THE patentability of genes is a complex, emotive and pressing issue worldwide.
It raises any number of health access, public policy, health expenditure, ethical and legal questions.
What is the effect of granting patents over human and microbial genes, non-coding sequences, proteins and derivatives?
Are gene patent laws enabling or restrictive? As a community, do we believe it is acceptable to patent a human gene? Where are the limits? And do these hamper genuine investment and research?
In November 2008, the Australian Senate referred key matters relating to the patenting of human genes and genetic material to a special committee for inquiry and report.
The inquiry was charged with looking into the impact of granting patent monopolies over such materials on the:
- Provision and costs of healthcare
- Provision of training and accreditation
- Progress of medical research
- Health and wellbeing of the Australian people.
The Senate Genes Patents Report was tabled on 24 November 2010 and contained 16 recommendations.
In late 2011, the Australian Government accepted recommendations on gene patents and patentable subject matter from this and two other relevant reports.
These were acted upon through the Raising the Bar reforms and other practical changes implemented by IP Australia.
The recently released consultation paper proposes two amendments to the Patents Act and addresses two key recommendations.
The first proposes the introduction of an objects clause to help resolve points of ambiguity. There are two options presented for discussion.
The second proposed amendment deals with patentability exclusion for an invention, the commercial exploitation of which would be wholly offensive to a reasonable and informed member of the public.
Comments are invited and welcome from anyone interested in the operation and impact of the patent system in Australia.
Written submissions to IP Australia on the proposed amendments close on 27 September 2013.