IP SPOTLIGHT MARCH 2020

WHO TO CONTACT If you require any assistance or additional advice in relation to PTEs in Australia, please get in touch with the authors of this article.

Accordingly, the PTE application was refused.

It is interesting to observe that while the Delegate acknowledged that claim 1 covered the reconstituted solution, the Delegate nonetheless concluded that the pharmaceutical substance per se for the purpose of s70(2) could not be the reconstituted solution. It is difficult to appreciate the methodology and analysis used to reach this conclusion. The patentee submitted in that regard: ‘It would be entirely perverse if a claim to a new formulation of a known stable and soluble drug that does not require reconstitution prior to administration […] could form the basis of a term extension, but not a claim to a new formulation of a drug that has stability and/or solubility issues and which formulation overcomes difficulties arising from those issues.’ (at 43) Despite any lack of clarity around the methodology used to reach this decision, the Delegate’s decision does make it clear that IP Australia is unfortunately of the view that extensions of term are not available where the pharmaceutical substance per se is a composition comprising components physically separated during storage or transport. We hope, for the sake of Australian innovation in this space and the patentees engaged in it, that the Federal Court of Australia will not support this view, when this question eventually arises for determination.

TIM FRANCIS Principal

CRAIG HUMPHRIS Principal

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