The Australian Patent Commissioner has appealed the Federal Court decision of Ono Pharmaceutical Co, Ltd v Commissioner of Patents [2021] FCA 643 (“Ono”) relating to pharmaceutical patent term extensions (PTEs) that we discussed recently.
While the appeal is proceeding, the Australian Patent Office (APO) have released an update to their practice, indicating that Sections 3.12.1.8, 3.12.2.1 and 3.12.2.2 of the Australian Patent Examiner’s Manual have been updated along with their application form for pharmaceutical patent term extensions in light of the Ono decision.
Section 3.12.1.8 of the Manual now states that “the relevant goods for the purpose of sections 70, 71 and 77” (i.e. for the purpose of the PTE application) “are those of the patentee, rather than those of a stranger or competitor” and that “When the patentee is not the sponsor, it will be necessary for the patentee to confirm when making the application for an extension of term that the application for inclusion in the ARTG was made with their consent”.
Accordingly, the updated PTE application form includes a new question which asks, “if the sponsor of the goods included in the ARTG is not the patentee, was the application for inclusion in the ARTG made with the consent of the patentee?”, and includes subsequent questions relating to the “first regulatory approval date” and “earliest first regulatory approval date” that refer to goods included in the ARTG following an application made by, or with the consent of, the patentee. Continue Reading