Australian Patent Term Extension: A “Long-Term” Battle

Aspen Pharma Pty Ltd and Ors and Commissioner of Patents and H Lundbeck (Joined Party) [2012] AATA 851 (4 December 2012)

If it was ever in doubt as to whether an application for an extension of a pharmaceutical patent term could be late filed after the due date, this recent decision would seem to have removed it, clarifying that late filing is permissible under the Australian extension of time regime.

An extension of term application for a patent claiming and disclosing a pharmaceutical substance must be filed within the later of 6 months from grant of the patent, or 6 months from first inclusion in the Australia Register of Therapeutic Goods of goods that contain, or consist of the substance. A separate regime (extension of time) is available enabling a due date to be extended for completing relevant acts (such as late filing of a patent application).

The issue in this case was whether filing of an extension of term application is a ‘relevant act” – i.e. whether the due date for filing the extension of term could be extended under the extension of time regime.

The patent related to Lundbeck’s antidepressant drug escitalopram which it markets in Australia as LEXAPRO. On the day before the patent expired, and some 121 months after the extension of term application was due, Lundbeck requested an extension of time to file the extension of term application, the effect of which was to extend the expiry date of the patent from 13 June 2009 to 9 December 2012.

Various generic pharmaceutical manufacturers who had been marketing their own escitalopram products after expiry of the patent term appealed the Australian Patent Office’s (APO) decision to grant Lundbeck’s extension of time. Specifically, they submitted that the combined effect of section 223(2) and regulation 22.11(4)(b) (both dealing with the extension of time regime) is that an extension of term application under section 70(1) is not a “relevant act” for the purposes of section 223(2) and therefore cannot be the subject of a grant of an extension of time pursuant to section 223(2).

The Administrative Appeals Tribunal (AAT) rejected this interpretation and hence affirmed the APO’s decision, stating that an application under section 70(1) for an extension of term is a “relevant act” for the purposes of section 223(2) and therefore can be the subject of a grant of an extension of time pursuant to section 223(2) provided the application for an extension of term is filed before the patent expires (which Lundbeck did). The AAT decision is found at: Aspen Pharma Pty Ltd and Ors and Commissioner of Patents and H Lundbeck (Joined Party) [2012] AATA 851 (4 December 2012)

What follows is that, provided the requirements of the extension of time regime are satisfied,  an extension of time application to extend patent term is only ineligible if the patent has expired when the application for an extension of term is filed. This conclusion is consistent with the APO’s Manual of Practice and Procedure and with the Explanatory Memorandum which accompanied the Bill that inserted the current extension of term provisions in the Act. Furthermore, this conclusion accords with the remedial intent of section 223.

The AAT also found that Lundbeck’s filing of the extension of term application some 121 months after the application was due on the basis of a misunderstanding of the law did not constitute unreasonable conduct or lead to undue delay. This again demonstrates the beneficial application of the Australia’s extension of time regime to patent applicants and patentees.

The take home message is quite clearly that if you have missed the due date to file an extension of term application for a pharmaceutical patent, you should immediately consider filing an extension of time application as soon as you become aware of an error in judgement or mental flaw that lead to the extension of term application not being filed by the due date.

Further information on extension of term and extension of time applications can be found at:
Freehills Patent Attorneys – Extension of term; and
Freehills Patent Attorneys – Extensions of time & late filing of patent applications.