Alphapharm Pty Ltd v H Lundbeck A/S

The High Court has, by majority, dismissed an appeal against a decision of the Full Federal Court dealing with the extension of the term of a patent on anti-depressant drugs, and the requirements for extending the time of those applications.

Lundbeck held the Australian patent on citalopram and escitalopram, used in the drugs Cipramil and Lexapro, both registered on the Australian Registry of Therapeutic Goods. Following earlier proceedings involving Alphapharm and Lundbeck, Lundbeck made an application with the Commissioner of Patents under s 223 to extend the time within which it could file an application to extend the term of the patent; in the legislative language, the doing of a ‘relevant act’. The Commissioner’s delegate granted that extension, and Alphapharm appealed to the AAT. The Tribunal and FCAFC affirmed the delegate’s decision, holding that s 223conferred the power on the Commissioner to grant the extension of time sought.

Section 71(2) states that an application for extension under s 70(1) must be made ‘during the term of the patent’ and within 6 months after the latest of either the date of the grant of the patent, the date of commencement of its first inclusion on the Register, or the date of s 71’s commencement. The central issue was whether reg 22.11(4)(b), which prescribes a definition of ‘relevant act’ as ‘filing, during the term of a standard patent under s 71(2) of the Act, an application under s 70(1)’, excluded from s 223(2)(a) both of the time requirements in s 71(2) or just the first time requirement (that it be made ‘during the term of the patent’ but not the within 6 month alternative requirements).

The majority (Crennan, Bell and Gageler JJ) agreed with the latter construction, argued for by Lundbeck and accepted by the AAT and FCAFC. Reading the regulation within its immediate context of ss 223 and 71(2), the majority noted that s 223 confers a general, broadly protective and remedial power to extend time, with the regulation filling a derivative purpose of ‘exclud[ing] a limited number of times from that general power’ (at [65]). While the first time limit in s 71(2) operates in conjunction with reg 22.11(4)(b) to avoid the problem of uncertainty in the Register ([68]), the second time limit is aimed at requiring the patentee to make the s 70(1) application within six months after satisfying all the criteria, that is, to decide whether it would extend its patent when the conditions aligned. If reg 22.11(4)(b) were read to exclude both of these limits, then the remedial power could never be extended, ‘no matter what the quality or provenance of any “error or omission” made in respect of that time’: [71]. This would be against the extension of term’s scheme of a broad remedial power that can account for regulatory delays.

The minority (Kiefel and Keane JJ) instead emphasised that the scheme relates to extending the time for a person to do a single ‘relevant act’: ‘There is but one action referred to in s 71(2) – making an application for extension of the term of a patent. That one action is to be done on a date that satisfies the two requirements as to time set out in s 71(2). It is that action to which s 223(2) would apply, were it not for reg 22.11(4)(b)’: at [111]. The additional words in reg 22.11(4)(b) identify the requirements of s 71(2) as relevant for an application under s 70(1): they ‘cannot alter the effect of the operative part of the regulation, which must identify the “relevant act”‘ excepted under s 223.

High Court Judgment [2014] HCA 42 5 November 2014
Result Appeal dismissed
High Court Documents Alphapharm
Full Court Hearing [2014] HCATrans 160  8 August 2014
Special Leave Hearing [2014] HCATrans 79 11 April 2014
Appeal from FCAFC [2013] FCAFC 129 18 November 2013
Trial Decision, AAT
[2012] AATA 851 4 December 2012
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About Martin Clark

Martin Clark is a PhD Candidate and Judge Dame Rosalyn Higgins Scholar at the London School of Economics and Political Science and Research Fellow at Melbourne Law School. He holds honours degrees in law, history and philosophy from the University of Melbourne, and an MPhil in Law from MLS. While at MLS, he worked as a researcher for several senior faculty members, was a 2012 Editor of the Melbourne Journal of International Law, tutor at MLS and various colleges, a Jessie Legatt Scholar, and attended the Center for Transnational Legal Studies Program.