The High Court's latest foray into patent law wrapped up last Wednesday 5 November 2014, with the Court handing down its judgment in the long running escitalopram litigation between Alphapharm (along with other generic parties) and Lundbeck.  The Court dismissed Alphapharm's appeal by a 3-2 majority (Justices Crennan, Bell and Gageler formed the majority, with Justices Kiefel and Keane dissenting). 

The majority held that reg 22.11(4)(b) of the Patents Regulations and s223(4) of the Patents Act permit an extension of the deadline for filing an application to extend the term of a patent, where the extension of time application is made more than six months after certain specified dates in s223(4), but during the term of the patent.  Here, the extension of time sought by Lundbeck in an application filed on the last day before patent expiry was almost ten years.

As we have previously discussed (see our post here), escitalopram is marketed in Australia by Lundbeck as the anti-depressant drug Lexapro.  There are now a number of generic escitalopram drugs available on the market. 

The extension of term scheme relied on by Lundbeck is intended to balance the competing interests of:

  • a patentee of a pharmaceutical substance who has faced delays in obtaining regulatory approval; and
  • the public interest in unrestricted use of the pharmaceutical invention, including by a generic pharmaceutical company, after the expiration of the patentee’s monopoly.

Being a decision which turns on questions of statutory interpretation, we can’t avoid referring to the relevant terms of the Patents Act.  Section 71(2) of the Act requires that an extension of term application be made:

  • during the term of the patent; and
  • within six months after the latest of three dates specified in s 71(2).  Relevant to this case is the first date on which a product containing the patented molecule obtains regulatory approval from the TGA.

Reg 22.11(4)(b) of the Patents Regulations provides that the Commissioner does not have the power to grant an extension of time under s223(2) of the Act for the doing of certain acts.  The question before the Court was whether reg 22.11(4)(b) meant that:

  • only the first timing requirement (that an application for an extension of term be made "during the term of the patent”) could not be extended (Lundbeck’s position); or
  • both timing requirements could not be extended (Alphapharm’s position).

In its judgment, the majority considered the pre-existing law and the legislative history of the relevant statutory provisions, and concluded that there was nothing in the relevant extrinsic materials or policy debates that supported Alphapharm’s position.  Lundbeck’s interpretation, however, was supported by the words of reg 22.11(4)(b) itself, its syntax and the immediate context of the regulation. 

In a footnote to the High Court’s decision, the next day (Thursday 6 November 2014) Justice Rares dismissed a Federal Court appeal by Alphapharm (and the other generic parties) from the Commissioner  of Patent’s decision dismissing their opposition to Lundbeck’s application to extend the term of the patent to 9 December 2012.  Justice Rares’ decision, available here, considered the application of s70(2) of the Patents Act, which sets out two pre-conditions, at least one of which must be satisfied before an extension of term will be granted.