It all adds up:
how a term extension can be
impacted if a patent covers more
than one pharmaceutical substance
Inspire December 2021
A recent Federal Court decision 1 has further considered Australia’s
patent term extension (PTE) provisions. Merck Sharp & Dohme
(MSD) is the registered proprietor of Australian patent 2002320303,
which relates to the treatment or prevention of diabetes.

10 The date of the patent is 5 July 2002
and the original term of the patent
was for 20 years, until 5 July 2022.

MSD successfully applied for PTE in
2009 and the term of the patent was
extended until 27 November 2023.

MSD contended that the respondent
(Sandoz) threatened to infringe the
patent. Sandoz had undertaken not
to exploit the patented invention
before the end of the original term
(5 July 2022) but refused to provide
any such undertaking during the
extended term, as they contended
that the PTE was invalid.

Legislative Background
S 70 of the Patents Act specifies
that to be eligible for an extension
of term, a patent must meet the
following requirements:
1 (2) 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);
(3)(a) goods containing, or consisting
of, at least one of those
pharmaceutical substances must
be included in the Australian
Register of Therapeutic Goods
(ARTG); (3)(b) 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
(4) the term of the patent must not
have been previously extended.

Merck Sharp & Dohme Corp. v Sandoz Pty Ltd [2021] FCA 947
S 71(2) outlines the deadline for filing
a PTE request, which is the latter of
either: (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
referred to in subsection 70(3).

S 77 provides that term of the
extension is equal to the period
beginning on the date of the patent
and ending on the earliest first
regulatory approval date in relation
to any of the pharmaceutical
substances referred to in s 70(2);
reduced (but not below zero) by 5
years, up to a maximum of 5 years.