Malta: a rapid route to EU generics market?

To achieve this, the company is building a new solid dose facility in Malta, which has the advantage of being outside the territory covered by the European Patent Convention.

A spokesman for the company told In-Pharmatechnologist.com​ that while Malta has had patent law in place since 2002, very few companies have bothered to file for protection there, perhaps because it is considered too small a market to bother with.

And that is good news for Siegfried​, which has had to work with the constraint that patents in Switzerland tend to run out a couple of years later than in the European Union. By having a plant outside the convention area, Siegfried will be able to carry out all the necessary process development and manufacturing for a new generic API and be ready to launch the day patent protection expires in the EU.

The company also looked at other countries outside the convention, including some in Central and Eastern Europe (CEE), but concluded that the majority have had protection for substance patents in place since the 1990s. And those that have not, such as Macedonia, present some problems in infrastructure that make them less compelling as centres for pharmaceutical production, he said.

The spokesman would not divulge the cost of setting up the new plant, which should finish construction at the end of 2005 and could be validated and ready for production in the first quarter of 2006.

The plant will be constructed in two phases, each providing capacity to make 450 million tablets and 200 million hard gelatine capsules a year. In time, the capabilities will be extended to include films and other technologies, he said. At present, Siegfried's Swiss facilities can make 800-900 million tablets a year, and around 200 million hard gel capsules.

The first product to be made at the Maltese plant will be amlodipine tablets, and this will be followed by a second product still in development, said Siegfried.