A number of blockbusters will become subject to generic substitution in Finland earlier than in many other European countries, i.e. whilst valid product patents are still in force in other European countries. This is the result of new legislation coming into force on 1 January 2009. The most significant amendments will enter into force on 1 April 2009.
As reported in our October 2008 Life Sciences Update, product patents for medicines were first adopted in Finland in 1995. A large number of patented medicines in Finland are protected, and will remain so until 2019, by the process patent only. In 2006, the Medicines Act (Section 57(c)) was amended to bring the Finnish system, i.e. the effect of the combination of the patent protection and generic substitution, closer to that of other countries: so far generic substitution has not been applied to pharmaceutical products that are protected by a valid process patent or SPC in Finland and by valid product patents or SPCs in at least five other EEA countries.
Section 57(c) will be abolished in 2009. As a result of the new legislation enacted by the Finnish Parliament in November 2008, at the same time a reference price system for medicinal products will be introduced in Finland in 2009.