Pharmaceutical patent term extensions (PTE) are a highly litigated area of patent law. Australia’s longest running PTE litigation relates to a patent for the antidepressant escitalopram. The latest installment in the escitalopram saga is now available, with the High Court of Australia handing down judgement in H. Lundbeck A/S v Sandoz Pty Ltd, CNS Pharma Pty Ltd v Sandoz Pty Ltd [2022] HCA 4. The decision clarifies that a patentee, but not an exclusive licensee, can bring infringement proceedings during the extended term of a patent which has previously expired, and PTE is subsequently allowed.
Lundbeck Denmark’s escitalopram patent as granted would have expired on 13 June 2009. However, on 25 June 2014 Lundbeck Denmark was granted an extension of term to 9 December 2012.
Section 79 of the Patents Act provides that if a patentee applies for PTE and the patent expires before the PTE application is determined, and the extension is subsequently granted, the patentee has the same rights to start proceedings in respect of the doing of an act (e.g., a potential infringement) during the extended term of the patent as if the PTE had been granted at the time the act was done.
The present High Court judgement concerned two appeals from decisions of the Full Court of the Federal Court.[1] Sandoz, the respondent in both appeals is a supplier of generic pharmaceutical products who sold generic escitalopram products during the extended term of the Patent. The first appeal was brought by Lundbeck Denmark and Lundbeck Australia being the former’s Australian subsidiary and exclusive licensee of the Patent.
Lundbeck Denmark and Lundbeck Australia had both claimed declaratory relief, damages and pre-judgment interest on the basis that Sandoz infringed the Patent by selling generic escitalopram products during its extended term. The primary judge in the initial Federal Court proceeding found against Sandoz.[2] The Full Federal Court, however, allowed Sandoz’s appeal, primarily on the basis that Sandoz held a non-exclusive licence from Lundbeck Australia for the extended term of the Patent.
The High Court disagreed, finding that Sandoz did not hold such a non-exclusive licence for the extended term. On this basis, Lundbeck Denmark, as patentee, had rights to bring proceedings against Sandoz under s 79 of the Act and were entitled to relief for Sandoz’s sales of generic escitalopram products during the extended term of the Patent. Lundbeck Australia, as exclusive licensee, did not have such rights because s 79 refers to the patentee alone. The matter has now been remitted to the Federal Court for the calculation of damages payable to Lundbeck Denmark.
For any questions regarding pharmaceutical patent protection, please contact annabella.newton@pof.com.au
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[1] Sandoz Pty Ltd v H Lundbeck A/S (2020) 384 ALR 35; Sandoz Pty Ltd v H Lundbeck A/S [No 2] [2021] FCAFC 47.
[2] H Lundbeck A/S v Sandoz Pty Ltd (2018) 137 IPR 408; H Lundbeck A/S v Sandoz Pty Ltd [No 2] [2019] FCA 46.
