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.
Section 3.12.1.8 of the Manual also includes a brief summary of the Ono case, stating that “the Court accepted the position that a patentee may not “pick and choose which of its products to nominate as the substance for the purposes of s 70 (at [134], [174]).”
It appears, based on the wording of the update from the APO, and the updated Manual and application form, that the APO has interpreted the Ono decision as determining that a PTE may be based on the patentee’s goods registered on the Australian Register of Therapeutic Goods (ARTG), but not an unrelated third party’s goods.
It remains to be seen whether this interpretation of the Ono decision is correct, as the decision may alternatively be interpreted as allowing a PTE to be based on any ARTG registered goods nominated by the patentee (that is within the scope of one or more claims and disclosed in substance in the complete specification), whether being the patentee’s own goods or that of a third party.i
We expect that the Appeal will be heard within the next 6 to 12 months, although it may then be a further 6 to 12 months before a decision on the Appeal issues. In the meantime, we understand that the APO will refuse to grant a PTE if the ARTG listed goods upon which a PTE application is based are goods of a third party having nothing to do with the patentee. Further, it is possible that where a PTE Applicant is not the sponsor for the relevant ARTG listed goods, the APO could request evidence supportive of an answer that the application for ARTG listing was made with the patentee’s consent.
We look forward to the outcome of the Appeal, which we hope will provide further clarity with respect to the Australian PTE provisions, and will keep you updated once the decision issues.
i Ono Pharmaceutical Co. Ltd v Commissioner of Patents [2021] FCA 643 [96]-[97] and [134].