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 expert panel appointed to conduct the review recently released a Background and Suggested Issues Paper. A copy of the Paper can be downloaded from http://pharmapatentsreview.govspace.gov.au/issues-paper/.
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 questions posed.
Question 1:
Is the breadth of pharmaceutical patents eligible for an extension of term appropriate?
Question 2:
Is the length of the extension of term provided for appropriate?
Question 3:
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 necessary?
Question 4:
Do the systems for opposition and re-examination provide appropriate avenues for challenging the granting and validity of a pharmaceutical patent?
Question 5:
Do interlocutory injunctions, as the law is currently applied, provide appropriate relief in cases involving pharmaceuticals?
Question 6:
Is Australian law on contributory infringement appropriate in relation to pharmaceuticals?
Question 7:
Are the current timeframes in which infringement proceedings must commence appropriate for pharmaceutical patents?
Question 8:
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?
Question 9:
Is the law on data exclusivity appropriate?
Question 10:
Are the laws on patent certificates appropriate?
Question 11:
Are the laws on copyright of product information appropriate?
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.
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