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.
Monday, January 25, 2010
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.
Wednesday, December 9, 2009
The Perils of Pure Positivism
The dominant paradigm among law schools training young students to be lawyers is to indoctrinate them into accepting the truth of legal positivism. This trend continues the once fashionable school of Critical Legal Theory (in which law is politics, pure and simple), which went out of fashion, at least as a term, with the collapse of the allegedly Marxist states. In "pure" legal positivism, there is a complete disconnect between law and morality, and the validity of enactments derives from the fact of their enactment (to simplify greatly). In law school, I too read Austin and Hart, and modern proponents like Dworkin, I just never bought them. Legal positivism is the legal equivalent of moral relativism, and leaves open the door to too many hypothetical conditions under which we would be forced to accept the justice of clearly unjust enactments. As a believer in Justice, I maintained my allegiance to the classical, liberal underpinnings of the US Constitution, grounded as it is in a form of natural law theory.
Yet, in the current debate over gene patents, I can see that the grip of legal positivism on lawyers, especially patent attorneys it seems, is tenacious. As I have argued, intellectual property is not derived from natural law, and is thus a set of purely positive enactments. If there were no conflicts with natural law, then all its enactments would be "just," or at least acceptable. It is clear that a number of patent attorneys arguing for the continuation of gene patents either see no truth to natural law theory at all, or cannot grasp the necessity that positive enactments may not justly contradict natural law. It seems most likely, from my recent debates with gene patent proponents, that embracing pure legal positivism is a convenient way in general for lawyers to avoid cognitive dissonance, as there is never the threat that one might have to defend a stance that is, by nature, unjust.
And so, my continuing call to recognize that law must be naturally constrained from granting ownership to things that, by nature, cannot be exclusively possessed, that belong to what I term a "commons by necessity" continues to be misconstrued as a utilitarian call to recognize common rights for some other purpose. Rather, it is a recognition of a simple, necessary law of being, much like that which requires 2+2 to equal 4. Some things, like natural laws, cannot be possessed to the exclusion of anyone. Naturally occurring genes fall into this category too, as a matter of natural law. Positivists who fail to grasp this, or who refuse to recognize this, are persuaded that this is but a matter of choice. To them, I would ask, have you forgotten your Orwell?
"In a time of universal deceit - telling the truth is a revolutionary act."
— George Orwell
Yet, in the current debate over gene patents, I can see that the grip of legal positivism on lawyers, especially patent attorneys it seems, is tenacious. As I have argued, intellectual property is not derived from natural law, and is thus a set of purely positive enactments. If there were no conflicts with natural law, then all its enactments would be "just," or at least acceptable. It is clear that a number of patent attorneys arguing for the continuation of gene patents either see no truth to natural law theory at all, or cannot grasp the necessity that positive enactments may not justly contradict natural law. It seems most likely, from my recent debates with gene patent proponents, that embracing pure legal positivism is a convenient way in general for lawyers to avoid cognitive dissonance, as there is never the threat that one might have to defend a stance that is, by nature, unjust.
And so, my continuing call to recognize that law must be naturally constrained from granting ownership to things that, by nature, cannot be exclusively possessed, that belong to what I term a "commons by necessity" continues to be misconstrued as a utilitarian call to recognize common rights for some other purpose. Rather, it is a recognition of a simple, necessary law of being, much like that which requires 2+2 to equal 4. Some things, like natural laws, cannot be possessed to the exclusion of anyone. Naturally occurring genes fall into this category too, as a matter of natural law. Positivists who fail to grasp this, or who refuse to recognize this, are persuaded that this is but a matter of choice. To them, I would ask, have you forgotten your Orwell?
"In a time of universal deceit - telling the truth is a revolutionary act."
— George Orwell
Friday, November 27, 2009
Save Money and Paper
Who Owns You? The Corporate Gold Rush to Patent Your Genes is available for the Kindle reader. I think I need to get me one of those gadgets soon! I also have the pdf of the book, which I found on a torrent site (irony of ironies). Let me know if you want it ;-)
There is a 4-part interview with me done in The Netherlands that has just been added to YouTube.
Finally, my talk at Cardozo Law School, Oct 22, 2009, regarding ethics and intellectual property (including some in-depth about the issue of gene patents) is also on YouTube now.
There is a 4-part interview with me done in The Netherlands that has just been added to YouTube.
Finally, my talk at Cardozo Law School, Oct 22, 2009, regarding ethics and intellectual property (including some in-depth about the issue of gene patents) is also on YouTube now.
Friday, November 20, 2009
Who Owns You: Review in Choice
(this review made it into this month's "Editors' Picks" as well)
Koepsell, David. Who owns you?: The corporate gold-rush to patent your genes. Wiley-Blackwell, 2009. 187p index afp; ISBN 9781405187312, $79.95; ISBN 9781405187305 pbk, $24.95. Reviewed in 2009 dec CHOICE.
Via reflective consideration of secondary sources, attorney and philosopher Koepsell (Technology Univ. of Delft, The Netherlands) explores economic, ethical, legal, and scientific questions raised by the patenting of one-fifth of the human genome. After two chapters that provide a usefully comprehensive introduction, subsequent chapters address his ontologically informed ethical approach; the evolution of genetic and genomic research; the role of DNA in distinctions among species and individuals; and the legal evolution of patents regarding genes and other natural substances. Koepsell advocates a more limited scope for genome-related patents on the basis of intellectual property case law. He argues against the existing state of genome patent law, and further argues that existing genome patent protections harm science and economic innovation. This readable book covers a lot of ground, but it could benefit from greater incorporation of existing economic, legal, and philosophical inquiry. Recent legal decisions in Europe and North America suggest that Koepsell's emphasis on the demonstration of both an innovation and a commercial use ultimately may prove central to future jurisprudence in cases involving these patents. Koepsell's timely book is highly recommended for all reading levels. Summing Up: Highly recommended. All readership levels. -- C. H. Blake, James Madison University
Reprinted with permission from CHOICE http://www.cro2.org/, copyright by the American Library Association.
Koepsell, David. Who owns you?: The corporate gold-rush to patent your genes. Wiley-Blackwell, 2009. 187p index afp; ISBN 9781405187312, $79.95; ISBN 9781405187305 pbk, $24.95. Reviewed in 2009 dec CHOICE.
Via reflective consideration of secondary sources, attorney and philosopher Koepsell (Technology Univ. of Delft, The Netherlands) explores economic, ethical, legal, and scientific questions raised by the patenting of one-fifth of the human genome. After two chapters that provide a usefully comprehensive introduction, subsequent chapters address his ontologically informed ethical approach; the evolution of genetic and genomic research; the role of DNA in distinctions among species and individuals; and the legal evolution of patents regarding genes and other natural substances. Koepsell advocates a more limited scope for genome-related patents on the basis of intellectual property case law. He argues against the existing state of genome patent law, and further argues that existing genome patent protections harm science and economic innovation. This readable book covers a lot of ground, but it could benefit from greater incorporation of existing economic, legal, and philosophical inquiry. Recent legal decisions in Europe and North America suggest that Koepsell's emphasis on the demonstration of both an innovation and a commercial use ultimately may prove central to future jurisprudence in cases involving these patents. Koepsell's timely book is highly recommended for all reading levels. Summing Up: Highly recommended. All readership levels. -- C. H. Blake, James Madison University
Reprinted with permission from CHOICE http://www.cro2.org/, copyright by the American Library Association.
Monday, November 9, 2009
Stop Lying about the Myriad Patents on BRCA 1 and 2
Numerous defenders of Myriad often claim that the patents do not cover naturally-occurring genes, but rather only "methods" created by humans, or "isolated and purified" genes, which they allege can only be created by man. After all, they claim, isolated genes do not appear in nature, and it takes the work of humans to create them. This is, of course, hogwash. Isolating a gene is accomplished in nature in the process of cellular metabolism. Protein synthesis is accomplished without human intervention, much less, human invention, because various forms of RNA read the beginnings and ends of genes, omit the introns, and construct proteins from the remaining (exon) codons. So, merely finding the beginning and end of a gene is, as I have analogized in my book and elsewhere, equivalent to reading a map, and noting a geographical feature therein. Nature made the feature, and defined its borders, and we simply find it and model it. So that's the "isolation" and it doesn't warrant patent.
The "purification" part is part of nature's bag of tricks too, as mRNA skips the introns (the non-protein coding regions), and in fact some laboratory methods for creating cDNA (thus "purifying" DNA) use mRNA to accomplish this. Again, nothing at all inventive.
Finally, the Myriad patents on BRCA1 and 2 claim un-modified genes -- mutations in the BRCA1 and 2 gene that occur naturally. Their sole inventive claim is "isolation." See the patent yourself, and look at the claims (pp. 153-156). Look specifically at this:
"1. An isolated DNA coding for a BRCA1 polypeptide, said polypeptide having the amino acid sequence set forth in SEQ ID NO:2.
2. The isolated DNA of claim 1, wherein said DNA has the nucleotide sequence set forth in SEQ ID NO:1.
5. An isolated DNA having at least 15 nucleotides of the DNA of claim 1.
6. An isolated DNA having at least 15 nucleotides of the DNA of claim 2."
Now, note: these are not method claims, they are not claims for cDNA, but rather over naturally-occurring mutations to naturally-occurring genes. As I discuss above, and in my book, and elsewhere in this blog, this is not inventive at all. Rewarding for discovery of laws of nature goes beyond the scope of patent, and it inhibits research, and access to the "commons by necessity" that is the human genome and laws of nature in general.
It is like saying that since detached bird wings do not exist in nature, one ought to be able to patent detached bird wings. It's madness, and everyone except patent lawyers and others getting wealthy off this insanity can see that.
The "purification" part is part of nature's bag of tricks too, as mRNA skips the introns (the non-protein coding regions), and in fact some laboratory methods for creating cDNA (thus "purifying" DNA) use mRNA to accomplish this. Again, nothing at all inventive.
Finally, the Myriad patents on BRCA1 and 2 claim un-modified genes -- mutations in the BRCA1 and 2 gene that occur naturally. Their sole inventive claim is "isolation." See the patent yourself, and look at the claims (pp. 153-156). Look specifically at this:
"1. An isolated DNA coding for a BRCA1 polypeptide, said polypeptide having the amino acid sequence set forth in SEQ ID NO:2.
2. The isolated DNA of claim 1, wherein said DNA has the nucleotide sequence set forth in SEQ ID NO:1.
5. An isolated DNA having at least 15 nucleotides of the DNA of claim 1.
6. An isolated DNA having at least 15 nucleotides of the DNA of claim 2."
Now, note: these are not method claims, they are not claims for cDNA, but rather over naturally-occurring mutations to naturally-occurring genes. As I discuss above, and in my book, and elsewhere in this blog, this is not inventive at all. Rewarding for discovery of laws of nature goes beyond the scope of patent, and it inhibits research, and access to the "commons by necessity" that is the human genome and laws of nature in general.
It is like saying that since detached bird wings do not exist in nature, one ought to be able to patent detached bird wings. It's madness, and everyone except patent lawyers and others getting wealthy off this insanity can see that.
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