Inspire September 2021
Recent decision
shakes up
Australia’s patent term
extension provisions
A recent Federal
Court decision,
Ono Pharmaceutical
Co v Commissioner
of Patents 1 ,
has significant
implications for
Australia’s patent
term extension
(PTE) provisions.

12 1
O no Pharmaceutical Co, Ltd v
Commissioner of Patents [2021] FCA 643
Relevant Legislation
To compensate patentees who may
lose time to exploit their invention
due to the regulatory delay involved
in bringing a new pharmaceutical
substance to market, some
pharmaceutical patents are eligible
for a term extension of up to 5
years. Section 70 of the Patents Act
specifies that an eligible patent must
meet the following requirements:
› The patent must both claim
and disclose one or more
pharmaceutical substances
per se (and/or one or more
pharmaceutical substances
when produced by a process
that involves the use of
recombinant DNA technology);
› goods containing, or consisting
of, the substance must be
included in the Australian
Register of Therapeutic
Goods (ARTG);
› the period beginning on the date
of the patent and ending on the
first regulatory approval date for
the substance must be at least
5 years; and
› the term of the patent must not
have been previously extended.

Section 71 outlines the deadline for
filing a PTE request, which is the
latter of:
(a) 6 months from the date the
patent was granted; or
(b) 6 months from the date of
commencement of the first
inclusion in the ARTG of goods
that contain, or consist of, any of
the pharmaceutical substances.

If a PTE application is granted,
s 77 provides that the term of the
extension is equal to the period of
time beginning on the date of the
patent, and ending on the earliest
first regulatory approval date
reduced by 5 years (but not below
zero), up to a maximum of 5 years.