In the 1990s the new science of gene technology was proving to give answers to many previously unanswered questions regarding hereditary diseases. One of these answers was the discovery of the genes BRCA1/2, mutations on which increase the likelihood for breast and ovarian cancer in women to up to 85%. There was a race among scientists to first identify the gene (originally it was thought to be just one) and sequence it, and in 1994 University of Utah filed a claim for the first patent in the name of Myriad Genetics, which has since held a practical monopoly on research into both genes and the testing for mutations on them. The patents cover not just specific mutations or methodologies of testing for these, but the entire genes, involving any use and research related to them. They were contested early on for a variety of reasons, relating both to the ethics of patenting human genome and to whether it is even reasonable to do so from a legal point of view. In 2009, the American Civil Liberties Union (ACLU) with others filed a suit against the United States Patent and Trademark Office (USPTO) and Myriad Genetics in order to have the patents declared invalid. They won the first case, which was since appealed by Myriad. The case was brought before the United States Supreme Court early in 2013. The gene patents were also contested in Europe for reasons related both to the effectiveness of the Myriad tests and to the ethics of patenting human genome. This text will focus on these ethics, specifically relating to treating parts of the human body as property, and how this in the BRCA case disproportionately affects women.
The very patentability of the human body becomes a matter of contention in cases such as the one related to the BRCA genes. Outside the world of intellectual-property rights, it seems commonsensical that every one of us owns our own genes (Stiglitz 2013), yet 20% of human genes are under some form of patent. There are two aspects to the matter; on the one hand, whether the isolation of a gene is actually to be considered as enough of an effort to warrant patenting, and the other hand, that of who actually owns the human body, and whether it even makes sense to speak of ownership of body parts.
There has been a long tradition in the US of allowing to patent purified natural products, including those present in the human body, as for example adrenaline (Fialho & Chakrabarty 2012:1230), yet when it comes to human genome the distinction between natural and purified is less clear-cut. Matthijs, a geneticist involved in the challenges of the European patents, takes the position that the isolation of a gene is more to be likened to a discovery than to an invention, only the latter being a patent-worthy effort, since it is simply a matter of isolating something that is already there (Matthijs 2006:99). Others argue that genes in themselves hold no utility and therefore should not be considered as something that can be patented (Fialho & Chakrabarty 2012:1230). Genes have also been likened to natural products in that they contain information, which makes them different from chemical compounds such as adrenaline (Matthijs 2006:99), and as such are to be likened to for example laws of nature, which are unpatentable (Fialho & Chakrabarty 2012:1229). Andrews argues that genes should be unpatentable simply by reason of them holding information that ought to be available to all (Andrews 2002:803).
The latter argument brings us to the second aspect of the question; who owns the human body? One of the comparisons brought up during the Supreme Court case in the US is that of patenting the liver, which is also a body part, yet is hardly considered patentable (Hearron et al. 2013). In this vein of argumentation, a gene, whether isolated or not, and whether mutated or not, is just another part of every human body, removing it from the realm of the patentable (Fialho & Chakrabarty 2012:1229). According to Stiglitz, this patenting and the monopoly it entails means that profits are put above the value of human life (in that women in this particular case are prevented from necessary testing, potentially putting their lives at risk) and above the individual's right to own his or her own body (Stiglitz 2013).
Foster makes a feminist analysis of the case, arguing that the entire language of patent law is written into a neoliberal biopolitical language that removes nature from the public domain and privatises it, giving private owners property rights over human tissue (Foster 2012:373). The case of the BRCA genes is highly gendered in that it affects women disproportionately, with less than 1% of breast cancers occurring in men (Williams-Jones 2002:127). There is a certain pressure for women to take these genetic tests, yet their choices are being constricted by Myriad's test being the only available one (Foster 2012:384). The briefs in the challenge to the patents in the US challenge the concrete patents but not the assumptions behind patent law as such, and an increased access to testing does not remove the obligation of women to donate bodily tissue for testing (ibid:385), which in itself may seem harmless but takes on a different significance when considering that women are forthwith considered primary caregivers and responsible for the medical needs of their children and families (ibid:375). The obligation to get tested for the best interest of their families means that they have to donate material which then becomes the intellectual property of scientists (ibid:382). Challenging the patents is almost entirely done within a language that is intelligible to the law and ignores this point (ibid:384), but one brief argued for gene sequences being seen as “common heritage of humanity” (ibid:386), in other words not as something that can be owned by anybody. Foster points out that the Myriad case being a case of women's right to healthcare makes it very useful as a general test case for gene patents as this adds to the stakes for the Supreme Court (ibid:383). This is not only a general case regarding humans' rights to their own bodies, it is about women's rights to determine their own medical choices and lives without constraint.
The polemics surrounding gene patents have been particularly prominent in the public eye recently due to the case before the US Supreme Court. Another factor drawing attention to it is the recent announcement by actress and director Angelina Jolie of her having had a double preventive mastectomy due to a 87% risk of breast cancer caused by a mutated BRCA1 gene running in her family. While Jolie is in the fortunate position of not having economic restrictions on her medical decisions, her opinion piece in the New York Times (Jolie 2013) points to the prohibitive costs of testing for many women in the US and elsewhere. While an important factor in this is the organisation of the American healthcare system, which is beyond the scope of this text, it is also an illustration of the importance Myriad's patents have on the lives of innumerable women worldwide. In this context it may be relevant to note that I am myself affected by a family history of BRCA mutations, making the controversy of these patents not only important at a level of who owns the human body and of principles relating to universal access to healthcare, but also a matter of great personal importance. The very law of gene patents transforms nature into private property, disproportionately affecting the female body. Women have for long been seen as responsible for the health of all their families, and the moral obligation to take genetic tests yet only having one option from which to choose makes their very bodies the intellectual property of someone else, and leaves them without any real choice of what to do or not to do with their bodies. It is thus a case both of ownership of nature and of the right to free medical choice.
Patent law as a whole reflects a very particular understanding of ownership which ignores the fact that all knowledge is built on prior knowledge (Stiglitz 2013). Patenting is meant to be a protection of an invention in order to make the investment put into it worthwhile, thus encouraging research, but when the protection is taken too far it can result in the opposite, as can be seen in the case of Myriad's patents, which have effectively curtailed all further research and left individuals with very constricted options, both regarding medical choices and which scientific directions to pursue, as the knowledge created has been removed from public space.
This is a slightly edited excerpt from a paper I handed in at Aarhus University for a course on international law. The main focus on the paper was on international property and patent law and its relation to the Myriad patents. The US Supreme Court has since reached a verdict and declared human genes unpatentable, though cDNA (synthetic copies of genes) can still be put under patent, making the actual effect debatable. But Myriad's patents are down, that's for sure, and by extension all patents on human genome. I meant to publish this around the time of the verdict, but had to wait until now, due to, ironically, issues of intellectual property law.
References
Andrews, Lori. 2002. Genes and patent policy: rethinking intellectual property rights. Nature Review 3, pp. 803-808
Fialho, Arsenio & Ananda Chakrabarty. 2012. Patent controversies and court cases: Cancer diagnosis, therapy and prevention. Cancer Biology & Therapy 13(13), pp. 1229-1234
Foster, Laura. 2012. Patents, Biopolitics, and Feminisms: Locating Patent Law Struggles over Breast Cancer Genes and the Hoodia plant. International Journal of Cultural Property 19, pp. 371-400
Hearron, Marc, James Mullen, & Matthew Kreeger. 2013. “United States: After “Myriad” Oral Argument, Supreme Court Set To Decide Patentability Of Isolated Human DNA Molecules”. Retrieved from http://www.mondaq.com/unitedstates/x/234882/Patent/After+Myriad+Oral+ Argument+Supreme+Court+Set+To+Decide+Patentability+Of+Isolated+Human+DNA+Molecules, last accessed 16-05-2013
Jolie, Angelina. 2013. My Medical Choice. New York Times. Retrieved from http://www.nytimes.com/2013/05/14/opinion/my-medical-choice.html?_r=3&, last accessed 17-05-2013
Matthijs, Gert. 2006. The European opposition against the BRCA gene patents. Familial Cancer 5, pp. 95-102
Stiglitz, Joseph. 2013. Lives versus Profits. Project Syndicate. Retrieved from http://www.project-syndicate.org/commentary/the-myriad-problems-of-intellectual-property-by-joseph-e—stiglitz, last accessed 27-05-2013
Williams-Jones, Bryn. 2002. History of a Gene Patent: Tracing the Development and Application of Commercial BCRA Testing. Health 10, pp. 123-146
Property Rights to the Human Body
The very patentability of the human body becomes a matter of contention in cases such as the one related to the BRCA genes. Outside the world of intellectual-property rights, it seems commonsensical that every one of us owns our own genes (Stiglitz 2013), yet 20% of human genes are under some form of patent. There are two aspects to the matter; on the one hand, whether the isolation of a gene is actually to be considered as enough of an effort to warrant patenting, and the other hand, that of who actually owns the human body, and whether it even makes sense to speak of ownership of body parts.
Isolated Genes as Discoveries or Inventions
There has been a long tradition in the US of allowing to patent purified natural products, including those present in the human body, as for example adrenaline (Fialho & Chakrabarty 2012:1230), yet when it comes to human genome the distinction between natural and purified is less clear-cut. Matthijs, a geneticist involved in the challenges of the European patents, takes the position that the isolation of a gene is more to be likened to a discovery than to an invention, only the latter being a patent-worthy effort, since it is simply a matter of isolating something that is already there (Matthijs 2006:99). Others argue that genes in themselves hold no utility and therefore should not be considered as something that can be patented (Fialho & Chakrabarty 2012:1230). Genes have also been likened to natural products in that they contain information, which makes them different from chemical compounds such as adrenaline (Matthijs 2006:99), and as such are to be likened to for example laws of nature, which are unpatentable (Fialho & Chakrabarty 2012:1229). Andrews argues that genes should be unpatentable simply by reason of them holding information that ought to be available to all (Andrews 2002:803).
Women's Rights to Their Own Bodies
The latter argument brings us to the second aspect of the question; who owns the human body? One of the comparisons brought up during the Supreme Court case in the US is that of patenting the liver, which is also a body part, yet is hardly considered patentable (Hearron et al. 2013). In this vein of argumentation, a gene, whether isolated or not, and whether mutated or not, is just another part of every human body, removing it from the realm of the patentable (Fialho & Chakrabarty 2012:1229). According to Stiglitz, this patenting and the monopoly it entails means that profits are put above the value of human life (in that women in this particular case are prevented from necessary testing, potentially putting their lives at risk) and above the individual's right to own his or her own body (Stiglitz 2013).
Foster makes a feminist analysis of the case, arguing that the entire language of patent law is written into a neoliberal biopolitical language that removes nature from the public domain and privatises it, giving private owners property rights over human tissue (Foster 2012:373). The case of the BRCA genes is highly gendered in that it affects women disproportionately, with less than 1% of breast cancers occurring in men (Williams-Jones 2002:127). There is a certain pressure for women to take these genetic tests, yet their choices are being constricted by Myriad's test being the only available one (Foster 2012:384). The briefs in the challenge to the patents in the US challenge the concrete patents but not the assumptions behind patent law as such, and an increased access to testing does not remove the obligation of women to donate bodily tissue for testing (ibid:385), which in itself may seem harmless but takes on a different significance when considering that women are forthwith considered primary caregivers and responsible for the medical needs of their children and families (ibid:375). The obligation to get tested for the best interest of their families means that they have to donate material which then becomes the intellectual property of scientists (ibid:382). Challenging the patents is almost entirely done within a language that is intelligible to the law and ignores this point (ibid:384), but one brief argued for gene sequences being seen as “common heritage of humanity” (ibid:386), in other words not as something that can be owned by anybody. Foster points out that the Myriad case being a case of women's right to healthcare makes it very useful as a general test case for gene patents as this adds to the stakes for the Supreme Court (ibid:383). This is not only a general case regarding humans' rights to their own bodies, it is about women's rights to determine their own medical choices and lives without constraint.
Conclusion
The polemics surrounding gene patents have been particularly prominent in the public eye recently due to the case before the US Supreme Court. Another factor drawing attention to it is the recent announcement by actress and director Angelina Jolie of her having had a double preventive mastectomy due to a 87% risk of breast cancer caused by a mutated BRCA1 gene running in her family. While Jolie is in the fortunate position of not having economic restrictions on her medical decisions, her opinion piece in the New York Times (Jolie 2013) points to the prohibitive costs of testing for many women in the US and elsewhere. While an important factor in this is the organisation of the American healthcare system, which is beyond the scope of this text, it is also an illustration of the importance Myriad's patents have on the lives of innumerable women worldwide. In this context it may be relevant to note that I am myself affected by a family history of BRCA mutations, making the controversy of these patents not only important at a level of who owns the human body and of principles relating to universal access to healthcare, but also a matter of great personal importance. The very law of gene patents transforms nature into private property, disproportionately affecting the female body. Women have for long been seen as responsible for the health of all their families, and the moral obligation to take genetic tests yet only having one option from which to choose makes their very bodies the intellectual property of someone else, and leaves them without any real choice of what to do or not to do with their bodies. It is thus a case both of ownership of nature and of the right to free medical choice.
Patent law as a whole reflects a very particular understanding of ownership which ignores the fact that all knowledge is built on prior knowledge (Stiglitz 2013). Patenting is meant to be a protection of an invention in order to make the investment put into it worthwhile, thus encouraging research, but when the protection is taken too far it can result in the opposite, as can be seen in the case of Myriad's patents, which have effectively curtailed all further research and left individuals with very constricted options, both regarding medical choices and which scientific directions to pursue, as the knowledge created has been removed from public space.
This is a slightly edited excerpt from a paper I handed in at Aarhus University for a course on international law. The main focus on the paper was on international property and patent law and its relation to the Myriad patents. The US Supreme Court has since reached a verdict and declared human genes unpatentable, though cDNA (synthetic copies of genes) can still be put under patent, making the actual effect debatable. But Myriad's patents are down, that's for sure, and by extension all patents on human genome. I meant to publish this around the time of the verdict, but had to wait until now, due to, ironically, issues of intellectual property law.
References
Andrews, Lori. 2002. Genes and patent policy: rethinking intellectual property rights. Nature Review 3, pp. 803-808
Fialho, Arsenio & Ananda Chakrabarty. 2012. Patent controversies and court cases: Cancer diagnosis, therapy and prevention. Cancer Biology & Therapy 13(13), pp. 1229-1234
Foster, Laura. 2012. Patents, Biopolitics, and Feminisms: Locating Patent Law Struggles over Breast Cancer Genes and the Hoodia plant. International Journal of Cultural Property 19, pp. 371-400
Hearron, Marc, James Mullen, & Matthew Kreeger. 2013. “United States: After “Myriad” Oral Argument, Supreme Court Set To Decide Patentability Of Isolated Human DNA Molecules”. Retrieved from http://www.mondaq.com/unitedstates/x/234882/Patent/After+Myriad+Oral+ Argument+Supreme+Court+Set+To+Decide+Patentability+Of+Isolated+Human+DNA+Molecules, last accessed 16-05-2013
Jolie, Angelina. 2013. My Medical Choice. New York Times. Retrieved from http://www.nytimes.com/2013/05/14/opinion/my-medical-choice.html?_r=3&, last accessed 17-05-2013
Matthijs, Gert. 2006. The European opposition against the BRCA gene patents. Familial Cancer 5, pp. 95-102
Stiglitz, Joseph. 2013. Lives versus Profits. Project Syndicate. Retrieved from http://www.project-syndicate.org/commentary/the-myriad-problems-of-intellectual-property-by-joseph-e—stiglitz, last accessed 27-05-2013
Williams-Jones, Bryn. 2002. History of a Gene Patent: Tracing the Development and Application of Commercial BCRA Testing. Health 10, pp. 123-146
No comments:
Post a Comment