The ECJ has issued its ruling today in Joined Cases C-207/03 and C-252/03 Novartis AG, UCL and the Institute of Microbiology and Epidemiology v Comptroller-General of Patents, Designs and Trade Marks for the United Kingdom and Ministre de l’Économie v Millennium Pharmaceuticals Inc., formerly Cor Therapeutics Inc, two cases on supplementary protection certificates (SPCs) for pharmaceutical products for which patent protection is expiring.
In Case C-273/03 Novartis, UCL and the Institute of Microbiology and Epidemiology applied for two SPCs, one for Basiliximab, an immunosuppressant, and the other for an antimalarial combination of Artemether and Lumefantrin. On 7 April 1998 and 22 January 1999 the Swiss granted marketing authorisations for Basiliximab and for the combination of Artemether and Lumefantrin. Those authorisations were automatically recognised in Liechtenstein, by operation of Liechtenstein law. Basiliximab and the combination of Artemether and Lumefantrin were granted marketing authorisations within the EU on 9 October 1998 and 30 November 1999. The UK Patent Office, considering that the duration of the SPCs should be calculated by taking into account the dates when the Swiss marketing authorisations were issued, granted SPCs for durations determined by reference to those dates. Novartis etc took the view that the duration of the SPCs should have been calculated by reference to the first marketing authorisations granted within the EEA, not Switzerland, and appealed to Patents Court which referred the matter to the Court for a preliminary ruling.
In Case C-252/03 Millennium's predecessor applied to the Luxembourg Minister for the Economy for an SPC under for Eptifibatide, for which the date of the first marketing authorisation in the EU was 1 July 1999. Millennium said in its application that a marketing authorisation had been issued for that medicinal product by the Swiss authorities on 27 February 1997. On the ground that Swiss marketing authorisations are automatically recognised under Liechtenstein law (Liechtenstein being an EEA state), the Minister issued an SPC and fixed its date of commencement as the date of the Swiss marketing authorisation. Millennium sued, claiming that that date should be replaced by 1 July 1999. Again, the matter was referred to the ECJ. After due deliberation that court ruled:
"In so far as an authorisation to place a medicinal product on the market issued by the Swiss authorities and automatically recognised by the Principality of Liechtenstein under that State’s legislation is the first authorisation to place that product on the market in one of the States of the EEA, it constitutes the first authorisation to place the product on the market within the meaning of Article 13 of Regulation 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products, as it is to be read for the purposes of the application of the Agreement on the EEA".The IPKat always wondered what use Liechstenstein was to the IP community. Now he knows.
More on SPCs here and here