From Kalorama's lead diagnostic analyst Shara Rosen:
"Hoots of joy could be heard at molecular test providers, worldwide. Finally the seven-year patent dispute surrounding BRCA testing had come to an end. Myriad Genetics’ (Salt Lake City, UT) strategy to enforce its IP on BRCA testing has been a source of many lawsuits since 2006. On that Thursday, the U.S. Supreme Court ruled that human genes cannot be patented.
|KALORAMA ANALYST SHARA ROSEN WEIGHS IN |
ON MYRIAD DECISION
Therefore, Myriad Genetics’ 17-year monopoly on BRCA testing for genetic risk for breast, ovarian cancer has come to an end. Labs, everywhere, are now free to include the BRCA gene in their test menus or test panels.
On the other hand, Myriad has worked diligently to promote BRCA testing and its BRACAnalysis test. 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, Myriad reported “molecular diagnostic revenue for fiscal 2009 increased 47% to $326.5 million from $222.9 million in fiscal 2008. The revenue improvement in the 2009 fiscal year was due primarily to Myriad's increased sales and marketing efforts, which have resulted in higher demand for the Company's molecular diagnostic products.” Myriad’s BRACAnalysis test earned approximately $400 million in 2012.
Industry consensus is firm: the decision represents a victory for cancer patients, oncologists and cancer researchers. Media headlines cited: the Supreme Court has ruled that human genes cannot be patented. Myriad has shown a brave face emphasizing that it still has an exclusive patent on cDNA a synthetic form of genes that can be used to indicate an increased genetic risk of cancer.
So .. what now? The Supreme Court ruling lead the headlines on Thursday and Friday, now Monday June 17 it is business as usual. However, BRCA testing has become big business and several labs have already announced their BRCA services and so Myriad Genetics now faces competition.
More importantly, the ruling is sure to have far reaching impact on genetic research and medicine. 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.
Patents on diagnostic systems for gene testing remain enforceable.
Thus the clear and well-balance ruling left the door open for intellectual property protection and incentives for innovation in genomic disease testing."
Shara Rosen is the author of The World Market for Cancer Diagnostics, 5th Edition: Precision Medicine Arrives.