Gene patents: “Discoveries not inventions”
Patents are designed to protect the commercial interests arising from an invention, not a discovery. Discoveries are part of the natural world and are there for all to explore and utilise.
Patents are designed to protect the commercial interests arising
from an invention, not a discovery. Discoveries are part of the
natural world and are there for all to explore and utilise. In
claiming a patent over a gene, the patent holder is making a claim
over something that he did not synthesise or create. On this point,
it is immaterial if gene patents cause harm or good to the
commercial interests of patent holders. As a matter of principle,
patents on naturally-occurring genes should not have been approved.
But patents on genes have been granted.
A patent should only be approved for something which is, in Mr
Wilson's words, "new, inventive, and usable". The method for
isolating a gene may meet these criteria and be patentable. I am
not aware that anyone has argued to the contrary. Medical
laboratories are full of machines and processes which comply with
this definition and are appropriately patented. But the isolation
of a gene from a patient's sample does not comply with this
definition. The chemical structure of the gene in the test tube
must, necessarily, be the same as the chemical structure of the
gene in the person. If this were not so, then medical tests based
on genetic material would be useless. Isolated genes are not
patentable because they are neither new nor inventive. But patents
on genes have been granted.
Mr Wilson states that, "...before the [Senate] Inquiry
recommends changes to Australia's patent laws opponents of the
system need to substantiate that there is a problem in the first
place". The problem with gene patents is not the law, but the way
in which it has been applied. From a legal perspective, patents can
only be granted for new, inventive, and useable inventions. But
patents have been granted on genes which are old, long-established
discoveries. The problem rests not with patent law, but with
mis-application of the law. The law does not need to be changed, it
needs to be followed.
If Mr Wilson wants to know about the adverse consequences of
gene patents, these have been documented by the Royal College of
Pathologists of Australasia in its submission to the Senate Inquiry. There is
also a recent
series of case studies in Genetics in Medicine which
assesses the consequences of gene patents in medical testing; these
are freely available.
The problem rests not with patent law,
but with mis-application of the law. The law does not need to be
changed, it needs to be followed.
I am particularly concerned by one of the arguments put forward
by Mr Wilson in support of maintaining the patentability of genes.
He argues that, in the absence of a patent, "innovators rely on
'trade secrets' to protect their technology" with a consequent
limitation in the sharing of knowledge. This is a spurious
argument. Genes are not 'technology'. Opponents of gene patents
want to ensure that discoveries are available to all, so that
everyone has the potential to generate their own benefit from the
discovery. The human genetic code should be in the public domain
with no control by commercial entities as to how it might be
exploited.
The adverse consequences of gene patents can, to a large extent,
be mitigated by ensuring that there are broad licensing
arrangements. At present, most gene patents are licensed broadly.
However, there are important exceptions as exemplified by the
experience of testing for familial breast cancer in both Australia
and the US. If we were discussing the patent of a tradable
commodity, then occasional exceptions to broad licensing may be
acceptable. But we are dealing with patents which can interfere
with the delivery of effective and equitable health care.
Exceptions to broad licensing should not be tolerated.
Broad licensing can address the adverse consequence of gene
patents. But licensing arrangements do not address the fundamental
principle that genes are discoveries, not inventions. I agree with
Mr Wilson that patent legislation does not need to be changed. But
the law as it stands does need to be applied.
Yours sincerely,
Graeme Suthers.
About the author
Dr Graeme Suthers
PhD FRACP FRCPA
Chair, Genetics Advisory Committee
Royal College of Pathologists of
Australasia
Dr Graeme Suthers is currently Deputy Head of the South
Australian Clinical Genetics Service, program director of the
State's Familial Cancer Service, senior visiting consultant in
clinical genetics to a number of teaching hospitals in Adelaide,
and a genetic pathologist in South Australia's public sector
pathology service.
He has been a member of a variety of local and national
committees, including committees of the Royal Australasian College
of Physicians, the Royal College of Pathologists of Australasia,
the Human Genetics Society of Australasia, Australasian Association
of Clinical Geneticists, NHMRC, Australian Cancer Network, The
Cancer Council Australia, Clinical Oncological Society of
Australia, NPAAC, Pathology Services Table Committee of the Federal
Department of Health & Ageing, and the Medical Services
Advisory Committee of the Federal Department of Health &
Ageing.
Top of page
