The Australian Federal Court has recently confirmed that, in certain circumstances, Patentees may ask for more time in which to file applications for Extensions of Term of their Patents. The Court also upheld the discretion of the Commissioner of Patents in considering an Extension of Time Application in which to request an Extension of Term.

The complex, recent Judgment of Aspen Pharma Pty Ltd v H Lundbeck A/S [2013] concerned an Appeal from the Administrative Appeals Tribunal (“AAT”) by Aspen Pharma Pty Ltd against a decision of the AAT and of the Delegate of the Commissioner of Patents. The Delegate had originally granted Lundbeck A/S an Extension of Time in which to apply for an Extension of Term of their Escitalopram Patent, Australian Patent No. 623144. The Appeal by Aspen to the Australian Full Federal Court was dismissed with costs.

This Judgment is relevant to any Patentee considering requesting an Extension of Term of a Patent in Australia.

The facts of the case

Citalopram, a racemic inhibitor useful in the treatment of depression, was covered by an Australian Patent owned by Lundbeck that expired on 5 January 1993. Cipramil, the hydrobromide salt of Citalopram which contained both enantiomers of Citalopram, was first included on the Australian Register of Therapeutic Goods (“the ARTG”) on 9 December 1997.

Escitalopram, a drug containing the (+)-enantiomer of Citalopram and sold under the name Lexapro, was covered by Lundbeck’s Australian Patent No. 623144, which expired on 13 June 2009. Lexapro was first included on the ARTG on 16 September 2003.

In Australia, an Extension of Term of a Patent may be requested under Section 70 of the Patents Act (Cth) 1990, where a pharmaceutical substance is disclosed in the Specification of the Patent and falls within the scope of the Claims thereof and where the goods containing, or consisting of, the pharmaceutical substance are included on the ARTG. The period beginning on the date of the Patent and ending on the first regulatory approval date for the substance must be at least 5 years and the Patent Term must not have been previously extended. An Application for Extension of Term must be filed during the Term of the Patent and within 6 months of the date on which the Patent was granted or the date of commencement of the first inclusion in the ARTG, whichever is the later.

On 22 December 2003, Lundbeck applied for an Extension of Term of their Escitalopram Patent, Australian Patent No. 623144, based on the date that Lexapro was first included in the ARTG, 16 September 2003. The request was granted and the term of the Patent was extended to 13 June 2014.

Shortly thereafter, Alphapharm Pty Ltd commenced Court Proceedings for revocation of the Patent and removal of the entry in the Patent Register recording the Extension of Term, contending that the Term should more correctly be based on the ARTG date of Citalopram, 9 December 1997, and not on the ARTG date of Lexapro, 16 September 2003. Citalopram, it was argued, included the (+)-enantiomer of Citalopram. Thus, Lundbeck’s request for an Extension of Term of the Escitalopram Patent was arguably filed after the deadline of 9 June 1998 calculated from the ARTG date for Citalopram.

Alphapharm Pty Ltd notified the Commissioner of Patents of these circumstances. The Commissioner of Patents corrected the Extension to 9 December 2012. However, neither Lundbeck nor Alphapharm agreed with this correction.

Prior Decisions on appeal

The Australian Federal Court agreed with Alphapharm’s arguments and found that the correct approval date for the Extension of Term Application was indeed the date of first inclusion of Cipramil on the ARTG, and not the date of Lexapro on the ARTG.

As a consequence, not only was Lundbeck’s Extension of Term incorrectly calculated, but Lundbeck’s request for an Extension of Term was also filed out of time. Final orders were made by the Full Court on 12 June 2009, the day before the Patent expired, that the Patent Register be rectified by removing the recordal of the Extension of Term.

Lundbeck immediately, and on the same day of the Court Order, filed a Request for an Extension of Time under Section 223(2) of the Patents Act (Cth) 1990, of 121 months (just over 10 years), in which to file an Application to extend the Term of the Patent.

In Australia, an Extension of Time in which to perform a relevant act under the Patents Act (Cth) 1990 may be requested under Section 223 provided that the failure to act was as a result of an error or omission, or circumstances beyond the control of the person concerned.

Lundbeck’s Application for an Extension of Time in which to apply for an Extension of Term was opposed by Aspen Pharma Pty Ltd, Sandoz Pty Ltd, Apotex Pty Ltd and Alphapharm Pty Ltd (“the Opponents”). The Commissioner’s Delegate nevertheless granted the Extension of Time requested.

The decision of the Commissioner’s Delegate was taken on appeal to the Administrative Appeals Tribunal (AAT). The AAT was asked to consider whether the Patents Act (Cth) 1990 conferred on the Commissioner of Patents the power to grant an Extension of Time in which to file an Application for an Extension of Term. The Tribunal believed that it did and affirmed the Delegates decision.

The AAT’s decision was taken on appeal by Aspen Pharma Pty Ltd to the Australian Full Federal Court on the question of law of whether the Patents Act (Cth) 1990 conferred on the Commissioner of Patents the power to grant an Extension of Time in the present circumstances. Aspen argued that Lundbeck intentionally failed to file the Application for Extension of Term before the due date and that there was no error or omission sufficient to permit Lundbeck to have an Extension of Time in which to request an Extension of Term.

The Appeal Court’s decision

The Australian Full Federal Court did not accept Aspen’s reasoning and held that there was nothing in the Patents Act (Cth) 1990 that would deny the Commissioner the power to extend either or both of these time limits.

Aspen argued that Lundbeck acted unreasonably in deliberately not making the Application for an Extension of Term despite being advised by their Australian Patent Attorney to do so. However, the Court was not convinced and regarded the erroneous belief by Lundbeck that an Application for Extension of Term could not be based on the inclusion of Cipramil in the ARTG to be sufficient grounds to grant the Extension of Time in which to file the Request for an Extension of Term. The Court took note of the years of complex litigation in which Lundbeck had engaged concerning their entitlement to extend the Term of the Patent, and regarded these circumstances as demonstrating Lundbeck’s intention to take all reasonable steps legally open to it to protect and advance its rights in this regard.

The AAT’s decision was therefore upheld. Consequently, the decision of the Commissioner’s Delegate to allow Lundbeck’s Application for an Extension of Time in which to file an Application for an Extension of Term was also upheld.

However, while Lundbeck has successfully applied for an Extension of Term of their Escitalopram Patent, Australian Patent No. 623144, this Application remains opposed by Aspen Pharma Pty Ltd, Sandoz Pty Ltd, Apotex Pty Ltd, and Alphapharm Pty Ltd (the Opponents). It remains to be seen whether the Request for an Extension of Term will be granted to Lundbeck.

Take Home Message

  • Section 223 of the Patents Act (Cth) 1990 confers power on the Commissioner of Patents to allow an Application for an Extension of Time in which to request an Extension of Term.
  • Under the Raising the Bar legislative changes, Extensions of Time under Section 223 of the Patents Act (Cth) 1990 are understood to be more difficult to obtain than under the previous Act. However, while Lundbeck’s Application for an Extension of Time was filed under the provisions of the old Act, the reasoning of this Judgment provides a welcome precedent for supporting requests for Extensions of Time under the new, stricter regime.