Gene patents are at the intersection of cutting edge technology, modern commerce and human ethics. And recently the Senate’s Community Affairs Committee has taken evidence as part of their inquiry into gene patents.
Over the last two decades around the world patents have been granted over isolated gene sequences for which a practical and useful application has been identified.
More often than not the practical application is a test for diagnosing a condition that the inventor has shown is associated with the gene.
A patent gives intellectual property rights over isolated gene sequences and its uses if the chemical structure of the isolated sequence was not previously known.
How the law responds to the regulation of gene patents represents the kind of thorny challenge which is uniquely facing public policy makers in the 21st Century.
Yet patents are not new. Originating in the 15th Century patents are a response to the dilemma of trail blazing.
The first person to make the trail expends enormous effort in the journey, while every person following completes the same journey with ease.
So why would any person blaze a trail? Yet as a society we need trails blazed.
Patents are our answer to this dilemma. In exchange for developing an invention and making it public, the inventor is provided with a monopoly over the commercial exploitation of the invention for a period of up to 20 years.
Patents provide an incentive to invent. They have been integral to the most extraordinary period of human innovation in history.
Where the rubber has hit the road in relation to gene patents has been the patent for the BRCA breast cancer susceptibility.
In 1994 American researchers isolated the BRCA1 gene sequence, determined its chemical structure and its association with familial breast cancer.
The resulting test enables women to be tested for the presence of mutations in the BRCA1 gene and take action to reduce their risk. It is an invention that is saving lives.
In Australia, Genetic Technologies Limited (GTL) is the licensee of the BRCA diagnostic test and provides an accredited testing service. Initially GTL permitted public hospitals to undertake BRCA testing, but later sought to enforce their patent.
It was this enforcement of the patent, and the fear that GTL’s testing service might be more expensive, which has fuelled the debate about human gene patenting.
While issues around the human genome are unique, the role of patents in the affordable provision of medicine is far from unique.
For example the availability of generic drugs for HIV suppression in the developing world in the face of patents held by drug companies is a debate that has raged for twenty years.
Yet without the availability of patents, research may never have been done to develop the drugs in the first place.
For those who argue against the availability of gene patents there are three issues of concern.
First, patents are not available for discoveries such as a new mineral or a new plant. Human gene sequences, it is argued, already exist and their identification represents a mere discovery not an invention.
Second, it is argued that patents such as the BRCA test patent prevent further research in the area which might help develop an even better diagnostic test.
Finally, is it ethical to have intellectual property rights over isolated human genes?
On the other side of the debate is the need to ensure that our system of intellectual property is robust. As technology companies scan the globe for the best place to do business key amongst their needs is a system of law which respects and protects their intellectual property.
This has been a comparative advantage for Australia in attracting the development of international technology to our shores which is vital in developing a high tech modern economy.
Pharmaceutical and biotechnology companies also argue that the development of gene-related technologies require the same sorts of activities and effort that are involved in the development of a new drug.
Accordingly the acquisition of intellectual property rights are the only way that such innovation can be commercially viable.
Most importantly there is a premium on Australia having laws which are consistent with the international patent system. To be out of step with international norms carries significant risks that Australia will be bypassed by the global innovation system.
Among developed or emerging economy affiliates to the World Intellectual Property Organisation only Brazil and Argentina currently prevent the patenting of gene technologies. To join this number there needs to be compelling reasons.
The Government’s agency responsible for patents is currently reviewing the patent system. The issue of the right to conduct research around existing patents will form part of this review.
But for the Government to go further in establishing an explicit ban on the right to obtain a gene related patent is a very big call.
Should that call be made? We await the outcomes of the Senate inquiry’s report with interest.
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