Seventeen-Year Monopoly on BRCA Testing Ended

The recent Supreme Court decision denying Myriad Genetics the monopoly on BCRA testing for genetic risk for breast and ovarian cancer will promote the molecular diagnostics industry.

Myriad earned approximately USD 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.

Shara Rosen, lead diagnostics analyst for Kalorama Information, said the Court struck a balance in its ruling Thursday: it permitted patents on the synthetic form of genes and on systems but did not allow patents on genes occurring in nature. She continued, "The clear and well-balance ruling left the door open for intellectual property protection and incentives for innovation in genomic disease testing. 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, that said tests are a 5.2 billion dollar market and will grow 8% each year to 7.6 billion by 2017. Ms. Rosen notes that since 1984, the US 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.

Kalorama Information's latest report 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.

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Myriad Genetics
Kalorama Information