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« Court Report | Main | Biotech/Pharma Companies Look to Market for Capital »

December 28, 2009

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Kevin,

I quite agree that patents on DNA sequences can be useful, but I fear your zeal to make this point has led you to overshoot your mark.

1. HPV patents. The Frazer you attack is the inventor whose patent on technology underlying Gardasil and Cervarix finally won a six-way interference in a CAFC appeal (involving Univ Queensland, Rochester, US National Cancer Institute and Georgetown). I think he probably knows something about patents in his own experience. It is far from clear what would have happened without those patents. Merck and GSK might not have developed their products, but the public health need is driving vaccine development in several Indian companies and elsewhere. And while Merck has been mounting trials in places where women die of cervical cancer (mainly Asia, Africa and South/Central America), it is the sad case that this marvelous and potentially life-saving technology is mainly available where cervical cancer screening is already good (and few lives are at stake) and unavailable where it would save those lives. It's a technical success story, but has yet to turn into a public health success story, and both sides should be cautious in over-claiming. This is one reason you'll find some of the scientists who were involved in HPV vaccine development are not cheerleaders for the current patent system--even those, like Frazer, who used it.

2. Penicillin. It is flat wrong that the main reason private pharmaceutical firms did not develop penicillin is lack of a patent incentive. Kingston and Neuschul have told that story well. Fleming did not pursue clinical use and it was Chain and Florey who took up the cause and saw the therapeutical possibilities. A wartime need drove R&D (and much of the important work was done on fermentation at USDA labs in Peoria), subsidized production, and guaranteed contract purchases for the final product. Your assertion that having a penicillin patent would have led to investment is almost certainly wrong, given the state of the science at the time. The missing ingredient was not money or exclusivity.

3. Salk & polio vaccine. Laurie Zoloth's comment does indeed echo Salk's quote to Edward R. Murrow "Would you patent the sun?" Jane Smith, in the book you allude to, shows he was doing a bit of grandstanding, and U Pitt would probably have patented his vaccine if they thought they could. They concluded they couldn't because of prior art the the patent law interpretations of their day.

And you're right that the ethical standards for human medical research were different then--there were no IRBs and no 45 CFR 46 regulations. But I don't think that has much to do with patenting.

4. Finally, the outrageous comment that it takes a billion dollars to develop a genetic test simply can't be even close to true. U Penn and 8 other labs were "cleared from the market" by Myriad, meaning those 9 labs already had BRCA tests available as a service. Similar stories are true for long-QT testing, ApoE genotyping, Duchenne testing, etc., where a private lab shut down testing at labs already offering a genetic test. It is demonstrably false that patent incentives are *necessary* to develop genetic diagnostics once the genotype-disease association has been published. It's certainly true that exclusivity can also get companies to offer such tests, and we can have a discussion about the net social benefit of that real effect of patents. You don't quite claim that patents are necessary to develop diagnostics, but you certainly imply it.

Finally, re the 3500 articles that have been published on BRCA. I agree it's hard to argue there's been a big chill attributable to the BRCA patents. But you overshoot when you say all the studies show no effect. Fiona Murray has two papers showing a modest dampening effect on research associated with patents, one in Nature Biotech articles and more recently looking at the Jensen & Murray DNA-sequence patents from their Science article.

I actually think the "research effect" is potentially interesting, because given the breadth of the claims, particularly US Patent 5,747,282, virtually all those 3500 papers would have involved use of isolated DNA molecules covered by the claims, and therefore infringing uses for any work done in the US, Canada, or Australia/New Zealand. Such pervasive infringement can't be a good thing, can it? Myriad deserves credit for allowing (sometimes collaborating in) such work, but I do think that post-Madey, the situation is metastable.

Dear Bob:

We don’t attack people here; we just point out our disagreements with their positions (sometimes forcefully).

Before I address your points, I need to put the discussion in context. Both here in the US in the ACLU case, and in Australia, the effort is not just to have courts (or the legislature) examine whether genetic diagnostic methods should be patentable. We could have an interesting discussion on this point, with pros and cons on both sides. But both the ACLU and the academics like Ian Frazer have taken the position that genes should not be patentable. And they have “supported” their position with “falsehoods, exaggerations and downright lies” (to paraphrase an earlier post), some of which I addressed. So any zealotry you discerned in the post was an effort to push back against this sort of distortion.

Turning to your substantive points, Mr. Frazer’s position has the whiff of hypocrisy to me – “patents for me but not for thee.” I’m sure he is a brilliant scientist, but in my experience brilliance in one field does not translate well to others, particularly ones in which one has no training, has strongly-, emotionally-based views, and gives someone a chance to voice an “influential” opinion on public policy questions. Sometimes that is a wonderful addition to the debate – Linus Pauling on nuclear weapons, for example. (But then, recall that Albert Einstein, speaking of Pauling, once said “Now, there is a genius.”) I don’t find Mr. Frazer’s contribution to have the same qualities.

The “billion dollar” figure was not directly related to genetic diagnostics, but encompassed biologic drug development because that is where the anti-gene patenting crowd has put the debate. I don’t know how much it costs to develop genetic diagnostic tests, but I suspect it is much more expensive that those of us who don’t do it may think.

As for the university hospitals, I have two comments. First, I am sure that they believe they can compete with Myriad in providing the tests. I have no idea if they can, but I do know that at least one of the hospitals on your list had a project on gene therapy shut down when a child died. This is tragic, but it points out (once again) that brilliant scientists are not always the people who we should entrust with bringing a product to market. “The best and the brightest” are not always the ones who can do the best or be the brightest, as we have seen multiple times on many fronts.

And, of course, I don’t think these university hospitals are offering to perform the tests for free. In my view, they want to wrap themselves in the cloak of selfless dedication to their patients while they operate a money-making diagnostic testing center. I don’t see them has wearing the white hats (the white coats, maybe) on this issue.

As for the non-existent “research exemption” to patent infringement, I agree that the fact that no basic researcher has been sued is a metastable state, but the fact is that study after study says that basic researchers pay no attention to patents when it comes to their research. (Indeed, institutionally-mandated Material Transfer Agreements are much more burdensome.) This fact, and the plethora of research articles on BRCA1 and BRCA2 (and the steady increase thereof) was mentioned to counter the falsehood that gene patents hinder research. There is no tragedy in the anticommons – it was a clever idea, but sometimes reality has to enter into the debate. It’s a little pathetic that “a modest dampening effect” is the best that can be done to support the “gene patents hinder basic genetic research” argument.

As for Dr. Salk, my point was that Jonas Salk as a standard bearer of ethical scientific behavior is ludicrous, in view of his treatment of retarded children as guinea pigs.

Finally, we can disagree about penicillin – reconstructing history is an inexact science at best. But any time a pharma company invests a lot of money on something, the odds of that something being commercialized go up – not very high, perhaps, because ultimately it depends on the science, but the chance are better than with no investment. And raising investment is supported by patenting.

But as always, you raise good points. Thanks for the comments, and Happy New Year.

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