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Thursday, March 28, 2013

Do you own your genes, or can Big Pharma patent them?

Source: ETech
Somebody should check and make sure that Kim Dotcom hasn’t started funding any research in genetics. Maybe those guys from the Pirate Bay, too. With a paper that must send chills of fear and vindication down the spine of every internet freedom fighter, researchers from Cornell University this week presented evidence that genetic copyright is a “direct threat to genomic liberty.” Could this be the newest, most easily altruistic frontier in copyright banditry?
The study in question looked at existing patented stretches of DNA, notably in the hotly contested BRCA1 gene [1], and set about testing whether these patented sequences might pop up elsewhere due to chance or redundant function. They searched the human genome for small and large sequences patented under just a single diagnostic test, and found that these sequences existed in 689 other places.
This isn’t all that surprising. As the researchers point out, take any 15-nucleotide sequence (a ’15mer’), check it against the human genome, and you’ll always find a match somewhere else. In medicine researchers are generally selecting stretches of DNA for some sort of useful function, and evolution happens to like useful things, too; if we can’t construct a 15mer at random and find it only once in the genome, how could we possibly hope a medically useful one, one with a distinct selective advantage, will be unique? The code for several types of protein motifs, most of which are much longer than 15 nucleotides, are repeated literally thousands of times in humans. (See: Your complete DNA genome can now be sequenced from a single cell [2].)
DNA strand, over a page of TGAC base pairs[3]That certainly sounds scary, but doesn’t this all seem just a little alarmist?
On the surface, genetic copyright in just another form of the classic problem: Can we better afford to deal with the pricing that results from strong biomedical patents, or with the lack of innovations that may result from their prohibition? This is one of the main problems facing the drug industry, which sees the vast majority of new medications developed by companies that, arguably, gouge customers in their most desperate times. We’re often presented with a dichotomy — do we want poor sick people, or dead sick people?
Yet, this study represents a growing movement within biomedical research, one aimed at changing the way we treat biological products. Traditionally, one could patent “anything under the sun that is made by man”, which would seem to exclude biological patents, but American and European patent authorities accept them by the thousands.
The most obvious reason for this is money — it costs a lot more money to find and characterize a gene, find a use for it, and develop a kit to exploit that use, than it does to boil a compound out of leaf. Take away the monetary incentive to invest the money necessary to do that, and the money won’t get invested. But how much control is an unfair amount, and how much compensation is enough — especially when the products at issue exist in all of us. Lead researcher Dr. Christopher Mason claims this portends a future in which “no physician or researcher can study the DNA of [their gene of interest]… without infringing a patent,” a claim that seems at least somewhat reasonable given his findings; with such ridiculous coverage under these patents, and so many thousands of patents in the pipe…
Next page: There are more important fish to fry, such as Big Pharma gouging customers for life-saving drugs [4]
Still, if these musings have merit, why is this discussion almost entirely hypothetical? The only genetic patent cases ongoing are those with a specific use at issue. The famous BRCA1 case that probably inspired this study involves a challenge to a specific diagnostic test for a specific gene. The researchers are unlikely to find too many people willing to defend a patent that keeps potentially life-saving tests priced thousands of dollars above cost, especially when the company in need of recompense for the initial research has already made many millions off of it, and has yet to reinvest that money by releasing any new therapies. (To be fair, the incessant lawsuits may have distracted them.)
The fact is that genetic patents specify a locus for their sequence, and while there may be some possible letter-of-the-law argument to generalize the sequences and apply them as nefariously as Dr. Mason fears, there has yet to be any real hint of movement in that direction. This discussion of researchers not being able to “look at ” genes of interest is simply silly; the only issue is whether they can use that gene in some therapy for some specific purpose. In 2001 the patents laws were amended to to require that any valid genetic patent must be for a genuine novel application of a gene purified from the genome. These restrictions alone would pose significant problems to any corporation attempting to, say, restrict research into BRCA1 for uses completely unrelated to theirs.
BRACAnalysis, the patented genetic test controlled by the embattled biocorp Myriad Genetics
In the case of BRCA1, researchers understandably wanted to be allowed to develop and use their own alternative to the pricy, patented monopoly on a potentially life-saving diagnostic. That may be a fine goal, but it doesn’t have anything particularly to do with conspiracy theories such as these. The researchers here have taken results that are really quite predictable and made all sorts of legal implications that are, at best, speculative. (See: Harvard cracks DNA storage, crams 700 terabytes of data into a single gram [6].)
Any application of patents in the way Dr. Mason describes would be met with resistance far stronger than we’ve seen surrounding BRCA1. He will, at that time, get to make all of his very valid arguments against such practices and, not to sound naive or anything, but he will probably prevail. Everybody knows without needing to be told that genetic patent is a real issue, worth discussing and worth taking seriously.
Still, until we start seeing movement in the direction of such abuses, let’s not get carried away. We have very real issues before us that need our attention, such as the tug of war between medicine as healing trade and medicine as real-world business. That’s important enough all by itself.
Now read: The quest for the $1,000 genome [7]
Research paper: doi:10.1186/gm431 [8] – “Pervasive sequence patents cover the entire human genome”
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