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A recent decision of the Israeli patent office provides a timely example of the differences between Australian and Israeli patent term extensions (PTE).

Recently, we examined a US decision that case highlighted differences between US and Australian law with respect to patent term extension (PTE) for patents covering pharmaceutical substances that have been granted regulatory approval. We concluded that relative to the US, Australia provides comparative advantages for PTE. 

Similarly, an Israeli decision from May 2020 demonstrates further differences when comparing Australian PTE with foreign PTE. Once again, our findings emphasise comparative advantages for Australian PTE relative to foreign PTE.

The Israeli case relates to Amgen’s Israeli patent 138857, with claims that cover blinatumomab (BLINCYTO®). Blinatumomab is a monoclonal bispecific T-cell engager (BiTE) that binds CD3 expressed on T cells and CD19 expressed on B cells. Blinatumomab is indicated for treating Philadelphia chromosome-negative relapsed or refractory acute lymphoblastic leukemia. Amgen obtained Israeli regulatory approval for blinatumomab on 13 October 2016 and requested PTE within the prescribed non-extendible 90 days from the date of regulatory approval.

A more significant difference in PTE practice between the two countries, and the issue on which the blinatumomab case turned, is the requirement that an Israeli PTE be directly tied to a corresponding PTE in the US and/or a corresponding supplementary protection certificate (SPC, but for present purposes effectively a PTE) in one of Italy, Germany, UK, Spain and France (EU-5). Simply put, an Israeli PTE lives and dies by the existence of the corresponding US and/or EU-5 PTE. 

In view of this peculiar requirement, where a PTE exists in the US and/or an EU-5 country, it is necessary to report to the Israeli patent office grant of those PTEs within the prescribed non-extendible 90 days from the date of grant of the US PTE or EU-5 PTE, or the later date of grant where both a US PTE and an EU-5 PTE are granted.

With respect to the Israeli PTE for blinatumomab, corresponding PTEs were granted in both the US and an EU-5 PTE. However, Amgen failed to report the PTEs to the Israeli patent office within the non-extendible period. Consequently, the PTEs were refused at first instance.

By way of comparison, under similar conditions, PTE must be requested within 6 months of the date of regulatory approval in Australia. And an Australian PTE is not tied to any foreign PTE. Instead, an Australian PTE is granted solely in consideration of the Australian patent and the Australian regulatory approval.

Combined with Australia’s universal healthcare and pharmaceutical reimbursement systems, Australian PTE provides advantages that should encourage pharmaceutical sponsors and/or owners to consider obtaining PTE in Australia.

If you have any further questions or require expert advice, please don't hesitate to contact us. 

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