While the proposed amendments include some fairly minor matters, the three key issues are measures to:
- implement the Protocol amending the TRIPS agreement, allowing Australian manufacturers to export pharmaceutical products to least developed and developing countries suffering from a health crisis (under a compulsory license from the Federal Court).
- allow for single trans-Tasman patent application (SAP) and examination (SEP) processes and a joint patent attorney regime for Australia and New Zealand. (See our blog dated 16 May 2011 discussing this initiative)
- extend the jurisdiction of the Federal Circuit Court to included Plant Breeder's Rights.
The inevitable hot topic will be the TRIPS issue. The TRIPS agreement was amended in recognition of the issue of a health crisis occurring in developing countries, whereby much needed medicine or pharmaceuticals are not only required, but at a low cost. In the case of a patented pharmaceutical, there is the potential for a patentee to stand in the way of the supply of the much needed pharmaceutical if the patentee is unable or unwilling to provide the pharmaceutical at the required low cost.
The proposed remedy is to allow third parties to apply for a compulsory licence to exploit the patent for the sole purpose of making and exporting the patented pharmaceutical to a country suffering from a health crisis.
While compulsory licence provisions exist in Australian patent legislation, they centre on the fact that, despite a demand, the patented invention is not being exploited, or sufficiently exploited, to meet the demand in the patent jurisdiction (i.e. Australia). The proposed changes look outside of Australia for the source of the need.
The TRIPS provisions will be likely to operate as a measure for coercing pharmaceutical patent owners to provide low cost aid in times of crisis under threat of allowing someone else to do so.
It will be an interesting spectacle seeing if the pharmaceutical lobbyists will have any effect upon the proposed TRIPS changes.
SIMON ELLIS
