Last week the Patent Office granted what must be a record extension of time under the extension of time provisions of the Patents Act (section 223).  The extension of over 121 months was granted to enable H. Lundbeck A/S ("Lundbeck") to file an extension of term application for its patent for escitalopram, which expired in June 2009. 

The Patent Office decision in Alphapharm Pty Ltd & Ors v H. Lundbeck A/S [2011] APO 36 is the latest chapter in the long running escitalopram dispute.  You may recall the decision of the Full Federal Court in H. Lundbeck A/S & Anor v Alphapharm Pty Ltd (2009) 81 IPR 228 where the Court upheld the first instance decision of Justice Lindgren that the extension of term of the escitalopram patent originally obtained by Lundbeck was invalid as it was made based on the wrong date (inclusion of the enantiomer on the ARTG rather than the racemate) and, as a result, the application was made out of time.  Upon refusal of an application by Lundbeck for special leave to appeal to the High Court, the extension of term of the escitalopram was removed from the Register and the patent expired at the end of the 20 year term (being 13 June 2009).

The day after the Full Court handed down its decision, and one day before the original term of the escitalopram patents was due to expire, Lundbeck submitted a new application for a section 70 extension of term, together with an application under section 223 for an extension of time in which to file the extension of term application.

The extension of time application was opposed by Alphapharm, Sigma, Sandoz and Apotex. 

In granting the extension of time, Delegate Ayers considered the effect of regulation 22.11(4)(b) which excludes "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" from the acts for which section 223 is available.

The Delegate notes that the opponents argued that section 223 is therefore not available to remedy the failure to file any application under section 70.  This was rejected by the Delegate, who construed the regulation as only excluding the failure to file a section 70 application before the expiry of the initial patent term.  As Lundbeck filed the application 1 day before the initial patent term expired, section 223 was available.

The error for the purposes of section 223 was held by the Delegate to be Lundbeck's failure to file an extension of term application based on the racemate registration, which was due to Lundbeck's misunderstanding of the law.

Upon finding that section 223 applied, the Delegate then considered the discretionary factors relevant to the grant of the extension of time.

Delay was reasonable

The opponents had argued that Lundbeck had unreasonably delayed in bringing the section 223 application.  It was first made aware of its error in July 2005 when Alphapharm wrote to the Commissioner and identified the error, which the Commissioner then sought to rectify.  The error was confirmed by the decision of the Delegate in May 2006 and the decision of Justice Lindgren in June 2008.  Despite this, the Delegate held that Lundbeck had acted reasonably as it was entitled to believe that it would win its case on appeal.

Third party interests not relevant

The Delegate also considered that the effect of an extension of time on third parties who had exploited the invention after expiry of the patent was not a relevant discretionary factor that would count against the grant of the extension.  The Delegate determined that those third parties (which includes parties not involved in the Court proceedings) entered the market with awareness of the commercial risk.

Public interest

The potential for an increase in the price of escitalopram to patients was a relevant consideration, however it was not given much weight as the price would have been at the higher level if the extension had been made correctly in the first instance.  The Delegate dismissed the potential for patient confusion (and reduced compliance) if some generic brands were removed from the market.

Emphasis was placed on the broader public interest in encouraging research into new and useful drugs, and it was held that this meant that on balance, the public interest weighs in favour of granting the extension. 

Overall, an interesting decision in relation to how the Commissioner will exercise her discretion in section 223 extension of time applications concerning the extension of term of a pharmaceutical patent.