As previously reported, the Australian Government announced a
review of the patent system as it relates to pharmaceuticals 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".
The Paper outlines the issues considered most relevant by the
panel and provides a list of key questions to be addressed during
the review (see below). Notwithstanding, it is clearly indicated
that the questions are only to serve as a framework for the review
and that written submissions need not to be limited by the
Is the breadth of pharmaceutical patents eligible for an
extension of term appropriate?
Is the length of the extension of term provided for
Are the recent amendments to increase the thresholds for the
grant of an Australia patent appropriate in the context of
pharmaceuticals? If not, why not and what further changes are
Do the systems for opposition and re-examination provide
appropriate avenues for challenging the granting and validity of a
Do interlocutory injunctions, as the law is currently applied,
provide appropriate relief in cases involving pharmaceuticals?
Is Australian law on contributory infringement appropriate in
relation to pharmaceuticals?
Are the current timeframes in which infringement proceedings
must commence appropriate for pharmaceutical patents?
Are follow-on patents being used to inappropriately extend
protection for pharmaceuticals? If so, how? And, if they are, is
this sound policy and what changes, if any, are needed?
Is the law on data exclusivity appropriate?
Are the laws on patent certificates appropriate?
Are the laws on copyright of product information
Written submissions to be considered during the review are due
by 5 p.m. on 21 January 2013.
Subsequently, hearings are to be held in February 2013 and the
panel aims to formulate a draft Report by March 2013 with the Final
Report tabled to be released in April 2013.
We welcome requests for further information regarding the
review, Australia's provisions governing pharmaceutical
patents/patent term extensions and the preparation of submissions
to the review panel.
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.
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