Thursday, April 21, 2005

Lichtenstein Counts:official

It is an ill-wind that blows no good, to idly misquote Shakespeare (possibly Richard III), and today’s ruling by the European Court of Justice, that Lichtenstein counts may have been greeted with peals from all the church bells in the Principality.

Novartis, the Swiss chemical company which precipitated the ruling, will be several million euro out of pocket and Switzerland may wish that it had joined the Euroepan Economic Area in a few year's time... if the ruling prompts companies to seek approval for thier pharmaceuticals in other territories first.

The decision by the European Court of Justice, the highest court in Europe, that once a drug is passed for use in Lichtenstein the clock starts running on its European patent protection clarifies a rule, which had become confused by a number of contradictory rulings by lower courts.

Novartis had the good grace to welcome the ‘clear basis’ for the way in which the length of supplementary protection certificates (SPCs), will be calculated. The certificates extend the patent life of ethical drugs in the European Union.

Novartis had gone to court claiming it was wrong to start the clock running on patented medicines in the European Economic Area once Switzerland approves a drug for use.
While Switzerland is not in the EEA, tiny Liechtenstein is, and Liechtenstein automatically assumes that when a pharmaceutical passes Switzerland’s approval process it is also approved in its territory.

It can take several years to gain approval in the EU, and the SPC was introduced in 1992 to extend the protection on newly discovered drugs and compensate companies for this delay.

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