The High Court of Australia has confirmed by a three to two
majority that extensions of time under s223(2) of the Patents Act
and the associated regulation permit the Commissioner of Patents to
extend the time within which to apply for a pharmaceutical patent
term extension under s70(1) - Alphapharm Pty Ltd v H Lundbeck
A-S  HCA 42 (5 November 2014).
To compensate patent owners for the lengthy period required to
obtain regulatory and marketing approval for new drugs, the
Australian Patents Act provides for patent term extensions of up to
5 years. The High Court decision concerns a patent term extension
on Lundbeck's patent covering the antidepressant drug
Escitalopram (LEXAPRO), (the Escitalopram Patent), which is the
(+)-isomer of Lundbeck's racemate drug citalopram
In December 2003, Lundbeck made an application for a patent term
extension for the Escitalopram Patent based on the inclusion of
LEXAPRO in the Australian Register of Therapeutic Goods (ARTG)
three months earlier, on 16 September 2003; - this conformed with
the relevant time limits set out in s71(2). However, in a decision
of the Full Federal Court in 2009, it was held that the patent term
extension request should have been based on the inclusion of
CIPRAMIL in the ARTG, which occurred on 9 December 1997.
Section 223(2) provides that, in certain circumstances, where a
"relevant act" which was required to be done within a
certain time was not done within that time, the Commissioner of
Patents can extend the time for doing the act. Consequently,
Lundbeck requested a 10-year extension of time under s223(2) to
apply for a patent term extension of the Escitalopram Patent based
on the date of inclusion of CIPRAMIL in the ARTG. This extension of
time was granted in 2011 and subsequently opposed by Alphapharm and
others who had launched generic versions of Escitalopram. However,
opposition to the extension of time was dismissed. The decision to
grant the extension of time was then appealed to the Administrative
Appeals Tribunal and the Full Federal Court. On both occasions the
appeals were dismissed. Alphapharm subsequently obtained special
leave to appeal to the High Court.
The issues and findings
Under s71(2) there are two time requirements that must be
satisfied when making a patent term extension application. The
application must be made during the term of the patent (the first
time requirement) and the application must be made within six
months of grant of the patent or the date of first inclusion of the
relevant pharmaceutical substance covered by the patent, whichever
is the later (the second time requirement).
The main issue considered by the High Court related to the
construction of regulation 22.11(4)(b), which defines acts that are
not eligible for an extension of time under s223(2). Alphapharm
submitted that regulation 22.11(4)(b), excluded both the first and
second time requirements in relation to applying for a patent term
extension. Lundbeck, on the other hand, asserted that only the
first time requirement was excluded from the extension of time
Ultimately the High Court held, by the majority of Justices,
that regulation 22.11 4(b) meant that the only time requirement
excluded is the first time requirement of section 71(2).
Specifically, the High Court found that Alphapharm's
construction of regulation 22.11(4)(b) gives the regulation an
operation which is inconsistent with one of the principal objects
of the extension of term scheme, namely "to provide an
'effective patent life' – or period after marketing
approval is obtained, during which companies are earning a return
on their investment – more in line with that available to
inventions in other fields of technology".
Conclusions and other developments
The High Court has confirmed the Commissioner of Patents'
right to extend the time within which to apply for a pharmaceutical
patent term extension under s70(1). In a related decision, on 6
November 2014, the Federal Court dismissed an appeal, by Alphapharm
and others, of the Commissioner of Patents' decision to allow
the patent term extension on Lundbeck's Escitalopram Patent (
This Federal Court decision will more than likely be appealed to
the Full Federal Court thus keeping the ten-year battle over the
extension of term for the Escitalopram Patent alive for some time
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.
Shelston IP has been awarded the MIP Global Award for
Australian IP Firm of the Year 2013.
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