Is a day coming when drug delivery systems regulated in
Australia by the Therapeutic Goods Administration and included on
the ARTG may benefit from an extension to their patent term of up
to 5 years?
As pharmaceutical companies are well aware, the Patents Act 1990
(Cth) contains provisions allowing the term of a standard patent to
be extended under certain conditions1. The objective of
introducing these provisions by amendment in 1998 was to ensure
that pharmaceutical patents had an effective patent life after
necessary regulatory approvals had been obtained that was more in
line with other fields of technology2.
Problem with application
The problem in seeking an extension for drug delivery systems
that may have taken a long time to develop, has been satisfying the
condition that one or more pharmaceutical substances per se must in
substance be disclosed in the complete specification of the patent
and in substance fall within the scope of the claim or claims of
It is the difficult "per se" limitation which has been
the focus of Court decisions in the past, requiring the claim to
the pharmaceutical substance to be unqualified by process, temporal
or environmental components. A 'pharmaceutical substance'
is defined to mean a substance (including a mixture or compound of
substances) for a therapeutic use involving particular
Accordingly, claims for a pharmaceutical substance when used, or
for use, in a separate drug delivery system will generally not be
directed to a pharmaceutical substance per se. The claim in
relation to a pharmaceutical substance must be for a new and
inventive product alone. On the basis of this reasoning, claims to
a container including a spray composition and a nozzle for nasal
administration were not capable of extension.5
Against this background, a recent Australian Patents Office
(APO) decision6 has granted an
extension in respect of Nuvaring (Aust R 96229). This product is,
in general terms, a vaginal contraceptive ring formed from a
thermoplastic polymer core that releases a mixture of steroidal
components, and a permeable skin. In the delegate's view, the
fundamental question was whether Nuvaring itself was a substance
(including a mixture or compound of substances). If so, the
problematic condition would be met.
Although no courts have considered the bracketed phrase it has
been the subject of a small number of APO decisions. In considering
these decisions the delegate considered that the term
"compound", contrary to its meaning in pure chemistry,
contemplated a compound formed by combining elements or parts, or
creating a union of parts, not necessarily limited to any
particular spatial arrangement7. Giving the term such a
broad meaning the delegate warned would not assist developers of
medical devices used with a pharmaceutical substance, the
provisions only applied to new and inventive
The delegate concluded that a pharmaceutical substance can
include a compound with a controlled spatial configuration if, as a
whole, it can still be considered a pharmaceutical
'substance'. However, the combination of such substance
with what would reasonably be considered a separate physical
device, layer or structure is excluded and would not be a
pharmaceutical substance per se. Obviously this may be a difficult
determination to make in practice. The delegate helpfully suggests
that the question may be determined by asking whether the
characteristics of what is claimed more predominantly lies with it
being a substance rather than a substance in combination with a
Evidence was accepted in relation to Nuvaring that the steroidal
components are mixed with and diffuse through the thermoplastic
materials in the core and the skin such that the component parts of
the product exhibited a level of integration or interaction that
was more characteristic of a pharmaceutical substance.
Is the Day Here?
Developers of drug delivery systems will need to consider on a
case by case basis whether the level of integration or interaction
between the component parts of a system will satisfy this
requirement. It may be that in practice an application for the
grant of an extension will be granted only in the clearest of
1 Patents Act 1990 (Cth) Pt 3 Ch 6
2 Explanatory Memorandum to the Intellectual Property
Amendment Bill 1997 at Pg 4
3 Patents Act 1990 (Cth) s70(2)(a)
4 Patents Act 1990 (Cth) Sch 1
5 IP Australia, Patents Manual of Practice and
Procedures, para 220.127.116.11; Boehringer Ingelheim International
v Commissioner of Patents (2001) AIPC 91-670 at - and
6 N. V. Organon  APO (28 May 2009)
7  APO (28 May 2009) at  and 
8  APO (28 May 2009) at 
The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
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