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 (CIPRAMIL).
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 provisions.
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 (http://www.shelstonip.com/news_story.asp?m=11&y=2014&nsid=347). 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 to come.