SPCs: the simplest issue is in doubt

Recent CJEU decisions on SPCs have brought little clarity to the meaning of ‘product’, and a recent Advocate General opinion in Bayer CropScience AG threatens to muddy the waters even further, says Paul England.

There has been a considerable amount of activity in the Court of Justice of the European Union (CJEU) recently on the subject of supplementary protection certificates (SPCs). A number of rulings have come down, and others have been referred to the court. Some of these have concerned what ought to be regarded as one of the most simple elements of the legislation: what is meant by a ‘product’, as defined, for the purpose of being capable of protection by an SPC?

But this question has proved to be anything but simple. This is unfortunate, because if something qualifies as a ‘product’ then it is potentially capable of up to five years’ additional exclusivity protection when the patent that protects it expires.

The recent rulings from the CJEU on products have concerned SPC protection for medicinal products, under Regulation (EC) No 469/2009 (the medicinal SPC regulation). These have been controversial. The reason is that under earlier authorities it had been understood that a product, as the regulation itself stipulates, is restricted to an active ingredient or combination of active ingredients. As a result, products which are, for example, new salts of previously authorised active ingredients are not capable of SPC protection.