This really cool new movie just came out. I can’t wait to see it. It’s called “Decoding Annie Parker,” starring Helen Hunt as Dr. Marie Claire King. Oh, you haven’t heard of Dr. Marie Claire King? She is one of the many rock stars of the genetics world, having discovered the BRCA1 gene back in the mid-1990s. (For more information about the film, possible screenings, and the BRCA1 gene, see their website http://www.decodingannieparkerfilm.com/)
Yes, those are the same BRCA genes associated with Hereditary Breast and Ovarian Cancer which we keep on urging you to be aware of and consider testing for (if appropriate). Most people actually don’t realize that there is only one lab (company) in the U.S., Myriad Genetics, that performs complete genetic testing for these genes, since it holds a patent on the BRCA1 and BRCA2 genes.
Wait, you haven’t heard of gene patents either?
Although genes are considered “products of nature,” many labs have patented genes, or well, the technology used to isolate, study and test the genes. If a lab holds a patent on a gene, they can:
A) Ignore the patent and allow others to test for the gene(s) free of charge
B) Enforce their patent and collect royalties from other labs in order to do testing on the gene(s)
C) Enforce their patent and fine labs a significant penalty if they do clinical testing on the gene(s)
Myriad Genetics, the lab in question, does both B and C. This basically means that if you wanted genetic testing for mutations in the BRCA genes because of a personal or family history of breast and/or ovarian cancer, I, as your genetic counselor, would only be able to send your testing to this one lab. If for some reason your insurance did not want to cover the testing, you would be responsible to pay for the testing yourself, which at this point would be upwards of $4,000. If you were unable to afford the cost of the testing, you would not be able to have the testing done.
Patents however, do encourage innovation and advancement of medical research. Myriad Genetics has the most experience with BRCA testing and interpreting the results. They maintain a database of variants of uncertain significance (which are uncertain results that we can get from genetic testing) and reclassify these variants, ie- reinterpret the results, as new information becomes available.
Since 2009, The American Civil Liberties Union (ACLU) and many medical and genetics organizations and individuals have been involved in a lawsuit against Myriad Genetics to try and overthrow the patents in question, but the case will likely have more far reaching implications (beyond BRCA) for both gene patents and intellectual property laws. The case has already been to the U.S. Supreme Court and was sent back to the Federal Appeals Court, only to reach the Supreme Court again. Arguments are scheduled to be heard this coming Monday, 4/15/13.
For more background information about the case, you can visit the following reputable sources:
The NY Times (March 2012) http://www.nytimes.com/2012/03/27/business/high-court-orders-new-look-at-gene-patents.html
The New Yorker (April 2013) http://www.newyorker.com/online/blogs/elements/2013/04/myriad-genetics-patent-genes.html
We’re all interested to see how this will turn out. Will the Supreme Court uphold the patents? Only time will tell…