A federal appeals court will hear arguments about whether companies can patent genes on July 20. The American Civil Liberties Union has challenged Myriad Genetics’ patents on the BRCA 1 and BRCA2 genes, which affect the risk of breast and ovarian cancer. The Supreme Court sent the case back to the Court of Appeals for the Federal Circuit last month.
The ACLU pointed out that studies have shown a new class of cancer drugs called PARP inhibitors can help cancer patients with specific BRCA mutations.”However, the FDA (Food and Drug Administration) will not approve the drugs unless all accompanying diagnostic tests are also FDA-approved. Myriad’s tests – like most genetic tests – have not been approved by the FDA,” the ACLU said in a statement.
“You’d think that Myriad would submit to FDA approval so that these drugs can make their way to the people that need them, but they have not. As a consequence, Myriad’s patents are preventing women from learning if they have the genes and preventing them from getting the treatment they need if they do.”
Any court decision could have wide-reaching implications for the biotechnology sector, which relies on extensive research about genetic niches to create tailored therapies. Without patents, some research in the the emerging new field of personalized medicine could become unprofitable.