IP SPOTLIGHT OCT 23

The Australian Patent Office confirms that patent term extensions application can (and sometimes should) be based on third party products. In the recent Australian Patent Office decision of Ono Pharmaceutical Co., Ltd. et al [2020] APO 43, the Office has confirmed that a patent term extension ( PTE ) must be based on the first pharmaceutical product containing a pharmaceutical substance falling within the scope of the claims that is included on the Australian Register of Therapeutic Goods ( ARTG ), regardless of whether or not the patentee is the sponsor of that pharmaceutical product. This decision confirms the earlier Patent Office decision of G.D. Searle LLC [2008] APO 31 ( Searle ), and has implications for patentees seeking to rely on the PTE regime moving forward. BACKGROUND The term of a standard patent in Australia is 20 years. 1 However, provisions in the Patents Act 1990 (Cth) ( the Act ) provide for the term of certain patents relating to pharmaceutical substances to be extended by up to five years under the PTE system. – – at least one pharmaceutical substance per se , or a pharmaceutical substance produced by a process that involves the use of recombinant DNA technology ( PSPS ), must in substance be disclosed in the specification and fall within the scope of the claims 2 – – goods containing or consisting of the substance must be included in the Australian Register of Therapeutic Goods ( ARTG ) 3 – – the first regulatory approval for that pharmaceutical substance must have occurred more than 5 years after the date of the patent 4 – – the application must be made within 6 months of either the date the patent was granted or the date of the “first inclusion” in the ARTG of goods that contain or consist of any of the PSPS, whichever is later. 5 The following factors must be satisfied in order to obtain a PTE:

The length of the extension is calculated by determining the period beginning on the date of the patent and ending on the “earliest first regulatory approval date”, reduced by 5 years. However, the maximum term of the extension is 5 years. 6 THE I SSUES AND PATENTEE’S SUBMI SS IONS The present case concerned Australian Patent Number 2011203119 in the name of Ono Pharmaceutical Co., Ltd. and E. R. Squibb & Sons, L.L.C. ( Ono ), which included claims to antibodies that competed with certain reference antibodies and which had a particular affinity to the target, immune checkpoint inhibitor PD-1. – – KEYTRUDA, which was included first on the ARTG, but was sponsored by the competitor Merck Sharp & Dohme – – OPDIVO, which was included second on the ARTG, and was sponsored by Ono. Ono’s request was based on OPDIVO (its own product), because this would result in a longer extension period, and would mean that the PTE application was filed within the 6-month window. Ono had also filed a separate PTE request based on KEYTRUDA in the event that its application based on OPDIVO failed (together with an extension of time request as the application was outside the 6-month window based on the ARTG inclusion of KEYTRUDA). The claims covered two blockbuster drugs, each of which comprised a different PSPS:

AUSTRALIAN PHARMACEUTICAL PATENT TERM EXTENSION UPDATE

The present decision only dealt with the PTE application based on OPDIVO.

Ono submitted that the Act contemplated that multiple PSPSs could be disclosed within a patent and that the PSPS on which the application was based was the subject to be considered when deciding whether the timing provisions were satisfied and for calculation of the length of extension, rather than substances that may already exist on the ARTG.

1 Section 67 Patents Act 1990 (Cth) 2 Section 70(2) Patents Act 1990 (Cth) 3 Section 70(3) Patents Act 1990 (Cth) 4 Section 70(3) Patents Act 1990 (Cth) 5 Section 71(2) Patents Act 1990 (Cth) 6 Section 77, Patents Act 1990 (Cth)

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