In our news alert of 16 October 2012, we advised that the Australian Government had announced a review into issues relating to Pharmaceutical patents, with a particular focus on patent term extensions (PTEs). Since then we have been awaiting the issuance of the Discussion Paper from the review panel.
Today the panel has released a Background and Suggested Issues Paper, available here.
Written submissions to the review are due by 5pm on 21 January 2012.
Hearings will then be scheduled for February 2013, with the draft Report planned to be issued by the Review Panel in March 2013 and the Final Report in April 2013.
From a brief review of the Issues Paper, it is clear that the review is intended to cover the spectrum of pharma IP from patents through to data exclusivity and copyright in PIs.
There is a strong focus on issues which have been magnified in Australian pharma patent litigation over the last few years including the scope and effectiveness of the present contributory infringement provisions in the Australian Patents Act and the interplay between our patents system, our regulatory system and our pharmaceutical reimbursement scheme in such litigation, particularly in the situation of interlocutory injunctions.
The majority of this recent litigation has been between innovators and generics with innovators being successful in more than 60% of cases at the interlocutory stage. Accordingly, many of these issues are raised against this background. The spectre of ‘evergreening’ is again raised in the review.
Rather alarmingly, the terms of reference of the Issues paper concludes with the statement that “(T)he review will also consider whether there is evidence that the patent system is being used to extend pharmaceutical monopolies at the expense of new market entrants. In doing this, the review will 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”.
Over the next few weeks, we will explore the issues further and send you regular updates. The key questions on which submissions are to be made are set out below:
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?
It is important that all our pharmaceutical clients have input into this review. Please contact the writer if you wish to provide comments or discuss any of the questions in more detail. Submissions are planned to be filed by a number of industry bodies and we will be assisting on several of these, specifically Medicines Australia (the industry body representing pharmaceutical innovator companies) and also the Institute of Patent Attorneys.
You are also welcome to individually contribute to the review by commenting on the blog here. The review panel will be posting topics and papers on the blog for further discussion during the review.