saint_monkey

60 Minutes had a story last night about the ACLU's attempts to overturn Myriad Genetic's patent on the genes BRCA1 and 2. (When these genes are found (usually in a very specific sub-set of ethnic jews,) they are 82% likely to be an indicator of future breast cancer, and a near 50% indicator of ovarian cancer. The operation of these genes is a clear tie to cancer, and should have been available for broad research by genetecists and oncologists, but they haven't been, because Myriad has "patented" these genes, and aggressively pursues anyone who attempts to work with them.)

Long (long, long) time readers of this blog may remember that I wrote about this (an my anger in the absolute and utter hubris of patenting someone's genetic heritage, and then making them pay for access to the content of their own genome,) in 2003: http://saint-monkey.livejournal.com/92152.html

Although Myriad will appeal, the lower courts have found in favor of the ACLU, and declared Myriad's patent to be invalid.

Of course, there are still those that disagree, but to these people, I want to ask: "Just how much could we have learned about breast cancer, and perhaps cancer in general by now, if this patent had been impossible to obtain, or invalidated back in 2003? Myriad has done what I argued they would do, they've restricted access to this gene (other than their own tests) for seven years, stalling progress in favor of profit.

Yesterday, a news release stated that two gene mutations, (titled BRCA1 and BRCA2) were MUCH better indicators of the risk for breast cancer than previously thought when the genes were identified. How much better? Well initial studies conservatively showed that the women with the mutated genes had about a 5% or 10% chance of developing breast cancer. ¹ The news release says that a University of Washington study "nails" the percentage at 82%. ²
Now, not all women that will get breast cancer will have this gene, but women that have this gene have an 82% chance of getting breast cancer. To add insult to injury, they also have, a 52% chance of getting ovarian cancer. Identifying this is by no means a panacea for breast cancer, but it’s still pretty good news. With the identification of a mutation that pretty much is a "cause" of a certain type of cancer on a specific genome, we can postulate that at least a few inroads can be made by studying similar genes. At the very least, high risk women can be tested to see if they have the mutation, predicting their risk for cancer.
Or at least, that’s the way it would be without a few … hitches in the system.

Between October 2000 and April 2001, Myriad Genetic Laboratories, Inc. (based in Utah, United States) was awarded a series of patents by the U.S. Patent office. These patents give Myriad extensive control over:
the BRCA1 and 2 genes…
a specific test that Myriad has developed for identifying the presence of BRCA1 and 2 genes (BRCAnalysis)
²

The patent makes sure that Myriad is the ONLY company that can create a test relating to this gene. This pretty much makes them the only church in town, and they can set the price at will. Right now, the test runs about $2800.00. Furthermore, the first portion of the patent ensures that if any company does research into the function of this gene, they must first gain a license from Myriad, and pay whatever they ask for that as well. This includes anyone who attempts to use this genetic information to locate a cure for breast cancer.
The position of Myriad is pretty standard in the industry. Myriad did the initial research targeting the gene as a potential marker for cancer, and they invested heavily in isolating the gene. (How much work did they do? And how much did they invest? Exact data is impossible to find, Myriad is protecting that information… However, prior to the map of the human genome, the isolation and identification of a specific gene that causes cystic fibrosis cost $150 Million dollars. ³ Once they had these Breast Cancer genes identified, they created a specific test, applied for a patent, and got it, so they deserve the loot. There was a lot of precedent for this, in 2000, a company called Human Genome Science isolated and patented a gene and they had no idea of its function. They admitted that they made an “educated guess” about the gene’s function given its location and predictions that their supercomputer gave them, but really, they patented a dark horse gene….Later, there was a lot of media activity, when a team of University researchers discovered that HGS’ patented gene was closely related to AIDS⁴
Now I’m not for robbing these people of any legitimate profit that they deserve from this research. Myriad should be allowed to patent and create future tests for this gene. But they should not be allowed to patent the SPECIFIC gene, and profit on future cures or tests developed without any future input from Myriad, especially when it clearly becomes part of the greater common good to research into the gene. Human suffering demands that we explore the avenue presented by BRCA1 and 2, and Myriad will make us pay. I do not think that is right.
¹http://www.cbsnews.com/stories/2003/10/23/health/printable579702.shtml
² http://www.cancer.ca/ccs/internet/standard/0,3182,3172_31282995__langId-en,00.html
³ http://www.the-scientist.com/yr1990/nov/opin2_901112.html (requires registration, so the text is as follows:

…it is estimated that it cost $150 million to isolate the gene for cystic fibrosis. With a detailed map of the human genome, this cost could essentially fall below $5 million--a 30-fold savings. With the sequence, it would cost considerably less…

)
⁴ http://www.aegis.com/news/lt/2000/LT000209.html
other links
Myriad Genetics http://www.myriad.com/
BRCA1 and 2 Mutation Prevalence tables http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=11896095&dopt=Abstract
Abstract on Genetic Intellectual Property Rights http://www.oecd.org/dataoecd/42/21/2491084.pdf

just fyi
i videotape a genetics class every other day, and a few days ago, they said that the idea that male pattern baldness is an "x-linked" gene ie: passed from the mother's side, hence the old saying "if your mother's father was balding, then you will be too." anyhow, that old belief has been found to be incorrect. the trait is controlled by as many as five genes interacting, and it has what they called "variable penetration, and varied expressivity." meaning that you may never go bald, or you may go a little bald later, etc. relate it to skin color if you need an analogy.

the genetics teacher brought this up because she said that five years ago, the idea of the x-linked baldness gene was a given. no genetecist would even debate it. some skeptic (probably a bald skeptic whose mother's father has a full head of hair.) went and shook up the whole academic genetics universe, just cause he or she wasn't happy with it. she used it as an example of the idea that in genetics, it is very hard to say that one thing is "the way it is" and it is very easy to be wrong.

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Myriad, BRCA and the Patenting of Specific Genes

Myriad and breast cancer

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