I read with interest this article outlining how a company and university have patented two human genes linked to breast and ovarian cancers. Now, the ACLU is suing Myriad Genetics on the grounds that it is unconstitutional and will inhibit innovation. I was also shocked to learn that about 20 percent of all human genes are patented, including genes associated with Alzheimer's, asthma and more. According to the article,
"Myriad's patents give it exclusive right to perform diagnostic tests on the genes, forcing other researchers to request permission from the company before they can take a look at BRCA1 and BRCA2, the ACLU said. The patents also give the company the rights to future mutations on the BRCA2 gene and the power to exclude others from providing genetics testing."
This is rather far reaching. I interpret this as an out and out monopoly on human genes whereby Myriad can charge whatever outrageous royalty fee they so choose, thereby inhibiting innovation toward those targets.
How do I see this playing out as more genes are patented?
Well, if the trend continues and the frenzy for the discovery and subsequent patenting of various genes continues, rather than having several researchers at universities and companies all working toward cures for various maladies in parallel with the hopes that their actual compound or assay will assist in diagnosing or treating diseases, you may have just the patent owner for each particular gene working on innovations, which in turn means 1 rifle round instead of a shotgun approach of hundreds of innovators competing for the prize. When competition and innovation is stifled, we end up with a lack of medical progress and it is evident that the human genome (although lately, many are saying the new frontier is the proteome) is where the next wave of medical advances will come from.
Here's what a professor of bioethics said in the article, (well put):
"It's like trying to patent the moon," he said. "You didn't do anything to create it, just discovered something that already existed. You can't patent things that are publicly available, that anyone can find. You have to create something, make something, do something with the thing."
What are your thoughts? Should companies be able to patent genes and other existing human anatomics without actually delivering a defined assay or new biologic/chemical entity to diagnose or treat an underlying malady?
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3 COMMENTS HERE
I'm surprised that it's actually taken this long.
I worked for a genomics company almost a decade ago, and we patented everything that came out of our sequencers that had potential value. Most of it was crap, but I can't tell you how many proteins we screened for potential "economic viability".
During the good ol' days of the Human Genome Project, companies wanted to get as much intellectual property as they could. Makes good business sense, but the ethics are a little shady.
For example, I imagine it's hard to tell a woman with breast cancer that Company XYZ owns her cancer gene. Scale that idea up for a few thousand cases a year, and you've got an angry mob with pink baseball bats in your parking lot.
But what it will do, is prohibit start ups or academics (people without much money) from working on a potential cure. I see the government stepping in and setting a maximum payment so Myriad can't overcharge, but doesn't make their own research cost prohibitive.
I am patent attorney. The lawsuit is frivolous. No one is patenting "genes" unless altered from their natural state by human intervention. DNA that is extracted and purified can also be patented, but that is not the same as patenting human "genes." The media headlines are misleading. The professor of bioethics you quoted doesn't know what he is talking about.
Bulls£@t, Mr. ToughMoneyLove: "purified and isolated" genes have some exons removed from the sequence. But this is like saying that removing impurities from water suddenly makes the water patentable, or that "isolating" Plutonium from Uranium suddenly makes the Plutonium patentable. I will grant that an engineered gene is inventive, but there's no inventive step involved in the "purification and isolation" being performed on natural genes before they receive patents.
for more on this argument, see my post here: http://www.scienceprogress.org/2009/04/gene-patents/
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