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Supplementary Protection Certificates

Supplementary Protection Certificates

21/10/04

The Advocate General of the European Court of Justice (ECJ) has now issued a non-binding opinion in connection with a case that will decide how to calculate the length of patent protection for new medicines in the European Union (EU). The decision which will shortly be issued by the ECJ, and is likely to adhere to the Advocate General’s opinion, will clarify how national patent offices should calculate the length of supplementary patent protection (provided for by a Supplementary Protection Certificate (SPC)) to which pharmaceutical companies can be entitled.

In order to protect public health, the marketing of a medicinal product is conditional upon obtaining an authorisation, which can be a slow and complex process. The period which elapses between filing a patent application and obtaining an authorisation, markedly reduces the period of exclusive use conferred by a patent. An SPC is a patent extension granted to pharmaceutical companies to compensate them for time spent waiting to obtain a marketing authorisation for a product before the product can be commercially launched.

Last year, the UK High Court referred two questions concerning a case between vartis and the UK Patent Office to the ECJ in view of the divergent opinions as to what constitutes the ‘first authorisaton in the Community’. The ‘Community’ referred to in the opinion consists of the members of the European Economic Area (EEA) under which a European Regulation relating to SPCs for medicinal products applies.

In 1998 and 1999 Novartis was granted market authorisations for two medicinal products by the Swiss authorities, which authorisations were automatically recognised in Liechtenstein on the basis of a customs union between Switzerland and Liechtenstein established in the early 1920s. While Switzerland has not ratified the agreement establishing the EEA, and consequently the European Regulation relating to SPCs does not apply there, Liechtenstein is part of the EEA

The questions referred to the ECJ were as follows:

1. Is the date of granting a marketing authorisation in Switzerland, which is automatically recognised in Liechtenstein, to be considered as the first authorisation to place a medicinal product on the market in the Community, for the purpose of calculating the duration of a SPC?

This is important since the date on which the first marketing authorisation was granted in the Community is to be taken into account for the purpose of calculating the duration of any SPC.

2. Is a competent authority within the EEA obliged to rectify any existing SPCs, the duration of which has been erroneously calculated.

The Advocate General’s non-binding opinion in answer to these questions was that:

1. Marketing authorisations issued in Switzerland are automatically effective in Liechtenstein and constitute a first authorisation to place the product on the market in the Community.

2. The national authorities of the EEA states are obliged to rectify any existing SPC where, when the dates were set, an error was made, provided that there are provisions under the relevant national law.

The ECJ’s decision is awaited and is likely to adhere to the Advocate General’s opinion.