Denise Caruso's new column at the New York Times kicks off with an essay on patents in the world of biotechnology. Most of the piece looks at how to build an intellectual property regime for biotechnology that serves the interests of society, not just a handful of companies. She cites a troubling, if not surprising, statistic: more than 20% of the human genome has already been patented, mostly by corporate biotech.
She also mentions the case of genetically-modified potatoes from biotech firm Syngenta. Not only are the GM spuds patented, they've been modified to be sterile without the application of a particular chemical. Potato farmers can't "copy" the crop without paying a fee.
The combination of these two facts is frightening. She doesn't use the term, but it's very clear as to what's going on here:
Genetic Rights Management.
Genetic Rights Management (GRM) is copy-protection for genes, a direct parallel to Digital Rights Management for CDs, DVDs, and other media. It's a term I came up with in 2002, as I was writing Transhuman Space: Broken Dreams. It's a way of preventing the duplication of patented genetic modifications by preventing unlicensed reproduction of individuals bearing those genes. It was an idea that struck me as the nearly-absurd but utterly plausible extension of trends in both biotech and intellectual property law; it now appears to be another case of successfully predicting the present.
Biotech companies are unlikely to successfully put GRM onto naturally-occuring human genes that they have patented. They'll try, but it seems likely to be a legal loser; despite the current situation of biotech companies having a strong monopoly on the genes they patent, ownership of one's own naturally-occuring genes is a sufficiently common-sense notion that, even if the courts upheld the patent rights, legislatures are likely to jump in to fix the laws. Biotech companies will be on firmer ground if they GRM-protect genemods that do not naturally occur in human beings, but can be used as a genetic treatment or enhancement.
The tools to make this possible already exist. One way would be through the use of Human Artificial Chromosomes (HACs). Bacterial genetic research often uses artificial chromosomes inserted into a bacterial nucleus, allowing researchers precise control over the placement and replication of the new genes. The same is possible with human biology, giving a cell which would normally have 46 chromosomes an extra, 47th, micro-chromosome with a small number of DNA base pairs. Case Western scientists reported the development of HACs in 1997, but the technique is not known to be in common use at this point. HACs would make the application of genetic rights management simple, either by applying the genemod directly via the artificial chromosome, or by putting the control mechanism in the HAC.
The notion of introducing sterility in a genetic modification recipient to prevent unlicensed duplication is a staggeringly awful idea, yet is the logical result of current practices. Human genes are, as Denise Caruso describes, already subject to strong patent rights.
As Tim Hubbard, a Human Genome Project researcher, noted at a 2001 conference: “If you have a patent on a mousetrap, rivals can still make a better mousetrap. This isn’t true in the case of genomics. If someone patents a gene, they have a real monopoly.”
This monopoly gives patent holders total control over patented genetic materials for any use whatsoever — whether for basic research, a diagnostic test, as a test for the efficacy of a drug or the production of therapies.
And biotech companies are already employing crude forms of GRM on genetically-modified plants and animals: so-called "terminator technology," blocking the reproduction of modified crops, has been around for years; and the recently-introduced hypoallergenic cats developed by Allerca arrive to their new owners pre-neutered/spayed.
It may be that GRM goes too far, and that any attempt to roll out such a system will result in backlash against the underlying notion of genetic patents. I hope so, at least; already, too much of what had been in the commons has been locked up as private intellectual property. But as we work to raise awareness of and resistance to overreaching by big bio, we need to recognize that things are not nearly as bad as they might yet be.
(Update: Be sure to look at the first comment, from Rob Carlson.)