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.
Friday, November 27, 2009
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.
Tuesday, November 3, 2009
Good News from the District Court
Judge Sweet did the right thing on the defendants' motions to dismiss, refusing to grant those motions, and ensuring this case can go forward on the merits. This is excellent news, and a sound rejoinder to the insistence by the likes of Holman, Noonan, Quinn, and other pro-gene-patent folks that this case was "frivolous." For non-lawyers, the claim of "frivolous" is particularly charged given that, in federal court, a lawyer can be sanctioned for bringing a frivolous claim. Moreover, in federal court, the pleading requirements for a claim are rather liberal, and as long as the claim is colorable, involves some real, federal case or controversy, and plaintiffs have suffered some injury which the court can redress, then the complaint is not frivolous.
I am still reading the decision, but it indicates that the court is certainly aware of the importance of this case, and the necessity of resolving the claims in federal court. Much depends upon it. I am thrilled about this decision since it means the merits will be resolved one way or another. The summary judgment motion is now pending, and has been fully briefed. Now we shall see how the court decides that motion, which would go to the merits of the claims, and then watch this baby go on up to appeal... eventually, to SCOTUS.
I am still reading the decision, but it indicates that the court is certainly aware of the importance of this case, and the necessity of resolving the claims in federal court. Much depends upon it. I am thrilled about this decision since it means the merits will be resolved one way or another. The summary judgment motion is now pending, and has been fully briefed. Now we shall see how the court decides that motion, which would go to the merits of the claims, and then watch this baby go on up to appeal... eventually, to SCOTUS.
Thursday, October 29, 2009
Doing Philosophy in Public
Lately, I feel that the ivory tower is crumbling. Or at least it is developing some stress fractures. This is a good thing. For too long, the academic world and the real world have been at odds. Academics, intent on fulfilling the career goals, and standardized path of academic achievement, have helped to perpetuate the lay-public's view that academics are isolated, uninvolved, and mostly irrelevant. Academic disputes might be heated, emotionally charged, and the may make or break academic careers, but rarely do these disputes matter to the world at large. As the link above notes, Henry Kissinger correctly noted that the bitterness of academic disputes "is in inverse proportion to the importance of the subject." Indeed, among academics the currency of the trade has often been to find an opponent, attack, and if possible, destroy. But does any of this intellectual parrying matter to anyone, and must this be the future model of the academy -- to provide a sort of Punch and Judy show as occasional tidbits to a bemused public already wary of the goings-on in university halls? Simply put, no. It doesn't need to be like that.
Sometimes, we can step outside this model, seek not only positive collaborations between the academy and the "real" world, but also work to make ourselves relevant to the public in broader ways. This is part of the virtue of applied ethics, and one reason I have been thrilled to be at TU Delft. Here, engagement in the world is part of the goal. Applied ethics means nothing without a world to apply it to, and projects and researchers working on applied ethics in the Dutch technical universities are not only training engineers to think ethically, but also engaged in projects involving policies affecting hundreds of thousands of people. This is as it should be. Never before have I felt more at home in striving for public policy changes based upon my research. Where once my goals to take my research and do something with it might have been met with scorn by entrenched academic establishments, I am now encouraged by an atmosphere that accepts and even embraces the next logical step: change.
Three years ago, when I began to approach the issue of gene patenting, it was more or less just an academic question to me. Yes I felt viscerally that this was an important issue, but I never realized the extent to which it impacted the lives of hundreds of thousands of people around the world (if not more), or the extent to which others were moved to finally act on the issue. When, two months after my book came out, the ACLU sued Myriad on this very issue, and now with the US dept of Health and Human Services making some progress in suggesting significantly altering gene patenting, I can see that applied ethics must naturally reach out as an academic field into the real world of activism.
I had the great fortune last week to be where the rubber meets the road on this issue, in what could legitimately be called "gene patent week" in New York City. There, I met with the attorneys for the ACLU, as well as a patent attorney who has been a harsh critic of my work, calling me, the ACLU, and other opponents of gene patenting "liars"(though, even now, he admits not having read my book). I met with Luigi Palombi, whose book Gene Cartels came out just recently, and does for the legal case against gene patents what mine does for the ethical case. I met the director of the film "In The Family," Joanna Rudnick, who possesses the BRCA1 mutation that makes her susceptible to breast and ovarian cancer, and who discovered in documenting her experiences that the patent that Myriad Genetics owns for that gene prevents her and many others from accessing information about their own bodies, from getting second opinions about her tests, and for many women, the prohibitive price of the test prevents even getting the test done in the first place. I met clinicians and researchers, like Debra Leonard and Ellen Matloff, each of whom has personal experience with how gene patents prevent doctors, researchers, and patients from getting access to information that is not only vitally needed, but part of nature, a natural law, and thus not properly owned. I met with Tania Simoncelli and Sandra Park, of the ACLU, who have striven each in her own way to actually end the process of gene patenting. Tania's background is in science, and she has fought for years to get a suit started, and Sandra is an attorney who is fighting valiantly in the courts. I met Dan Ravicher and Chris Hansen, of the Public Patent Foundation and the ACLU, each of whom has staked his organization's reputations on bringing this courageous and necessary suit.
These people humbled me. What began for me as an academic issue is now personal, and a matter of activism. This is not academia, and the rhetoric around the edges of the debate, the name calling, insinuation, and arguing about the meanings of terms and legal rulings must be put into perspective. People are being hurt, and these harms are not academic. They are wrong. Public policy must change. Never before has it been clearer to me that this is not just an issue for debate, but the cusp of something big.
I had the great fortune to meet and interview James Watson, co-discoverer of the structure of DNA, and I asked him about gene patenting. He opposes it, and he says his opposition was why he was "fired" from the Human Genome Project. He stated in our 45 minute on-camera interview that "something has to give" and that gene patenting cannot continue. It is harming too many people. I value his judgment as a scientist, and his concern as a person came through when he expressed his disdain for the costs associated with a non-inventive test that has been given an exclusive monopoly through patent.
I particularly value the energy, commitment, and involvement of academics, lawyers, clinicians, and counselors -- all those named above and many more unmentioned, who have moved beyond the academic issues involved and sought to change the world because they know that their cause is just. They have staked their reputations, their careers, money, relationships, and futures on pursuing this change, and their commitment should embolden us all. It gives me strength, and makes me thankful that here, applied philosophy means involvement in the world, unashamedly pursuing the good, and making philosophy relevant once again.
Sometimes, we can step outside this model, seek not only positive collaborations between the academy and the "real" world, but also work to make ourselves relevant to the public in broader ways. This is part of the virtue of applied ethics, and one reason I have been thrilled to be at TU Delft. Here, engagement in the world is part of the goal. Applied ethics means nothing without a world to apply it to, and projects and researchers working on applied ethics in the Dutch technical universities are not only training engineers to think ethically, but also engaged in projects involving policies affecting hundreds of thousands of people. This is as it should be. Never before have I felt more at home in striving for public policy changes based upon my research. Where once my goals to take my research and do something with it might have been met with scorn by entrenched academic establishments, I am now encouraged by an atmosphere that accepts and even embraces the next logical step: change.
Three years ago, when I began to approach the issue of gene patenting, it was more or less just an academic question to me. Yes I felt viscerally that this was an important issue, but I never realized the extent to which it impacted the lives of hundreds of thousands of people around the world (if not more), or the extent to which others were moved to finally act on the issue. When, two months after my book came out, the ACLU sued Myriad on this very issue, and now with the US dept of Health and Human Services making some progress in suggesting significantly altering gene patenting, I can see that applied ethics must naturally reach out as an academic field into the real world of activism.
I had the great fortune last week to be where the rubber meets the road on this issue, in what could legitimately be called "gene patent week" in New York City. There, I met with the attorneys for the ACLU, as well as a patent attorney who has been a harsh critic of my work, calling me, the ACLU, and other opponents of gene patenting "liars"(though, even now, he admits not having read my book). I met with Luigi Palombi, whose book Gene Cartels came out just recently, and does for the legal case against gene patents what mine does for the ethical case. I met the director of the film "In The Family," Joanna Rudnick, who possesses the BRCA1 mutation that makes her susceptible to breast and ovarian cancer, and who discovered in documenting her experiences that the patent that Myriad Genetics owns for that gene prevents her and many others from accessing information about their own bodies, from getting second opinions about her tests, and for many women, the prohibitive price of the test prevents even getting the test done in the first place. I met clinicians and researchers, like Debra Leonard and Ellen Matloff, each of whom has personal experience with how gene patents prevent doctors, researchers, and patients from getting access to information that is not only vitally needed, but part of nature, a natural law, and thus not properly owned. I met with Tania Simoncelli and Sandra Park, of the ACLU, who have striven each in her own way to actually end the process of gene patenting. Tania's background is in science, and she has fought for years to get a suit started, and Sandra is an attorney who is fighting valiantly in the courts. I met Dan Ravicher and Chris Hansen, of the Public Patent Foundation and the ACLU, each of whom has staked his organization's reputations on bringing this courageous and necessary suit.
These people humbled me. What began for me as an academic issue is now personal, and a matter of activism. This is not academia, and the rhetoric around the edges of the debate, the name calling, insinuation, and arguing about the meanings of terms and legal rulings must be put into perspective. People are being hurt, and these harms are not academic. They are wrong. Public policy must change. Never before has it been clearer to me that this is not just an issue for debate, but the cusp of something big.
I had the great fortune to meet and interview James Watson, co-discoverer of the structure of DNA, and I asked him about gene patenting. He opposes it, and he says his opposition was why he was "fired" from the Human Genome Project. He stated in our 45 minute on-camera interview that "something has to give" and that gene patenting cannot continue. It is harming too many people. I value his judgment as a scientist, and his concern as a person came through when he expressed his disdain for the costs associated with a non-inventive test that has been given an exclusive monopoly through patent.
I particularly value the energy, commitment, and involvement of academics, lawyers, clinicians, and counselors -- all those named above and many more unmentioned, who have moved beyond the academic issues involved and sought to change the world because they know that their cause is just. They have staked their reputations, their careers, money, relationships, and futures on pursuing this change, and their commitment should embolden us all. It gives me strength, and makes me thankful that here, applied philosophy means involvement in the world, unashamedly pursuing the good, and making philosophy relevant once again.
Summary of recent events at Biopolitical Times
The good people at the Center for Genetics and Society offer an excellent recap of recent events in the battle over gene patenting. It encapsulates some of the major recent developments I have blogged about here, and includes a link to the GRITtv debate with Quinn and me. There's momentum, there's interest, and very soon, there will start to be decisions one way or another. Stay tuned!
Wednesday, October 28, 2009
Aaron Fellmeth review in Bioethical Inquiry
Although Fellmeth finds the book insufficiently academic, and bemoans my failure to tie up the loose ends of all of the questions raised by gene patenting, he gives some praise:
"Judging by its provocative yet rhetorical title,
informal tone, and modest number of citations to the
work of others, Who Owns You? is clearly not
addressed to the academic or research communities;
nonetheless, it contains a good deal of helpful
information for the lay public relating to the relevant
(and some irrelevant) biology and biochemistry,
intellectual property law, and ethics of gene patenting.
Koepsell’s gift of conversational writing facilitates
communication of complex ideas to the uninitiated.
On the whole, the book explains much of its subject
matter well."
I did set out to write an accessible general introduction to the topic, and I find that people who have read the book are pleased with its style and tone, as well as interested in a topic they knew little about before reading the book. Moreover, I do admit quite clearly near the end of the book that many of the issues raised, including the link between genes and individuals, remain unanswered and outside the scope of the book.
Finally, Fellmeth's review points to a recurring issue, and that is that lawyers and legal scholars who read my arguments generally miss the point I make in elucidating a new theory of the commons, the "commons by necessity," and this is likely due to the positivist trend in legal scholarship. Steven Poole's review in The Guardian at least notes my "quirky" approach to natural law, which is at the heart to my conclusions about the genome being a "commons by necessity." Overall, I am happy with Fellmeth's review because unlike Holman, he is honest and comprehensive about the whole of the work. He approaches the whole book and not just parts of it, and his differences with my conclusions and approach are honest and not apparently tinged with any conflicting interests. Nonetheless, he takes issue with things that are arguable, and alleges that, for instance, patents on DNA cover something sufficiently "altered" to make them patentable. Here, it is clear we disagree, though like Holman, he calls this my "error."
I'm in touch with Fellmeth, and thanked him for the review. As I said to him, my books have met with reviews that range all over the map, but somehow, over time, the ideas I am working on developing, regarding the nature of ideas, property, the commons, and innovation, have benefited from good, honest, open debate. Judging from the positive response I received last week in NYC, and my interactions with the community of people both affected by gene patents personally, and working to eradicate them, I feel good about the future, and my contributions to changing the law.
"Judging by its provocative yet rhetorical title,
informal tone, and modest number of citations to the
work of others, Who Owns You? is clearly not
addressed to the academic or research communities;
nonetheless, it contains a good deal of helpful
information for the lay public relating to the relevant
(and some irrelevant) biology and biochemistry,
intellectual property law, and ethics of gene patenting.
Koepsell’s gift of conversational writing facilitates
communication of complex ideas to the uninitiated.
On the whole, the book explains much of its subject
matter well."
I did set out to write an accessible general introduction to the topic, and I find that people who have read the book are pleased with its style and tone, as well as interested in a topic they knew little about before reading the book. Moreover, I do admit quite clearly near the end of the book that many of the issues raised, including the link between genes and individuals, remain unanswered and outside the scope of the book.
Finally, Fellmeth's review points to a recurring issue, and that is that lawyers and legal scholars who read my arguments generally miss the point I make in elucidating a new theory of the commons, the "commons by necessity," and this is likely due to the positivist trend in legal scholarship. Steven Poole's review in The Guardian at least notes my "quirky" approach to natural law, which is at the heart to my conclusions about the genome being a "commons by necessity." Overall, I am happy with Fellmeth's review because unlike Holman, he is honest and comprehensive about the whole of the work. He approaches the whole book and not just parts of it, and his differences with my conclusions and approach are honest and not apparently tinged with any conflicting interests. Nonetheless, he takes issue with things that are arguable, and alleges that, for instance, patents on DNA cover something sufficiently "altered" to make them patentable. Here, it is clear we disagree, though like Holman, he calls this my "error."
I'm in touch with Fellmeth, and thanked him for the review. As I said to him, my books have met with reviews that range all over the map, but somehow, over time, the ideas I am working on developing, regarding the nature of ideas, property, the commons, and innovation, have benefited from good, honest, open debate. Judging from the positive response I received last week in NYC, and my interactions with the community of people both affected by gene patents personally, and working to eradicate them, I feel good about the future, and my contributions to changing the law.
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