THE HUMAN GENOME PROJECTS:
HELP OR HINDRANCE FOR GENE PATENTING?
by Matthew Albright

The results of the Human Genome project have been called “humbling,” surprising, affirming, and “nothing but an expensive science project.” In the wake of joint news announcements by both the private research conducted by Celera and the publicly funded research conducted under the auspices of the National Institutes of Health, scientists bragged of the accomplishment and wondered about unanswered questions it unearthed.

One of the ponderables: how will gene patenting be affected by the results of the human genome project? Or, perhaps a better question, how will the project’s results be interpreted by the popular press, the intellectual property lawyers, the biotech industry, and the United States Patent and Trademark Office? How will these interpretations affect the policy of granting gene patents to private corporations and government entities?

There is, perhaps, good news and bad news for those who advocate a moratorium on gene patents.
On the one hand, both genome projects have affirmed what many scientists have been saying all along: the idea of a single-function gene is a myth. The most “humbling” result of the human genome project is the fact that Homo sapiens have just a third more genes than a roundworm. Both human genome projects, by estimating the total number of human genes at 30,000 to 40,000, implicitly refute the deterministic language that has been used by the biotech industry to patent and own so-called “disease genes” and “behavior genes.” As well, the destruction of the single-function gene myth should ring the death knell for some of the underlying assumptions that drive gene therapy experiments.

In a New York Times editorial following the release of the news about completing the human genome sequencing, Stephen Jay Gould proclaimed, “The collapse of the doctrine of one gene for one protein, and one direction of causal flow from basic codes to elaborate totality, marks the failure of reductionism for the complex system that we call biology…”

Even Craig Venter, president of Celera whose very business plan seemed to depend on gene patents,
agreed: “The notion that one gene equals one disease or that one gene produces one key protein is flying out of the window,” he told the Financial Times.

Furthermore, both human genome projects demonstrated the increasing difficulty of defining what a gene actually is. The “junk DNA” that many researchers regarded as useless now requires re-analysis. The Alu sequence (a common piece of repetitive “junk DNA”) and “fossil record” DNA will be reexamined by further studies to assess their functions in relation to the rest of the genome.

“The junk is amazing,” Eric Lander, head of genome sequencing at the Whitehead Institute, told Reuters.
These two related indicators ––the multiple unexplored functions of the DNA sequences that constitute “the gene” and the definition of the gene itself–– may demand that the United States Patent and Trademark Office examine more closely the “utility” requirement when reviewing gene patents (Ed. Note: see Warren Kaplan’s companion article). In other words, it is hard to award a patent to an inventor who appears to have very little idea of what their invention is or how it functions.

Already, some predict that the number of lawsuits between companies that own patents on specific genes and those that try to conduct further research or explore new uses for those genes will be on the increase. 40,000 genes are not a lot to work with and the patent system does not facilitate sharing of research materials. The outcome of these lawsuits may yet find that general patents on specific genes are too broad and unsupportable in courts of law.

More likely, however, even broader monopolies may be given to those who have already patented genes or will do so soon. The human genome project has made clear that corporations that have already claimed genes as their own have, in fact, laid claim to a higher percentage of the entire human genome than they at first realized. Looking at the four leading private companies who patent genes, about 750 human genes have been patented by them so far and applications for about 20,000 more are pending. In the case that the pending patents are all awarded (which is unlikely, as many will prove to be redundant), those four private companies could own half of the human genome.

Furthermore, as Craig Venter has already indicated, the new fish to catch with patents may be the proteins. The reductionism that we have seen with the now antiquated idea of a single-function gene may simply be reconcentrated on the proteins. Proteomics, the analysis of complete complements of proteins, will take over where genomics has proven inadequate: giving simplistic genetic determinants for human health and behavior.

In order for the biotech industry to survive at all ––at the very least it has yet to break even financially–– the reductionist and determinist ideals must be maintained in their marketing. Easily definable, single-function units of biological material are necessary for making any real money. It is hard to market genes and proteins if molecular biology is continually described as a hornets’ nest of undecipherable relationships.

In the end, the results of sequencing the human genome may not affect gene patenting one way or another. Gene patenting will continue to depend on the lawyers, the biotech industry’s public relations, and the economic powers that be, who will all put their own spin on research data. Scientific results – no matter how humbling -- can never be politically neutral.

For footnotes to this article, please contact the CRG office.