February 2014 - Patent Term Extension (PTE) provisions in
Australia have recently been the subject of an extensive review.
The Government has recently announced, however, that it has no
plans to release the Final Report.
As previously reported (see "Australia's Pharmaceutical
Patents Under Review" and "Australia's Pharmaceutical
Patents Under Review - submissions due by 21 January 2013") a
Government review of the Australian pharmaceutical patents system
was set up in 2012 to determine whether it is "effectively
balancing the objectives of securing timely access to competitively
priced pharmaceuticals, fostering innovation and supporting
employment in research and industry" and, in particular,
whether the system "is being used to extend pharmaceutical
monopolies at the expense of new market entrants".
A Review Panel was formed and a Background and Suggested Issues
Paper issued in November 2012. Following written submissions and
public hearings in Sydney, Melbourne and Canberra, the Review Panel
issued a Draft Report in April 2013 and provided its Final Report
to the Government in May 2013. Shelston IP, represented by Jacinta
Flattery-O'Brien, attended the Sydney hearings and made
submission that were cited in the Draft Report (Shelston IP was the
only patent attorney firm mentioned in the Draft Report).
The Draft Report contained several recommendations, including
reducing the length of PTEs and, instead, providing direct
subsidies for research and development. PTEs are intended to
compensate patentees for the time taken to obtain regulatory
approval and, in the case of blockbuster drugs, can be worth
hundreds of millions of dollars to a patentee. Accordingly, this
recommendation sent shock waves through the pharmaceutical industry
and the Government's response to the Final Report was awaited
with much anticipation.
However, following lodgement of the Final Report (which was not
published), the Government was silent with regard to the
Pharmaceutical Patents Review until 11 February 2014, when the
Minister for Industry, Ian Macfarlane, responded to a Question in
Writing and stated the following:
"The Government has no plans to release the final
report at this stage. The Government is not considering the
recommendations made by the panel in the draft report. The
Pharmaceutical Patents Review panel delivered its final report to
the previous government in May 2013, which did not release the
report. As the Pharmaceutical Patents Review was commissioned by
the previous government and conducted by an independent panel, the
government is not obliged to release the report".
Following lodgement of the Final Report, a Federal election
resulted in a change of Government and it would appear that the new
Government is in no hurry to revisit the Pharmaceutical Patents
Review. As such, PTEs will be available in Australia for the
The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
Shelston IP has been awarded the MIP Global Award for
Australian IP Firm of the Year 2013.
To print this article, all you need is to be registered on Mondaq.com.
Click to Login as an existing user or Register so you can print this article.
As a licensor or a licensee, here are some tips you should consider when negotiating your next licence agreement.
Some comments from our readers… “The articles are extremely timely and highly applicable” “I often find critical information not available elsewhere” “As in-house counsel, Mondaq’s service is of great value”
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).