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« Biotech/Pharma Docket | Main | Paragraph IV Disputes Conference »

February 04, 2010


So the three members of the SACGHS task force with actual practical experience disagee with its conclusions? Are the other committee members simply telling Sebelius what she wants to hear and to hell with any evidence?

For those interested in listening to the Podcast, here is a link to the BIO webpage with the podcast MP3 File on it (its at the end of the article)


Much of the SACGHS talk was centered around trust and genetic testing. It is strange that those studying genetic testing face unwarrented biases every day, yet don't take the time to research the true meaning and scope of patents. They all cite the Myriad BRAC patent as one that hinders research, yet a new BRAC paper publishes at least every month. Doesn't appear to have been any slow down in BRAC research. They also quote quite frequently that "no one has the right to patent my genome" yet not one valid patent reads on the human as they claim. This is a bunch of arm waving and emotional statements without any factual basis. Not everyone can afford a BRAC test through Myriad genetics (~$2000), but not everyone can afford a full body MRI scan, not everyone can afford AIDS medications, not everyone can afford cancer treatements, ... There are a lot of life saving medications that aren't available to everyone, we should work on that aspect of health care instead of one simple BRAC analysis. There is a lot of evidence that inventions developed in universities would not generate commercial products without small start-up companies. Small start-up companies cannot compete without strong patent protections. If you cut out patent protection, you will reduce the number of marketable products that come out of univerisities and small businesses.


Keep in mind there are two different fronts: 1) composition patents for isolated nucleic acids, and 2) method patents for correlating a disease/condition/trait with the presence/absence of a genetic marker (some people call these diagnostic method patents). Reasonable people can and do disagree over whether composition patents for isolated nucleic acids should be prohibited (I think such patents should not be prohibited). But no reasonable person thinks method patents for generically correlating a disease/condition/trait with the presence/absence of a genetic marker should be permitted. It has to do with promoting the progress of science and the useful arts. The former type of patent accomplishes this to one degree or another, but not the latter. Correlations between disease/conditions/traits and genetic markers will be discovered, and tests based on such correlations will be developed and marketed, regardless of the existence of patents. If anything, patents on these correlation methods interfere with the progress of science and the useful arts. Anyone, and I mean ANYONE, who says otherwise is either intellectually-challenged, or stands to lose financially from the prohibition of such patents. That is all for today.

Dear Mike:

As you know if you've been following the debate on Patent Docs, people with more than minimal brain function can (and do) disagree with Gary's position. Preventing patenting of diagnostic methods (genetically-based or otherwise) can be expected to have chilling effects on disclosure, either in toto or at least to the extent that a scientific paper is not held to the same disclosure requirements that a patent application is (i.e., best mode). This may be less of the case for "low-hanging fruit" correlations like BRCA1 and BRCA2 with breast and ovarian cancer, but it is certainly the case for more multifactorial/multigenic diseases, like most of the ones that kill most people (colon cancer, heart disease, diabetes, etc.).

Now, it may be the case that physicians need protection from patent infringement liability in this area like they have for practicing surgical methods - 35 U.S.C. 287(c) (I think) is the place in the statute where this protection is granted. But that statute does not protect drug companies and other commercial entities from practicing patented methods, nor should big diagnostic companies be given a free pass on selling diagnostic tests and services because the end-product is human disease. This is true if only because there is no logical reason that such a policy should not extend to all living things, or all things living things depend upon. (You can see how the principle could get out of hand.)

So there is a consistent, logical policy position that diagnostic method claims (which, unlike business method claims are not a recent creature of patent law) have and should be patentable (even if we exempt physicians from infringement liability).

And if patriotism is the last refuge of the scoundrel, alleging financial interest as a motivation for someone disagreeing with you must be the last refuge of anyone without a sound argument to the contrary.

Thanks for the comment


But you don't have a sound argument. Regarding the disclosure thing, where is the evidence? I mean, what self-respecting journal is going to accept a manuscript disclosing a correlation between a disease/condition/trait, multifactorial or otherwise, and a marker (or panel of markers) which does not disclose the precise basis for the correlation, including the identity of the marker (or panel of markers)?

And to your other point, diagnostic method patents are a relatively recent phenomenon. Perhaps not as recent as business method patents, but pretty recent.

I know that you like to rip on Breyer for his dissent in LabCorp v. Metabolite (and Stevens and Souter for joining) as if it was some kind of wacky liberal, ivory tower-ish position, but have you ever read the Solicitor General's brief in that case? Don't forget that was under a Republican administration...

Dear Gary:

I'm not suggesting this will be in a journal - I think the big risk is disconnecting the academia - startup - big co-progression that has defined this area for 30 years if there is no protection for the academia - startup piece. Big companies only need patents on what can be reverse engineered, and I think there are ways to skin the diagnostic cat (particularly in genomics) that would be next to impossible to reverse-engineer on the timeframe of patent expiry.

We'll be looking at when diagnostic patent method claims first arose and get back to you.

Finally, as I recall the Solicitor's opinion was that the Court shouldn't take the case, and they did anyway. But regardless of the Solicitor's position on the merits, political parties shouldn't matter - the issue should be what promotes disclosure (and a secondary issue of what protects startups from big companies; remember, IBM and Xerox didn't start the personal computer revolution, and no big pharma was first in biotech - if a small company or sole inventor can't protect their IP, it will hurt the rest of us much more than an improvidently-granted patent will).

Thanks for the comment.


Yes, the SG urged the Court to not grant the writ, but that is beside the point. The point is that a Republican, pro-business, anti-socialist administration believed the key claim to not be patent-eligible. So it's not just the liberal Breyer, the senile Stevens, and the totally out there Souter that had a problem with the patent. Actually, we know that Scalia had a problem with it too.

Dear Gary:

And we don't know what Justice Sotomayor or the Chief Justice thinks. As for Justice Scalia, he has shown no indication that his substantial erudition extends to patent law.

Let's see what the Court does with Bilski and Prometheus before we speculate as to whether diagnostic method claims are patent-eligible. Until then, we both have our opinions.

Thanks for the comment.


Actually, we don't know what Kennedy, Thomas, Ginsburg, or Alito thinks either. I just think that when Breyer and Scalia agree on something, that's a pretty powerful indication of how the Court would rule.

I think we both know that Bilski is going to be decided very narrowly, with the Court rejecting the CAFC's test, but killing the application anyway (a la Rader).

So then it's up to Prometheus v. Mayo. The CAFC panel (which included a District Court) completely botched this case up, and the Court has to fix it.

I know that we fundamentally disagree on the legitimacy of these "determine and infer" patents, but I do appreciate that you post my comments just as if I agreed with every position you took. Keep up the good work.


Not to suggest that you don't have other things to do, particularly for paying clients, but did you ever look into when diagnostic/biomarker correlation method claims first started appearing? Certainly not an easy job. My guess is that they don't exist much, if at all, before the 90s.

Dear Gary:

A search of "diagnosing" and "method" in the PTO patent database gets 4,431 hits from 1976 to the present, including:


The earliest use of "biomarkers" in a claim is USP 4,357,420 (1982) and 5,686,237 (1997). Some of this may have to do with nomenclature.

Thanks for provoking me to look.

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