臨床病理学ジャーナル

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The BRCA Gene Patent Rulings for Individualized Medicine Implications

Mark A Nelson*

According to the National Institute of health, 12 percent of women in the general population will develop breast cancer in their lifetimes, compared to 60 percent of women who have inherited a mutation in either the BRCA1 or BRCA2 genes. In regard to ovarian cancer, 1.4 percent of women may be diagnosed in their lifetime, however the percentage rises to 15-40% women with a BRCA1 or BRCA2 mutation. Consequently, determining the BRCA1 and BRCA2 mutation status of women can markedly influence their risk of developing breast and or ovarian cancer.

Myraid Genetics identified these genes and subsequently built an estimated $300 million-a-year business testing women. Myriad holds 23 patents related to the BRAC1 and BRCA2 genes. Myriad’s patent has been challenged on the basis that they discourage scientific research and development of new tests for ovarian and breast cancer and therefore threatened women’s health. In fact no other company or commercial laboratory can perform the test, hence women cannot get second opinions.