

Do you have thermometer's, unisolated, in your body atm?

does brca cDNA occur naturally? I know they can pinpoint the 1/2's exact position in the genome, but can someone clarify to me the cDNA claim portion? cDNA is present in some viruses and is arguably the same in function.

Dear CL:

The short answer to your question is "no" for the BRCA genes. But I need to expand the explanation a little.

The claim is to an isolated cDNA encoding the BRCA gene having a specific sequence. It is not to all "cDNAs" so that the existence of viral cDNA (having a different sequence) does not impact the claim. No one is claiming all cDNAs of all sequences.

I could make an argument that the "isolated" part even distinguishes viral cDNA in cells from viral cDNA isolated from the cell, but I don't need to in order to provide an answer to your question. But consider: if I discover and isolate an improved lubricant from crude oil, can I patent it? If I can, why not an isolated DNA?

Thanks for the comment.

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