The ACLU claims that Myriad's 1994 patent on the genes is illegal, unconstitutional and should be thrown out. The issue of importance to the cancer patients involved is that Myriad's monopoly on the tests for mutated BRCA1 and 2 prevents patients from getting a second opinion on the results of their tests, and from obtaining a more affordable version of the test.
In my mind, patenting genes is like patenting anything else in medicine. By invoking a 20-year period of exclusive rights, development of the patented technology or drug is inhibited. This is the way it has worked with pharmaceuticals for eons: drugs remain produced, distributed and exorbitantly priced by the pharmaceutical companies who patent them, and become eligible for other companies to optimize and distribute generically when that 20-year period is up.
The opposition to this argument is that patenting genes causes more stunting to medical innovation -- and, by default, medical cures -- than does patenting of drugs and other medical technology. By patenting genes and the single test that has been developed to identify them, patients interested in the risk those genes may pose to them are forced to rely on the interpretation of the patenting company. In the case of BRCA1 and 2, patients cannot get a second opinion outside of Myriad Genetics; they are forced to rely on the results obtained from Myriad's test and on the interpretation of Myriad's doctors.
My response to this opposition is as follows:
Genes are only a single indication of disease. It has been reported that "inherited BRCA1 and BRCA2 mutations account for 5 to 10 percent of breast cancers and 10 to 15 percent of ovarian cancers among white women in the United States" (Campeau et al 2008) -- having the mutations is not a definitive diagnosis of cancer. It has also been reported that this percentage is even smaller: "[a]pproximately 5-10% of breast carcinomas and 10% of ovarian carcinomas are ascribable to a genetic susceptibility. Of these, about 40% are related to genetic mutations in the genes BRCA1 and BRCA2" (Palma et al 2006). Take from that statistical discrepancy what you will -- I guarantee there was not a new census taken between 2006 and 2008.
If patenting of genes inhibits patients from getting a second opinion on their genetic tests, it seems that seeking a verification through other diagnostic methods is not only an acceptable option, but a preferable one. Treatment of breast/ovarian cancers in particular are radically invasive and life-altering; until the BRCA gene identification tests are available "generically", mammograms, MRI and screenings for other genetic markers of breast/ovarian cancers are not only options but -- in my very humble opinion -- an incredibly good idea before making decisions about radical mastectomy and chemo:
"Clinical testing options for BRCA1 and BRCA2 are limited in the United States. In contrast to genetic testing for BRCA1 and BRCA2, genetic testing for other cancer susceptibility genes (MSH2, MLH1, PTEN, TP53, etc) is available from numerous profit and notfor- profit laboratories, with a range of testing options and prices."
"In addition to DNA sequencing of BRCA1 and BRCA2, genetic testing for other major breast cancer susceptibility genes including CHEK2, PTEN, and TP53 is clinically available in the United States." (Walsh et al 2008)Patients at risk for cancer should not limit their diagnosis to the outcome of a single kind of test when there are several out there, and certainly not to a single genetic test which measures only susceptibility. I do not argue against the legitimacy of a patient's concern, I just don't think that this particular argument is reasonable ground to make illegal the patenting of genes by their discoverers.
I am not sure I agree with the ACLU's argument either:
“What they have really patented,” says Chris Hansen of the ACLU to the New York Times, “is knowledge.”Really? If that is a legitimate statement, then every biomedical patent in the world is a blockade against knowledge, and they should all be overturned. Patenting is a measure taken to protect and honor the discoveries of researchers. It gives them the opportunity to make advancements on their own discoveries before the whole world is allowed to take a crack at them.
"Genes are informational. [By] allowing a company to have a patent on the actual sequence you are restricting the free flow of information," Tania Simoncelli, ACLU's science advisor, told Pharmacogenomics Reporter back in May. Simoncelli's colorful expatiation of this comment can be found here.THE POINT OF PATENTS IS TO TEMPORARILY RESTRICT THE FLOW OF INFORMATION. IF YOU WANT TO BRING THE FIRST AMENDMENT INTO THIS, YOU HAVE TO FIGHT ALL PATENTING OF ALL DISCOVERIES EVER.
BIOMEDICAL RESEARCH HAS BEEN PATENTING GENES SINCE THE 1980's AND DOCTORS HAVE BEEN PISSED OFF ABOUT IT SINCE THE 1980's. IF THE PATENT OFFICE WAS WORRIED ABOUT GENE PATENTING BEING CONTRARY TO THE PUBLIC INTEREST, THEY WOULD NOT ISSUE THEM.
In short, I have yet to find a legitimate argument made by the ACLU against patenting the BRCA1 and 2 genes, much less any gene. I'm not saying that genes should or should not be patentable; what I'm saying is that the ACLU is making a poor argument, and needs to approach this from more of a patient access angle.
Maybe what needs to happen here is for gene patenting to selectively be restricted to 5 years instead of 20. Five years is nothing from a scientific standpoint, and wouldn't actually allow researchers the opportunity to make significant headway before the rest of the world chimed in, but it would at least give them a head start without making prospective patients wait an inordinate amount of time for reasonable diagnosis or treatment. And five years of profit from over-priced tests certainly ain't bad.