Advance non-infringement ruling on BRCA patents sought

2 October 2013

A US company is seeking a federal court judgement that it would not infringe Myriad’s BRCA gene patents were it to offer genetic testing for BRCA mutations.
Whilst Myriad Genetics is the major patent holder for the BRCA genes in the US, some fundamental elements relating to the gene sequences themselves (as opposed to methods of detection or application) were recently ruled invalid by the Supreme Court (see previous news).
Now Counsyl, a company based on pre-conception genetic screening, has asked a California federal district court to examine whether it could offer BRCA1 and BRCA2 genetic testing for mutations associated with the hereditary risk of breast and ovarian cancer without infringing the valid elements of the Myriad patents.
Since the patent ruling, Myriad has adopted a strategy of aggressive defence of its intellectual property relating to the BRCA genes as multiple potential new providers of testing services enter the market (see previous news). Counsyl have said that Myriad’s litigation history ‘puts at risk Counsyl's legal rights and ability to market its genetic tests and related services’ for the BRCA genes, which is why they have taken the unusual step of seeking a pre-emptive court judgment before moving to provide testing services.
Comment: Companies already sued by Myriad for patent infringement have filed complaints to say that Myriad is merely attempting to maintain its current monopoly on BRCA testing (which accounts for the majority of its income and maintains a high price). This is a plausible scenario, because even if competitors are not infringing the Myriad patent claims, the cost of the legal defences incurred by those taken to court by Myriad may be high enough to frighten off others.

Counsyl, which emphasises offering affordable genetic testing, appears to be attempting to outmanoeuvre Myriad. Consumers are hoping to see the cost of BRCA testing – which is increasingly pertinent for choosing personalised cancer treatments, as well as informing potential mutation carriers on their future risk of disease - fall sharply if competitors can break into the market.  

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