Abstract

The discovery of the BRCA1 gene had an immediate and profound impact on medical practice by providing a means to assess and manage breast and ovarian cancer risk in individuals and their families carrying a mutation in the gene. The patenting of BRCA1 and then BRCA2 (another cancer-predisposing gene) by Myriad Genetics Inc. raised controversial ethical and legal issues relating to access and research, and its enforcement caused growing discontent. In the USA, the validity of the patents on the isolated BRCA1 and BRCA2 genes was challenged in court. After a four-year legal battle, the US Supreme Court invalidated both patents. This commentary reviews the discovery of these cancer-predisposing genes from the perspective of one of the co-discoverers of BRCA1. It also discusses the socio-ethical impact of the patenting of BRCA1 and BRCA2 and the legal implications of the US Supreme Court's decision.

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