Thursday, December 16, 2010
New Issue of GeneWatch Magazine
My Article: Naturally Occurring Genes and the Commons by Necessity appears in the latest issue of GeneWatch Magazine, a publication of the Council for Responsible Genetics. There is an impressive line-up of authors for this issue, including Chris Holman, Kevin Noonan, Robert Cook-Deegan, and interviews with Daniel Ravicher and Sandra Park. Most of these arguments are the usual, utilitarian sort on both sides of the issue. I tried to be clear in my article about the deontological, ethical necessity of not patenting unmodified parts of nature, expanding and clarifying, I hope, the arguments I began to make in my book. I have yet to see a decent reply to these deontological arguments beyond the usual utilitarian pleas. The whole issue is worth reading to see the various perspectives and arguments. I am proud to be among the authors, and thankful to the editors.
another amicus brief in which Who Owns You gets cited.
This Amicus brief cites to my book, and discusses briefly my notion of the commons by necessity. Always nice to see someone is paying attention. Many thanks to the authors and amici. There are 12 briefs by amici in support of plaintiff-appellees, and 16 for the appellants. Now we wait for oral argument,which ought to be fun. Wish I could watch.
Wednesday, December 15, 2010
A nice brief from amici AMA and others, by Lori Andrews and Joshua Sarnoff
Saturday, October 30, 2010
game over
Just a brief respite from my hiatus to call attention to the recent filing by the US Department of Justice in support of plaintiffs in the AMP v. Myriad suit. It vindicates the arguments I made all along that isolated genes are not inventions, but are parts of nature, and thus not patent-eligible. It will be interesting to see how this plays out in the lawsuit, and how the PTO will react. Read the brief: it's succinct, straightforward, and spot-on. I can almost hear the wailing and gnashing of teeth from the bio-tech industry clear across the Atlantic ocean. Ah, sweet justice.
Wednesday, October 6, 2010
Hiatus
It's been a while since I updated, and I doubt I will have much time to continue to update this blog in the next few months. We are expecting a child next month, our first, and I just put the wraps on my new book due out next summer (you can pre-order it now, if you want).
Obviously, the fight against gene patents will continue, and as the AMP vs. Myriad appeal works its way up through the courts, I am sure I will chime in with my thoughts. As well, we expect the film to be finished by early 2011 at the latest. I'll keep you all informed.
Thanks for continuing to follow this important, ongoing struggle.
best,
David
Obviously, the fight against gene patents will continue, and as the AMP vs. Myriad appeal works its way up through the courts, I am sure I will chime in with my thoughts. As well, we expect the film to be finished by early 2011 at the latest. I'll keep you all informed.
Thanks for continuing to follow this important, ongoing struggle.
best,
David
Wednesday, August 18, 2010
Thank You, Brian Leiter
Last summer, I was horrified when I read a scathing review of my book by Chris Holman. I drafted a hasty response on the invitation of James Hughes at the IEET Blog in which I questioned Holman's reading of my book (as he appeared to address only a few pages of it) as well as his objectivity, due to his long-term connections with the biotech industry. To this day, and to my knowledge, he does not deny consulting or otherwise working on behalf of BIO (he is certainly well-known by BIO), although he says he owns no shares in any biotechs using gene patents. My questioning of his motives and neutrality earned me a rebuke from Brian Leiter, who is a law school professor and author of a well-known blog, as well as a J.D./Ph.D. in philosophy like me (although he teaches in a law school, and not a philosophy department). Leiter is known by philosophers mostly for his Gourmet Report which ranks philosophy departments. Although Mr. Leiter had clearly not read my book, he gleefully publicized Holman's review, and publicly rebuked my response (for features he himself has employed), ignoring my pleas for him to pay attention to the substance of my arguments, and Holman's lack of substance in his review (and even Leiter calls for such potential conflicts to be disclosed when he is the subject of criticism).
Despondent that Mr. Leiter's gossipy coverage might tarnish my reputation, I sought the advice of my mentor, a philosopher of long-standing, international reputation. I was advised to relax. Leiter was not that important in philosophical circles (beyond his rankings, which departments do pay attention to), nor his blog that important. "all publicity is good publicity," I was told. And in fact, my mentor was right.
Stephan Kinsella (a patent attorney whom I have since befriended) read about me through Leiter's blog and came to my public defense, bolstering my arguments frequently with his perspective as a patent attorney. And since Holman's review, the majority of reviews of my book, including in Choice, The Guardian, The Yale Journal of Biology and Medicine, The Journal of High Technology Law, Metapsychology Online Reviews, Ethical Perspectives, and elsewhere, have been quite positive. Patent attorneys have tended to be negative, just as they have been critical of the ACLU's claims in the AMP v. Myriad case. But even more importantly than any review, the issue has gained terrific traction this year, the public is becoming aware, and there is the real possibility of changing public policy.
I will never fully understand Mr. Leiter's motivations (although he was on the board of the publication that solicited Holman's review, and did personally peruse and clear the review before publication), nor the delight of some in the scandal-sheet style attacks on my claims (or maybe just on me). My arguments have stood the test, and moreover, the same reasoning is motivating courts and institutions to change the law. This is much more than I hoped for. I am happy to withstand the attacks of academics and patent attorneys, as long as the word gets out, and these arguments get heard. Most people understand well that natural products and laws of nature ought not to be monopolized, as Judge Sweet held, and that the end of gene patents will be a step toward justice. I have had the great good fortune this past year to meet courageous people who have stepped beyond the theory, and sought to change things. I have mentioned them in this blog, including Luigi Palombi, the ACLU and its attorneys, plaintiffs in the AMP v. Myriad case, and others. I am thankful for their commitment to this important issue. Finally, I should thank you, Brian Leiter, for helping to make this a phenomenal year for justice and for helping to connect me with so many wonderful activists, working to change the system.
UPDATE: Indeed, justice has fully prevailed. The Supreme Court adopted the reasoning I advocated and invalidated most gene patents, and a 2d edition of my book is coming out in May 2015, with a chapter devoted to the Myriad case which set the new precedent.http://whoownsyou-drkoepsell.blogspot.ca/
Despondent that Mr. Leiter's gossipy coverage might tarnish my reputation, I sought the advice of my mentor, a philosopher of long-standing, international reputation. I was advised to relax. Leiter was not that important in philosophical circles (beyond his rankings, which departments do pay attention to), nor his blog that important. "all publicity is good publicity," I was told. And in fact, my mentor was right.
Stephan Kinsella (a patent attorney whom I have since befriended) read about me through Leiter's blog and came to my public defense, bolstering my arguments frequently with his perspective as a patent attorney. And since Holman's review, the majority of reviews of my book, including in Choice, The Guardian, The Yale Journal of Biology and Medicine, The Journal of High Technology Law, Metapsychology Online Reviews, Ethical Perspectives, and elsewhere, have been quite positive. Patent attorneys have tended to be negative, just as they have been critical of the ACLU's claims in the AMP v. Myriad case. But even more importantly than any review, the issue has gained terrific traction this year, the public is becoming aware, and there is the real possibility of changing public policy.
I will never fully understand Mr. Leiter's motivations (although he was on the board of the publication that solicited Holman's review, and did personally peruse and clear the review before publication), nor the delight of some in the scandal-sheet style attacks on my claims (or maybe just on me). My arguments have stood the test, and moreover, the same reasoning is motivating courts and institutions to change the law. This is much more than I hoped for. I am happy to withstand the attacks of academics and patent attorneys, as long as the word gets out, and these arguments get heard. Most people understand well that natural products and laws of nature ought not to be monopolized, as Judge Sweet held, and that the end of gene patents will be a step toward justice. I have had the great good fortune this past year to meet courageous people who have stepped beyond the theory, and sought to change things. I have mentioned them in this blog, including Luigi Palombi, the ACLU and its attorneys, plaintiffs in the AMP v. Myriad case, and others. I am thankful for their commitment to this important issue. Finally, I should thank you, Brian Leiter, for helping to make this a phenomenal year for justice and for helping to connect me with so many wonderful activists, working to change the system.
UPDATE: Indeed, justice has fully prevailed. The Supreme Court adopted the reasoning I advocated and invalidated most gene patents, and a 2d edition of my book is coming out in May 2015, with a chapter devoted to the Myriad case which set the new precedent.http://whoownsyou-drkoepsell.blogspot.ca/
Labels:
brian leiter,
chris holman,
david koepsell,
Stephan Kinsella
Thursday, August 12, 2010
A Nice interview/article
Drew Halley interviewed me for the singularity hub, a news blog site devoted to issues having to do with futurism in general. His article does a nice job setting out the history of the issue briefly, and then concludes with an interview he did with me while I was at the Open Science Summit. Here's a link to the full article. http://singularityhub.com/2010/08/11/who-owns-you-20-of-the-genes-in-your-body-are-patented-video/
Wednesday, August 4, 2010
Open Science and Economics
The Open Science Summit (here are my slides) has concluded, and it marks the start of a very important ongoing conversation, including discussions we should continue to have about the practical effects of patents on innovation. My arguments have always been both theoretical and practical. While Ron Bailey at Reason relates "Numerous studies have so far failed to find that gene patents are a big impediment to either research or innovation" in reporting on our session at the Summit, there are also numerous such studies showing that the impact is in fact bigger than some make it out to be. One noteworthy recent addition to the empirical evidence is this article, by Heidi Williams of Harvard University - Department of Economics; National Bureau of Economic Research (NBER), entitled "Intellectual Property Rights and Innovation: Evidence from the Human Genome" which just came out this past month. She sent me the following link, and below I summarize and provide some useful quotes:
Williams tracks the progress of individual discoveries, looking at the research that was conducted on both patented and unpatented genes, and comparing the rate of innovation and commercialization resulting from both. she states, in describing her methodology: "My empirical analysis relies on a newly-constructed data set that traces out the distribution of Celera's IP across the human genome over time, linked to gene-level measures of scientific research and product development outcomes." ... significantly, she finds:
"For each gene, I collect data on publications investigating potential genotype phenotype links, on successfully generated scientific knowledge about genotype-phenotype links, and on the development of gene- based diagnostic tests that are available to consumers. Both the cross-section and panel specifications suggest Celera's IP led to economically and statistically significant reductions in subsequent scientific research and product development outcomes. Celera genes have had 35 percent fewer publications since 2001 (relative to a mean of 1 publication per gene)."
finally, she concludes:
"I estimate a 16 percentage point reduction in the probability of a gene having a known but scientifically uncertain genotype-phenotype link (relative to a mean of 30 percent), and a 2 percentage point reduction in the probability of a gene having a known and scientifically certain genotype-phenotype link (relative to a mean of 4 percent). In terms of product development, Celera genes are 1.5 percentage points less likely to be used in a currently available genetic test (relative to a mean of 3 percent). The panel estimates suggest similarly-sized reductions, on the order of 30 percent. Taken together, these results suggest Celera's short-term IP had persistent negative effects on subsequent innovation relative to a counterfactual of Celera genes having always been in the public domain. The panel estimates measure a transitory effect of Celera's IP, and suggest that innovation on Celera genes increased after Celera's IP was removed. However, the cross-section estimates measure more persistent e ffects and suggest that Celera genes have not 'caught up'"
The evidence is growing more damning all the time. This study cites the Murray study I have previously cited here, and nails the lid in the coffin, as far as I can tell, on the economic effects of gene patents. I hope you'll read this paper. I am thankful that economists like Williams are continuing to blow the lid on the real story of patents, and how they inhibit both science and commerce.
Williams tracks the progress of individual discoveries, looking at the research that was conducted on both patented and unpatented genes, and comparing the rate of innovation and commercialization resulting from both. she states, in describing her methodology: "My empirical analysis relies on a newly-constructed data set that traces out the distribution of Celera's IP across the human genome over time, linked to gene-level measures of scientific research and product development outcomes." ... significantly, she finds:
"For each gene, I collect data on publications investigating potential genotype phenotype links, on successfully generated scientific knowledge about genotype-phenotype links, and on the development of gene- based diagnostic tests that are available to consumers. Both the cross-section and panel specifications suggest Celera's IP led to economically and statistically significant reductions in subsequent scientific research and product development outcomes. Celera genes have had 35 percent fewer publications since 2001 (relative to a mean of 1 publication per gene)."
finally, she concludes:
"I estimate a 16 percentage point reduction in the probability of a gene having a known but scientifically uncertain genotype-phenotype link (relative to a mean of 30 percent), and a 2 percentage point reduction in the probability of a gene having a known and scientifically certain genotype-phenotype link (relative to a mean of 4 percent). In terms of product development, Celera genes are 1.5 percentage points less likely to be used in a currently available genetic test (relative to a mean of 3 percent). The panel estimates suggest similarly-sized reductions, on the order of 30 percent. Taken together, these results suggest Celera's short-term IP had persistent negative effects on subsequent innovation relative to a counterfactual of Celera genes having always been in the public domain. The panel estimates measure a transitory effect of Celera's IP, and suggest that innovation on Celera genes increased after Celera's IP was removed. However, the cross-section estimates measure more persistent e ffects and suggest that Celera genes have not 'caught up'"
The evidence is growing more damning all the time. This study cites the Murray study I have previously cited here, and nails the lid in the coffin, as far as I can tell, on the economic effects of gene patents. I hope you'll read this paper. I am thankful that economists like Williams are continuing to blow the lid on the real story of patents, and how they inhibit both science and commerce.
Thursday, July 22, 2010
Open Science Summit, Berkeley, July 28-31
I've been getting ready for this exciting event, among other things. Here's a nice preview at H+ Magazine. Check it out, and if you're in Berkeley then, come to the event!
Tuesday, June 29, 2010
Bilski!
Of course, SCOTUS would issue this decision while I was traveling. It's not as groundbreaking as anyone would hope, cuts a very narrow path ruling on Bilski's business method patent (not patent-eligible under 101) and little else. There are many nice quotes suggesting the Supremes don't want any more expansive of a reading of what might be patent-eligible, but neither do they seem to be unanimous in wanting to narrow it. All of which is to say, more status quo for software, business methods, and other such things. But what does it mean for the Myriad case? Well this also seems to be good news, as the Bilski decision relies on the holdings of Chakrabarthy,Gottschalk v. Benson, Diamond v. Diehr, and Parker v. Flook, which line of cases establishes the exception under 101 holding products of nature and abstract ideas ineligible for patent. Sweet relied on Bilski in rejecting the patented methods for the BRCA diagnostic test, holding that the mere comparison of two strings of DNA was too abstract to be eligible for patent under section 101.
As a brief philosophical aside: Abstract is not the correct, operative phrase in any of these cases, logically-speaking. Something is either abstract or concrete. There's the ratio "Pi" (which is an abstract entity) and there are circular objects, which are concrete. There is no continuum. What the courts all mean is "overly-general." So, "the placing of luncheon meat between two pieces of bread" encompasses too much, is overly general, and not patent-eligible under this notion. But a particular new, non-obvious, useful sandwich would be eligible.... More to come as I ruminate on the case and its various concurrences....
As a brief philosophical aside: Abstract is not the correct, operative phrase in any of these cases, logically-speaking. Something is either abstract or concrete. There's the ratio "Pi" (which is an abstract entity) and there are circular objects, which are concrete. There is no continuum. What the courts all mean is "overly-general." So, "the placing of luncheon meat between two pieces of bread" encompasses too much, is overly general, and not patent-eligible under this notion. But a particular new, non-obvious, useful sandwich would be eligible.... More to come as I ruminate on the case and its various concurrences....
Thursday, June 3, 2010
Proof that science works
This week, a research team out of the Cleveland Clinic announced that they had successfully tested a breast cancer vaccine on mice. The work to develop this vaccine was made possible with a mere 1.5 million USD grant from the National Institutes of Health, a federal funding agency in the US. Oddly, while defenders of the Myriad patents on BRCA1 and 2 often claim that the diagnostic test wouldn't have been developed but for patents, and that the money generated by such patents is necessary for further breakthroughs in health, there is no evidence that Myriad has invested any of its over 300 million USD per year profits from the BRCA1 and 2 tests in developing any cures. Why would they? For the remaining 5 years of their patent, they can rake in their monopoly rates, generating huge profits above and beyond the costs of the original research, and not have to invest in any new research. They also now have a patent on the pancreatic cancer gene and can rake in more money from those diagnostics. So why bother with a cure?
Publicly-funded science, on the other hand, devoid of the conflict of interest generated by the corporate need for profits, works. The work on the breast cancer vaccine is showing just how. I could find no patent, either, registered for the work on the vaccine. Perhaps, like Jonas Salk, Dr. Vincent Tuohy would view such a patent as the equivalent of patenting the sun. Let's hope. Meanwhile, this story illustrates how science can work, and why the arguments regarding the necessity of patents to fuel medical breakthroughs is bunk.
Publicly-funded science, on the other hand, devoid of the conflict of interest generated by the corporate need for profits, works. The work on the breast cancer vaccine is showing just how. I could find no patent, either, registered for the work on the vaccine. Perhaps, like Jonas Salk, Dr. Vincent Tuohy would view such a patent as the equivalent of patenting the sun. Let's hope. Meanwhile, this story illustrates how science can work, and why the arguments regarding the necessity of patents to fuel medical breakthroughs is bunk.
Sunday, May 16, 2010
Trailer for the movie, "Who Owns You?"
My co-producer, and the director of the documentary we are producing, Taylor Roesch, has put together an engaging trailer. The principal shooting for the doc is complete, and he lined up a great range of experts to speak on the subject. We will wrap up shooting late this summer here in The Netherlands, and plan to put together a rough cut in time for some of the festivals. I'm really proud of Taylor's work, please check it out:
Who Owns You? - A Documentary - Trailer from Taylor Roesch on Vimeo.
Friday, May 14, 2010
The tension mounts
I swear I will post soon, as soon as the Supreme Court rules on Bilski. That case is going to be a watershed moment, one way or another, for patents as it will decide the patentability of "business methods" and possibly more. Moreover, Judge Sweet used it heavily in deciding that the BRCA1 and 2 method claims were invalid. In the mean time, please check out an interview I recently did for the Philosophy Compass blog, The Philosopher's Eye. Keep your fingers crossed for the Bilski decision to come out next week!
Thursday, April 15, 2010
My Review of Luigi Palombi's book, Gene Cartels
It appears in this month's Script-ed, and since it's a creative commons license, I am posting it here as well:
"Book Review
Gene Cartels: Biotech patents in the age of free trade
Luigi Palombi
Cheltenham, UK; Northampton, MA (USA): Edward Elgar, 2009, 416 pp, £85, ISBN 978 1 84720 836 1 (hbk).
DOI: 10.2966/scrip.070110.230
It is a shame that there are so few existing copies of Luigi Palombi’s Gene Cartels. The initial press run for this remarkable book was apparently less than 1000, yet this is a book that every policy maker even remotely connected to issues of patents, economics, and biotech should read.
Palombi’s background is in law. He worked for years as a patent lawyer, writing and arguing for biotech patents. Over time, he grew disenchanted with the scope and reach of patents being granted on biotechnology “innovations”, especially as more and more patents began to be granted further “upstream”, over things that were not inventions, but rather discoveries. He is now a researcher with the Regulatory Institutions Network at the Australian National University. He devotes his research and activism to eliminating “gene patents” and his magnum opus on the legal case against gene patents works methodically through not just recent law on the subject but the history of patent law itself.
Palombi traces the history of patent from its historical roots as a mode of privilege granted by sovereigns and places current debates about both the effectiveness and justice of such monopolies into much needed context. Some modern defenders of patents fail to discern that intellectual property is an artificial device which skews free markets, tending instead to ignore the unnatural, state-sponsored nature of the patent monopoly. Palombi deftly shows us otherwise and comes out strongly, backed both by history and legal theory, against patents as either a necessary or efficient economic tool for innovation. He moves deliberately through a useful discussion of modern day patent regimes and the effects of globalisation and harmonisation of IP regimes, primarily with those of the US and western democracies. He then moves on, just about 200 pages in, to grapple with the subject of biotech patents, and specifically those on genes.
Taking a clear stand against the modern trend in US patent law and extending this to other patent regimes, Palombi rejects the central notion that mere “isolation” or an element of nature is sufficiently inventive to warrant a patent. In a pivotal chapter, the “isolation contrivance” is traced through the cases that gave it credence, and destroyed piece by piece as based upon flawed legal reasoning. It is the lynchpin of the argument favouring patents on “isolated” gene sequences and Palombi shows how this now accepted dicta has resulted in legal nonsense that can no longer stand scrutiny – especially the type of methodical scrutiny Palombi provides.
Simply put, Palombi shows, through careful examination of the evolution of the law regarding “isolated and purified” natural products that patents extended to them defy reason as well as the purposes of intellectual property law itself. The remaining hundred and some pages provide the most explicit, detailed, and definitive arguments against the legality of gene patents so far. He takes us through patents on EPO, adrenaline, genetically-engineered, recombinant bacteria, and then finally through modern-day diagnostic patents on naturally-occurring mutations to naturally-occurring genes, such as Myriad’s patents on the BRCA1 and 2 gene mutations whose presence indicates a propensity for breast and ovarian cancers. In each case, he shows through the legal cases how the law has been perverted from its original intention to reward invention to become a prize doled out now for mere discoveries – the age-old territories of the sciences rather than industry.
Critical to Palombi’s work is his detailed discussion of both the legal and practical consequences of the current situation. The cartels afforded by gene patents, he argues, are unprecedented in the law, gaining monopolies over much more than the mere sequences but also to any and all protein products of those sequences. These cartels then control every facet of a particular gene’s expression, including any treatments that might be developed for genetic diseases, as well as all diagnostic tools. Moreover, as is made clear in the case of the BRCA 1 and 2 patents, research is legally, and sometimes practically, road blocked by such patents.
Palombi’s analysis is deep and broad, providing technical, legal details of the gene patent situation around the world. Influenced as it has been by US laws and corporations, gene patents have now spread throughout Europe and other industrialised nations, despite the proclamation of the various partners in the Human Genome Project that the human genome was our “common heritage”. He concludes his discussion, having demolished the notion that isolation of genes is inventive in any sense previously necessary for patents, by discussing in depth the history of the BRCA1 and 2 patents, and pondering what the current situation means for research in synthetic biology. His prognosis is bleak and his conclusions are justified by his elaborate recounting of not just the errors but ultimate effects of gene patents for both basic science and clinical practice.
This book is essential ammunition for those who oppose gene patenting, and lays out the legal case expertly. My own book, Who Owns You? (Wiley-Blackwell, 2009), was motivated by similar concerns, and makes an ethical case against gene patents from a philosophical perspective but I wish I had had Palombi’s book at my disposal when I was writing, because his legal case is iron-clad and unassailable. Not only will the reader be left wondering how we got to the point where unaltered genetic sequences are afforded patents, but he or she will be moved to confront the policy-makers and jurists who now stand poised to be able to finally stop this practice, to follow the dictate of law, logic, and justice, and to liberate the genome as the common heritage that it is once again.
David Koepsell
Professor, Delft University of Technology, Netherlands
© David Koepsell 2010"
"Book Review
Gene Cartels: Biotech patents in the age of free trade
Luigi Palombi
Cheltenham, UK; Northampton, MA (USA): Edward Elgar, 2009, 416 pp, £85, ISBN 978 1 84720 836 1 (hbk).
DOI: 10.2966/scrip.070110.230
It is a shame that there are so few existing copies of Luigi Palombi’s Gene Cartels. The initial press run for this remarkable book was apparently less than 1000, yet this is a book that every policy maker even remotely connected to issues of patents, economics, and biotech should read.
Palombi’s background is in law. He worked for years as a patent lawyer, writing and arguing for biotech patents. Over time, he grew disenchanted with the scope and reach of patents being granted on biotechnology “innovations”, especially as more and more patents began to be granted further “upstream”, over things that were not inventions, but rather discoveries. He is now a researcher with the Regulatory Institutions Network at the Australian National University. He devotes his research and activism to eliminating “gene patents” and his magnum opus on the legal case against gene patents works methodically through not just recent law on the subject but the history of patent law itself.
Palombi traces the history of patent from its historical roots as a mode of privilege granted by sovereigns and places current debates about both the effectiveness and justice of such monopolies into much needed context. Some modern defenders of patents fail to discern that intellectual property is an artificial device which skews free markets, tending instead to ignore the unnatural, state-sponsored nature of the patent monopoly. Palombi deftly shows us otherwise and comes out strongly, backed both by history and legal theory, against patents as either a necessary or efficient economic tool for innovation. He moves deliberately through a useful discussion of modern day patent regimes and the effects of globalisation and harmonisation of IP regimes, primarily with those of the US and western democracies. He then moves on, just about 200 pages in, to grapple with the subject of biotech patents, and specifically those on genes.
Taking a clear stand against the modern trend in US patent law and extending this to other patent regimes, Palombi rejects the central notion that mere “isolation” or an element of nature is sufficiently inventive to warrant a patent. In a pivotal chapter, the “isolation contrivance” is traced through the cases that gave it credence, and destroyed piece by piece as based upon flawed legal reasoning. It is the lynchpin of the argument favouring patents on “isolated” gene sequences and Palombi shows how this now accepted dicta has resulted in legal nonsense that can no longer stand scrutiny – especially the type of methodical scrutiny Palombi provides.
Simply put, Palombi shows, through careful examination of the evolution of the law regarding “isolated and purified” natural products that patents extended to them defy reason as well as the purposes of intellectual property law itself. The remaining hundred and some pages provide the most explicit, detailed, and definitive arguments against the legality of gene patents so far. He takes us through patents on EPO, adrenaline, genetically-engineered, recombinant bacteria, and then finally through modern-day diagnostic patents on naturally-occurring mutations to naturally-occurring genes, such as Myriad’s patents on the BRCA1 and 2 gene mutations whose presence indicates a propensity for breast and ovarian cancers. In each case, he shows through the legal cases how the law has been perverted from its original intention to reward invention to become a prize doled out now for mere discoveries – the age-old territories of the sciences rather than industry.
Critical to Palombi’s work is his detailed discussion of both the legal and practical consequences of the current situation. The cartels afforded by gene patents, he argues, are unprecedented in the law, gaining monopolies over much more than the mere sequences but also to any and all protein products of those sequences. These cartels then control every facet of a particular gene’s expression, including any treatments that might be developed for genetic diseases, as well as all diagnostic tools. Moreover, as is made clear in the case of the BRCA 1 and 2 patents, research is legally, and sometimes practically, road blocked by such patents.
Palombi’s analysis is deep and broad, providing technical, legal details of the gene patent situation around the world. Influenced as it has been by US laws and corporations, gene patents have now spread throughout Europe and other industrialised nations, despite the proclamation of the various partners in the Human Genome Project that the human genome was our “common heritage”. He concludes his discussion, having demolished the notion that isolation of genes is inventive in any sense previously necessary for patents, by discussing in depth the history of the BRCA1 and 2 patents, and pondering what the current situation means for research in synthetic biology. His prognosis is bleak and his conclusions are justified by his elaborate recounting of not just the errors but ultimate effects of gene patents for both basic science and clinical practice.
This book is essential ammunition for those who oppose gene patenting, and lays out the legal case expertly. My own book, Who Owns You? (Wiley-Blackwell, 2009), was motivated by similar concerns, and makes an ethical case against gene patents from a philosophical perspective but I wish I had had Palombi’s book at my disposal when I was writing, because his legal case is iron-clad and unassailable. Not only will the reader be left wondering how we got to the point where unaltered genetic sequences are afforded patents, but he or she will be moved to confront the policy-makers and jurists who now stand poised to be able to finally stop this practice, to follow the dictate of law, logic, and justice, and to liberate the genome as the common heritage that it is once again.
David Koepsell
Professor, Delft University of Technology, Netherlands
© David Koepsell 2010"
Monday, April 5, 2010
60 Minutes
60 Minutes did a great job with their segment, "Patented". It really is worth watching. Kudos to all involved, including Kevin Noonan, with whom I have sparred on the subject, who did a good job standing up for his side. I hope he'll take part in the documentary we are making as well. It is worth noting that the "lies" Noonan accused me of were the same statements made by Morley Safer on the 60 Minutes segment, though he seems a bit more politic in his references to the TV show than to my book (which he hadn't read, by his own admission, at the time).
This summer, Taylor and I should be able to edit something together in time, hopefully, for a couple festivals, perhaps the Rotterdam Film Festival here in Europe would be a good start. Overall, the timing on this subject really has been amazing. Little did I know when writing my book that the ACLU would bring this suit, nor especially that the time-table on the suit would coincide so well with the launch of the book. I'm been privileged to meet so many activists and academics involved in this debate at this critical time, and really am in awe of their commitment. Glad to see such momentum and media attention finally for this critical issue.
This summer, Taylor and I should be able to edit something together in time, hopefully, for a couple festivals, perhaps the Rotterdam Film Festival here in Europe would be a good start. Overall, the timing on this subject really has been amazing. Little did I know when writing my book that the ACLU would bring this suit, nor especially that the time-table on the suit would coincide so well with the launch of the book. I'm been privileged to meet so many activists and academics involved in this debate at this critical time, and really am in awe of their commitment. Glad to see such momentum and media attention finally for this critical issue.
Labels:
60 minutes,
aclu,
aclu v. myriad,
brca patents,
kevin noonan,
patented,
who own you,
who owns genes
Thursday, April 1, 2010
Two brief media hits
An op-ed co-authored with Ken Alfano in the Washington Times today, and a radio interview this morning on The Takeaway, out of WNYC, syndicated nationally in the US. A couple more, potentially big, are in the works. I did a lengthy pre-interview yesterday with a US national network. The good news is that this decision got the media to finally pay some attention to this issue, and the momentum is now with our side of the story. I cannot praise enough those with both the ACLU and Public Patent Foundation for bringing this lawsuit, and calling much needed attention to the problem of gene patents. More to come...
**UPDATE** Here's an excellent piece from Forbes explaining why the technology of cheap sequencing, and the potentially profitable and beneficial services that could be offered, demand that gene patents cease.
**UPDATE 2** so, apparently Joseph Priestley could have (or could not have) patented O2. Read through all the comments to see a truly Alice in Wonderland chain of reasoning.
**UPDATE** Here's an excellent piece from Forbes explaining why the technology of cheap sequencing, and the potentially profitable and beneficial services that could be offered, demand that gene patents cease.
**UPDATE 2** so, apparently Joseph Priestley could have (or could not have) patented O2. Read through all the comments to see a truly Alice in Wonderland chain of reasoning.
Wednesday, March 31, 2010
Win!
I must remember to take more holidays. Everything truly interesting seems to happen when I'm far from my computer. Of course, the ACLU's suit against Myriad is the big news, with proponents of gene patenting scrambling to find fault, or predicting armageddon as the result of Judge Sweet's well-crafted decision. Essentially, the judge held, as I have argued here and in my book, that the patents granted on gene sequences cover products of nature, which are otherwise not eligible for patent protection. He saw past the cute, lawyerly tricks that have been used to try to argue that "isolation and purification" of a gene result in something, somehow unique, and he found as reason and logic dictate: nature made the patented sequences at issue in the case, not man, and the patents are invalid under Section 101. See also my post "It's the novelty."
Expect a long, hard slog as this case moves up to the Federal Circuit Court of Appeals, and then, obviously, to the Supreme Court. Meanwhile, we may get a clue as to SCOTUS's leanings when they issue a decision in Bilski.
Expect a long, hard slog as this case moves up to the Federal Circuit Court of Appeals, and then, obviously, to the Supreme Court. Meanwhile, we may get a clue as to SCOTUS's leanings when they issue a decision in Bilski.
Tuesday, March 30, 2010
WOW
...on holiday at the moment, and this keyboard is too odd to do a detailed post, but suffice it to say for the moment that I am stunned and thrilled that the District Court ruled against Myriad! Much more soon!
Labels:
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Thursday, March 4, 2010
Commons Sense
One of my recurring frustrations in making my case against gene patents is the failure by some to grasp the argument I am trying to make regarding the nature of "the commons". Perhaps I have been unclear, or maybe the approach I am taking to property law and justice is too far afield from those more frequently made to be immediately understood. Yesterday, however, I gave a guest lecture in an ethics course for ICT students (software programmers, mostly), and gained a lot from the experience. These students not only grasped the argument, but embraced it, and helped to clarify a subtlety that I need to elaborate upon in defining the "commons by necessity" that I believe genes and other parts of the universe belong to.
Briefly, to summarize, I argue that the justice of property rights derives from the logical and practical ability of people to enclose a space, and the need for a rival to use violence to dispossess a possessor of the space. Thus, property rights in land and movables are grounded in these brute facts. There is no such grounding for intellectual property rights. Moreover, there are parts of the universe that cannot be justly owned, and IP claims over these "commons by necessity" are unjust. These are parts of the universe which cannot be held exclusively by anyone, as a matter of brute fact. Examples include: the laws of nature, radio spectra, and genes which are de facto unencloseable. My thanks to Stephan Kinsella who helped me to realize that this applies, actually, to all ideas, and thus makes all IP law a similar incursion on an unencloseable commons by necessity.
My thanks go to some of the students yesterday who pointed out a fine distinction in the realm of objects belonging to the commons by necessity (as opposed to the commons by choice, which includes encloseable spaces over which we make choices to maintain no private ownership). They pointed out that there are commons not just by logical necessity like radio spectra and laws of nature, but also those that might be called commons by practical necessity which includes sunlight. So one could, given enough time and technical capabilities, enclose the sun and harness its power monopolistically, but this is a very remote technical possibility.
Genes, I argue, are logically unencloseable, and thus clearly belong to the commons by necessity, and attempts to give monopolistic control over them are per se unethical. If there's only one point I hope readers take away from my book, this is it.
**update: I just learned Who Owns You? is being translated into Portuguese! My first book came out in Japanese and Portuguese, so maybe Japan will soon follow suit. I'll keep you updated.
Briefly, to summarize, I argue that the justice of property rights derives from the logical and practical ability of people to enclose a space, and the need for a rival to use violence to dispossess a possessor of the space. Thus, property rights in land and movables are grounded in these brute facts. There is no such grounding for intellectual property rights. Moreover, there are parts of the universe that cannot be justly owned, and IP claims over these "commons by necessity" are unjust. These are parts of the universe which cannot be held exclusively by anyone, as a matter of brute fact. Examples include: the laws of nature, radio spectra, and genes which are de facto unencloseable. My thanks to Stephan Kinsella who helped me to realize that this applies, actually, to all ideas, and thus makes all IP law a similar incursion on an unencloseable commons by necessity.
My thanks go to some of the students yesterday who pointed out a fine distinction in the realm of objects belonging to the commons by necessity (as opposed to the commons by choice, which includes encloseable spaces over which we make choices to maintain no private ownership). They pointed out that there are commons not just by logical necessity like radio spectra and laws of nature, but also those that might be called commons by practical necessity which includes sunlight. So one could, given enough time and technical capabilities, enclose the sun and harness its power monopolistically, but this is a very remote technical possibility.
Genes, I argue, are logically unencloseable, and thus clearly belong to the commons by necessity, and attempts to give monopolistic control over them are per se unethical. If there's only one point I hope readers take away from my book, this is it.
**update: I just learned Who Owns You? is being translated into Portuguese! My first book came out in Japanese and Portuguese, so maybe Japan will soon follow suit. I'll keep you updated.
Monday, March 1, 2010
Brief update
The blog is in a holding pattern these days, waiting for courts to do their thing, and trying not to hold my breath. There are still some promising developments to report in the fight against gene patents, including the fact that soon, The Australian Senate inquiry into gene patents should conclude with some form of decision. My friend Luigi Palombi has been heavily involved in that fight, and my fingers are crossed. A good decision there will give us momentum here, and, of course, vice versa.
Also, Congressman Becerra's bill, The Genomic Research and Accessibility Act is once again (or still) on the horizon. I hear that they are looking for a Senate sponsor, and then hopefully, that effort will move forward. The timing is right, with Sebelius confronted with making a decision on the recommendations of the panel regarding limiting gene patents, the ACLU case under deliberation, and continued and growing public attention to the issue, something has to break soon.
Also, Congressman Becerra's bill, The Genomic Research and Accessibility Act is once again (or still) on the horizon. I hear that they are looking for a Senate sponsor, and then hopefully, that effort will move forward. The timing is right, with Sebelius confronted with making a decision on the recommendations of the panel regarding limiting gene patents, the ACLU case under deliberation, and continued and growing public attention to the issue, something has to break soon.
Friday, February 5, 2010
Bayh-Dole, IP giveaways, and TARP: an analogy
Were you upset by TARP? You know, the big government giveaway to banks that were "too big to fail"? Many on both the right and the left were outraged at this huge, unwarranted redistribution of taxpayer funds to prop up banks whose woes related to their own mismanagement of risks. Questions remain now about how that money was distributed, including questions about conflicts of interest and the choices of which banks should receive the money. The underlying practical and ethical question is: should taxpayers be forced to underwrite the profits (or losses) of private entities?
Well, the answer given by the experience of the Bayh-Dole Act is: absolutely, stop asking questions. We've been doing this for decades now, and the Bayh-Dole Act is but one example. Publicly-funded scientific research can be used to the exclusive profit of private entities, thanks to essentially the same mechanism behind TARP. The PTO (rather than Tim Geithner) is the arbiter of who reaps the rewards. What is certain is that patent attorneys have profited, and found new places to work in "technology transfer offices," even while there is no evidence that society as a whole (meaning you, the taxpayers) have gotten anything we wouldn't have gotten without the act.
Well now those crying about the SACGHS report calling for slight modifications in the patenting of human genes, are claiming that this will totally undo Bayh-Dole. Of course, this is ridiculous, as the SACGHS suggestions do not go nearly far enough in recognizing the immorality of allowing exclusive control over parts of nature. If only the Congress would look critically at Bayh-Dole, and undo it completely as yet another government-sponsored redistribution of wealth from the poor to the rich. We could also talk about how it has corrupted science, and academia, and leads to all sorts of new conflicts of interest, but that's for another time. Suffice it to say that hypocrisy abounds when it comes to those who profess to embrace free markets. What they really embrace is state-supported profiteering on the backs of taxpayers. Bayh-Dole is but one example, as is IP law in general. And now that the corporations can influence the political debate directly through political contributions, the fight for our individual rights seems ever more Sysiphaen.
UPDATE Bahy-Dole and our lesser angels: did tech transfer, Bayh-Dole, and IP prompt a recent multiple murder??
Well, the answer given by the experience of the Bayh-Dole Act is: absolutely, stop asking questions. We've been doing this for decades now, and the Bayh-Dole Act is but one example. Publicly-funded scientific research can be used to the exclusive profit of private entities, thanks to essentially the same mechanism behind TARP. The PTO (rather than Tim Geithner) is the arbiter of who reaps the rewards. What is certain is that patent attorneys have profited, and found new places to work in "technology transfer offices," even while there is no evidence that society as a whole (meaning you, the taxpayers) have gotten anything we wouldn't have gotten without the act.
Well now those crying about the SACGHS report calling for slight modifications in the patenting of human genes, are claiming that this will totally undo Bayh-Dole. Of course, this is ridiculous, as the SACGHS suggestions do not go nearly far enough in recognizing the immorality of allowing exclusive control over parts of nature. If only the Congress would look critically at Bayh-Dole, and undo it completely as yet another government-sponsored redistribution of wealth from the poor to the rich. We could also talk about how it has corrupted science, and academia, and leads to all sorts of new conflicts of interest, but that's for another time. Suffice it to say that hypocrisy abounds when it comes to those who profess to embrace free markets. What they really embrace is state-supported profiteering on the backs of taxpayers. Bayh-Dole is but one example, as is IP law in general. And now that the corporations can influence the political debate directly through political contributions, the fight for our individual rights seems ever more Sysiphaen.
UPDATE Bahy-Dole and our lesser angels: did tech transfer, Bayh-Dole, and IP prompt a recent multiple murder??
Monday, January 25, 2010
Scientists get it
A very nice and thorough review at Yalepatents.org, by Joseph B. Franklin. Unlike many in the patent community, he comprehends the ontological argument I make about the injustice of gene patents, as well as my broader arguments about IP law and its lack of grounding in natural law.
I've also heard from attorney, engineer, and professor Kenneth M. Alfano of the University of Michigan, who writes an excellent piece for the Mississippi Law Journal arguing that the doctrine of non-obviousness should bar gene patents. His reasoning is a well-considered expansion of some existing arguments, and breaks new ground in this fight. It's good to see more people paying attention, and making these necessary arguments, and I hope to collaborate with him on an editorial piece.
**UPDATE** The Boston Globe today (Feb 1) has a good editorial coming down on the right side of this issue.
I've also heard from attorney, engineer, and professor Kenneth M. Alfano of the University of Michigan, who writes an excellent piece for the Mississippi Law Journal arguing that the doctrine of non-obviousness should bar gene patents. His reasoning is a well-considered expansion of some existing arguments, and breaks new ground in this fight. It's good to see more people paying attention, and making these necessary arguments, and I hope to collaborate with him on an editorial piece.
**UPDATE** The Boston Globe today (Feb 1) has a good editorial coming down on the right side of this issue.
Wednesday, January 13, 2010
LA Times hits the nail on the head
Echoing many of my own sentiments, this editorial in the LA Times gets it right. The patents involved cover naturally-occurring entities, not artifacts, and as such fall squarely outside of what ought to be considered patentable subject matter. I have drafted an editorial of my own which I am shopping around, trying to focus the debate on this crucial issue, and clear up the purposeful confusion generated by pro-gene patent attorneys. As usual, Kevin Noonan over at Patent Docs disparages the editorial authors for getting everything wrong and not understanding patent law. This is the typical line. We understand it completely, just not the way you want us to do so, Kevin. Your interpretation strains logic, and reason, and protects your clients and your vested interests, but the public is beginning to see through this charade, and challenge the status-quo. Let's hope the judge does too.
Tuesday, January 5, 2010
Nice Review in the Yale Journal of Biology and Medicine
Since it's Open Access, I'm also reproducing it here in its entirety:
Copyright ©2009, Yale Journal of Biology and Medicine
Who Owns You? The Corporate Gold Rush to Patent Your Genes
Reviewed by Molly C. Kottemann
Molly C. Kottemann, Yale University, Department of Genetics;
David Koepsell
Who Owns You? The Corporate Gold Rush to Patent Your Genes.
2009. Wiley-Blackwell: West Sussex, UK. ISBN: (Paperback) 978-1405187305. US $24.95 200 p
This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial No Derivatives License, which permits for noncommercial use, distribution, and reproduction in any digital medium, provided the original work is properly cited and is not altered in any way.
“Science cannot stop while ethics catches up,” claimed the president of the American Association for the Advancement of Science in 1950. In Who Owns You? The Corporate Gold Rush to Patent Your Genes, the author, philosopher, and legal scholar David Koepsell describes and dissects the tangle that results when science, in the form of wide-scale genomic sequencing, is permitted to proceed without a strict ethical and legal framework. Part primer, part prescription, Koepsell’s book offers a portrait of the current state of sequencing technology and the laws that regulate the use and status of its products, then proceeds to interrogate the fundamental validity of our existing system.
It is surprising — not to mention existentially disturbing — to learn that more than 20 percent of the human genome is currently owned by corporations, research institutes, and universities. Even more surprising is that the author claims that these patent systems have been cobbled together in a manner that is largely unmindful of legal precedent or philosophical soundness. Despite the sensationalist title, Koepsell generally steers clear of reactionary recoil, instead providing a measured consideration of the issues that arise at the intersection of intellectual property and human biology.
Beginning with the as-yet ignored basics, the author first deconstructs the relationship between genes and people, deftly highlighting the difficulty in owning and regulating the former without infringing upon the rights of the latter. Next, he sets out a history of patent law and how it traditionally has treated naturally occurring objects and resources, pointing out the discrepancies between these treatments and the management of genetic property rights. Finally, Koepsell evaluates the pragmatic consequences of this regulatory practice and examines our current system to see if it is tenable within the context of scientific progress.
At a time in which science is becoming increasingly rarified, the author presents a refreshingly interdisciplinary treatment of his subject. Difficult concepts in biology, policy, and ethics are each patiently explained, making it a book suitable for readers of diverse backgrounds. The author’s own background in philosophy, however, lends the text a syntax and vocabulary that may be unfamiliar — even uncomfortable — to the scientist or doctor. In this sense, the book feels subtextually targeted at legal scholars or philosophers despite its ambitions toward broadness, but Koepsell’s obvious passionate belief in the topical importance of this debate maintains the reader’s interest.
Who Owns You? is the first long-form, comprehensive treatment of the implications of gene patenting. As such, it deserves much credit for bringing the debate into the public eye, though it’s no template for policy change in itself. Perhaps most important is its application of philosophical analysis to bio-policy, an underutilized approach critical to scientific advancement. Koepsell’s book serves as a worthy starting point for anyone interested in interconnecting genetics, property law, and philosophy.
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