The European opposition against the BRCA gene patents.
In 2001, the European Patent Organisation (EPO) granted 3 patents on the BRCA1 gene (EP-B-699754, EP-B-705903, EP-B-705902) to Myriad Genetics. The patents, and the option of the patent holder to strictly exert its monopoly right by requesting that all diagnostic testing be done at its laboratory in the United States, has evoked strong reactions in Europe. Several opposition procedures have been started against these patents. After oral hearings at the EPO in Munich in May 2004, the first patent was revoked due to errors contained in the initially filed sequence. At oral proceedings in January 2005, the other two patents were severely limited in scope. The discussion on inventive step on the cloning of the BRCA1 gene - other than the one that relates to the priority date - has not taken place. In other words, the EPO has not questioned the patentability of this gene per se. The author participated in the hearings in Munich and would like to give the genetic community a firsthand account of the case.
Matthijs
Gert
G
Center for Human Genetics, University of Leuven, Herestraat 49, B-3000, Leuven, Belgium. gert.matthijs@med.kuleuven.ac.be
D001943:Breast Neoplasms / Q000235:genetics; D005060:Europe; D005260:Female; D019398:Genes, BRCA1; D024522:Genes, BRCA2; D036281:Genetic Research; D005823:Genetics / Q000592:standards*; D006801:Humans; D010051:Ovarian Neoplasms / Q000235:genetics; D010330:Patents as Topic / Q000331:legislation & jurisprudence*; D011050:Policy Making