The Human Genome Gold Rush
Statement by Dr. David King at HGA press briefing 14/6/00
"Any company that wants to be in the business of using genes, proteins, or antibodies as drugs has a very high probability of running afoul of our patents. From a commercial point of view, they are severely constrained - and far more than they realize."1 Dr William A. Haseltine, Chairman and CEO, Human Genome Sciences.
It has been evident from the start that a major aim of the Human Genome Project (HGP) was to support the pharmaceutical industry. However, it is unlikely that the project's founders anticipated the degree to which basic genomics research would turn into a gold rush, and the unpleasant conflicts that have arisen over patenting and sharing of data. Private companies are now going to extraordinary lengths to monopolise information in ways that conflict with the basic ethics of science. The result is a situation in which a a relatively small number of companies are in a position to exert significant control over the whole future of medicine.
Patents on human genes
In any other field of science, the HGP would be absolutely pure 'blue skies' research. However, there is a peculiarity in genetics, which stems from the fact that the basic data is embodied in a chemical molecule and there is thus a precedent for patenting information. The sequence of a gene is a discovery, whereas patents are granted on inventions. Notwithstanding this basic distinction, pharmaceutical corporations and entrepreneurial biotechnology companies have seized on the opportunity to patent something far earlier in the normal sequence from basic scientific discovery to inventive technology. In so doing, they gain far broader patents than would normally be possible, since a basic discovery is capable of a range of applications, such as diagnostic tests, gene therapies and pharmaceutical products. A patent on a gene thus allows a company to control a very wide range of possibilities, and by getting in at the ground floor they constrain others' opportunities to build on their work. But despite the drugs industries 'emotional blackmailing slogans, such as 'No Patents, No Cures', like other industries they could perfectly well manage with patents on individual products.
In addition to violating the basic distinction between discovering part of nature and inventing something new (which patent lawyers have got round by various unconvincing sophistries) patents on human genes also violate the patent criteria of obviousness. Gene discovery in the HGP has now become entirely mechanised -- all that is necessary to discover and patent gene sequences is the possession of sufficient capital to buy sequencing machines. Neither is it necessary to have the slightest idea of the function of a gene: when Human Genome Sciences patented the CCR5 gene in the 1980s, it had no idea that it was a receptor for the AIDS virus, and thus a potentially highly lucrative drug target. Thus the company is likely to profit from the gene not through any scientific merit, but rather as speculators in the financial futures markets do.
The result of the connivance of lawyers and legislators with the drugs industry's demands is a situation in which they are over 4 million patents on human genome sequences. This is only slightly less than the total number of patents ever granted in the USA. Human Genome Sciences has even gone so far as to patent the entire genome of a number of bacteria, including one that causes meningitis. Companies such as Incyte, Human Genome Sciences and Celera now own hundreds of thousands of patents, the majority of which are on short sequences of DNA. Here, the aim is purely to grab territory. It is not without reasons that scientists such as John Sulston, the leader of the UK section of the HGP, have described gene patenting as barbaric. The publicly-funded HGP is to be congratulated on its policy of immediate publication of genome sequence data. Tony Blair and Bill Clinton's declaration earlier this year in support of the policy is meaningless and hypocritical given their continued support for the patenting of human genes.
The future of medicine
The result of gene patenting is to give commercial ventures undue control over the future of medicine. Such companies can decide whether the development of particular products deriving from a gene is in their commercial interest or not and can prevent others from developing them. For example, most gene therapy products are being designed to be administered repeatedly rather than as one-time cures.
Gene patenting also distort the basic science of genetics. In genetics more than in any other field there exists massive conflict of interest, as corporations fund the work of academic scientists. Such collaborations regularly require scientists to refrain from the normal practice of sharing information and materials amongst themselves, and since science is predominantly a collaborative process of making small steps forward, this can only harm science and ultimately harm the interests of patients.
In fact, commercial greed is already having harmful effects on patients. A recent survey of American genetic testing laboratory directors revealed that many were being forced to halt genetic testing services due to the royalty demands of genomics companies and the complexity of negotiations with the companies. In Britain, NHS laboratories are being forced to pay royalties for breast cancer gene testing to a US company, even though British scientists still claim that they discovered the genes first.
Conclusion
Unless something is done
the effects of commercialisation of the human genome will be felt
for decades to come. The Campaign Against Human Genetic
Engineering supports a ban on the patenting of genes and living
organisms. The EU should repeal its biotechnology patents
directive, and patent offices should rescind and reject patents
on human genes.
1. Fisher, Lawrence. "The Race to Cash in on the Genetic Code," New York Times, August 29, 1999.