Astrazeneca AB v Comptroller-General of Patents, Designs and Trade Marks

The duration of a supplementary protection certificate depends on the first authorisation to place the product on the market in the relevant territory. The court considered whether a Swiss marketing authorisation, automatically recognised in Liechtenstein, could constitute that authorisation for the purposes of the EEA. The issue was not acte clair and was referred to the Court of Justice of the European Union. The court provisionally considered that the EEA adaptations to the SPC Regulation might require the Swiss authorisation to be treated as a qualifying authorisation. It also considered that the nature of the authorisation should be assessed consistently under Articles 3 and 13. Separately, it provisionally preferred the reasoning in Synthon BV v Merz Pharma GmbH & Co KgaA and Generics (UK) Ltd v Synaptech Inc concerning Article 2 over the approach in Neurim Pharmaceuticals (1991) Ltd v Comptroller-General of Patents.

AstraZeneca appealed against the Comptroller’s decision, recorded as BL O/146/12, granting an SPC for gefitinib with an expiry date of 1 March 2019. The Comptroller treated a Swiss marketing authorisation, automatically recognised in Liechtenstein, as the first authorisation for calculating the SPC’s duration. AstraZeneca argued that the relevant authorisation was the later European marketing authorisation, which would produce the maximum five-year SPC period and an expiry date of 22 April 2021.

The appeal raised questions concerning Articles 2 and 13 of the SPC Regulation, including whether the Swiss authorisation could constitute the first authorisation to place the product on the market in the EEA, and whether the product would thereby be outside the Regulation’s scope.

1. Reference made. The court held that the questions concerning Articles 2 and 13 of the SPC Regulation were not acte clair. There was also a divergence between national patent offices as to whether a Swiss authorisation automatically recognised in Liechtenstein was the first authorisation for Article 13(1). The questions were therefore referred to the Court of Justice of the European Union.
2. The first reference asked whether such a Swiss authorisation, although not granted under the administrative procedure in Directive 2001/83/EC, could constitute the first authorisation to place the product on the market for Article 13(1). The court also referred questions concerning the significance of the European Medicines Agency’s assessment of the clinical data and the later suspension and reinstatement of the Swiss authorisation.
3. The court provisionally found the reasoning of the Advocate General in Novartis AG v Comptroller-General of Patents, Designs and Trade Marks persuasive. A teleological interpretation of the EEA adaptation to Article 3(b) could apply it to Article 13. On that view, there was no inconsistency between Novartis and Hässle AB v Ratiopharm GmbH or Synthon BV v Merz Pharma GmbH & Co KgaA. It was immaterial that the product was not in free circulation throughout the EEA or that Liechtenstein could not grant SPCs.
4. The court provisionally considered that the suspension and later reinstatement of the Swiss authorisation did not provide a cogent basis for distinguishing Novartis. The product had been authorised for marketing in Liechtenstein between 2 March 2004 and 24 October 2005.
5. On Article 2, the court referred a further question asking whether, if Article 13(1) required an authorisation granted under Directive 2001/83/EC, the earlier marketing of the product under the Swiss authorisation rendered it ineligible for an SPC. The court preferred the reasoning in Synthon and Generics to that in Neurim, considering it more consistent with Pharmacia Italia SpA, Massachusetts Institute of Technology and Yissum Research and Development Company of the Hebrew University of Jerusalem v Comptroller-General of Patents.
6. The questions were referred for a preliminary ruling. No final determination was made on the duration or eligibility of AstraZeneca’s SPC.

1. Comptroller-General of Patents, Designs and Trade Marks: The Comptroller granted the SPC and calculated its duration by reference to the Swiss marketing authorisation, resulting in an expiry date of 1 March 2019.
2. High Court (Patents Court): AstraZeneca’s appeal was not finally determined. The court referred questions on Articles 2 and 13 of the SPC Regulation to the Court of Justice of the European Union.