Myriad Genetics, Inc. ("Myriad") internationally obtained patents on the pair of genes known as BRCA1 and BRCA2 ("the BRCA genes"), responsible for many cases of hereditary breast and ovarian cancers, between 1998 and 2003. The scope of gene patents granted to Myriad was so broad that it enabled Myriad to establish an international monopoly on the entirety of diagnostic testing for the BRCA genes. Due to the broad BRCA gene patents and Myriad's restrictive licensing practices, BRCA diagnostic tests which were previously offered for free of cost or relatively low costs in the U.S., Europe, and Canada have become unavailable or significantly more expensive. This has generated strong reactions - from research institutes, genetics laboratories, genetics societies, and even governments - to the BRCA gene patents particularly in Europe and Canada.
The effects of broad upstream gene patents on downstream biomedical research have been the subject of heated patent policy debate. Numerous patent policy reports articulating concerns about the "anticommons" effect and restricted access to gene-based inventions have proposed patent policy changes to adequately address such concerns. Especially, Myriad's restrictive licensing policies on the BRCA gene patents did in fact have direct influence on the patent policies of European countries and Canada.
The purposes of this study are to explore, through a case study of the BRCA gene patent controversy, the negative impact of gene patents on biomedical research and to propose a solution that may mitigate such negative impact of gene patents.