Intellectual property and development: beware the 'genome divide'
Policymakers need to understand the public health consequences of allowing intellectual property rights on DNA
Anna George warns of the implications for public health if companies are allowed to patent DNA Photograph: Mopic / Alamy/Alamy
Jane Parry wrote on this network in January about how genomics could help developing countries deal with disease. Her article provides a timely reminder of the health problems faced by all countries, but particularly developing countries. The cost implications of an estimated 371 million people with type 2 diabetes is staggering when the consequences for health budgets are considered. When combined with effects from the other non-communicable diseases, all governments face public health demands of epic proportions.
Developing smart preventive health strategies to identify high-risk groups, for example through genome testing, can help target resources to those most at risk. This was certainly one of the expectations of health professionals when the human genome project was completed in 2003 and presented as a gift to the world.
Unfortunately, these high expectations have not been realised. The intrinsic value of this global project is being circumscribed by the expansion of intellectual property rights over genomic DNA. An estimated 20% of the human genome is subject to patents that can impose complex legal and cost constraints on medicines and diagnostics.
A distinction needs to be made at this point to indicate that the issue raised here is not an argument against patenting of inventions based on "modified" gene sequences; it is the practice that enables the isolated, but otherwise unmodified, genomic DNA to be included in patent claims that is being questioned. This intellectual property practice is not universal. For example, countries such as Brazil do not allow this practice, but its intellectual property framework is nevertheless consistent with World Trade Organization intellectual property obligations. Brazil's approach allows the continuing use and access to the original gene sequence.
Given the challenges embedded in the non-communicable diseases agenda, it is time to have a much better understanding of the consequences of intellectual property rights that block access to unique genomic DNA. It is also time to question – as the European Parliament did in January – whether those responsible for important policy matters understand the consequences for the developing world of allowing intellectual property rights over such unique products of nature.
The 2002 Genomic and World Health comprehensive report of the World Health Organization advisory committee on health research highlighted problems with patents locking away the use an original gene sequence. The 2010 WHO initiative suggested options to deal with a growing developed/developing "genome divide". But until recently little scrutiny has been applied to legal and policy frameworks that enable the incremental expansion of intellectual property rights into this scientifically important area of health.
The US initially led the way developing this intellectual property practice with patents on gene sequences awarded as early as the mid 1980s. Australia followed in 1995 and the EU completed implementation of its directive in 2007. The consequences are now beginning to register with health policy specialists and governance regulators as the following two important US studies indicate.
The US Academy of Science/NRC report recorded: "The nature of biological inquiry and the norms of behaviour in the scientific community have changed in the wake of the Human Genome Project and the birth of proteomics … This sea change has occurred while both universities and industry have been aggressively seeking and defending intellectual property protection for discoveries, many of them well upstream of commercial application. Thus the potential for a perfect storm exists, in which future discoveries in genomics and proteomics that would benefit the public health and well-being could be thwarted by an increasingly complex intellectual property regime."
Another US report – Gene patents and licensing practices and their impact on patient access to genetic tests – prepared for the US Department of Health, provided significant evidence-based analysis. The conclusion was that "… a substantial number of existing patents on genes and methods of diagnosis pose a threat to the development of multiplex testing, parallel sequencing, and whole-genome sequencing, the areas of genetic testing with the greatest potential future benefits".
So how did we get to this situation where key scientific and regulatory bodies are belatedly realising the consequences of extending intellectual property monopoly rights which can capture products of nature such as gene sequences? Other products of nature, such as gold, uranium or a technologically important rare earth, when extracted from the natural environment, have not been patentable. A novel extraction tool can be patented, also a created product using gold or rare earth, but the extracted gold or rare earth itself cannot be patented.
Understanding the political and economic circumstances that enabled patents over genomic DNA cannot be explored further here but suffice to say that a major barrier faced by the non-intellectual property rights expert is the esoteric language and contorted legal rational applied. Even when the issue of why human genes are patented is raised publicly, the response is couched in technical jargon – it is not your genes that are being patented but an isolation process that extracts snippets of DNA that are not naturally occurring and are only seen in a laboratory setting.
What is never admitted to, willingly, is the consequence: how access to the original gene sequence also is blocked for the life of the patent. This occurs because the isolated but otherwise unmodified genomic DNA is identical to the original gene sequence. Both the "isolated form" and the original gene sequence have the same chemical composition. The original gene sequence cannot be reproduced or used for any purpose without the permission of the patent owner, including for checking the quality of diagnostic results. Scientific research can take place, but generally only for non-commercial purposes.
No doubt any attempts to alter intellectual property rights present a significant political challenge, but there are legal and legislative developments under way in the US and Australia questioning the legitimacy of patents over these isolated but otherwise unmodified genomic DNA. The specific focus is on Myriad Genomics' breast and ovarian cancer BRCA 1 & 2 gene sequence patents. Given that approximately 20% of the human genome is patented, including patents over Alzheimer's, epilepsy and hepatitis gene sequences, this legal process is fundamentally important.
For those tasked with the governance of intellectual property, health or innovation policy, these legal debates should be followed carefully. The legal outcomes will help define current and future access to the human genome.
The significant legal challenge to gene sequences has been under way in the US since 2009 and includes two appeals at the US federal court level and now elevated to the supreme court. A final decision is expected mid year. Worth noting is that the appeal process elicited several amicus briefs that should be of interest to health advocacy groups, policy experts and to the media. The amicus brief submitted by the US Justice Department on behalf of the US government is particularly significant. The key argument put is that patents should never have been awarded over isolated but otherwise unmodified genomic DNA. This extraordinary statement came as a shock to the intellectual property and biotech/pharma industries. The US amicus brief was unambiguous: isolated but otherwise unmodified genomic DNA is not a human made invention.
The global health challenges identified through the non-communicable disease agenda are vast and we are only at the beginning of a new era of technological transformation that will be driven by genomics, proteomics and nanotechnology. Ensuring open access to such basic scientific genomic data is a necessary step to enable the scientific collaboration and inventive solutions to evolve. The so-called "genome divide" is not just between developed and developing countries but also between closed and open access to these unique produces of nature that no one invented.
Anna George, a former Australian diplomat, is an adjunct professor at Murdoch University, in Perth, Western Australia, and also a Chatham House associate fellow at the Centre on Global Health Security
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Developing smart preventive health strategies to identify high-risk groups, for example through genome testing, can help target resources to those most at risk. This was certainly one of the expectations of health professionals when the human genome project was completed in 2003 and presented as a gift to the world.
Unfortunately, these high expectations have not been realised. The intrinsic value of this global project is being circumscribed by the expansion of intellectual property rights over genomic DNA. An estimated 20% of the human genome is subject to patents that can impose complex legal and cost constraints on medicines and diagnostics.
A distinction needs to be made at this point to indicate that the issue raised here is not an argument against patenting of inventions based on "modified" gene sequences; it is the practice that enables the isolated, but otherwise unmodified, genomic DNA to be included in patent claims that is being questioned. This intellectual property practice is not universal. For example, countries such as Brazil do not allow this practice, but its intellectual property framework is nevertheless consistent with World Trade Organization intellectual property obligations. Brazil's approach allows the continuing use and access to the original gene sequence.
Given the challenges embedded in the non-communicable diseases agenda, it is time to have a much better understanding of the consequences of intellectual property rights that block access to unique genomic DNA. It is also time to question – as the European Parliament did in January – whether those responsible for important policy matters understand the consequences for the developing world of allowing intellectual property rights over such unique products of nature.
The 2002 Genomic and World Health comprehensive report of the World Health Organization advisory committee on health research highlighted problems with patents locking away the use an original gene sequence. The 2010 WHO initiative suggested options to deal with a growing developed/developing "genome divide". But until recently little scrutiny has been applied to legal and policy frameworks that enable the incremental expansion of intellectual property rights into this scientifically important area of health.
The US initially led the way developing this intellectual property practice with patents on gene sequences awarded as early as the mid 1980s. Australia followed in 1995 and the EU completed implementation of its directive in 2007. The consequences are now beginning to register with health policy specialists and governance regulators as the following two important US studies indicate.
The US Academy of Science/NRC report recorded: "The nature of biological inquiry and the norms of behaviour in the scientific community have changed in the wake of the Human Genome Project and the birth of proteomics … This sea change has occurred while both universities and industry have been aggressively seeking and defending intellectual property protection for discoveries, many of them well upstream of commercial application. Thus the potential for a perfect storm exists, in which future discoveries in genomics and proteomics that would benefit the public health and well-being could be thwarted by an increasingly complex intellectual property regime."
Another US report – Gene patents and licensing practices and their impact on patient access to genetic tests – prepared for the US Department of Health, provided significant evidence-based analysis. The conclusion was that "… a substantial number of existing patents on genes and methods of diagnosis pose a threat to the development of multiplex testing, parallel sequencing, and whole-genome sequencing, the areas of genetic testing with the greatest potential future benefits".
So how did we get to this situation where key scientific and regulatory bodies are belatedly realising the consequences of extending intellectual property monopoly rights which can capture products of nature such as gene sequences? Other products of nature, such as gold, uranium or a technologically important rare earth, when extracted from the natural environment, have not been patentable. A novel extraction tool can be patented, also a created product using gold or rare earth, but the extracted gold or rare earth itself cannot be patented.
Understanding the political and economic circumstances that enabled patents over genomic DNA cannot be explored further here but suffice to say that a major barrier faced by the non-intellectual property rights expert is the esoteric language and contorted legal rational applied. Even when the issue of why human genes are patented is raised publicly, the response is couched in technical jargon – it is not your genes that are being patented but an isolation process that extracts snippets of DNA that are not naturally occurring and are only seen in a laboratory setting.
What is never admitted to, willingly, is the consequence: how access to the original gene sequence also is blocked for the life of the patent. This occurs because the isolated but otherwise unmodified genomic DNA is identical to the original gene sequence. Both the "isolated form" and the original gene sequence have the same chemical composition. The original gene sequence cannot be reproduced or used for any purpose without the permission of the patent owner, including for checking the quality of diagnostic results. Scientific research can take place, but generally only for non-commercial purposes.
No doubt any attempts to alter intellectual property rights present a significant political challenge, but there are legal and legislative developments under way in the US and Australia questioning the legitimacy of patents over these isolated but otherwise unmodified genomic DNA. The specific focus is on Myriad Genomics' breast and ovarian cancer BRCA 1 & 2 gene sequence patents. Given that approximately 20% of the human genome is patented, including patents over Alzheimer's, epilepsy and hepatitis gene sequences, this legal process is fundamentally important.
For those tasked with the governance of intellectual property, health or innovation policy, these legal debates should be followed carefully. The legal outcomes will help define current and future access to the human genome.
The significant legal challenge to gene sequences has been under way in the US since 2009 and includes two appeals at the US federal court level and now elevated to the supreme court. A final decision is expected mid year. Worth noting is that the appeal process elicited several amicus briefs that should be of interest to health advocacy groups, policy experts and to the media. The amicus brief submitted by the US Justice Department on behalf of the US government is particularly significant. The key argument put is that patents should never have been awarded over isolated but otherwise unmodified genomic DNA. This extraordinary statement came as a shock to the intellectual property and biotech/pharma industries. The US amicus brief was unambiguous: isolated but otherwise unmodified genomic DNA is not a human made invention.
The global health challenges identified through the non-communicable disease agenda are vast and we are only at the beginning of a new era of technological transformation that will be driven by genomics, proteomics and nanotechnology. Ensuring open access to such basic scientific genomic data is a necessary step to enable the scientific collaboration and inventive solutions to evolve. The so-called "genome divide" is not just between developed and developing countries but also between closed and open access to these unique produces of nature that no one invented.
Anna George, a former Australian diplomat, is an adjunct professor at Murdoch University, in Perth, Western Australia, and also a Chatham House associate fellow at the Centre on Global Health Security
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