Myriad holds several patents related to mutations in the breast cancer type 1 susceptibility (BRCA1) and BRCA2 genes — which are associated with an increased risk of breast and ovarian cancer — that include claims to isolated DNA, diagnostic methods and drug screening methods. These patents were challenged by a collective of plaintiffs including professional societies, researchers, genetic counsellors and women affected by cancer.
“This case presents a perfect storm of issues,” says Elizabeth Haanes, a patent attorney who advises biotech clients in areas such as immunology, genomics, proteomics and gene therapy at Sterne, Kessler, Goldstein & Fox, Washington DC, USA. “The claims to isolated DNA in Myriad's patent are by far the most contentious. Policy arguments against patent eligibility for these claims include the beliefs that patenting of isolated DNA is tantamount to patenting a person's genes, and restricts access to health care. On the side in favour of patent eligibility for isolated DNA, policy arguments largely focus on the need for patent protection to spur innovation and development,” she highlights.
This is a preview of subscription content, access via your institution