Two major pharmaceutical companies have challenged Australia’s Commissioner of Patents in the Federal Court about the time limits within which an application can be made to extend a patent term.
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- Ono Pharmaceutical and Bristol Myers Squibb have sought judicial review by the Federal Court of an Australian Patent Office (APO) ruling which rejected their application for a patent term extension (PTE). The application was heard on 12 March 2021.
- In the ruling, described by the patentees as “manifestly absurd or unreasonable”,1 the APO confirmed its historical view that PTE applications under the Patents Act 1990 (Cth) (the Act) must be filed within six months of the first inclusion on the Australian Register of Therapeutic Goods (ARTG) of goods containing or consisting of any pharmaceutical substance falling within the claims of the patent, regardless of whether it was the product sponsored by the patentee, or indeed was a product sponsored by a third party.
- This is the first time this issue has been directly considered by the Court. If the APO’s decision is upheld by Justice Beach, a very experienced patent judge, this may impose additional practical burdens on patentees. Further, it would confirm another Australian point of departure from an increasingly harmonised international patent regime.
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