BRCA Patents Struck Down

Myriad Genetics is a company that owns the patent on the BRCA1 and BRCA2 genes - tumour suppressor genes involved in breast (and other) cancer heredity, and important for genetic testing. This is pretty lucrative for the company since it means they control diagnostic testing based on these genes. As Bayman has written before they've been highly defensive of these patents and restrictive of the tests, threatening to sue provinces that offer BRCA screening other than Myriad's own BRCAnalysis and demanding that patient samples be sent to their Utah headquarters.

Gene patents are great for the companies that own them, but can be problematic for patients who might need these tests and researchers trying to investigate disease. Around 20% of the human genome is 'owned' by some other interest, but the tide is beginning to turn. A ruling yesterday by a New York federal judge has overturned Myriad's BRCA patents, a ruling that will no doubt affect the status of other gene patents.

The key aspects of the ruling is that 1) the patented material - the isolated BRCA1/2 DNA - is "not 'markedly different' from native DNA and is therefore not patentable under US law and 2) the method - BRCA1/2 sequence analysis - is not patentable.

This is good news for consumers (i.e. patients), researchers and a different set of corporate interests (eg. genetic testing services like 23andMe), though there will inevitably be an appeals process before the dust settles and we know for sure where patents like these stand.

Read the full, 156-page, ruling here (there's some interesting stuff in there) and further commentary at The Questionable Authority and Genetic Future.