Patenting and Licensing of Genes and Genetic Diagnostic Methods
The least one could say about the breast cancer (BRCA) case, it that it has caused a stir in the field of genes and patenting. Under the existing legislation, genes and genetic sequences are patentable in Europe, in the US and in most other countries. However, the debate has never been closed, i.e. many people and organisations are still questioning the patentability of genes and genetic tests. The only way out is to define pragmatic solutions, that respect the rights of the patent owners and the users, and at the same time, warrant the patient’s right and access to affordable health care provisions.
One reason why the market system does not always operate properly in the case of patents on genes is because genes and genetic sequences are different from classical chemical compounds. Genes and genetic sequences have an informational content. There is also no way of “inventing around” the sequence if it is patented, because each gene sequence is unique in its kind. At first glance, this problem could practically be circumvented by royalty-free licenses. However, this is criticised by patent owners and supporters of the patenting system because it disregards the efforts and funds that the grantees have invested. The geneticists who oppose against patenting of genes and genetic tests on principle believe that the description of an association between a gene and a disease amounts to little more than a discovery. Patent specialists and patents offices claim that the problem is in licensing, not in patenting. Indeed, most countries lack a system that ensures guidance and surveillance of licensing of genetic inventions. The compulsory licensing system, which is the traditional safeguard against excesses in licensing, may have to be replaced by other systems, like the ‘patent pool’ or ‘clearing house’ models. However, the necessary organisations for collecting the incomes from gene licensing are not in place, and it will not be easy to install them in practice.