The ruling is sure to have far-reaching impact on genetic research and medicine. Labs, everywhere, are now free to include the BRCA gene in their test menus or test panels. Several labs have already announced their BRCA services.
New York, NY (PRWEB) June 17, 2013
The balanced Supreme Court decision on the Myriad Genetics patent dispute is likely the fix that the molecular in vitro diagnostics industry needed, according to Kalorama Information. The IVD market research firm said the seven-year dispute surrounding BRCA testing has been a source of many lawsuits since 2006 and should boost the molecular diagnostics industry. Therefore, Myriad Genetics’ 17-year monopoly on BRCA testing for genetic risk for breast, ovarian cancer has come to an end.
Rosen said the Court struck a balance in its ruling Thursday, (Myriad Genetics vs ASSOCIATION FOR MOLECULAR PATHOLOGY No. 12–398 Supreme Court of the United States) which permitted patents on synthetic form of genes and on systems but not allowing patents on genes occurring in nature.
"The clear and well-balance ruling left the door open for intellectual property protection and incentives for innovation in genomic disease testing," said Shara Rosen, lead diagnostics analyst for Kalorama Information. "Patents on diagnostic systems for gene testing remain enforceable."
Tests aimed a molecular target for use in clinical decision-making will produce much faster revenue growth than traditional IVD tests, according to Kalorama Information. Kalorama Information said tests are a 5.2 billion dollar market and will grow 8% each year to 7.6 billion by 2017. Rosen notes that since 1984, the U.S. Patent and Trademark Office had issued more than 40,000 patents related to genes and it is estimated that about 25% of human genes have been patented. These patents are now invalid. That could open up huge opportunities in genetic disease research and the genetic testing for innumerable diseases.
"The ruling is sure to have far-reaching impact on genetic research and medicine," said Shara Rosen, diagnostic analyst for Kalorama Information. "Labs, everywhere, are now free to include the BRCA gene in their test menus or test panels. Several labs have already announced their BRCA services."
According to Kalorama, Myriad remains a formidable competitor in the market operating without a monopoly but with a lead. It had worked diligently to promote BRCA testing and its BRACAnalysis test to anchor its standing despite the court's rule. For example, in 2008/09 Myriad ran a BRACAnalysis Direct-to-Consumer Campaign in the southern region of the United States, principally Texas and Florida. September 2009, Myriad launched a hereditary breast and ovarian cancer Public Awareness Campaign in Illinois, Indiana, Kentucky, Missouri and Ohio. Also in September 2009, Myriad announced that its sales force will provide doctors the tools to provide counseling in- house and as a result physicians can bill insurers directly for this service.
It worked, says Kalorama. Myriad earned approximately $400 million last year from its molecular tests. The company has shown a brave face, emphasizing that it still has an exclusive patent on cDNA.
Kalorama Information's latest report on “Cancer Diagnostics” discussed the issues around the Myriad gene patent dispute in length. The report provides estimates of markets and market segments and profiles hundreds of competitors in the market. The report can be obtained at Kalorama Information's website at: http://www.kaloramainformation.com/Cancer-Diagnostics-Edition-7560357/
About Kalorama Information
Kalorama Information, a division of MarketResearch.com, supplies the latest in independent medical market research in diagnostics, biotech, pharmaceuticals, medical devices and healthcare; as well as a full range of custom research services. We routinely assist the media with healthcare topics. Follow us on Twitter, LinkedIn and our blog.