We recently highlighted that the decision of Beach J of the Federal Court of Australia in Ono Pharmaceutical Co, Ltd v Commissioner of Patents [1] had raised as many questions as it had answered in relation to Patent Term Extensions (PTEs). His honour offered a scathing criticism of the literal absurdity of the Commissioner’s position, before rejecting it.

Perhaps unsurprisingly the Commissioner of Patents has now appealed the decision.

Until the appeal is decided, the Commissioner has stated that she “will apply a new practice when assessing any PTE request received during this time, consistent with the [Federal Court’s liberal] finding in Ono”. To that end, the timing provisions of the PTE provisions will not be enlivened by regulatory approval of a pharmaceutical substance of a stranger or competitor.

Interestingly, the official form provided by IP Australia to make a PTE request now captures additional information regarding the patentee’s connection to the goods relied on. In particular the Commissioner asks:

“If the sponsor of the goods included in the ARTG [Australian regulatory approval] is not the patentee, was the application for inclusion in the ARTG made with the consent of the patentee?”

More specifically, the patentee must declare the earliest first regulatory approval date for any pharmaceutical substance falling within the scope of the claims for which regulatory approval was gained by, or with the consent of, the patentee.

You may recall that the decision in Ono focused heavily on the intended beneficial nature of the PTE provisions and that we had suggested that there are numerous ways in which a patentee may derive benefit without themselves taking the pharmaceutical to market. By tying the patentee to the sponsor through the action of consent, it would appear that the Commissioner may be angling for a very low bar to be set in determining whether the patentee had indeed benefited. Indeed, Beach J summarily decided against considering the role of any sponsor in making his decision [2] and we suspect that this may be the fertile ground upon which the appeal is based. It may also reinstate the relevance of KEYTRUDA to this particular PTE request, since that product is effectively being marketed with the consent of the patentee in Australia under license. Time will tell.

Until the appeal is decided, it is reasonable to expect that the Commissioner will determine the outcome of a number of PTE requests. In the event that the decision is successfully appealed, this does raise the question of the legitimacy of those interim decisions.

In such circumstances it is open to the Commissioner to consider rectifying the register to remove a detail “wrongly existing in the Register”. The temporality of that provision suggests that even if the PTE had been applied for and granted with the best intentions, it may nonetheless be vulnerable to removal. However the power to rectify the Register is discretionary and the factors weighing against removal could include the conduct of the party making the PTE request, and the consequences of removing the PTE.