Calls For Change to Aussie Patent Law

Unless the Australian government extends and increases its protection of pharmaceutical patents, they may lose the reputation and stance they currently hold as a leading global trading partner in the industry.



AusBiotech – an organization who states an objective ‘to promote the global growth of Australian biotechnology’ – maintains there are many options for bringing the country’s status back in line with its peers, including the introduction of longer initial patent periods or the increase of extension periods.  Acting as part of a national government review initiative, the life sciences industry group believes that this approach would provide greater certainty to the pharmaceutical industry and the government.

Towards the end of 2012, Australia's federal government launched a review of the region’s current extension arrangements (which allow drug patents in some circumstances to be extended for up to five years beyond the normal term) for pharmaceutical patents.  Among numerous key issues, the panel of experts appointed to oversee the review was asked to consider the importance of the existing patent system in providing employment and investment in research and industry and Australia's position as a net importer of patents and medicines.

Since 1995, Australia’s patent term extension provisions have provided an assumed reasonable period (15 years) of exclusivity after regulatory approval.  Yet, this timeframe is proving rather unreasonable under current conditions.  An analysis of recently published data collected by IP Australia shows that a mere 53.22% of patent extensions have provided a sufficient time span from the date the product is initially recorded in the Australian Register of Therapeutic Goods.  AusBiotech has therefore recommended that the length of time taken for administrative processes prior to the approval and listing of any pharma product needs to be factored into what is acknowledged as the realistic exclusive period covered by a patent.

The research facility Medicines Australia has also called on the nation’s government to use the review to consider extending the patent life of novel medicines. Last October, the group’s chief executive, Dr. Brendan Shaw said, “There is a growing argument that patent terms in Australia are too short.”

“Given it takes as long as three years to get a new medicine listed on the Pharmaceutical Benefits Scheme (PBS) and rejection rates by the Pharmaceutical Benefits Advisory Committee are increasing, it's timely to look at whether patent terms are long enough.”

According to AusBiotech’s report, a major PBS submission requires the collection of rigorous data on effectiveness and cost-effectiveness, and the time – and costs – required to execute this explains the drug listing delay outlined by Shaw.  The related fear is that pharma companies will choose not to apply for PBS listing as a result of this lengthy process and seek alternative platforms for selling and marketing their products instead.

While the patent regime review was well overdue and has succeeded in offering innovative reform methods, the investigation has also demonstrated just how far Australia’s pharma industry needs to come.  If the Antipodean continent intends to remain a player in the global pharma landscape, economy, innovative companies must be encouraged to create and invest in the region – and this may mean a complete overhaul of the patent structure as it stands.