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The Australian Government has announced a review of the
pharmaceutical patents system to establish 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". Importantly, according
to the
terms of reference, evaluation of the provisions of
the Australian Patents Act 1990 (Cth) governing patent
term extensions (PTEs) will be central to the process. The review
will also consider how patents for new formulations are granted,
consider the treatment of new methods of manufacturing and new uses
of known products, the impact of contributory infringement
provisions and the impacts of extending patent monopolies on entry
of generic pharmaceuticals into the market.
The expert panel appointed to conduct the review consists of
three members, namely:
Mr Tony Harris (former NSW Auditor-General and Parliamentary
Budget Officer, as Chair),
Professor Dianne Nicol (Associate Dean, Research, Law Faculty
at the University of Tasmania) and
Dr Nicholas Gruen (CEO of Lateral Economics).
Following a public consultation process, the panel is required
to make recommendations relating to:
The availability of competitively priced pharmaceuticals in the
Australian market;
The role of Australia's patent system in fostering
innovation and hence to bringing new pharmaceuticals and medical
technologies to the market;
The role of the patent system in providing employment and
investment in research and industry;
The range of international approaches to extensions of term and
arrangements for pharmaceutical inventions;
Australia's obligations under international agreements
(including free trade agreements and the World Trade Organisation
agreements); and
Australia's position as a net importer of patents and
medicines.
We will advise the due date for submission of comments to the
review panel once an invitation issues. Given the broad terms of
reference and the differing interests of stakeholders in the
Australian pharmaceutical industry, we expect submissions to be
many and diverse. Two press releases in response to the
Government's announcement of the review provide a glimpse of
the discussions which will no doubt ensue during the public
consultation period: the first by Medicines Australia calls for
longer patent terms and quotes the CEO of Medicines Australia, Dr
Brendan Shaw, as saying that the review "should consider
the compelling case to extend the patent life of innovative
medicines"; while the second by the Generic Medicines
Industry Association (GMiA) advises "[m]arket exclusivity
must ONLY be provided for truly innovative medicines" and
"it is imperative that the legal framework support
appropriate, timely and efficient market entry of follow-on generic
medicines".
The final report of the panel is to be provided to the
Government in early 2013.
We welcome requests for further information regarding the
review, Australia's provisions governing pharmaceutical
patents/PTEs and the preparation of submissions to the review
panel.
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