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Gene patents are a hindrance to innovation Gene patents are a hindrance to innovation
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You carry a set of instructions in every cell, encrypted in DNA. Your genome, 3 billion letters of genetic code, is not only unique to you now, but is unique to every human who has ever and will ever exist. It contains about 22,000 genes and it was a surprise to geneticists on completion of the Human Genome Project in April 2003 that we bear so few, fewer than a roundworm. But what you might find even more shocking is that hundreds, possibly thousands of these genes are effectively owned by someone else.You carry a set of instructions in every cell, encrypted in DNA. Your genome, 3 billion letters of genetic code, is not only unique to you now, but is unique to every human who has ever and will ever exist. It contains about 22,000 genes and it was a surprise to geneticists on completion of the Human Genome Project in April 2003 that we bear so few, fewer than a roundworm. But what you might find even more shocking is that hundreds, possibly thousands of these genes are effectively owned by someone else.
The birth of gene patenting rapidly followed our ability to read human genes in the 1990s, and in general patents cover the processes of extracting, reading and diagnostic tests for specific bits of an individual's DNA. There is a myth that one fifth of the genes that each of us bears in our cells are patented, but this does not quite stand up to close scrutiny: the language used in many of these patents does not necessarily preclude their use. Nevertheless, any useful work, including research and genetic diagnosis, on a significant chunk of your unique genetic makeup is prohibited unless licensed.The birth of gene patenting rapidly followed our ability to read human genes in the 1990s, and in general patents cover the processes of extracting, reading and diagnostic tests for specific bits of an individual's DNA. There is a myth that one fifth of the genes that each of us bears in our cells are patented, but this does not quite stand up to close scrutiny: the language used in many of these patents does not necessarily preclude their use. Nevertheless, any useful work, including research and genetic diagnosis, on a significant chunk of your unique genetic makeup is prohibited unless licensed.
This might seem baffling. Patents bestow ownership on a process or an invention. Your genes are neither. But the fuzziness of the law has meant that patents can be issued on isolated genes. The best documented case concerns two genes that all of us have, BRCA1 and BRCA2. Certain versions of these predispose women to breast and ovarian cancers, and so in the 1990s, a company called Myriad Genetics obtained the patent on these with the intent of charging for the diagnosis. The costs are about $3,500 (£2,300). This was challenged in the US courts in 2010, the patents revoked, but Myriad won them back on appeal. In the next few weeks, the US supreme court will review the appeal decision, and rule on whether your DNA can be owned. The outcome will be of profound importance.This might seem baffling. Patents bestow ownership on a process or an invention. Your genes are neither. But the fuzziness of the law has meant that patents can be issued on isolated genes. The best documented case concerns two genes that all of us have, BRCA1 and BRCA2. Certain versions of these predispose women to breast and ovarian cancers, and so in the 1990s, a company called Myriad Genetics obtained the patent on these with the intent of charging for the diagnosis. The costs are about $3,500 (£2,300). This was challenged in the US courts in 2010, the patents revoked, but Myriad won them back on appeal. In the next few weeks, the US supreme court will review the appeal decision, and rule on whether your DNA can be owned. The outcome will be of profound importance.
As well as denying access to medical diagnoses, these patent thickets also hinder scientific progress. By its very nature, research leads in unpredictable directions. Imagine a young researcher working on trying to understand a disease, for example, a cancer. The genes involved in such a complex disease are many and form intricate biochemical pathways – genes interacting with dozens of others. But as soon as they reach one that is under patent protection, they must seek and pay for permission to continue. Last year, a study in the UK suggested that often these were simply ignored, though this is clearly not a solution to the problem. These types of patents impede research and innovation, and only winners are the lawyers.As well as denying access to medical diagnoses, these patent thickets also hinder scientific progress. By its very nature, research leads in unpredictable directions. Imagine a young researcher working on trying to understand a disease, for example, a cancer. The genes involved in such a complex disease are many and form intricate biochemical pathways – genes interacting with dozens of others. But as soon as they reach one that is under patent protection, they must seek and pay for permission to continue. Last year, a study in the UK suggested that often these were simply ignored, though this is clearly not a solution to the problem. These types of patents impede research and innovation, and only winners are the lawyers.
This situation is poised to get even murkier as the field of synthetic biology grows. Synthetic biology is an evolved descendant of genetic modification, but rather than being a purely scientific endeavour, it has engineering solutions in its sights: biology remixed and designed to address global issues such as food, drugs and fuel production. Projects include the production of malaria treatments, of diesel, of cancer-targeting assassins. The manufactories are cells, designed and invented and therefore subject to much clearer patenting.This situation is poised to get even murkier as the field of synthetic biology grows. Synthetic biology is an evolved descendant of genetic modification, but rather than being a purely scientific endeavour, it has engineering solutions in its sights: biology remixed and designed to address global issues such as food, drugs and fuel production. Projects include the production of malaria treatments, of diesel, of cancer-targeting assassins. The manufactories are cells, designed and invented and therefore subject to much clearer patenting.
However, at least in some quarters, there is a great will to encourage innovation and avoid the murk that accompanied gene patenting. Based in California, the BioBricks Foundation is the driver of the synthetic biology revolution. It hosts a catalogue of components, currently comprising around 10,000 parts, available for free for the construction of biological tools. The parts in question are pieces of DNA – some are genes, others regulators of genes.However, at least in some quarters, there is a great will to encourage innovation and avoid the murk that accompanied gene patenting. Based in California, the BioBricks Foundation is the driver of the synthetic biology revolution. It hosts a catalogue of components, currently comprising around 10,000 parts, available for free for the construction of biological tools. The parts in question are pieces of DNA – some are genes, others regulators of genes.
The foundation states that its mission is "to ensure that the engineering of biology is conducted in an open and ethical manner to benefit all people and the planet". It believes that "fundamental scientific knowledge belongs to all of us and must be freely available for ethical, open innovation". The principle it employs is "get some, give some", and there is an expectation that users can build with the freely available parts if they submit their inventions back into the catalogue.The foundation states that its mission is "to ensure that the engineering of biology is conducted in an open and ethical manner to benefit all people and the planet". It believes that "fundamental scientific knowledge belongs to all of us and must be freely available for ethical, open innovation". The principle it employs is "get some, give some", and there is an expectation that users can build with the freely available parts if they submit their inventions back into the catalogue.
In the US, the Patent Act of 1790 was founded "to promote the useful arts". The products of science are the foundations of civilisation, and for the benefit of all. Without mature and sensible laws governing biological patents, they are in danger of becoming the embodiment of impediment to progress.In the US, the Patent Act of 1790 was founded "to promote the useful arts". The products of science are the foundations of civilisation, and for the benefit of all. Without mature and sensible laws governing biological patents, they are in danger of becoming the embodiment of impediment to progress.
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