The Commerce of Human Genes

Nearly a fifth of all known human genes have been patented in the US, the majority by private companies, a new study reveals. The research, published in the journal Science, matched patented genes to their locations in the human genome. It showed that almost 4382 of the 23,688 genes present in the National Center for Biotechnology Information (NCBI) Gene database are claimed in 4270 different patents. Around 63 per cent of them are assigned to private firms, say authors Kyle Jensen and Fiona Murray of the Massachusetts Institute of Technology.

Critics of gene patenting argue that it stifles research, slows down the development of new medicines and increases the cost of genetic diagnostic tests. The worldwide patenting of two genes involved in hereditary breast cancer, BRCA1 and BRCA2, by US firm Myriad Genetics, was met with strong opposition by scientists in Europe. Following a series of challenges, nearly all the patents were either revoked or amended, so that most BRCA gene testing can now be carried out free of charge in European laboratories.

However, supporters of gene patenting say that protecting intellectual property is crucial for securing investment in later research, and central to the success of the biotech industry. In the latest study, the researchers wanted to gain an accurate picture of the gene patents taken out in the US. They found that the 4270 patents are owned by 1156 different assignees, with nine of the top ten being US-based. The top patent assignee is Incyte Pharmaceuticals/Incyte Genomics, whose intellectual property rights cover 2000 human genes.

The researchers found that many genes were claimed by several different patents - CDKN2A, a gene involved in cancer, and the bone growth gene BMP7 are the most patented genes in the genome, with 20 patents each. 'Our data raise a number of concerns about gene patents, particularly for heavily patented genes', said Murray. 'We worry about the costs to society if academic scientists and industry have to walk through a complex maze of patents in order to make more progress in their research', she told National Geographic magazine.

Commenting on the study, Helen Wallace, of the UK pressure group Genewatch, told the Guardian newspaper that gene patenting 'encourages a search for genes, when many problems with health could be addressed by better research into diet, social and economic factors'. UK bioethicist John Harris said that the pharmaceutical industry argues that they need to protect the products of their research, otherwise they would not invest in future research. 'However, I worry this kind of patenting could have impacts on the cost of health and the freedom to access it', he added.

The charity Cancer Research UK (CRUK) has obtained a Europe-wide patent on the BRCA2 gene, which is involved in hereditary breast and ovarian cancer. It intends to make the patent freely available to publicly-funded laboratories across the continent, so that research and diagnostic work on the gene can continue. The situation was previously complicated by patents held by US firm Myriad Genetics, on BRCA2 and another gene involved in breast cancer, called BRCA1.

Most breast and ovarian cancers are not inherited, but around 5-10 per cent are caused by inherited mutations - many of them in one of two genes, called BRCA1 and BRCA2. Myriad Genetics has faced criticism from scientists, governments and patient groups opposed to the patents that it holds on tests that look for mutations in these two genes. However, CRUK holds a UK patent on BRCA2, which is apparently wider than Myriad's and so covers more applications.

Cancer Research Technologies Limited (CRT), the commercial subsidiary of CRUK, has now successfully applied for a European patent on BRCA2, and has agreed to waive the fees for all public laboratories wishing to work on the gene. 'Myriad had been trying to offer commercial deals to researchers working on BRCA1 and 2' said John Toy, medical director of CRUK, adding that 'our patents will break that gridlock'.

CRUK was granted the BRCA2 patent on the basis that it funded much of the work that lead to the gene's discovery, at the Institute of Cancer Research, London, in 1995. The announcement was welcomed by Gert Matthijs, of University Hospital Leuven, in Belgium, speaking on behalf of the European Society of Human Genetics. He told The Scientist magazine that the BRCA2 patent issue illustrates why Europe needs new legislation on the licensing of genes and genetic tests. 'If someone holds a patent on a gene, it creates a monopoly because no-one can invent a competing product as they could with other items, such as drugs' he explained.