AG OPINES ON SPC REFERENCE

Advocate General Ruiz-Jarabo Colomer of the European Court of Justice has delivered his Opinion in Cases 207/03 (Novartis and UCL and 253/03 (Millennium Pharmaceuticals Inc) on the term of validity of suppmentary protection certificates (SPCs) that extend protection for pharmaceutical and agrochemical products past the expiry date of any patent granted for them, to compensate for time lost in trialling products before they can be marketed under their patent. The duration of SPCs in the European Economic Area (EEA) is calculated by reference to the date on which the patented product, having been tried and tested, receives its first market authorisation in the EEA.

The question for the ECJ to consider is what happens where the first market authorisation is granted by Switzerland -- which lies outside the EEA -- given that Swiss market authorisations are automatically extended to the tiny Duchy of Liechtenstein, which lies inside it?

In para.76 of his Opinion Advocate General Jarabo has advised the ECJ to rule that

"(1) Under Article 13 of Council Regulation 1768/92, marketing authorisations issued in Switzerland which, in the framework of the customs union with Liechtenstein, are automatically effective in Liechtenstein, constitute a ‘first authorisation to place the product on the market in the Community’.

(2) The authorities of the EEA States are obliged to correct the dates by reference to which the duration of the supplementary protection certificates is determined where, when the dates were set, an error was made, provided that, under the relevant national legal system, the decision is amenable to review".

This appears to the IPKat to be an Opinion based on the practical realities of economic life in the EEA rather on technical legal niceties. He suspects that the ECJ will adopt it.

More on SPCs here and here
More on Liechtenstein here, here and here