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« A Primer on Claim Construction -- Comments on Dr. Mason's Response | Main | Washington College of Law Post Argument Discussion of AMP v. Myriad »

April 11, 2013

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Comments

Kevin,

Thanks for rendering "order" out of this "chaos."

Kevin,

One other comment. As I noted in my comment below, I agree with you that we patent attorneys share some responsibility for the confusion over what these nucleotide patent claims cover. But what I'm very concerned about is that the views of these scientists, academic or otherwise, on what these nucleotide patent claims cover is being given undue credibility that they frankly don't deserve, be it in court cases or by the popular media. That's my biggest concern and beef here.

Kevin,

I agree. I have seen these "peer-reviewed" articles submitted as exhibits at trial. However, they are not peer-reviewed in the practicing/academic legal community, but the academic/scientific community. Unfortunately, a saying comes to mind: "Great minds think alike, but fools seldom differ."

It is understandable that many scientists, physicians, and lawyers who aren't patent practitioners tend to misinterpret the meaning of patent claims. It is baffling, however, that they are bold enough to publish on a topic they do not understand. Nevertheless, the public listens to them.

Another critical point they don't seem to understand is that secrecy is often the next best alternative for any category of technology where patent protection is stripped away (Kevin's reference in the last sentence). I wonder how long it would have taken for others to figure out PCR if Cetus had kept it secret rather than patented?

Kevin,

Very interesting discussion and right on point. But of course, I am a patent practioner who has been involved with patenting isolated polynucleotides for the last 20 years. The question in my mind is: how can the Supreme Court exclude "gene patenting" (as understood by the lay press) without diluting investments in other technologies ? If there is reason to exclude patenting polynucleotides that have corresponding sequence in nature, isn't that for Congressional action and not the Court ?

Dear Antoinette:

In theory they could render a very narrow decision based on the uniqueness of human DNA (akin to Judge Sweet's opinion distinguishing DNA from other biomolecules) that might leave DNA from other organisms patent eligible.

And while you are right that this should be up to Congress, the Court is exercising its supervisory powers to ensure that the PTO is executing laws falling within Congress's power to enact.

Thanks for the comment.

Kevin, I agree that more dialogue (and fewer assumptions) are needed to come to an understanding, especially in the science community, about what these patents cover and what rights they confer.
I think there is more going on here than a lack of dialogue and mistaken assumptions, however. Dr. Mason did not disclose his active involvement in the Myriad litigation, and he openly sought to influence the outcome of the pending Supreme Court case both in his paper and elsewhere. He has been researching this question for years and has been interacting with the lawyers (some of them patent lawyers) at PUBPAT and the ACLU. Given his longstanding professional involvement with the issue, I find it, frankly, hard to understand how he could now misunderstand the operation and meaning of patent claims in ways that allowed him to reach such a convenient result at such a convenient time. The ACLU made repeated reference to his recent paper in its reply brief to the Supreme Court. And his article was actively played to the popular press at a strategic point in time.

Kevin,
Thanks for a very interesting article. Couple of comments as a scientist who does not practice law:
Although you make the point that an important part of "gene patents" is the capability to produce the full-length protein for use as a diagnostic or therapeutic, the claims related to 15-mer DNA molecules are also very important. Two DNA molecules 15-25 nucleotides in length are required for PCR amplification of a gene (potentially useful as a precursor to sequencing of portions of a gene). Likewise, a single short DNA molecule is used to initiate Sanger sequencing of a gene. Slightly longer DNA molecules (often between 25 and 60-mer) are attached to a solid support (microarrays, for instance) for analysis of gene expression and for analysis of DNA copy number. As a result, I find claims 5 and 6 of '282 to be quite worrisome.

To address that, I turn to your discussion of Kepler et al. Quoting from above:
"Rather, it is that claims of this scope are invalid, since the prior art is much more replete with these sequences than was expected."

If one can demonstrate a single nucleotide sequence deposited prior to the BRCA1 discovery that contains a 15-mer in common with the BRCA1 coding sequence (likely), would a court likely invalidate '282 claims 5 and 6 completely? Or as an alternative, would the claim be whittled down to those DNA molecules that were novel at the time of filing?

I would hope that '282 claim 16 could also be invalidated under similar grounds. It could be construed to apply to PCR pairs for much of the chromosome 17.

Dear Greg:

I suppose one way to address the question is to ask whether companies like Affymetrix (which are producing commercial oligo arrays) have been sued or required to license any primers that were not explicitly claimed. And, of course, to determine whether these were "unique" as that term is now understood with regard to distribution in the human genome.

More to the point, while we might envision interpretations whereby a company could initiate a lawsuit, the fact that no one has is a reminder that companies don't do so lightly.

Thanks for the comment.

Dear Moo:

We don't inquire about Prof. Mason's motives (the ACLU's and PubPat's are clear), mostly because they are irrelevant to this discussion. (If asked, perhaps Myriad's lawyers could refer the Justices to our blog discussion.).

What's important here is that the Professor identify his grounds and bases for his conclusions, and for us to address them. I think in fairness a reader will understand that Prof. Mason's conclusions are at least ill-considered.

Thanks for the comment

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