One of the main arguments against gene patenting is that it stifles research, prevents scientific advances and stops the development of new therapies. Therefore a licence is not needed in Europe in order to develop a new BRCA gene tests using an alternative fragments of the BRCA gene: Diagnostic Testing and the Ethics of Patenting DNA [online]. Research- Technology Management 2010 Sep 1;53(5) 11. Threat to breast cancer testing after controversial patent ruling. 2010 May 28 [cited 2010 Oct 28]; Available from: ULR: innovation/2010/0528/122427097271213. Initial sequencing and analysis of the human genome [online].To limit the extent of this effect, there are research exemption rules in the patent laws of many European countries and in the US, which allow “pure” research to use patented genes without the need for a licence . 2008 Sec 4 [cited 2010 Oct 28]; Available from: ULR: 2010 November 30 Available from: full/409860a0This article was written by Gengshi Chen and was originally published in The Science in Society Review at the University of Cambridge by The Triple Helix Inc.
Because Myriad Genetics, which holds a patent on the BRCA genes, is the only laboratory to provide the genetic test, Ms Girard had to undergo the life-changing surgery without knowing for certain whether it was absolutely necessary .
Ms Girard is only one of tens of thousands of women in this situation, left with no choice but to accept the outcome of a single indeterministic genetic test result, which in addition is subject to human errors in the test laboratory.
Generally, US patent laws are more liberal in the consideration of patentable matters than the European equivalent, allowing more gene patents to be approved .
The European Patents Office (EPO), an intergovernmental patent approval organisation, has 3 main criteria for the patentability of an invention: it has to be new, be susceptible to industrial application and involve an inventive step.
In addition, the Biotech Patent Directive adopted in 1998 by the EPO contains further criteria and restrictions to clarify the patentability of biotechnological matters .