Supplemental Protection Certificates: Liechtenstein Loophole explained

To compensate for the time lost in clinical trials and regulatory clearance before a medicinal product can be sold, a patent owner is often entitled to a Supplementary Protection Certificate ("SPC"), in effect to extend patent protection beyond the standard 20 year period. Under Regulation (EEC) No. 1768/92 (the "Regulation") which harmonised the grant of SPCs in the EU and EEA, the duration of the SPC is calculated by reference to the delay between the date of patent application and the date of first marketing authorisation (subject to a maximum of 5 years).

Liechtenstein (a member of the EEA) has no patent office, but has by treaty operated a customs union agreement with neighbouring Switzerland (outside the EEA) whereby the grant of a Swiss patent confers protection in both Liechtenstein and Switzerland.

A referral to the ECJ arose from the decisions of the national authorities of both the UK and Luxembourg to treat a marketing authorisation in Switzerland as the first authorisation to place the product on the market in the Community, by virtue of its effect in Liechtenstein. In each case, since the Swiss authorisation had predated regulatory consent elsewhere, that decision curtailed the life of the SPC. Accordingly, the patentee for each product appealed.

The patentees had argued before the ECJ that because products subject to a Swiss authorisation could not be sold anywhere in the EEA other than Liechtenstein, they were not fully placed within the relevant market: a market of some 30,000 people could hardly be described as the free movement of medicinal products within the EEA. The Advocate General rejected this argument, emphasising that the intention of the Regulation was to provide a uniform approach across the EEA for the duration of SPCs, not the free movement of patented goods. Accordingly, once those products were lawfully placed on the market in the EEA, no matter how discrete that market may be, that would be the relevant date for first authorisation.

If the ECJ follows the decision of the Advocate General when its judgment is published later this year, the case will finally provide certainty for a question that has troubled regulators and pharmaceutical companies alike since the Regulation first came into force. It would also mean that if a Swiss marketing authorisation is considered by a pharmaceutical company as part of a pan European product launch, care should be taken to ensure that a premature Swiss launch does not cut short any Supplemental Protection Certificate.

For further information please contact Stephen Whybrow on T: +44(0) 207 367 2175 or by email at [email protected] or Nick Beckett on +44 (0) 207 367 2490 or by email at [email protected] or or Tom Scourfield on T: +44(0) 207 367 2707 or by email at [email protected]