CJEU: Relief for the pharma industry – possible to obtain a number of supplementary protection certificates on the basis of just one patent

The pharmaceutical industry faces a serious challenge with regard to patent protection for medicinal products. The period that lapses between the filing of an application for a patent for a new medicinal product and authorisation to place the medicinal product on the market oftentimes makes the period of effective protection under the patent insufficient to cover the investment put into the research. To obtain a more adequate protection, the pharma industry can rely on supplementary protection certificates (SPC) as laid down in Regulation (EG) Nr. 469/2009, which extend the duration of the exclusive patent right.

However, according to Art. 3 of the above mentioned regulation, one condition for obtaining an SPC is, that the product in question has not already been the subject on an SPC.

Due to a request for a preliminary ruling under Art. 267 TFE, the CJEU had to decide if it is possible to obtain a number of SPCs on the basis of just one basic patent, if that patent protects several different products or ingredients or a combination of such ingredients.

The Court held that with regard to the objective of the regulation – which is to encourage research in the pharmaceutical sector – it is possible, in principle, to obtain several SPCs on the basis of such a patent in relation to each of those different products. However, this only applies if each of those products is protected as such by the basic patent within the meaning of the Regulation and is contained in a medicinal product, which itself is subject to a marketing authorisation.

CJEU – Georgetown University (C-484/12)