FEDERAL COURT OF AUSTRALIA
H Lundbeck A/S v Alphapharm Pty Ltd [2016] FCA 1232
ORDERS
NSD 643 of 2014 BETWEEN: H LUNDBECK A/S
First Applicant
LUNDBECK AUSTRALIA PTY LTD ACN 070 094 290
Second Applicant
AND: ALPHAPHARM PTY LTD
Respondent
JUDGE:
JAGOT J
DATE OF ORDER:
21 OCTOBER 2016
THE COURT ORDERS THAT:
1.The separate questions be answered…
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Details
- Case
- [2016] FCA 1232
- Decision Date
CaseChat Overview and Summary
In the Federal Court of Australia, H Lundbeck A/S filed an application against Alphapharm Pty Ltd concerning an application to withdraw an admission in their defence. The dispute centred on the status of H Lundbeck A/S as the exclusive licensee of a patent for the drug escitalopram, known as the Lexapro patent, in Australia. The issue arose after H Lundbeck A/S admitted that it was not the exclusive licensee of the patent from 14 June 2009 to 9 December 2012, but later sought to withdraw this admission. Alphapharm challenged the withdrawal, arguing that issue estoppel and abuse of process doctrines should prevent H Lundbeck A/S from changing its position.
The court was required to decide whether Alphapharm was estopped from questioning the status of H Lundbeck A/S as the exclusive licensee, and whether the withdrawal of the admission constituted an abuse of process. The court examined the principles of issue estoppel, which prevent a party from asserting a position that is inconsistent with a previous position they have taken, and the doctrine of abuse of process, which prevents a party from using the court process to achieve an unfair advantage. The court assessed whether the admissions made by H Lundbeck A/S were deliberate, clear, and unequivocal, and whether there were any special circumstances that justified the withdrawal.
The court found that Alphapharm was not estopped from questioning the status of H Lundbeck A/S as the exclusive licensee. The admissions made by H Lundbeck A/S were not unequivocal and were made in the context of a broader dispute over the validity and extension of the patent term. The court also determined that the withdrawal of the admission did not amount to an abuse of process. The court held that H Lundbeck A/S had not acted unfairly or improperly, and that there were no special circumstances that warranted preventing the withdrawal. The court's decision allowed H Lundbeck A/S to withdraw its admission, leaving the issue of its status as the exclusive licensee open for further determination in the proceedings.
The court ordered that Alphapharm Pty Ltd and/or Aspen Pharma Pty Ltd were not estopped from raising the issue of whether the Second Applicant was the exclusive licensee of the patent in dispute from 14 June 2009 to 9 December 2012. Additionally, the respondents were not precluded from placing the matter of whether the Second Applicant was the exclusive licensee of the patent in issue from 14 June 2009 to 9 December 2012 by reason of the doctrine of abuse of process. These orders clarified the legal positions of the parties and allowed the matter to proceed to further determination.
The court was required to decide whether Alphapharm was estopped from questioning the status of H Lundbeck A/S as the exclusive licensee, and whether the withdrawal of the admission constituted an abuse of process. The court examined the principles of issue estoppel, which prevent a party from asserting a position that is inconsistent with a previous position they have taken, and the doctrine of abuse of process, which prevents a party from using the court process to achieve an unfair advantage. The court assessed whether the admissions made by H Lundbeck A/S were deliberate, clear, and unequivocal, and whether there were any special circumstances that justified the withdrawal.
The court found that Alphapharm was not estopped from questioning the status of H Lundbeck A/S as the exclusive licensee. The admissions made by H Lundbeck A/S were not unequivocal and were made in the context of a broader dispute over the validity and extension of the patent term. The court also determined that the withdrawal of the admission did not amount to an abuse of process. The court held that H Lundbeck A/S had not acted unfairly or improperly, and that there were no special circumstances that warranted preventing the withdrawal. The court's decision allowed H Lundbeck A/S to withdraw its admission, leaving the issue of its status as the exclusive licensee open for further determination in the proceedings.
The court ordered that Alphapharm Pty Ltd and/or Aspen Pharma Pty Ltd were not estopped from raising the issue of whether the Second Applicant was the exclusive licensee of the patent in dispute from 14 June 2009 to 9 December 2012. Additionally, the respondents were not precluded from placing the matter of whether the Second Applicant was the exclusive licensee of the patent in issue from 14 June 2009 to 9 December 2012 by reason of the doctrine of abuse of process. These orders clarified the legal positions of the parties and allowed the matter to proceed to further determination.
Orders
Orders of the court
1. The separate questions be answered as follows:
(a) Are Alphapharm Pty Ltd and/or Aspen Pharma Pty Ltd estopped from raising the issue of whether the Second Applicant was the exclusive licensee of the patent in dispute from 14 June 2009 to 9 December 2012?
Answer: No.
(b) Should the Respondents (or any of them) be precluded from placing the matter of whether the Second Applicant was the exclusive licensee of the patent in issue from 14 June 2009 to 9 December 2012 by reason of the doctrine of abuse of process?
Answer: No.
Note: Entry of orders is dealt with in Rule 39.32 of the Federal Court Rules 2011.
Background
Background to the litigation
It will be apparent from the above that, insofar as the current proceedings are concerned, the admissions were first made on 9 December 2015 and sought to be withdrawn on 29 March 2016. Due to these and other interlocutory steps not yet determined, directions for evidence have not yet been made and the proceedings have not been fixed for hearing.Facts said to give rise to estoppels/abuses of process Lundbeck applied for the Lexapro patent for (+) – citalopram (also known as escitalopram) on 13 June 1989. The Lexapro patent was granted on 31 August 1992. Pursuant to s 67 of the Act, the standard term of the Lexapro patent was to expire on 13 June 2009. The compound (+) – citalopram is the (+) – enantiomer of citalopram which is a racemic mixture containing equal amounts of (+) and (-) enantiomers of citalopram. Citalopram was disclosed in Australian Patent No 509445 owned by Lundbeck which expired on 5 January 1993 (the Citalopram patent) and the drug Cipramil (an antidepressant drug marketed by Lundbeck Australia in the form of an acid salt addition of citalopram) was registered on the Australian Register of Therapeutic Goods (the ARTG) from 9 December 1997. On 27 May 2004, in response to an application by Lundbeck lodged on 22 December 2003, the Commissioner granted Lundbeck an extension of term of the Lexapro patent until 13 June 2014 based on a view that the provisions of the Act and the Therapeutic Goods Act 1989 (Cth) (Therapeutic Goods Act) enabled the extended term to be granted by reference to the date of registration of Lexapro (a drug containing the active compound (+) – citalopram) on the ARTG, which occurred on 16 September 2003. On 26 September 2005, Lundbeck and Lundbeck Australia entered into an agreement described as an Exclusive Licence Deed. This is said to be the foundation for the status of Lundbeck Australia as the exclusive licensee of the patent in Australia. On 6 July 2005, Alphapharm commenced a proceeding in this Court against Lundbeck challenging the validity of the Lexapro patent and of the extension of term of that patent, the latter on the basis that the provisions of the Act and the Therapeutic Goods Act meant that the relevant date for any extension of term of the Lexapro patent was the date of registration of Cipramil, the consequence being that Lundbeck was out of time to apply for an extension of term. On 13 October 2005, the Lundbeck parties cross-claimed against Alphapharm for infringement of the Lexapro patent. The claimed infringements concerned Alphapharm’s alleged threat to manufacture and sell goods containing (+) – citalopram in Australia if Alphapharm obtained the necessary regulatory approvals and listings, and actions taken by Alphapharm to obtain registration of its (+) – citalopram product on the ARTG. There was no suggestion that Alphapharm had marketed or sold a (+) – citalopram product in Australia. In the cross-claim it was alleged that Lundbeck Australia “is, at the date of filing this Cross-Claim” the exclusive licensee of the Lexapro patent. Alphapharm did not admit this allegation.
Evidence
Evidence Before The Court
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Decision
Reasons for decision
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Ratio Decidendi
Legal Principle Established
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