A new finding has discovered that the human genome may be highly networked. That is, genes do not operate in isolation, but rather they are networked together in a far more complex ecosystem than previously thought. It may be impossible to separate one gene from another in fact. This throws into question not only our understanding of genetics and the human genome, but also the whole genomics industry, which relies heavily on the idea that genes and drugs based on them can be patented:
The principle that gave rise to the biotech industry promised benefits that were equally compelling. Known as the Central Dogma of molecular biology, it stated that each gene in living organisms, from humans to bacteria, carries the information needed to construct one protein.
The scientists who invented recombinant DNA in 1973 built their innovation on this mechanistic, "one gene, one protein" principle.
Because donor genes could be associated with specific functions, with discrete properties and clear boundaries, scientists then believed that a gene from any organism could fit neatly and predictably into a larger design - one that products and companies could be built around, and that could be protected by intellectual-property laws.
This presumption, now disputed, is what one molecular biologist calls "the industrial gene."
"The industrial gene is one that can be defined, owned, tracked, proven acceptably safe, proven to have uniform effect, sold and recalled," said Jack Heinemann, a professor of molecular biology in the School of Biological Sciences at the University of Canterbury in New Zealand and director of its Center for Integrated Research in Biosafety.
In the United States, the Patent and Trademark Office allows genes to be patented on the basis of this uniform effect or function. In fact, it defines a gene in these terms, as an ordered sequence of DNA "that encodes a specific functional product."
In 2005, a study showed that more than 4,000 human genes had already been patented in the United States alone. And this is but a small fraction of the total number of patented plant, animal and microbial genes.
In the context of the consortium's findings, this definition now raises some fundamental questions about the defensibility of those patents.
If genes are only one component of how a genome functions, for example, will infringement claims be subject to dispute when another crucial component of the network is claimed by someone else?
Might owners of gene patents also find themselves liable for unintended collateral damage caused by the network effects of the genes they own?
And, just as important, will these not-yet-understood components of gene function tarnish the appeal of the market for biotech investors, who prefer their intellectual property claims to be unambiguous and indisputable?
While no one has yet challenged the legal basis for gene patents, the biotech industry itself has long since acknowledged the science behind the question.
"The genome is enormously complex, and the only thing we can say about it with certainty is how much more we have left to learn," wrote Barbara Caulfield, executive vice president and general counsel at the biotech pioneer Affymetrix, in a 2002 article on Law.com called "Why We Hate Gene Patents."
"We're learning that many diseases are caused not by the action of single genes, but by the interplay among multiple genes," Caulfield said. She noted that just before she wrote her article, "scientists announced that they had decoded the genetic structures of one of the most virulent forms of malaria and that it may involve interactions among as many as 500 genes."
Even more important than patent laws are safety issues raised by the consortium's findings. Evidence of a networked genome shatters the scientific basis for virtually every official risk assessment of today's commercial biotech products, from genetically engineered crops to pharmaceuticals.