The High Court has finally drawn a line under the argument between Alphapharm Pty Ltd and H Lundbeck A/S concerning the latter’s application for further time to lodge an extension of term application. Finding in favour of Lundbeck, the effect of the decision is to retroactively extend the life of Lundbeck’s important patent directed to Escitalopram – a widely prescribed anti depressant and anti anxiety drug – by about three and a half years. The battle between the parties has taken just over nine years to work its way through the Australian court system.
In a highly technical argument, the High Court was asked to review whether or not it was possible to use the saving provisions of s223(2)(a) to obtain an extension of time to carry out a ‘relevant act’ being the lodgement an extension of term application in in accordance with the requirements of s71(2) of the Patents Act:
s71(2) An application for an extension of the term of a standard patent must be made during the term of the patent and within 6 months after the latest of the following dates:
(a) the date the patent was granted;
(b) the date of commencement of the first inclusion in the Australian Register of Therapeutic Goods of goods that contain, or consist of, any of the pharmaceutical substances referred to in subsection 70(3)
(c) the date of commencement of this section.
The general savings provision s223(2)(a) is qualified by s223(11) of the Patents Act which legislates that:
…… relevant act means an action (other than a prescribed action) in relation to a patent, a patent application, or any proceedings under this Act (other than court proceedings)……..
22.11(4) For the definition of relevant act in subsection 223(11) of the Act, the following are prescribed:
…… (b) filing, during the term of a standard patent under subsection 71(2) of the Act, an application under subsection 70(1) of the Act for an extension of the term of the patent;
Both parties turned to fist principles of statutory interpretation and legislative history to make their arguments. Alphapharm contended that r22.11(4)(b) should be interpreted to separate the ‘relevant act’ from the time requirements within which it must be done. Their submission therefore was that, where the ‘relevant act’ was filing an extension of term application, the regulation excludes both of the periods defined in s71(2): that is, firstly, within the term of the patent AND secondly, also within 6 months of the later of the three subsections. Lundbeck argued that the ‘relevant act’ could not be divorced from the time period in which it must be done, and so the exclusion of r22.11(4)(b) is applicable only to an application made outside the time period defined by the expiry of the patent, as the exclusion states on a plain reading. Both parties arguments were founded in the fact that Lundbeck’s effective application for an extension of the term of their patent was made just inside the first time period, but well outside the second.
In a 3:2 decision, the Court found that the requirement that an extension of term application be made before the expiry of the patent has its origins as long ago as 1903 in ensuring that the interests of the general public were served by not having to manage the commercial uncertainty associated with the possibility of an extension of the term being sought after patent expiry. By contrast, the requirement that the application be made within 6 months of the later of patent grant or regulatory approval is all about ensuring that the unexploited patents are not maintained on the Patent Register. Consistent with this, the Court preferred Lundbeck’s argument that the ‘relevant act’ was inextricably linked to both time periods for completion of the act, and found that the plain English interpretation of r22.11(4) supported the view that, only where the patent term had already expired, was an extension of term application precluded by the qualifications of the general extension of time savings provisions.