IP SPOTLIGHT OCT 23

“ Patentees should also consider filing separate patent applications for each PSPS to ensure that the maximum period of extension can be sought for each patent, based on the relevant ARTG inclusion. ”

Ono also argued that the PTE should be based on OPDIVO (it’s own product) rather than KEYTRUDA (third party product) because the policy objectives of the PTE scheme would be frustrated if the timing for making an application and the length of the extension were calculated based on a third party’s registration. The patentee submitted that the policy objectives were to compensate patentees for the additional time, expense and difficulty in developing and commercialising a “new drug”. If the PTE could be based on a third party product, the result would be “manifestly unreasonable” because it would expose the Commissioner to making errors in recording PTEs on the register as PTE applications may inadvertently be based on the incorrect (patentee’s) product, particularly if the patentee was not aware of a third party product on which the application should have been based. Ono provided a list of burdens that would be placed on the Commissioner and patentees if third party products could form the basis of PTE applications. In making these arguments, the patentee asked the Delegate to reconsider the prior Patent Office decision of Searle. In Searle, where there were two PSPSs within the scope of the claims that had been included in the ARTG at different times, the Patent Office decided that the PTE application had to based on the product that was first included on the ARTG, regardless of the sponsor. DECI S ION The Delegate did not accept Ono’s submissions and confirmed the Searle decision. Whilst the Delegate acknowledged that there is some ambiguity in the Act as to which PSPS was referred to in each section, there was nothing in the Act or the prior case law that suggested that only products on the ARTG sponsored by the patentee could form the basis of a PTE application. The reference to the “first regulatory approval date” and “first inclusion” was a reference to the earliest inclusion on the ARTG of the first product (regardless of the sponsor).

Furthermore, if the 6-month window for filing the PTE application has been missed because the patentee was unaware of a relevant third party ARTG application, the patentee will have to seek on extension of time in order to file its application. Extensions of time can be very difficult to obtain as there are strict requirements that must be satisfied in order to qualify. We therefore recommend these deadlines are closely monitored (including both the deadline triggered by patent grant and any deadline triggered by ARTG listing). Patentees should also consider filing separate patent applications for each PSPS to ensure that the maximum period of extension can be sought for each patent, based on the relevant ARTG inclusion.

The Delegate also reviewed the policy considerations around the PTE regime in considering whether this outcome was “manifestly absurd or unreasonable”. The policy behind the PTE regime was to compensate patentees for the time and expense taken to commercialise a “new drug”, as stated in the explanatory memorandum and second reading speech. The Delegate considered that if there was already a drug falling within the scope of the claims on the ARTG, the patentee was not seeking an extension for a “new drug”, and therefore, the policy considerations did not support the patentee’s position. To the extent that there may be errors on the register due to PTEs granted on based imperfect information, the Delegate pointed to the power to correct the Register under section 191 of the Act. WHAT DOES TH I S MEAN FOR PATENTEES? This decision makes it clear that both the deadline for filing a PTE application (i.e. the 6 month window) and the length of any PTE is calculated based on the first inclusion on the ARTG of a product that contains any PSPS claimed in the patent, regardless of who the sponsor of the product is. Patentees should therefore be careful to monitor the ARTG for any third-party products that may contain PSPSs falling within the scope of their claims, as the clock may start ticking well before the patentee has registered their product on the ARTG.

BINDHU HOLAVANAHALLI Associate

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