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.

A Myriad of Genetic Fascism

We've talked about the potential evils of biotech patents on the Bayblab in the past, but I must confess I've been ignorant about just how far companies will go in their attempts to abuse the patent system. Based on genetic research it conducted on genetically isolated Mormon families in Utah, Myriad Genetics obtained patents for genetic testing of breast cancer susceptibility genes in 2000-2001. The Cancer Cancer Society describes how Myriad is attempting to abuse its patent rights:

"In July 2001 Myriad issued a cease and desist notice in Canada instructing provincial governments to stop using any test other than BRCAnalysis to detect genetic abnormalities on the BRCA1 and 2 genes. Myriad’s patents give the company the exclusive right to perform diagnostic testing for BRCA 1 and 2 abnormalities. The patents have enabled Myriad to demand that all patient samples be sent to the company’s headquarters in Utah for analysis, which increases the cost associated with the test tremendously. The response of provinces to Myriad’s order has varied. The provinces that continue using tests other than BRCAnalysis risk facing legal action by Myriad."

Excuse me? A patent gives you the right to bar others from extracting revenues using the technology or method in question (ie a genetic test). It is obviously not a title deed granting the holder ownership of a piece of every human being's genome in every country where the patent is held. I think it's pretty obvious that individuals should have the right to use any means they choose to learn about their own genome.

Hopefully Canadian governments will follow through with the Canadian Cancer Society's demands and limit this ridiculous attempt by Myriad to commandeer the Canadian Patent System and plunder Canadian genomes. Maybe we also need to add explicit protection of personal genetic information to the Canadian Charter of Rights and Freedoms.