The High Court of Australia by a 3:2 majority yesterday dismissed the appeal by Alphapharm Pty Ltd (“Alphapharm”) against the Full Federal Court of Australia’s decision to allow an extension of time to apply for a patent term extension (PTE) in relation to Australian Patent No. 623144, owned HLundbeck A/S (“Lundbeck”)
The High Court’s decision is crucial for all patentees who may have missed the deadline for filing a PTE application due to an error or omission.
Extension of term
Australian legislation provides for an extension of term of up to 5 years for pharmaceutical patents. Section 71(2) of the Patents Act 1990 (“the Act”) provides that an application for extension of term must be made during the term of the patent, and within 6 months after the latest of: (a) the date of grant of the patent; (b) the date of first inclusion of goods that contain, or consist of, the pharmaceutical substance in the Australian Register of Therapeutic Goods (ARTG); or (c) the date of commencement of s 71(2).
Extension of time
The provisions of section 223(2) of the Act allow for extensions of time to do a “relevant act” where it could not be done within a certain time due to an error or omission by the person concerned, his/her agent or attorney, or circumstances beyond the control of the person concerned. Case law has established that an application for extension of time should be filed without undue delay once the error or omission is discovered.
Section 223(11) defines a “relevant act” as being an action (other than a prescribed action) in relation to a patent, a patent application, or any proceedings under the Act. For the purposes of s 223(11), regulation 22.11(4)(b) of the Patents Regulations 1991 defines “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 patent” as a “prescribed action”.
We refer you to our article of 19 June 2009 for a brief review of an earlier decision of the Full Federal Court in H Lundbeck A/S v Alphapharm Pty Ltd to deny a PTE for the subject patent under s 71(2), as that extension was based on the date of inclusion in the ARTG of the pharmaceutical substance in question, escitalopram (an anti-depressant drug, sold as Lexapro) of 16 September 2003. In that decision, the Court decided that the PTE should have been based on an earlier inclusion in the ARTG of citalopram (an anti-depressant drug, sold as Cipramil) on 9 December 1997, because escitalopram is the (+)-enantiomer of citalopram (a racemate).
Having been denied a PTE based on the date of inclusion of escitalopram in the ARTG, with one day remaining of the 20-year patent term Lundbeck applied to the Commissioner in 2009 for a 10-year extension of time to apply for a PTE based on the date of inclusion of citalopram in the ARTG. The extension of time was granted in 2011. Alphapharm and three other generics opposed grant of the extension of time, and the Commissioner dismissed each of the four oppositions.
Alphapharm then appealed to the Administrative Appeals Tribunal for a review of the Commissioner’s decision, challenging the power of the Commissioner to grant an extension of time under section 223(2) to apply for a PTE. The Tribunal found that section 223(2) conferred power to the Commissioner to grant an extension of time in respect of applications for PTE.
On appeal, the Full Federal Court affirmed the decision of the Tribunal, and an Application for Special Leave to Appeal to the High Court of Australia by Alphapharm was allowed.
The High Court decision
The primary issue before the High Court rested on the construction of reg 22.11(4)(b), in the context of s 71(2) and s 223(2). Alphapharm asserted that reg 22.11(4)(b) applies to both the first and second requirements of s 71(2), i.e. that the PTE application be made during the term of the patent, and that the application be made within 6 months of the latest of the three specified dates, are both “prescribed acts” and are therefore prohibited by reg 22.11(4)(b) from extensions of time.
Crennan, Bell and Gageler JJ considered the relevant legislative and judicial history and concluded that:
“There is no reason to suppose that s 223 of the Act lacks the broadly protective and remedial operation accorded to its immediate predecessor by numerous courts, including this Court”.
Their Honours went on to state that:
"There is nothing in any of the extrinsic materials, or in the long policy debates on simplifying extensions of term, which would suggest any rationale for excluding the second time requirement from the remedial power to extend time under s 223(2)(a)".
The majority judgement determined that to ask whether a "relevant act" is "prescribed" provides “an incomplete and inadequate foundation for construing reg 22.11(4)(b)” and that the ease with which the second time requirement under s 71(2) could have been excluded by the legislature is an indication that it was not intended to be excluded.
The majority concluded that the first time requirement, i.e. that an application for extension of term be made during the term of the patent, is the only time requirement of s 71(2) that is excluded by reg 22.11(4)(b), confirming that extensions of time to apply for PTEs are permissible in Australia where both the application for extension of time and the application for PTE are filed while the patent is still in force.
Importantly, on a related note, Rares J of the Federal Court today dismissed the appeal from the Opposition by Alphapharm and other generic parties to Lundbeck’s PTE based on the racemate (citalopram) in Alphapharm Pty Ltd & Ors v H Lundbeck A/S & Anor.