Remember the monster movies churned out periodically by Hollywood? The formula is almost unchanging. A scientist finds a strange egg (or several) on an expedition in the wilds, nurtures it and brings it to civilisation (usually New York) and before you know it, these hatch into monsters who want to devour humans and destroy their habitat. There are countless variations on the theme but the central idea is this: serendipitous surprises are rare; you could be unleashing a Frankenstein with such finds.
Something similar is happening with gene discoveries. All those wonderful breakthroughs made in the 1990s as the human genome was being mapped are now turning into a nightmare for everyone: from people susceptible to certain genetic health risks to research institutes and governments as companies patent certain gene sequences and put a stop to their use for further research or from using the clinical tools developed from certain genes — except for a fat fee, of course.
The most well-known of these cases is that of the American diagnostics company Myriad Genetics whose actions have sparked the most furious debate on the implications of gene patents. The company owns the patent for the BRCA test that measures the risk of hereditary breast cancer in certain women. It was a test available since the mid-1990s in the US, Canada and Europe through most public and private health insurance plans. Myriad came into notoriety when it insisted that all such tests should be centralised at its Salt Lake City headquarters. Canada and British Columbia temporarily suspended women’s access to the tests citing increased costs which their public health services could not afford. Each test cost around $3,000.
Now, the storm has moved to Australia where Genetic Technologies, which licenses the breast cancer patents from Myriad, is insisting on similar conditions. From November 6, says the Melbourne-based company, public hospital laboratories can no longer conduct their own testing for the inherited breast cancer gene mutations known as BRCA1 and BRCA2. Instead, samples have to be sent to the company for processing. Naturally, there has been an outcry in Australia. In a letter sent earlier this year, Genetic Technologies warned laboratories, “in the interests of avoiding costly and time-consuming litigation” not to contest its demand.
You could argue that a company which owns the patent or is licensed to enforce it should have the right to impose such conditions. There are two major issues with such a stance. One, of course, is the predatory pricing that such a monopoly gives the patent holder. The other is more serious: it can block any further research. According to a report in The Sydney Morning Herald last week, thousands of genetic samples are held in public laboratories in a data-bank built up since BRCA1 and BRCA2 testing began in 1995. The exact form of mutations, says the newspaper, is being identified now, more than decade after the samples were collected. If all the samples are sent to a private laboratory, the Australian health service will never get to research these genes and learn more about genetic predisposition.
Myriad, on the other hand, has by forcing North American countries to send all the samples to Utah, gained immense knowledge about gene mutations. However, the danger is that if a single laboratory does all the testing, there will be none to set the benchmark since all competitors are out of the reckoning. In fact, a woman cannot even donate her breast cancer gene to any other institution or scientist because Myriad holds a patent.
So why should such a patent have been granted in the first place? The major culprit in this regard is the US Patent and Trademark Office (USPTO) began to hand out gene patents rather liberally much to the chagrin of a lot of people, including scientists decoding the genome. The result is that a fifth of the genes in the human body are already privately owned.
The Europe Union, on the hand, has been more cautious about patenting of genes. In fact, in 2004, the European Patent Office revoked Myriad’s BRCA patent, paving the way for cheaper screening across the continent. It said there was no prior art in Myriad’s claim.
Now the European Society of Human Genetics has suggested a new way of looking at intellectual property (IP) over genes. Since access to genetic testing can be impeded every step of the way from the discovery of new genes and mutations all the way up to availability of genetic tests, it suggests that we focus on who will develop the genetic tests and what IP rights they should have over their work instead of concentrating on who has the right to have a genetic test and how. It may be a bit late in the story to shackle the gene patent fiends.
