The Guardian: Analysis - How to patent a gene
Signing up to 'a patent on life': Britain agrees today to an EU directive that could mean that the ownership of your blood cells and your genes could be transferred to a company that holds the patents. What's going on? David Rowan reports
BREAKFAST time on Tuesday was rather more eventful than usual in the north London neighbourhood of Lord Simon of Highbury. At 7.15am, a dozen or so protesters broke the calm of the Competitiveness Minister's Islington townhouse to suspend from the roof a bright yellow banner reading 'No patents on life', and to stick a few 'Patent pending' signs on trees in his garden. The BioPirates, as the protesters styled themselves, departed once the police arrived, but not before clarifying their purpose: this had been nothing less, they declared, than their very last chance to stall 'the race to commodify life'.
They will not have succeeded. For today, Lord Simon will sign up to a European Union directive that environmentalists, religious groups, some scientists and even that rare sighting, a dissenting New Labour MP, speak of in the absolutist language of the corporate conspiracy. The Directive on the Legal Protection of Biological Inventions, designed to allow biotechnology companies to patent the results of their research, is 'a frightening prospect and fundamentally immoral', in the words of Greenpeace. According to a group of British scientists, it will 'threaten the very foundations of scientific research'. And as the MP Alan Simpson puts it, it will transfer the ownership of your blood cells, your genes, and your resistance to hereditary disorders to 'greed-driven' companies that hold the patents.
You may not have heard of the directive, which will enter one of the later pit-stops today on its way to becoming European law. It was introduced two years ago, after an earlier proposal failed over ethical concerns, to codify the patenting of genetic material across the animal and plant kingdoms. In July this year the European Parliament agreed to a draft of the directive, although it suggested some amendments in response to the objectors' fears that it would offer a blanket 'patent on life'. Today the amended proposal will come to the Council of Ministers, where - subject to qualified majority voting - the directive is likely to go through to the European Parliament for a second opinion before becoming law.
Lord Simon is likely to indicate Britain's approval. John Battle, the Department of Trade and Industry minister most closely involved with the directive, stresses that 'it does not afford patent rights to anything which is not patentable under current law', but will merely clarify the situation across Europe and 'harmonise the patenting regime'. 'We don't dispute that there are major ethical concerns,' says a DTI spokeswoman, 'which is why we are holding a major consultation exercise next summer. But patent law is about property rights - and this directive is not the most appropriate place to address the ethical question.' Advances in biotechnology can indeed already be patented under European patent law.
What concerns campaigners against the directive is the wide nature of the rights the new patents will afford private companies. 'At issue is whether these patents should be much broader in nature than other patents,' says Abby Munson, campaign director of the Genetics Forum. 'Whether, for example, someone who isolates and characterises natural material should be able to patent not just the method by which this was done, but the material itself.'
Nor is it simply environmental organisations that have voiced concern. The Clinical Genetics Society, the Clinical Molecular Genetics Society, the Association of Clinical Cytogeneticists and the Genetic Nurses and Social Workers Association, recently issued their own joint statement: 'We do not believe that such sequences (patents on fragmentary sequences from human DNA, of no known function or utility) should be patentable, partly because of the lack of demonstrable utility, and partly because of the inevitable and unnecessary confusion which would arise when several groups were found to hold patents on parts of the same overall functioning sequence ... A natural human gene sequence is part of the human body, and as such should not be patentable.'
The draft directive certainly takes a broad view of how far exactly ownership should extend. It is intended to allow the patenting of genetic 'inventions' rather than mere discoveries. But article 3:2 states that 'biological material which is isolated from its natural environment or processed by means of a technical process may be the subject of an invention even if it already occurred in nature' (emphasis added). That, at the very least, blurs the distinction.
Furthermore, critics point out that corporations would merely need to identify a gene and describe its function to secure monopoly rights to any therapies developed in connection with that gene. Campaign groups across Europe have been opposing a patent granted in Germany to the US company Biocyte, which covers all human blood cells taken from the umbilical cord of a new-born child and used for therapeutic processes. All Biocyte has done, say the campaigners, is show that these blood cells can be isolated and deep-frozen.
It is what the draft directive implies for the human body, rather than its meaning for plant and animal genes, that has recently concerned campaigners most. 'An element isolated from the human body or otherwise produced is not excluded from patent ability,' it states in article 5:1 . 'A sequence or partial sequence can be the subject of a patentable invention.' This, some campaigners worry, will actively encourage new patents, and not, as the DTI claims, merely harmonise existing law.
'By explicitly allowing the patenting of genes and other living organisms, this directive will ensure a rush of patents on living organisms that have hitherto been granted hesitantly and on an ad-hoc basis,' says Maya Vaughan of the Gaia Foundation. 'It will also make challenges to unethical and broad-sweeping patents, such as the one on umbilical-cord blood cells, much more difficult.'
Other campaigners take a more emotive view about the risks of allowing life to be patented: they recall the case of the Seattle physician who patented the cells of his patient, John Moore, without Moore's informed consent - which Novartis, a Swiss company, used to derive pharmaceutical products. Or they talk about the Hagahai, people in the remote highlands of Papua New Guinea, who had their first contact with the outside world in 1984. Blood samples were collected after they had been exposed to viruses, and later the National Institute of Health in the US was granted a patent on a Hagahai man's cell line (which was later overturned).
More specifically, opponents fear that private ownership of genes will limit scientific research that would benefit all. As a group of scientists wrote in Nature: 'The present directive from Brussels succeeds only in threatening free access to material and freedom to pursue promising lines of enquiry.' Then the are the potential costs to the NHS and other users. Manchester Regional Genetics Centre was billed for $5,000 by a Toronto-based biotech company which had applied for a patent on a kit for testing cystic fibrosis. Dr Gareth Evans, consultant in medical genetics in Manchester, warns that the NHS will have to pay licence fees and royalties on all patented genes. 'Genetic tests for heart disease and breast cancer may involve the testing of 15 or more genes each,' he says. 'This will mean 15 separate royalties to be paid.'
YET THE Government has on balance tended towards the pharmaceutical industry's own concerns. If Britain does not sign up to the directive, the DTI warns, there is a 'big chance' that pharmaceutical companies currently based here will move elsewhere - an argument, notably, also heard recently about the Formula One industry. Besides, it stresses that the directive will not give companies the rights to the genes themselves: private companies 'must demonstrate they have developed a technical process - it has to be an invention, not a discovery'.
In lobbying the Government, the biotechnology industry said the directive was essential, not least for Britain's economy. It pointed to the sector's health, and the risk of investment moving away to the US. British-based biotechnology companies invest more than £2 billion a year in research, it said; 93 per cent of Europe's listed bioscience companies are based here, accounting for more than 60 per cent of the European industry. 'Without patents, investment in the next generation of products would dwindle to the significant detriment of patients and the industry,' it says. 'They are an absolute prerequisite for investment in research in an industry where it takes around 10-12 years and more than £200 million to research and develop each new medicine with no guarantee of success.'
It is undeniable that biotechnology has been of broad benefit: it has allowed the development of treatments for a range of diseases from cancer to cystic fibrosis. Increasingly, new medicines are being based on the body's own molecules: last year, for instance, diabetics were able to use an improved form of insulin, lispro, made by changing the order of some amino acids in a protein. But one key argument is whether this would continue if the ownership of the genes themselves remained unregulated under European law. Alan Simpson points out that if patents are granted to one company, other competing research projects would have no choice but to be abandoned.
TODAY'S Council of Ministers vote will not end the debate. The Government, indeed, says it wants it to become broader and more open. But there is now little chance that genes, human or otherwise, will escape regulation through European patent law. If that moves the debate beyond the more scare mongering and bigoted tones of a few of the protesters, some at least will be grateful.
Professor Steve Jones, eminent geneticist and author of In The Blood, believes that much of the current debate on patenting is misplaced. He dismisses campaigners' worries about the ownership of human beings as 'romantic obscurantism': 'It's just silly - you can't own a human being. Such arguments are giving chemicals a soul they don't have.' The argument today, Jones believes, should not be about whether particular DNA sequences should be patented, but about who owns the patents. 'The parallel, to me, is the copyright laws. In the 19th century, many writers, Dickens included, stopped writing for a time because their stuff was stolen. It's the same for gene research: no one is going to invest in it if that were the risk.'
What should be debated now, Jones says, is not the issue of patenting DNA, 'but the more technical argument about whether DNA is a discovery or an invention. I don't know whether it is one or the other: all scientists can do is advise the patent lawyers their views - and you'll find there is no consensus.'
Sources: Directive 95/0350(COD) and COM (97)446 Final; Greenpeace Briefing on Amended Proposal; Letter from Brian Goodwin and others to Nature magazine; Guardian article, 11/7/97; Association of the British Pharmaceutical Industry; Gaia Foundation; Hereditary Breast Cancer Helpline (01629 813000); Cancer Research Campaign; Myriad Genetics.
++++
Case study: How to own a gene
Last year an American company, Myriad Genetics of Utah, applied in Europe to patent a gene known as BRCA1 that it identified in 1994. Women with a mutated version of the gene have an 85 per cent chance of developing breast cancers. Myriad's patent application is comprehensive: it includes the gene's coding, methods of screening for it, kits for detecting mutations, even a transgenic animal which carries an altered form of the gene. Myriad says it needs a patent because of the sums it spent on finding the gene.
How the test works:
There are 23 pairs of human chromosomes.
The BRCA1 gene lies on a small area of chromosome 17. A test can be done to see if members of a family have a similar gene pattern to relatives known to be affected. In the US, Myriad charges about $2,400 to screen for BRCA1 and a second gene, BRCA2. Once the fault is found, it charges a few hundred dollars to screen other family members. In the UK, the first screening costs about £600.
Critics point out that Myriad used the earlier research of other scientists to find the gene and so should not own exclusive rights. They also worry that a patent would allow this one company all future rights to develop tests for it, to set charges for it, to test only in Myriad-approved laboratories, and to monitor the results. And all women with the mutant gene would depend on the work of one company.
David Rowan is editor of the Analysis page
(The Guardian, November 27 1997)
BREAKFAST time on Tuesday was rather more eventful than usual in the north London neighbourhood of Lord Simon of Highbury. At 7.15am, a dozen or so protesters broke the calm of the Competitiveness Minister's Islington townhouse to suspend from the roof a bright yellow banner reading 'No patents on life', and to stick a few 'Patent pending' signs on trees in his garden. The BioPirates, as the protesters styled themselves, departed once the police arrived, but not before clarifying their purpose: this had been nothing less, they declared, than their very last chance to stall 'the race to commodify life'.
They will not have succeeded. For today, Lord Simon will sign up to a European Union directive that environmentalists, religious groups, some scientists and even that rare sighting, a dissenting New Labour MP, speak of in the absolutist language of the corporate conspiracy. The Directive on the Legal Protection of Biological Inventions, designed to allow biotechnology companies to patent the results of their research, is 'a frightening prospect and fundamentally immoral', in the words of Greenpeace. According to a group of British scientists, it will 'threaten the very foundations of scientific research'. And as the MP Alan Simpson puts it, it will transfer the ownership of your blood cells, your genes, and your resistance to hereditary disorders to 'greed-driven' companies that hold the patents.
You may not have heard of the directive, which will enter one of the later pit-stops today on its way to becoming European law. It was introduced two years ago, after an earlier proposal failed over ethical concerns, to codify the patenting of genetic material across the animal and plant kingdoms. In July this year the European Parliament agreed to a draft of the directive, although it suggested some amendments in response to the objectors' fears that it would offer a blanket 'patent on life'. Today the amended proposal will come to the Council of Ministers, where - subject to qualified majority voting - the directive is likely to go through to the European Parliament for a second opinion before becoming law.
Lord Simon is likely to indicate Britain's approval. John Battle, the Department of Trade and Industry minister most closely involved with the directive, stresses that 'it does not afford patent rights to anything which is not patentable under current law', but will merely clarify the situation across Europe and 'harmonise the patenting regime'. 'We don't dispute that there are major ethical concerns,' says a DTI spokeswoman, 'which is why we are holding a major consultation exercise next summer. But patent law is about property rights - and this directive is not the most appropriate place to address the ethical question.' Advances in biotechnology can indeed already be patented under European patent law.
What concerns campaigners against the directive is the wide nature of the rights the new patents will afford private companies. 'At issue is whether these patents should be much broader in nature than other patents,' says Abby Munson, campaign director of the Genetics Forum. 'Whether, for example, someone who isolates and characterises natural material should be able to patent not just the method by which this was done, but the material itself.'
Nor is it simply environmental organisations that have voiced concern. The Clinical Genetics Society, the Clinical Molecular Genetics Society, the Association of Clinical Cytogeneticists and the Genetic Nurses and Social Workers Association, recently issued their own joint statement: 'We do not believe that such sequences (patents on fragmentary sequences from human DNA, of no known function or utility) should be patentable, partly because of the lack of demonstrable utility, and partly because of the inevitable and unnecessary confusion which would arise when several groups were found to hold patents on parts of the same overall functioning sequence ... A natural human gene sequence is part of the human body, and as such should not be patentable.'
The draft directive certainly takes a broad view of how far exactly ownership should extend. It is intended to allow the patenting of genetic 'inventions' rather than mere discoveries. But article 3:2 states that 'biological material which is isolated from its natural environment or processed by means of a technical process may be the subject of an invention even if it already occurred in nature' (emphasis added). That, at the very least, blurs the distinction.
Furthermore, critics point out that corporations would merely need to identify a gene and describe its function to secure monopoly rights to any therapies developed in connection with that gene. Campaign groups across Europe have been opposing a patent granted in Germany to the US company Biocyte, which covers all human blood cells taken from the umbilical cord of a new-born child and used for therapeutic processes. All Biocyte has done, say the campaigners, is show that these blood cells can be isolated and deep-frozen.
It is what the draft directive implies for the human body, rather than its meaning for plant and animal genes, that has recently concerned campaigners most. 'An element isolated from the human body or otherwise produced is not excluded from patent ability,' it states in article 5:1 . 'A sequence or partial sequence can be the subject of a patentable invention.' This, some campaigners worry, will actively encourage new patents, and not, as the DTI claims, merely harmonise existing law.
'By explicitly allowing the patenting of genes and other living organisms, this directive will ensure a rush of patents on living organisms that have hitherto been granted hesitantly and on an ad-hoc basis,' says Maya Vaughan of the Gaia Foundation. 'It will also make challenges to unethical and broad-sweeping patents, such as the one on umbilical-cord blood cells, much more difficult.'
Other campaigners take a more emotive view about the risks of allowing life to be patented: they recall the case of the Seattle physician who patented the cells of his patient, John Moore, without Moore's informed consent - which Novartis, a Swiss company, used to derive pharmaceutical products. Or they talk about the Hagahai, people in the remote highlands of Papua New Guinea, who had their first contact with the outside world in 1984. Blood samples were collected after they had been exposed to viruses, and later the National Institute of Health in the US was granted a patent on a Hagahai man's cell line (which was later overturned).
More specifically, opponents fear that private ownership of genes will limit scientific research that would benefit all. As a group of scientists wrote in Nature: 'The present directive from Brussels succeeds only in threatening free access to material and freedom to pursue promising lines of enquiry.' Then the are the potential costs to the NHS and other users. Manchester Regional Genetics Centre was billed for $5,000 by a Toronto-based biotech company which had applied for a patent on a kit for testing cystic fibrosis. Dr Gareth Evans, consultant in medical genetics in Manchester, warns that the NHS will have to pay licence fees and royalties on all patented genes. 'Genetic tests for heart disease and breast cancer may involve the testing of 15 or more genes each,' he says. 'This will mean 15 separate royalties to be paid.'
YET THE Government has on balance tended towards the pharmaceutical industry's own concerns. If Britain does not sign up to the directive, the DTI warns, there is a 'big chance' that pharmaceutical companies currently based here will move elsewhere - an argument, notably, also heard recently about the Formula One industry. Besides, it stresses that the directive will not give companies the rights to the genes themselves: private companies 'must demonstrate they have developed a technical process - it has to be an invention, not a discovery'.
In lobbying the Government, the biotechnology industry said the directive was essential, not least for Britain's economy. It pointed to the sector's health, and the risk of investment moving away to the US. British-based biotechnology companies invest more than £2 billion a year in research, it said; 93 per cent of Europe's listed bioscience companies are based here, accounting for more than 60 per cent of the European industry. 'Without patents, investment in the next generation of products would dwindle to the significant detriment of patients and the industry,' it says. 'They are an absolute prerequisite for investment in research in an industry where it takes around 10-12 years and more than £200 million to research and develop each new medicine with no guarantee of success.'
It is undeniable that biotechnology has been of broad benefit: it has allowed the development of treatments for a range of diseases from cancer to cystic fibrosis. Increasingly, new medicines are being based on the body's own molecules: last year, for instance, diabetics were able to use an improved form of insulin, lispro, made by changing the order of some amino acids in a protein. But one key argument is whether this would continue if the ownership of the genes themselves remained unregulated under European law. Alan Simpson points out that if patents are granted to one company, other competing research projects would have no choice but to be abandoned.
TODAY'S Council of Ministers vote will not end the debate. The Government, indeed, says it wants it to become broader and more open. But there is now little chance that genes, human or otherwise, will escape regulation through European patent law. If that moves the debate beyond the more scare mongering and bigoted tones of a few of the protesters, some at least will be grateful.
Professor Steve Jones, eminent geneticist and author of In The Blood, believes that much of the current debate on patenting is misplaced. He dismisses campaigners' worries about the ownership of human beings as 'romantic obscurantism': 'It's just silly - you can't own a human being. Such arguments are giving chemicals a soul they don't have.' The argument today, Jones believes, should not be about whether particular DNA sequences should be patented, but about who owns the patents. 'The parallel, to me, is the copyright laws. In the 19th century, many writers, Dickens included, stopped writing for a time because their stuff was stolen. It's the same for gene research: no one is going to invest in it if that were the risk.'
What should be debated now, Jones says, is not the issue of patenting DNA, 'but the more technical argument about whether DNA is a discovery or an invention. I don't know whether it is one or the other: all scientists can do is advise the patent lawyers their views - and you'll find there is no consensus.'
Sources: Directive 95/0350(COD) and COM (97)446 Final; Greenpeace Briefing on Amended Proposal; Letter from Brian Goodwin and others to Nature magazine; Guardian article, 11/7/97; Association of the British Pharmaceutical Industry; Gaia Foundation; Hereditary Breast Cancer Helpline (01629 813000); Cancer Research Campaign; Myriad Genetics.
++++
Case study: How to own a gene
Last year an American company, Myriad Genetics of Utah, applied in Europe to patent a gene known as BRCA1 that it identified in 1994. Women with a mutated version of the gene have an 85 per cent chance of developing breast cancers. Myriad's patent application is comprehensive: it includes the gene's coding, methods of screening for it, kits for detecting mutations, even a transgenic animal which carries an altered form of the gene. Myriad says it needs a patent because of the sums it spent on finding the gene.
How the test works:
There are 23 pairs of human chromosomes.
The BRCA1 gene lies on a small area of chromosome 17. A test can be done to see if members of a family have a similar gene pattern to relatives known to be affected. In the US, Myriad charges about $2,400 to screen for BRCA1 and a second gene, BRCA2. Once the fault is found, it charges a few hundred dollars to screen other family members. In the UK, the first screening costs about £600.
Critics point out that Myriad used the earlier research of other scientists to find the gene and so should not own exclusive rights. They also worry that a patent would allow this one company all future rights to develop tests for it, to set charges for it, to test only in Myriad-approved laboratories, and to monitor the results. And all women with the mutant gene would depend on the work of one company.
David Rowan is editor of the Analysis page
(The Guardian, November 27 1997)
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