Nov. 12, 2002
| For many years, a fierce argument has been raging over whether genes, plants, and seeds should be patentable. A patent gives a monopoly right to the commercial exploitation of an invention for 20 years in exchange for publication about how the invention was produced. The pharmaceutical and ag-bio industries argue that genes, plants, and seeds must be patentable to give companies the confidence to invest the time and money needed to develop gene-based drugs or biotech crops.
Others maintain that genes and crops are not inventions at all, and that by allowing them to be patented, control is placed in the hands of a few. As a result, access to new treatments could be restricted and seeds made too expensive for the poor. A host of gene patents covering areas that may be important in developing a malaria vaccine, for example, are hindering public-sector efforts to develop affordable vaccination for the developing world.
Two new reports from eminent bodies undermine the assertion that patents on genes are good for innovation and highlight the detrimental effect that patenting drugs, crops, and seeds can have on developing countries.
In July 2002, the Nuffield Council on Bioethics (an independent body formed by the Nuffield Foundation, a charitable trust) published its report, "The Ethics of Patenting DNA." The Nuffield report questions whether, by allowing patents on genetic material, innovation for the public good is stimulated or stifled. The report considers the requirements for patentability (that an invention must be novel, inventive or nonobvious; and useful or have industrial application) and the exclusions to patentability (discoveries or inventions contrary to morality).
|When it comes to gene patents, the Nuffield Council calls for a more rigorous application of the basic tests for patentability.
The Nuffield Council does not rule out genes from patentability, but it does argue that the tests for novelty, inventiveness, and usefulness must be applied more stringently. By picking out four areas where gene patents are being claimed — in diagnostic tests, as research tools, in gene therapy, and for the production of pharmaceutical proteins — the report highlights how patents can be inappropriately awarded to the detriment of the public interest.
In September 2002, the Commission on Intellectual Property Rights (CIPR), set up by the British government's Department for International Development, published its report, "Integrating Intellectual Property Rights and Development Policy." It concluded that an expansion of intellectual property rights was unlikely to generate significant benefits for most developing countries. The commission considered that forcing developing countries to accept developed world practices in patenting was likely to lead to higher-priced medicines and seeds, making poverty reduction more difficult.
The Struggle Over BRCA
Britain has already begun to experience the downsides of gene patenting in terms of genetic tests. When a gene has been associated with a disorder — a matter of putting together information on disease prevalence or severity with a gene mutation — rather than being an invention, it is obvious that a test could be developed to identify whether a particular gene is present. This should not meet tests of patentability, yet patents have been awarded for tests for breast-cancer-susceptibility genes, among others.
A U.S. company, Myriad Genetics Inc., has been awarded nine U.S. patents on the breast/ovarian cancer genes BRCA1 and BRCA2, as well as patents covering antibodies to the BRCA proteins. The patents give Myriad exclusive rights to commercialize laboratory-testing services, diagnostic kits, and therapeutic products that use the BRCA1/2 sequences. BRCA1 was discovered as the result of an international collaboration involving many women volunteers. Much of the work on BRCA2 took place in Britain at the Sanger Centre in Cambridge and the Institute of Cancer Research — which still claims that it discovered the gene first. (The BRCA2 gene was first published by the British group in Nature in 1995; Myriad simply issued a press release announcing they were patenting it.)
Britain's National Health Service, which has been developing its own tests, is still in negotiations with Myriad over licensing and royalty payments. The French Ministry of Health says that Myriad has an excessive monopoly and threatens basic research. The ministry asserts that Myriad's test costs $2,500 and fails to identify 10 percent to 20 percent of mutations, compared with $680 for a test developed in France. The Nuffield Council concluded that patents should be restricted to specific tests developed using a gene, and should not include the gene sequence because the inventiveness requirement is not met.
Patents are also being claimed for DNA sequences to be used as research tools. Often these are not whole genes, but are determined by computer analysis of differences between individuals' gene sequences with little or no knowledge about their biological function or usefulness in terms of making a product. Here, the Nuffield Council suggested that research could be hindered, and that such patents should be discouraged because the utility and usefulness requirement is often not met.
The Nuffield report also recommended that gene patents should not extend to gene therapy because once an abnormal gene is associated with a disease, inserting a normal gene — or correcting or replacing the faulty gene — is an obvious step. Rather, they recommended that patents covering the difficult problems of getting gene therapy to work were more worthy.
Developing countries are suffering to an even greater extent from the pressure to allow patents on medicines, plants, and seeds, as the CIPR's report reveals. The report argues that what is in the interest of developed countries in terms of patentability may be threatening the ability of developing countries to build their own industries, and feed and treat their people.
The CIPR calls for the World Trade Organization's TRIPS (Trade-Related Intellectual Property Rights) agreement to allow countries to exclude genes, plants, and seeds from patentability and for developing countries to write compulsory licensing laws ensuring that affordable drugs can be made locally and use differential pricing where they can. The intellectual property laws of the developed world, the CIPR also concluded, do nothing to encourage research on the diseases affecting poor countries.
What Does the Developing World Want?
The CIPR and Nuffield Council's studies mark a new era in critical thinking about gene patenting and demonstrate a willingness to re-evaluate the balance between public interest and private profit. When it comes to gene patents, the Nuffield Council calls for a more rigorous application of the basic tests for patentability. This could make an enormous difference, but problems remain.
In purely practical terms, patent offices face a huge backlog of patent claims on genes and gene sequences. Whether they have the resources or willingness to investigate claims thoroughly is doubtful. A better solution is simply not to allow patents on genes, leave this knowledge in the public domain, and only give monopoly rights when real innovation and application has been demonstrated.
The recommendations in the CIPR's report could make a real difference to developing countries. The question, however, is whether they will gain support from the developed world, which is anxious to push intellectual property rules in their own interest, often with scant regard for the interests of the poor. The CIPR accepted that the TRIPS council, the WTO, and other global institutions could act in the interests of the poor and change their practices. The construction of these bodies and the interests that dominate them mean this is unlikely to succeed, and more radical change will be needed.
Sue Mayer is the director of GeneWatch UK, a not-for-profit group monitoring developments in genetic technologies from a public interest perspective. She may be reached at email@example.com.