The lawsuit was brought by a range of plaintiffs including professional societies, researchers, genetic counsellors and women affected by breast cancer. Together, they asserted that the gene patents were unlawful under the US Patent Act and the US Constitution because they patented a product of nature, and that the patents should not have been granted by the US Patent and Trademark Office (PTO). Although the current action is focused on patents relating to BRCA1 and BRCA2, the outcome could have far-reaching implications for all gene patents.
The court noted that it is widely accepted in the scientific community that Myriad has taken the position that any activity related to BRCA1 or BRCA2 infringes on its patents — for example, even though Myriad's test misses large-scale genetic rearrangements that are also associated with a risk of cancer, testing for such large-scale rearrangements cannot be undertaken because of infringement. So, the patents effectively permit Myriad to be the only company able to carry out genetic diagnostic testing of BRCA1 and BRCA2 in the United States.
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