New issue paper on a ‘Review of Pharmaceutical Patents’

On 15 October 2012, the Parliamentary Secretary for Industry and Innovation, Mark Dreyfus, announced the establishment of a Pharmaceutical Patents Review Panel. The panel has now released an issues paper inviting public submissions on the topic. A link to the issues paper can be found here.

One of the key topics of interest relates to the issue of extensions of term under Australian patent law. Pharmaceutical patents are potentially eligible for a grant of an extension of term beyond the normal maximum 20 years. The extension mechanism is designed to be a matter for compensating a patentee for being unable to commercially exploit the patent while delays are encountered when seeking regulatory approval from the Therapeutic Goods Administration.

It should be noted that no other type of invention is able to apply for an extension of term and, in fact, there are particular requirements that dictate what can be considered a pharmaceutical patent.

Australia, in accordance with obligations under the TRIPS agreement, is required to offer some form of extension of patent term for pharmaceutical patents. However, the extent of extension or how it should be applied and calculated is left open under the TRIPS agreement.

The issues paper notes that a comparative study of extensions of term by Australia and other major jurisdictions indicates that Australia may be more generous in the extent of extra term granted compared with other countries. This implies that the Review Panel may indeed be targeting this issue to align Australia’s extension of term provisions closer to those applied elsewhere.

The closing date for public submissions for review is 21 January 2013.


by Simon Ellis