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March 26, 2009

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Noonan: 1
Cook-Deegan: 0

Kevin "I disagree that your proposals would weaken patents at the margins -- the proposals in your commentary would impose your concepts of morality and public benefit -- patient rights -- for mine, or others."

This is rather confused. First of all, we do live in a representative democracy. Nobody, not even Cook-Deegan, is proposing a dictatorship whereby Cook-Deegan's views are substituted for our own. If anything, the morality of those who presently rely on the patent system for monetary gain is very much imposed on everyone, like it or not, and that is not likely to change in our lifetime. You protest too much, Kevin.

Also, it is not clear why Cook-Deegan's proposals would have much effect other than weakening the patent system "at the margins" to achieve the results that Cook-Deegan deems are preferred. Do you believe, Kevin, that efforts to identify genetic tests for disease will cease if Cook-Deegan's proposals are implemented? If so, why do you believe that?

Dear Lurv:

I try not to protest too much, but I also don't think the patent system is imposed on us (any more than anything else the government does is imposed - you take a confusing position yourself for someone reminding me that we live in a representative democracy).

I don't think Mr. Cook-Deegan's proposals act at the margins - they would preclude patent enforceability unless a patentee complied with his ideas of how they should behave. I think those behaviors are socially desirable, but I don't think they should be enforced by putting the patent right at risk.

While I don't think that research into genetic tests will cease if Mr. Cook-Deegan's proposals were implemented, I do think they would not be developed into robust clinical tests. This is because it takes a great deal to establish the reliability of such tests before we permit them to form the basis for patient or physician decisions about treatment. This is absolutely how it should be - we don't want un-verified tests to be used for such important decisions.

But the fact is that there must be some exclusivity involved to justify the investment risk. One way to do this is patents and another is trade secret. The former has the advantage that the method is disclosed (fully, in the U.S. due to the best mode requirement), so that the rest of us get the unfettered benefit of the technology once the patent expires. I think Mr. Cook-Deegan's proposal could drive the technology into trade secret protection, and then the public would not benefit.

So ultimately I am trying to take the long view - short-term exclusivity to promote funding of test development, followed by unrestricted use after patent expiry. I think Mr. Cook-Deegan's approach is short-sighted, because it imposes additional costs that could (and I expect would) inhibit investment in these technologies.

All the research in the world cannot substitute for an actual clinical test. I think that's what everyone wants; we just disagree on how to get there.

Thanks for the comment.

Kevin:

Would you be in favor of a marketing exclusivity scheme for new clinical diagnostics? Right now the laws are such that drugs which are new chemical entities are entitled to a period of marketing exclusivity. This typically doesn't mean very much in the context of drugs because the patents on the drugs extend well beyond any such exclusivity. But this would seem to solve the incentive problem for development of new clinical diagnostics, no? Obviously the compromise is that such diagnostics would need to be subject to a more rigorous approval process than they are now, but is this so terrible? Wouldn't it help to weed out all the junk tests that are out there? I understand that this is complete heresy to many diagnostics companies, but it certainly appears that the days of obtaining and enforcing broad process patents for biomarker correlations are probably over.

Dear Gary:

An interesting suggestion. It is another way to get to the same place - through regulation - and may be an attractive alternative should the Bilski/Breyer/Classen wing of patent jurisprudence prevail.

Thanks for the comment.

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