September 19, 2011
The Public-Interest Patent Option
by John Willinsky ? September 19, 2011
On July 29th, 2011, the U.S. federal appeals court reaffirmed, in effect, the right to patent genes, if in limited cases. The court?s ruling overturned a lower court decision that voided a patent held by Myriad Genetics on BRCA1 and BRCA2, two human genes used in determining the risk that women face with breast and ovarian cancer. Much hinges on the outcome of such patent challenges, given the thousands of genes that have been patented in the United States and elsewhere.
The appeals court accepted that the chemical structure of DNA, once removed from a cell was ?markedly different? from the DNA found in nature, that is within the chromosone. In this way, the court upheld the general rule that what nature renders remains common to us all, while what is humanly produced is subject to patent. It also upheld in this case the limited nature of patents, by ruling against Myriad?s ability to patent its method of analyzing patient risks levels, declaring that Myriad?s filing involved, ?patent-ineligible abstract mental steps.??
The suit against Myriad?s patents was filed by the American Civil Liberties Union and the Public Patent Foundation (acting on behalf of cancer patients, who can face a $3,000 charge for the breast cancer risk test), as well as medical researchers and societies. The Obama administration filed an amicus curiae arguing against the patenting of DNA. In covering the case for the New York Times, Andrew Pollack has not unreasonably suggested that it may make its way to the Supreme Court. As well, Pollock refers to how ?critics say it is unethical to patent something that is part of the human body or the natural world.?
I would argue that the court respected this stance, by finding that the DNA in question was no longer part of the human body. But then I want to offer a second point of critique, based on a line of research I have underway on how work done in the name of learning (and the learned), in such institutional settings as universities, tends to give rise to a distinct class of intellectual properties, one that differs from commercial properties and places a different set of opportunities and responsibilities on the owners of those learned properties.?
This distinction has a long legal history and is entrenched through fair use clauses, the academic exception, various tax exemptions, Bayh-Dole Act, etc. At the same time, the distinctiveness of the intellectual properties of learning is still very much open to debate and dispute. Let me show how the distinction is both missing and operative in the case of the BRCA1 and BRCA2 gene patents. The ethical issue here, then, is not the DNA?s relation to the body, before and after it is extracted. It has to do with how the patent is used by those who have rights in it.?
In the U.S., along with Myriad Genetics, which is located in Salt Lake City, the other party with rights to these gene patents is the University of Utah Research Foundation. The Foundation seeks ?to promote, conduct, encourage and facilitate research, development and dissemination of knowledge, and the application of knowledge in all fields of learning.? One way of achieving that goal is to direct a portion of the licensing fees paid to the Foundation for such patents to more research. This might well seem justified until one realizes that there is another way of addressing the responsibilities that arise from the creation of intellectual property in the name of learning and the development of knowledge.?
Seven years earlier, Cancer Research UK won its case to extend its UK patent for the BRCA2 gene (based on the work of Mike Stratton funded by Cancer Research UK) to all of Europe. Many researchers applauded and welcomed this extension of patent rights because Cancer Research UK grants royalty-free access to BRCA2 for publicly owned and non-profit labs. This organization used the patent to protect the public?s right to benefit from BRCA2, while retaining an ability to license it to commercial enterprises.
This is sometimes referred to as ?defensive patenting,? protecting an invention from being patented by others. In this case, a publicly funded agency is using the patent defensively ? should we call it ?ethical patenting? or ?public-interest patenting?? ? to keep this invention in the public realm. By a strange twist in this knowledge-based economy, Cancer Research UK allows for both public and commercial use of its patent, thereby breaking the (seemingly anti-capitalist) monopoly that can lead to undue commercial exploitation.?
Public-interest patenting strikes me as recognizing the distinctive intellectual properties of learning. It responsibly honors the public trust involved in the funding of learning and learned inquiry. It is one way to redirect the university patent race, set off in the U.S. by the Bayh-Dole Act of 1980, into a matter of greater public good.
On July 29th, 2011, the U.S. federal appeals court reaffirmed, in effect, the right to patent genes, if in limited cases. The court?s ruling overturned a lower court decision that voided a patent held by Myriad Genetics on BRCA1 and BRCA2, two human genes used in determining the risk that women face with breast and ovarian cancer. Much hinges on the outcome of such patent challenges, given the thousands of genes that have been patented in the United States and elsewhere.
The appeals court accepted that the chemical structure of DNA, once removed from a cell was ?markedly different? from the DNA found in nature, that is within the chromosone. In this way, the court upheld the general rule that what nature renders remains common to us all, while what is humanly produced is subject to patent. It also upheld in this case the limited nature of patents, by ruling against Myriad?s ability to patent its method of analyzing patient risks levels, declaring that Myriad?s filing involved, ?patent-ineligible abstract mental steps.??
The suit against Myriad?s patents was filed by the American Civil Liberties Union and the Public Patent Foundation (acting on behalf of cancer patients, who can face a $3,000 charge for the breast cancer risk test), as well as medical researchers and societies. The Obama administration filed an amicus curiae arguing against the patenting of DNA. In covering the case for the New York Times, Andrew Pollack has not unreasonably suggested that it may make its way to the Supreme Court. As well, Pollock refers to how ?critics say it is unethical to patent something that is part of the human body or the natural world.?
I would argue that the court respected this stance, by finding that the DNA in question was no longer part of the human body. But then I want to offer a second point of critique, based on a line of research I have underway on how work done in the name of learning (and the learned), in such institutional settings as universities, tends to give rise to a distinct class of intellectual properties, one that differs from commercial properties and places a different set of opportunities and responsibilities on the owners of those learned properties.?
This distinction has a long legal history and is entrenched through fair use clauses, the academic exception, various tax exemptions, Bayh-Dole Act, etc. At the same time, the distinctiveness of the intellectual properties of learning is still very much open to debate and dispute. Let me show how the distinction is both missing and operative in the case of the BRCA1 and BRCA2 gene patents. The ethical issue here, then, is not the DNA?s relation to the body, before and after it is extracted. It has to do with how the patent is used by those who have rights in it.?
In the U.S., along with Myriad Genetics, which is located in Salt Lake City, the other party with rights to these gene patents is the University of Utah Research Foundation. The Foundation seeks ?to promote, conduct, encourage and facilitate research, development and dissemination of knowledge, and the application of knowledge in all fields of learning.? One way of achieving that goal is to direct a portion of the licensing fees paid to the Foundation for such patents to more research. This might well seem justified until one realizes that there is another way of addressing the responsibilities that arise from the creation of intellectual property in the name of learning and the development of knowledge.?
Seven years earlier, Cancer Research UK won its case to extend its UK patent for the BRCA2 gene (based on the work of Mike Stratton funded by Cancer Research UK) to all of Europe. Many researchers applauded and welcomed this extension of patent rights because Cancer Research UK grants royalty-free access to BRCA2 for publicly owned and non-profit labs. This organization used the patent to protect the public?s right to benefit from BRCA2, while retaining an ability to license it to commercial enterprises.
This is sometimes referred to as ?defensive patenting,? protecting an invention from being patented by others. In this case, a publicly funded agency is using the patent defensively ? should we call it ?ethical patenting? or ?public-interest patenting?? ? to keep this invention in the public realm. By a strange twist in this knowledge-based economy, Cancer Research UK allows for both public and commercial use of its patent, thereby breaking the (seemingly anti-capitalist) monopoly that can lead to undue commercial exploitation.?
Public-interest patenting strikes me as recognizing the distinctive intellectual properties of learning. It responsibly honors the public trust involved in the funding of learning and learned inquiry. It is one way to redirect the university patent race, set off in the U.S. by the Bayh-Dole Act of 1980, into a matter of greater public good.
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