Much has been made of Angelina Jolie’s decision to have a preventive double mastectomy after discovering that she carried genetic mutations in the BRCA1 gene that put her at very high risk of developing breast cancer. The fact that the test she took to determine her risk cost $3,000 has also excited remark.
The test in question can only have been Myriad Genetics’ BRACAnalysis. This is because Myriad claims that any and all other BRCA1 or BRCA2 tests infringe its patents – because its patents cover the BRCA1 and 2 genes themselves. Next month the US Supreme Court will rule on whether this intellectual property will be permitted to stand, and its decision will affect Myriad, other industry players, US healthcare systems and the thousands of women now seeking assessment.
Myriad’s monopoly enables it to charge what it likes for its test, and it is charging a lot. Around 250,000 BRACAnalysis tests are run each year, at up to $4,000 a pop. In order for this cost to be covered by an insurance company, the patient must satisfy certain requirements such as having a relative with a BRCA mutation.
Other tests that work as well or better than Myriad’s have been developed, largely by academic organisations, and could be sold at much lower prices. Partly with this in mind – and partly on principle – campaigners have brought a case against Myriad disputing its contention that genes can be patented.
There has been a fair amount of back-and-forth on the case. A District Court decision in 2010 ruled that Myriad’s patents were invalid, but the company appealed, and just over a year later a federal court came to the opposite conclusion (Myriad gene ruling provides a little breathing space for industry, August 2, 2011).
This decision, though, was revoked by the Supreme Court in March 2012 and the case was tried once more in federal court, again resulting in a ruling in Myriad’s favour. At this point the Supremes themselves took over; the highest court in the US has heard oral arguments in the case and is expected to rule by the end of June.
Derik de Bruin, an analyst at Bank of America Merrill Lynch, believes that the most likely outcome of the case would see the court ruling that DNA patents are ineligible, while upholding claims based on complimentary DNA (cDNA), which has been synthesised separately by Myriad and is not the same as native DNA.
If the court decides to uphold the native DNA patents, Myriad would keep its current monopoly. But not for long: the company’s patents covering the BRCA genes run out in 2018. Myriad must milk its cash cow while it can, and the Supreme Court’s decision will be vital in determining whether it will be able to. The ruling will also serve as a test case, and could open the doors for other companies to patent genes for commercial gain.
The Court’s decision will also be crucial in determining how much the test will cost in the future. Ms Jolie earned $30m in 2011; hopefully this level of income will not be required.