The majority of the High Court (Crennan, Bell and
Gageler JJ) has dismissed Alphapharm's appeal against a
decision granting Lundbeck an extension of time in which to apply
to extend the term of its patent for LEXAPRO. The
decision is consistent with IP Australia's longstanding
practice of considering extension of time applications for late
extension of term applications provided that the patent has not yet
Alphapharm argued that the Commissioner of Patents did not have
power to grant the extension of time as, it argued, regulation
22.11(4)(b) of the Patents Regulations excluded applications for
extensions of term from the operation of the extension of time
provisions. Lundbeck argued that, properly construed, the
regulation only excludes extension of time for filing an extension
of term application after the initial term of the patent
had expired. Lundbeck filed its extension of term application on
the day before the original patent term expired.
Under section 71 of the Patents Act, an extension of term
application must be filed (i) during the term of the patent and
(ii) within 6 months of the latest of three set dates (one of which
is the registration of goods containing the pharmaceutical
substance on the Australian Register of Therapeutic Goods
(ARTG)) (the "6 month
The Commissioner has power under section 223 to extend time
where a deadline is missed due to the failure to do a
"relevant act". A "relevant act" is defined as
"an action (other than a prescribed action) in relation to a
patent". The "prescribed actions" for which an
extension of time is unavailable are set out in regulation
22.11(4). These include regulation 22.11(4)(b), "filing,
during the term of a standard patent as required by
subsection 71(2) of the Act, an application under
subsection 70(1) of the Act for an extension of the term of the
Alphapharm argued that the action that is required to be done is
filing an extension of term application and that is the
very action that is prescribed by regulation 22.11(4)(b). This view
was accepted by the minority (Kiefel and Keane JJ).
Lundbeck argued that by using the words "during the term of
a standard patent" the regulation specifically singles out the
expiry date deadline as one that cannot be extended whereas the
"6 month deadline" remains capable of extension.
The majority found support for Lundbeck's construction in
the pre-existing law in which extensions of time were permitted,
the legislative history in which allusion was made to the
availability of extension of time provisions and the protective and
remedial purpose of the extension of time provisions.
The 6 month deadline is sometimes missed as a consequence of a
failure to alert the patent department in a pharmaceutical company
that regulatory approval has been obtained (which triggers the
deadline). Often this involves a failure by a local licensee. If
the High Court had allowed Alphapharm's appeal, a number of
extensions of term granted by IP Australia would have been at risk.
The High Court's decision upholds IP Australia's ability to
grant extensions of time in appropriate circumstances.
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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