Myriad Genetics, a leading US molecular diagnostic company, has been granted exclusive rights to an analysis of the RAD51C gene. Mutations of the gene have been associated with an increased risk for hereditary breast and ovarian cancer and the company now hopes to develop a commercial test for RAD51C.
Mark Capone, president of Myriad, said: 'This intellectual property will enhance our ability to provide patients and health care providers important information on a patient's predisposition to hereditary breast and ovarian cancer'.
RAD51C was identified in 2010 as a susceptible gene for hereditary breast and ovarian cancer by scientists from the German Consortium for Hereditary Breast and Ovarian Cancers, which shares the patent co-exclusively with Myriad in Germany, working in collaboration with other researchers across Germany.
Myriad holds a portfolio of nine molecular diagnostic tests, including the BRACAnalysis. Last year, the US Federal Court of Appeals allowed Myriad to continue to hold patents it has acquired over tests for BRCA1 and BRCA2 gene sequences after the American Civil Liberties Union (ACLU) and Public Patent Foundation (PUBPAT) organised a claim challenging their validity.
The plaintiffs argued that isolating the BRCA1 and BRCA2 genes from the body is not creating something new - a requirement for awarding a patent - and the US Department of Justice at the time also expressed its opposition to the principle that genes should be eligible for patent protection.
Lawyers for Myriad argued the company had created something new, which was distinct from the way it is found in nature. The discovery of gene sequences are then claimed to be the intellectual property of the investigating scientist or company. The plaintiffs have reportedly filed a petition to appeal to the Supreme Court.
It is thought the majority of hereditary breast and ovarian cancers are considered to be the result of mutations in the BRCA1 or BRCA2 genes. Myriad says that studies indicate pre-symptomatic individuals who carry gene mutations are able to lower their risk of developing ovarian cancer by approximately 60 percent through preventative therapies.
But opponents to so-called gene patents argue that high fees can reduce patients' access to diagnostic tests – Myriad charges up to $3,000 for use of its BRCA1 or BRCA2 test – and prevents competitors from producing cheaper alternatives. Myriad denies that access is hindered and says the test is often part-funded by the US Government and is in most cases covered by insurance.
The Supreme Court is due to decide on whether to grant the petition to appeal early this year.
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