Lundbeck extension of time upheld in LEXAPRO extension of pharmaceutical patent term saga

Lundbeck extension of time upheld in LEXAPRO extension of pharmaceutical patent term saga

Lundbeck extension of time upheld in LEXAPRO extension of pharmaceutical patent term saga

Aspen Pharma Pty Ltd and Ors and Commissioner of Patents and H Lundbeck [2012] AATA 851

The Administrative Appeals Tribunal (AAT) has handed down the latest decision in the LEXAPRO saga, upholding an Australian Patent Office decision to grant patentee H Lundbeck A/S an unprecedented extension of time of 121 months to request a pharmaceutical patent term extension of Australian Patent No. 623,144, covering escitalopram (LEXAPRO).

Background to the LEXAPRO decision

Escitalopram, a selective serotonin reuptake inhibitor (SSRI) and the active compound in LEXAPRO, is the ( )-enantiomer of the racemate citalopram. The racemate citalopram, comprising both the ( )-enantiomer and (-)-enantiomer, was earlier patented and sold as an antidepressant under the name CIPRAMIL, having first received marketing approval on 9 December 1997.

However escitalopram, the ( )-enantiomer, was subsequently found to be more efficacious than either the racemate or the (-)-enantiomer. Accordingly, Lundbeck applied for a patent for the single enantiomer escitalopram, and obtained marketing approval for the pharmaceutical LEXAPRO on 16 September 2003. The initial 20 year patent term for the Australian Patent covering escitalopram, was due to expire on 13 June 2009. Based on the 16 September 2003 inclusion of LEXAPRO in the Australian Register of Therapeutic Goods (ARTG), Lundbeck applied under s70 of the Patents Act 1990 to extend the term of the patent until 13 June 2014.

An application for a pharmaceutical extension of term under s70 must be made during the term of the patent, and within six months after the latest of (a) the date of grant of the patent; (b) the date of first inclusion in the ARTG; or (c) the date of commencement of the extension of the term provisions, being 27 July 1999.

Patent term extension and validity of Lexapro patent challenged

The basis for the extension was questioned (along with the validity of the patent) by Alphapharm and others, with the matter reaching the Full Federal Court in 2009. In that instance, the majority held that the claims were valid, finding that the disclosure of the racemate in the earlier CIPRAMIL patent did not anticipate the separate or isolated ( )-enantiomer escitalopram (LEXAPRO) as claimed. However, with regard to the extension of patent term, the Full Federal Court unanimously upheld the first instance finding that the first inclusion in the ARTG of goods which contained or consisted of the ( )-enantiomer escitalopram, was the earlier inclusion of the racemate CIPRAMIL on 9 December 1997. As such, the application for an extension of term was not based on the correct entry in the ARTG, and was thus invalid. Given that CIPRAMIL first received marketing approval prior to commencement of the current extension of term provisions, the latest date for an application to be made based on the inclusion of CIPRAMIL in the Register was within six months of the date of commencement of the provisions, being 27 July 1999. At the conclusion of the Full Federal Court case in 2009, the prescribed period for applying for a pharmaceutical extension of term based on the correct earlier inclusion had elapsed.

Lundbeck filed application for extension of time on last possible date

Australian patent law includes provisions in s223 for the grant of extensions of time for doing a ‘relevant act’ that is required to be done in a certain time, where failure to do the act within the prescribed time results from, inter alia, an error or omission by an applicant or patentee or his or her agent or attorney.
The day before the 20 year patent term was due to expire (and the last possible date for an application to be made) Lundbeck filed an application for an extension of time with the Australian Patent Office, to enable an application for an extension of patent term to be made based on the earlier listing of the racemate CIPRAMIL. The Commissioner’s delegate awarded the extension of time, finding that the original deadline was missed due to a genuine misunderstanding of the law on the part of the patentee, which constituted an ‘error or omission’ for the purpose for s223.
Not surprisingly, a number of pharmaceutical manufacturers including Alphapharm Pty Ltd, Apotex Pty Ltd, and Aspen Pharma Pty Ltd, (hereafter ‘the Applicants’) – who had marketed their own escitalopram products throughout the intervening period – lodged an application for review of the Commissioner’s decision with the Administrative Appeals Tribunal (AAT).

The Administrative Appeals Tribunal (AAT) Decision on the Lundbeck case

The Applicants questioned the Commissioner’s findings that Lundbeck genuinely believed in July 1999 that a s70 extension of term application could not be based on the racemate, CIPRAMIL. Furthermore, the Applicants disputed that Lundbeck genuinely misunderstood the relevant law, and thus argued there was no ‘error or omission’ as required to support an extension of time.

Was there an “error or omission” to support an extension of time?

In 1999, within six months of the date of commencement of the extension of the term provisions, Mr Petersen, an attorney for Lundbeck, was of the view that that the extension of patent term could only be based on the first regulatory approval of goods “containing or consisting of” the single enantiomer, being LEXAPRO, and not the racemate CIPRAMIL. In fact, in 1999 Lundbeck had not considered whether the extension could or in fact should be based on the inclusion of CIPRAMIL rather than LEXAPRO in the ARTG. However, contrary to Lundbeck’s view, the Full Federal Court subsequently held in 2009 that the application for an extension of term application should have been based on the inclusion of CIPRAMIL in the Register, and the latest date for an application to be made was thus 27 July 1999 (within six months of the date of commencement of provisions). Lundbeck submitted that as a result of its genuine misunderstanding of the law it failed to file the application based on the inclusion of CIPRAMIL, and furthermore, if not for this error, then it would have filed an application in time.
In light of Mr Petersen’s submissions, the AAT considered that there was a relevant “error or omission” as evidenced by Lundbeck’s conduct.

Was Lundbeck’s conduct reasonable?

The Applicants also claimed that Lundbeck’s conduct was such as to disentitle it from being granted an extension. Some of the reasons cited by the Applicants included:

  • Overall length of, and failing to satisfactorily justify, the delay in applying for an extension of time;
  • Misleading the delegate of the Commissioner by not disclosing frankly all of the conduct, knowledge, and advice received;
  • Adopting and maintaining the clearly erroneous view of the position taken by it before and even after the decisions of the Federal Court; and
  • Failing to make a contingent application for an extension of time, which in itself was a calculated commercial risk.

Of note, Lundbeck was informed of possible reduction of the patent term by their Australian attorneys, Watermark, when proceedings were first commenced by Alphapharm in 2005. At that time, the attorneys at Watermark did raise the possibility of applying for an extension of time as contingency in the event Alphapharm succeeded in the Federal Court action.

However, Lundbeck maintained that it did not consider this suggestion from Watermark as formal or final advice, but rather as a preliminary comment. The matter was immediately referred to Lundbeck’s solicitors, Corrs, for further comment and was not acted upon.

Lundbeck led evidence from two experienced Australian attorneys in support of the reasonableness of their conduct – Mr Michael Caine, a partner of Davies Collison Cave, and Ms Shahnaz Irani, a principal of Spruson & Ferguson. Mr Caine and Ms Irani both indicated that the Federal Court’s interpretation of the words “contain, or consist of” in section 71(2)(b), did not accord with the views held in the profession at the time. Additionally, both Mr Caine and Ms Irani indicated that if any “contingent” extension application were to have been filed prior to the outcome of the Federal Court proceedings, the Commissioner would have deferred consideration of the application until the final conclusion of the court proceedings.

The AAT agreed with the views of Mr Caine and Ms Irani that Lundbeck’s interpretation of the Act was consistent with the views of the profession at the time, and that no practical or useful purpose would have been served by filing an application on a contingent basis as it would not have been considered by the Patent Office until the court proceedings had been resolved. Furthermore, the AAT held that the “advice” Lundbeck received from attorneys at Watermark was merely preliminary in the nature, simply indicating a possible course of pre-emptive or protective action in respect of litigation that had only just commenced.

Did Lundbeck mislead the Delegate?

The Applicants submitted that Lundbeck had misled the delegate in applying for the extension of time by not disclosing all advice it had received in respect of the matter. Specifically, Lundbeck did not disclose to the delegate the substance of the initial advice received from Watermark and Corrs, regarding possible reduction of patent term and the possibility of making a contingency application. Further, the Applicants suggested that the existence of the advice indicated that Lundbeck and their attorneys could not claim that they had genuinely misunderstood the extension of term provisions.
However, on this point, the AAT again stressed the preliminary nature of the advice received by Lundbeck, concluding that in making an application for the extension of time, it was in fact not necessary or appropriate for Lundbeck to inform the delegate of such preliminary observations.

Administrative Appeals Tribunal Outcome

In light of the above considerations, the AAT upheld the decision of the delegate to grant Lundbeck an extension of time to apply for an extension of term. The AAT decision does raise a number of questions; namely, how far does a patentee’s obligation extend in providing a full and frank disclosure, and to what end can s223 rectify an “error or omission”?

Unsurprisingly, given the significant commercial interest in escitalopram, Aspen Pharma, Alphapharm and Apotex appealed the decision to the Federal Court on 21 December 2012. The matter has been referred to the Chief Justice for direction as to whether the appeal should be heard by the Full Federal Court (NSD2236/2012).