The Parliamentary Secretary for Industry and Innovation, Mark Dreyfus, has appointed a panel to review the patenting of pharmaceuticals in Australia.
According to the Terms of Reference, the review:
will evaluate whether the system for pharmaceutical patents is effectively balancing the objectives of securing timely access to competitively priced pharmaceuticals, fostering innovation and supporting employment in research and industry.
Central to this will be an analysis of the pharmaceutical extension of term provisions of the Patents Act 1990 (s.70).
The 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.
The panel consists of 3 members:
- Mr Tony Harris, former NSW Auditor-General and Parliamentary Budget Officer, as Chair
- Professor Dianne Nicol, Associate Dean, Research, of the University of Tasmania, and
- Dr Nicholas Gruen, CEO of Lateral Economics.
A public consultation process will form part of the review which appears to include consultation with stakeholders and an opportunity for public submissions.
According to the press announcement, the panel is due to submit its final report by April 2013.
Of course, there is already a review of compulsory licensing under way following the BRCA controversy. I do not know if it is related to this review or not, but back in May, Senator Heffernan questioned the Director-General of IP Australia about what steps the Government may have been taking to recover payments under the Pharmaceutical Benefits Scheme to pharmaceutical companies for patents subsequently found invalid. The Senator alleged that the sums involved amounted to hundreds of millions of dollars. The Director-General referred the Senator to the Department of Health and Aging, which has responsibility for these matters.
The videocast of the 3rd Annual Francis Gurry Lecture is now available:
De-linking intellectual property from exclusive rights
by James Love, Director, Knowledge Ecology Limited. The blurb says:
The traditional justification for IP rights-atemporary monopoly to stimulate innovation and inverstment-is increasingly being questioned. If knowledge is more valuable when widely shared, and if freedom to use knowledge is socially and economically important, we need to de-link intellectual property protection from exclusive rights. But how?
I personally found the Q & A session helped crystallise what Mr Love was arguing. Very thought-provoking.
Apparently, the written paper will provide more explanation and amplification in due course. In the meantime, you may get an understanding of how Mr Love’s proposals could work in a pharmaceutical context here and here
Lid dip: Andrew Christie
IP Australia has issued a consultation paper on implementing the TRIPS protocol.
The TRIPS protocol is the modification (or is that clarification?) of TRIPS obligations to improve the availability of “crisis” pharmaceuticals in least developed and developing countries. From the discussion paper:
The TRIPS Protocol seeks to address this problem by amending the TRIPS Agreement to permit WTO members to issue compulsory licences to produce patented pharmaceutical products for export to least-developed and developing countries. The main features of the Protocol are:
• Licences may only be issued for products of the pharmaceutical sector needed to address public health concerns.
• Countries eligible to import pharmaceuticals under the system comprise any least-developed WTO country or any other WTO country that has notified the TRIPS Council.
• Importing countries are obliged to provide the TRIPS Council with details such as the names and quantities of the products needed and whether they need to issue a compulsory licence in their own country.
• Exporting countries are obliged to notify the TRIPS Council of a range of details and ensure that importing countries have done the same.
• Both importers and exporters must have in place anti-diversion measures to ensure the products produced under the system reach the intended market and are not re-exported.
Read the paper here (pdf).
Submissions due by 4 June 2010.
I’m not quite sure why, but the blogosphere is increasingly chattering again about relaxing the rules against infringing a patent by making the protected product (esp. a pharmaceutical) for export:
IP’s What’s Up reviews the TRIPS status including the DOHA declaration and its rather tentative take up.