H Lundbeck A/S v Commissioner of Patents

Case

[2005] FCA 1718

28 NOVEMBER 2005


Details
AGLC Case Decision Date
H Lundbeck A/S v Commissioner of Patents [2005] FCA 1718 [2005] FCA 1718 28 NOVEMBER 2005

CaseChat Overview and Summary

In the matter of H Lundbeck A/S v Commissioner of Patents, the parties involved were H Lundbeck A/S (Lundbeck), the Commissioner of Patents, and Alphapharm Pty Ltd (Alphapharm). The dispute centered around the patent for the (+)-Enantiomer of Citalopram and the process for its preparation, which was due to expire on 13 June 2009. Lundbeck had applied for an extension of the patent term, which was subsequently granted until 13 June 2014. However, the Commissioner of Patents proposed to amend the patent term to 9 December 2012, based on an earlier ARTG registration for Cipramil, the racemic mixture of the isomers.

The key legal issues before the court were whether the Commissioner of Patents was correct in proposing to amend the patent term and if the TGA proceeding and the revocation proceeding should be heard concurrently. The court had to determine if the Commissioner's decision to amend the patent term was legally sound and whether joining Alphapharm as the second respondent and hearing both proceedings together would be efficient and appropriate.

The court reasoned that it was undesirable to have the two proceedings heard separately due to the overlapping issues and expert witnesses. However, Alphapharm and Lundbeck Australia should have the opportunity to present their views on the proposed order for concurrent hearings. The court decided to adjourn Alphapharm’s motion in the regulation 10.7(7) proceeding to the final hearing, and order that Alphapharm be joined as the second respondent. If Alphapharm wishes to resist the order for concurrent hearings, it must notify Lundbeck Australia and the court by a specified date, and both parties would then file and serve affidavits and motions for a hearing.

The final orders included joining Alphapharm as the second respondent, reserving costs, setting deadlines for submissions, and outlining the procedure if Alphapharm chooses to resist the order for concurrent hearings. The proceedings were to be heard on a specified date.
Details

Areas of Law

  • Intellectual Property Law

Legal Concepts

  • Patent Term Extension

  • Regulatory Approval

  • Concurrent Proceedings

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