Thousands of gene patents have been issued – yet in most cases they are not inventions, and patenting harms the public interest, warns Sue Mayer

For some years a fierce argument has been raging over whether genes 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 industry argues that genes must be patentable to give companies the confidence to invest the time and money needed to get gene-based drugs or products to market. Others claim that genes are not inventions at all – and that by allowing the patenting of gene sequences, control is being put in the hands of a few and access to new treatments restricted. For example, a host of gene patents covering areas that may be important in developing a malaria vaccine are hindering public sector efforts to develop affordable vaccination.

In July the Nuffield Council on Bioethics published a significant new report, The ethics of patenting DNA. The report questions whether, by allowing patents on genetic material, innovation for the public good will be stimulated or stifled. It considers, on the one hand, the requirements for patentability – that an invention must be novel, inventive (not obvious), and be useful or have industrial application – and, on the other, the exclusions to patentability – discoveries or inventions contrary to morality.

The Nuffield Council does not rule out genes from patentability but argues 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 shows how patents can be awarded which harm the public interest.

The UK has already begun to experience the downsides of gene patenting when it comes to genetic tests. When a gene has been associated with a disorder – and this 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 US company, Myriad Genetics, has been awarded nine US 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 commercialise laboratory testing, 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 NHS, which has been developing its own tests, is still in negotiations with Myriad over licensing and royalty payments. The French Ministry of Health claims that Myriad has an excessive monopoly and threatens basic research. The ministry claims that Myriad’s test costs ?1,650 (US$2,500) and fails to identify 10-20 per cent of mutations, while a test developed in France costs ?450.

The Nuffield Council concluded that patents should be restricted to tests developed using a gene, but 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 sequences 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 considers that research could be hindered and such patents should be discouraged because the utility and usefulness requirement was often not met.

The Nuffield report also recommends that gene patents should not extend to gene therapy because, once an abnormal gene is associated with a disease, inserting a normal gene to correct or replace the faulty one is an obvious step. Rather, the Nuffield Council recommends giving preference to patents covering the difficult problems of getting gene therapy to work.

The only area where the Nuffield Council gives clear endorsement of gene patenting is for genes coding for a protein that could be used therapeutically, such as insulin or beta-interferon. Here, it feels that others could ‘invent around’ the protein, making minor changes to make it more active, for example. It also recommends that the scope of the claims be drawn narrowly to include the specific therapeutic use defined only.

The Nuffield Council’s study marks a new era in critical thinking about patenting genes and a willingness to re-evaluate the balance between the public interest and private profit. When it comes to gene patents, it 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.

More importantly, the Nuffield Council accepts that genes are patentable in principle and cites gene sequences for therapeutic proteins as a clear example of this. Identifying the biological function of a protein and discovering its therapeutic usefulness will be a long process, relying on accumulated knowledge of many people. Yet by allowing a patent claim on the gene sequence, monopoly control is suddenly awarded.

This first-past-the-post system will discourage cooperation and will embed the concept that discoveries about the natural world can be claimed as inventions. A better solution is simply not to allow patents on genes, to leave this knowledge in the public domain and give monopoly rights only when real innovation and application has been demonstrated.