ST: The folly of patenting genes

The folly of patenting genes
Straits Times; Andy Ho, Senior Writer
IN 1994, biopharmaceutical company Myriad Genetics won the race to isolate and patent two genes in which certain mutations point to heightened risks of breast and ovarian cancers.
Using these patents, the University of Utah spin-off then developed diagnostic tests for the two genes called BRCA1 and BRCA2.

A gene has many definitions, but a simple one is that it stores genetic material passed from one generation to the next. When a gene is patented, no competitor may offer any test for this gene unless licensed to do so.
Each test for the BRCA1 and BRCA2 genes from Myriad costs US$4,000 (S$5,000). In 2001, Myriad issued 'cease and desist' letters to laboratories around the world not licensed to do BRCA tests.
According to a 2006 study published in Nature Biotechnology, much of gene patent policy debate in many countries was triggered by Myriad's act of enforcing its patent rights. Last year, United States activists challenged those very rights. This March, they won in a lower court in New York. Understandably, Myriad went up to the federal Court of Appeals.
In a surprising policy reversal, the US government recently declared it no longer supported the patenting of human genes. This came after it had already granted patents on 4,382 human genes - or about 20 per cent of all genes in the human genome.
Whatever the outcome of the present proceedings, the case is likely to be litigated up to the Supreme Court, whose eventual decision will rumble throughout the whole biotech industry.
Already, the biomedical industry is feeling its way around the US government policy reversal. In fact, that policy reversal is overdue, righting a wrong decision. Why do I say so?
For one, the arguments in favour of gene patents are spurious. Harvard professor Sheila Jasanoff in Designs On Nature (2007) argues that the very existence of the biotech industry depends on gene patents. She notes that the industry as a whole has few products on the market as yet and thus relies on patents of human genes as a main measure of its success.

Basically, the argument for granting patents on the genes that companies sequence goes like this: It is very costly to invest in people and technology to sequence genes. A company should be able to recoup its investment in the form of property rights in the genes they discover and sequence. Then others will have an incentive to invest in such costly research, which benefits us all.
But such arguments are rightly rejected these days. Critics point out that you cannot patent something that occurs in nature, like genes. Even if isolated and purified, a gene remains a product of nature, so it is not patent-worthy.
More to the point, gene patents lead to a monopoly in an important service - like Myriad's BRCA tests. When it returns an inconclusive test result, there is no second opinion available. There is no competition to spur Myriad on to improve its tests: A French study suggests that Myriad's tests fail in 10 to 20 per cent of cases.

Finally, research is hindered since scientists have no way to work with the genes unless licensed by Myriad. Indeed, researchers who were working on the BRCA genes stopped their studies once the patents were granted.
In fact, you get into a ridiculous situation where research into the whole genome, say, would stall because you run into a 'patent thicket'. In that case, you would need to purchase licences from different patent owners - some of whom could scupper the entire effort by deciding not to license 'their' genes anyway.
Most fundamentally, the entire patent process suffers from a serious problem of definition when it comes to genes.
Not only do we not know what a particular gene does in the body, but the question of what makes up a gene is not really known. You cannot grant a patent for a gene when it is not clearly understood yet what a gene really is, or what it does.

In the early part of the 20th century, genes were thought to be strung out on chromosomes 'like beads on a string'. Thus genes were viewed as discrete and stable particles.
Then the twisted ladder or double helix of DNA was discovered in 1953. Genes were reconceived as nucleotide sequences that made up its rungs.
It was thought that each gene held the information to synthesise one protein. This 'one gene, one protein' idea became the central dogma of molecular genetics and is one familiar to many adults today.
By the 1980s, scientists were discovering that depending on the combinations, parts of the same gene could be used to make different proteins. It was later understood that some products made by genes act like regulators for other genes - activating and promoting or repressing and terminating their expression.
There is also cross-talk between genes and 'junk DNA', a misnomer for those regions of the genome thought earlier to have no utility. It is known now that sections of junk DNA sort out the complex molecular signals that overlapping genes send out. Recently, US scientists identified within a region of junk DNA the very gene that causes muscular dystrophy.

If the science appears complicated, the overall picture is in fact very simple. Genes are complex, and the interaction of genes even more so. They are not discrete material units faithfully synthesising proteins in a simple linear fashion.
Genes function contextually. Since 2007, the 'networked gene' has become a preferred way of describing a gene, one more accurate than the earlier descriptions of 'one gene, one protein', or even 'one gene, multiple proteins'.
In 2006, the top science journal Nature highlighted the far-ranging disagreement among biologists on the issue. Harvard geneticist William Gelbart was quoted as saying: 'I find it sometimes very difficult to tell what someone means when they talk about genes because we don't share the same definition.'
Yet patent applications continue to use the word 'gene' as if its meaning were unambiguous. And companies continue to be granted patents - property rights in genes - when the scope and reach of these rights are not really known.
Until we understand more clearly what genes are, a moratorium on such patents is to be welcomed.

andyho@sph.com.sg
Source: Straits Times © Singapore Press Holdings Ltd. http://www.straitstimes.com/PrimeNews/Story/STIStory_598988.html