Pharmaceutical patent
linkage in Australia –
how does it work?
There is no patent listing system
(equivalent to the US FDA’s Orange
Book) in Australia. The current patent
linkage system extends only to the
requirements asked of companies
when they apply for regulatory
approval for generic and biosimilar
medicines. Patent holders have little
say in the current system.

The current system
Before a pharmaceutical product
can be marketed or distributed in
Australia, it must be registered
on the Australian Register of
Therapeutic Goods (ARTG), which
is maintained by the Therapeutic
Goods Administration (TGA). Small
molecule drugs and biologics are
both treated as therapeutic goods by
the TGA.

When applying to the TGA for
regulatory approval for a generic
or biosimilar product which uses
data submitted to the TGA by an
originator, the applicant is required
to provide a certificate stating that
either (a) their product does not
infringe a valid claim of a patent that
has been granted in relation to the
product or (b) where there is a valid
existing patent, that they have given
notice to the patentee.

In practice, applicants generally
supply a certificate under option
(a) on the assertion that that a
patent is invalid unless a court
holds otherwise. Furthermore,
applications to the TGA to register a
product in the ARTG are confidential
and only become public following
TGA approval when the product is
included in the ARTG.

This means patentees typically do
not receive notice of the impending
launch of a generic or biosimilar
product until after it has been
approved and registered on the ARTG.

PBS Schedule and impact
of generic/biosimilar
market entry
Products that are registered on the
ARTG may be sold in the private
market or under the Pharmaceutical
Benefits Scheme (PBS), where they
are subsidized by the government.

When the first generic or biosimilar
version of a product already
included on the PBS is listed, an
automatic price reduction of 25%
is applied to all versions of the
product that have the same manner
of administration as the generic or
biosimilar, including the originator.

This price drop is irreversible even
if the generic drug is later removed
from the market due to, for example,
patent litigation.

To restrain these activities,
patentees may apply to the court
to obtain an interlocutory injunction
which, if granted, may remain
in place until the infringement
(and any invalidity case) has been
determined by the court after a
substantive hearing. As generic/
biosimilar products can be launched
immediately upon ARTG registration,
patent holders must act quickly upon
becoming aware of the registration
if they wish to prevent the product
from entering the market and/or
obtaining PBS listing.

The irreversible price drop caused
by PBS listing of a generic product
can provide support for the patent
holder’s interlocutory injunction as
it is a clear example of irreparable
harm for which damages may be
an inadequate remedy. In such
instances, while the court will
consider the validity of the claims
in question before granting an
injunction, the generic must typically
demonstrate a strong case for
invalidity for an injunction to
be refused.

Changes to current
system proposed
Legislative changes to introduce an
earlier patent notification scheme
for first generic and biosimilar
medicines are currently in progress.

The proposed changes would
require applicants for the first
generic and biosimilar form of an
originator product to notify the
patent holder when their application
is accepted for evaluation by the
TGA. This notification is earlier
than the current system and should
therefore be fairer to patent holders.

These legislative changes were set
to be introduced to Parliament in late
2020 although, at time of writing, no
further progress has been made.

Conclusions The current patent linkage system
in Australia is minimal and quite
different to systems elsewhere.

It means that patent holders must
be vigilant in monitoring product
registrations and must act quickly
to assert their patent rights if they
wish to prevent the entry of a
generic/biosimilar product into
the Australian market.

Inspire July 2022
While Australia does have a form
of patent linkage, it is currently a
limited system and in practice is
not very useful for patentees.

...patentees typically
do not receive notice
of the impending
launch of a generic
or biosimilar product
until after it has
been approved and
registered on
the ARTG
9 Dr Annabella Newton | Senior Associate
MChem(Hons) MCommrclLaw PhD AMRSC MRACI
GAICD annabella.newton@pof.com.au