Discovering what mutations mean
Researchers concerned about patent infringement may abandon research on mutations within patented genes, hindering progress to understand all of a mutation's effects. In a 2001 survey, close to 50 percent of researchers in the American Society for Human Genetics said that they have had to limit their research because of gene patents, according to the AMA brief.
Clinical trials of treatments for ovarian and related cancers would benefit from knowledge of patients' gene mutations, but in many trials, the cost of genetic testing is prohibitively expensive, the brief says.
Myriad argues that scientific research has not been limited by their patent, and says that there have been more than 10,000 scientific papers published on BRCA.
Dr. Kirk Manogue, vice president of technology transfer at The Feinstein Institute for Medical Research in Manhasset, N.Y., said that there have been some safeguards built in to allow research on patented genes to continue without infringement on patent rights.
Myriad's patents on the BRCA1 and BRCA2 genes means that it has a monopoly on genetic testing for mutations in those genes, and is able to charge a higher price for the test than it would if there was a competitive market.
Because of this monopoly, the test likely costs more than it would if others were allowed to offer competing tests, the AMA brief says.
The actual cost to the company for testing for BRCA1 and BRCA2 mutations is about $200, substantially less than what Myriad charges patients, according to NPR. Myriad says that the high price is needed to earn back the money the company spent researching the genes and developing the test.
In addition, while innovators are trying to lower the cost of whole-genome sequencing to less than $1,000, it's possible that gene patents may add to the cost. If every gene in the human genome were patented and required a $100 royalty fee, those fees would add up to more than $2.5 million, the AMA brief says.
However, Manogue said it's not clear that whole-genome sequencing infringes on the rights of gene patent holders. Gene patents might not apply to genes in the context of whole genomes, Manogue said.
Pass it on: Gene patents affect both genetic research and access to genetic tests for patients, critics of gene patents argue.
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