Sharing genes is patently obvious
Opinion piece - Ian Frazer
Weekend Australian, Page 11, Saturday, 08 August 2009
As a scientist and patent holder I can understand why clinical researchers seek to have their inventions patented. Individuals or corporations whose talent and hard work result in a useful invention ought to benefit from a system that protects their investment of time and effort and their willingness to make the invention public by ensuring their labour and creativity are rewarded.
Patent law was developed in the 17th century as an incentive to ingenuity, to help make the benefits of invention widely available and to further develop novel uses for the invention. However, patenting of a naturally occurring gene sequence and claiming the right to benefit from the use of that gene sequence by others fails on both counts.
First, there is no more invention in isolating and characterising biological material that exists in our bodies, using existing research techniques, than in collecting and arranging a set of postage stamps. Second, claiming a monopoly on the use of a particular gene sequence in an already existing diagnostic test method can lead to restricted public access to vital diagnostic services.
Gene patent owners have told a Senate committee that awarding gene patents is necessary to encourage investment in biotechnology research. The reality, however, is that a gene patent can also be a licence to monopolise its use, eliminating the competitiveness and information sharing essential to the development of genetic therapies whose invention should be rewarded by a patent Restricting the research use of a gene sequence could delay the development and testing of truly inventive and practical uses of the gene and its protein product for diagnosis and therapy. This would he to the detriment not only of the wider community, but also of the biotechnology industry itself.
Gene patent attorneys and their clients contend there is sufficient inventiveness in isolating a gene sequence to claim a patent over the process and over the gene sequence itself. But the evidence suggests otherwise.
Five years ago the Australian Law Reform Commission completed a seemingly exhaustive review of gene patenting in Australia.
Nowhere in its report did it make the simple point that gene patents should no longer be granted because sequencing genes amounts to tailoring pre-existing technology to discover something in our bodies.
The report cites academics as arguing that "the cloning and sequencing of a gene is unlikely to amount to an inventive step". It then recommends that patent examiners receive additional training and examination guidelines be developed for biotechnological inventions.
But how much education do you need to learn that patenting genes is fundamentally invalid? It would have been easier for the report to simply say genes are not inventions and they should not he patented. Law reform, apparently, is not that simple.
Hopefully, the Senate inquiry into gene patents, which began this week, will be much more direct in its recommendations.
Science sits on the cusp of a surge in the use of genes in the diagnosis and treatment for major illnesses. The collegiate tradition of sharing raw data among researchers must be allowed to continue unfettered so new technologies can be developed to benefit all.
Major medical science breakthroughs such as Pasteur’s immunology discoveries or Florey’s penicillin antibiotic were gifted to humankind for global benefit. They have contributed enormously to the increases in life expectancy we enjoy today.
Clearly, medical science has evolved phenomenally. Patent law remains rooted in its own dark age.
If we allow patenting of genes we ’re allowing patenting of ourselves. The patent system should protect inventive medicines developed from research using data on gene sequences. But a gene sequence used to develop the invention should not qualify the gene ’s sequencer to receive benefits.
It is now more than nine years since then US president Bill Clinton and British prime minister Tony Blair made a joint announcement that gene patents should he banned.
Unfortunately, we are no closer to a resolution.
Since then the US and Europe have been caught up in legal battles around the issue, including an American case at present before the Supreme Court For Australia, however, there is limited value in looking to international precedent for guidance. We do not have a huge domestic biotechnology sector and we are not uniquely placed to trade with the US.
But our unique circumstances could be an advantage. Australia’s government can set a precedent for putting the public interest at the forefront of genetic science. It could do so by declining to grant future patent applications seeking to protect genetic sequence information if there is no subsequent inventive step leading to a defined practical application.
Cancer Council Australia calls for a comprehensive government review of the problems of gene patenting and recommends that the law be amended to exclude gene sequences from the definition of patentable subject mailer.
Until this happens non-commercial use of gene sequence information should be encouraged for research and diagnostic purposes.
It is crucial we address this issue now, before the wave of gene technology breaks. The Senate may never inquire into a more important public health mailer.
Ian Frazer is Cancer Council Australia president, former Australian of theYear and inventor of the cervical cancer vaccine.