US appeals court rules that biotechnology company cannot block competitor’s breast cancer tests

Myriad Genetics has lost its appeal over patents on the BRCA genes that are associated with a higher risk of breast and ovarian cancer. A US appeals court ruled that claims for three of the company’s patents covering tests for the BRCA1 and BRCA2 genes are not eligible for patent protection. The ruling gives competitor companies further space to develop similar tests for mutations in BRCA genes.

What has been rejected are Myriad’s claims against Ambry Genetics, a California-based company that sells medical kits designed to test for the presence of mutations in these genes. The court ruled that the DNA primers used by Myriad’s test were indistinguishable from isolated DNA and, therefore, could not be patented.

The decision also referenced the 2013 US supreme court opinion that rejected other Myriad patent claims. The appeals court agreed that neither naturally occurring DNA, nor synthetically created compositions that are structurally identical to the naturally occurring compositions, are eligible for a patent.

Myriad said it is still reviewing the court’s decision and will consider its options. ‘We believe that strong patent protection is essential to innovation because it guarantees a period of reward in return for a significant investment of resources,’ says Myriad spokesperson Ron Rogers. He tells Chemistry World that investment in molecular diagnostics development has been down for six consecutive years, primarily due to uncertainty around intellectual property (IP) rights and patent protection. This latest loss for Myriad adds to this uncertainty around IP, Rogers suggests.