Large parts of your genome, the genetic code that is the distinct code that defines your humanity, have been patented and commodified. Exclusive property rights over that information have been awarded to private companies, locking up important research and depriving patients of life saving medical treatment.
Patents are the oldest and most powerful form of intellectual property, bestowing upon the inventor the exclusive right to commercially exploit an invention for a limited period of time. The concept of what can be patented under the legislation is derived from the Statute of Monopolies 1623. An invention is defined in the Schedule to the Act as “any manner of new manufacture the subject of letters patent or grant of privilege within S6 of the Statute of Monopolies”.
The phrase “manner of new manufacture” includes both products and processes which are capable of industrial application. (see the NRDC case). “Manner of manufacture” is an evolving and dynamic concept, having been interpreted in subsequent cases. (See CCOM Pty Ltd v Jiejing Pty Ltd). To be eligible as patentable subject matter an invention must be one that offers some advantage which is material in the sense that the process belongs to a useful art as distinct from a fine art, that its value to the country is in the field of economic endeavour.
In April 2009 the Intellectual Property Research Institute of Australia was engaged in a discussion before a Senate Inquiry on the topic as to whether or not Genes should be patented.
Many organisations and eminent Scientists have made submissions including the Cancer Council of Australia.
Their view is set out as follows:
“Gene sequences (and genetic mutations linked to specific diseases) are not an invention, but rather the discovery and isolation of naturally occurring substances. As a fundamental part of human biology, gene sequences are increasingly pivotal to an extraordinarily important, burgeoning field of health science – and one that must not be restricted by measures ostensibly designed to reward invention which may lead to the establishment of commercial monopolies….Rather than rewarding innovation, gene patenting is contrary to patent law as developed by the courts and, if allowed, can actively discourage scientific research and discovery….Under current arrangements in Australia, there is no adequate legal protection to ensure genetic testing for cancer risk remains freely accessible and at reasonable cost to the health system and consumers“
It is seen as fundamentally flawed to grant monopolies to materials that are identical to those found in the human body. As genes were never specifically created there are no firm rules on the patenting of gene sequences that are ‘discovered’.
Yet companies have managed to monopolise both the test for isolating gene sequences in addition to the raw genes themselves. You might ask the question how an isolated and purified gene differs from the same gene in the human body?
Proponents of gene patents argue that their right to inventions arise legitimately through the discovery and extraction process. However, the concept of a single gene is an artifact, an abstract concept, so the argument goes. Genes do not exist as discrete entities in the human body or in nature, but a part of our entire complement of genomic DNA.
What the particular inventor has done is identified a particular group of letters that have a particular function that is useful. They say they have been able to identify and extract that and define it as having a function. In isolating a gene sequence, it becomes a discrete entity, maintained in a vector, where it can be replicated easily and manipulated easily. Whilst analogous to what we have in our human body, it is something quite different when it is in an isolated form, and it is the isolation process which is the useful information they would argue. The gene itself is merely a research tool.
As IP Watchdog point out this is as “inventive” as marking the boudaries of natural features, like mountains, on a map. It gives the mapmaker no right to the mountain, nor to preclude others from depicting that mountain. Whilst that concept relates to old copyright cases, the same reasoning is applicable. Like any natural phenomenon there should be firm rules in place to distinguish between rewards for discoveries and patents for inventions. We have seen how the major genetic database vendors human gene sequences have lobbied for misappropriation principles to be incorporated into legislative database proposals to try to package these sequences into databases, granting them potentially protection in perpetuity. Those which to use them for research purposes face having to pay huge licence fees for access to them.
As with any natural phenomenon there should be firm rules in place to distinguish between rewards for discoveries and patents for inventions.
When the human genome was mapped in 2000 both Clinton and Blair stated the raw data should be free, yet patents are placing control on the raw data, data that should be free to realise the promise of this research in advancing the knowledge of human disease. It is a fiction that once you remove the gene from it’s natural environment, the body, you have an invention.
No related posts.