Scope of breast cancer gene patents 'slashed'

The European Patent Office (EPO) has taken another step towards preventing US firm Myriad Genetics from obtaining a monopoly on genetic tests for hereditary breast and ovarian cancer. Myriad originally filed several patents relating to the BRCA1 gene, three of them in Europe. However, the EPO revoked one of these patents entirely in May 2004, and it has now announced that it will cut the scope of the remaining two. According to a report in the journal Nature, the ruling is 'a victory for those who use the gene to diagnose cancers'.

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 it holds on tests that look for mutations in these two genes. There were concerns that the patents were too restrictive, and could give Myriad a monopoly on testing for mutations in the two genes. The company required that all tests were to be carried out in its laboratories in Salt Lake City, Utah at a cost of over $2600.

However, the revoking of one of the patents last year means that the company can no longer charge European laboratories for performing tests to look for BRCA1 gene mutations. Myriad has filed an appeal against this ruling, which followed an earlier decision to grant a Europe-wide patent for a BRCA2 gene test to the charity Cancer Research UK (CRUK). The charity said it would waive all fees for public laboratories wishing to carry out BRCA2 tests.

Now, the EPO has amended the remaining two patents on the BRCA1 gene, one of which originally included any piece of DNA used to detect the gene. The EPO has now ruled that this should be restricted to a single piece of DNA, or 'probe'. The third patent covered 34 different known mutations in the BRCA1 gene, but has now been restricted to the most common one, which frequently occurs in Ashkenazi Jews. This means that this particular gene mutation is the only BRCA1 mutation still protected by patents.