The present decision relates to
whether, even if the requirements
outlined above may have been
satisfied at an earlier point in time
in relation to one pharmaceutical
substance, a PTE application can
be made at a later point in time
based on another pharmaceutical
substance which also satisfies the
requirements. The patentees, Ono Pharmaceutical
and E.R. Squibb & Sons, made
two applications to extend
their Australian patent titled
“Human monoclonal antibodies
to programmed death 1 (PD-1)
and methods for treating cancer
using anti-PD-1 antibodies alone
or in combination with other
immunotherapeutics”. The first
application was based on their own
pharmaceutical product marketed
under the name OPDIVO which was
included in the ARTG on 11 January
2016. The second application was
based on an earlier pharmaceutical
product called KEYTRUDA
marketed by a third party competitor
of the applicants, Merck Sharp
& Dohme, which was included
in the ARTG on 16 April 2015.

The applicants’ preferred
application was the OPDIVO
application because, if granted,
it would entitle the applicants to
a longer extension of term than the
KEYTRUDA application. Moreover,
the KEYTRUDA application was
made out of time and required
an extension of time under s 223.

Historically, the Commissioner’s
position has been that, where two
substances within the scope of
the patent had been included in
the ARTG at different times, the
PTE request had to be based upon
the earliest included good on
the ARTG. When the matter was
considered by the Patent Office,
the Delegate held that the OPDIVO
application was not based on the
good on the ARTG with the first
regulatory approval date, which
was KEYTRUDA.

Appeal to Federal Court
The patentee appealed to the
Federal Court, arguing that the
relevant ‘first regulatory approval
date’ should be the approval date of
their own product, not the approval
date of a third party’s goods.

They contended that where two
substances within the scope of
the patent had been included in
the ARTG at different times, the
PTE could be based on any one
of the pharmaceutical substances
which fulfilled the requirements
of s 70 and that the relevant
‘first regulatory approval date’
is that of the good containing
the pharmaceutical substance
specified in the PTE request.

The Court agreed with the
patentees’ construction, and
held that the relevant goods and
pharmaceutical substance for the
purpose of PTE were those of the
patentee, OPDIVO, and not those
of a third party having nothing to
do with the patentee. His honour,
Beach J, considered that the
Commissioner’s construction
would “ lead to manifest absurdity
or unreasonableness”, resulting in
“serious practical problems which
would be unduly onerous and not
beneficial to any patentee” such
as having to review each and every
approval granted on the ARTG.

At this stage, it is
unclear how the Court
would rule where two
substances within the
scope of the patent had
been included in the
ARTG at different times
which both belonged
to the patentee.

Change to Patent
Office Practice
The Patent Office have interpreted
this to mean that an unconnected
third party’s ARTG listing will not
provide the relevant “earliest first
regulatory approval date”.

As a result of this decision, the
patent office have changed their
practice and are asking that, where
the sponsor of the ARTG listing
is not the patentee, the patentee
indicates whether the application for
inclusion in the ARTG was made by
them, or with their consent.

It remains to be seen whether
or not this is the correct
interpretation, as the Court also
stated that it was for the patentee
“to stipulate the pharmaceutical
substance” in the PTE request.

At this stage, it is unclear how
the Court would rule where two
substances within the scope of
the patent had been included in
the ARTG at different times which
both belonged to the patentee.

The Court did appear to agree
that a patentee should not be
“permitted to pick and choose
which of its products to nominate
as the substance” which could
be taken to mean that, in such
a situation, the PTE request must
be based on the earliest included
good of the patentee.

The Commissioner has appealed
the decision and so future decisions
should provide further clarity on this
important area of patent law.

Conclusions For now, a patentee’s PTE request
is no longer likely to be affected
by the earlier registration of a third
party’s product that happens to fall
within the scope of their claims.

This is a good outcome for patentees.

Applicants for PTE are usually doing
so because they have a connection
to the listed goods. Therefore, the
number of patentees who will no
longer be able to rely upon unrelated
registered goods to extend their
patents is likely to be small.

Patentees may wish to review
their PTE portfolio because this
decision opens up the possibility
that, where a PTE request has been
allowed on the basis of an earlier-
listed third party product, it may
now be possible to obtain a longer
extension based on the patentee’s
own later-listed product.

Inspire September 2021
Background 13
Annabella Newton | Senior Associate
MChem(Hons) MCommrclLaw PhD
AMRSC MRACI GAICD
annabella.newton@pof.com.au