European Commission – Measures intended for intellectual property in the pharmaceutical sector

On Monday 28 May, the European Commission submitted the proposal for a regulation aimed to amend the legislation in force (Regulation (EC) No. 469/2009) concerning the supplementary protection certificate (SPC) for medicinal products.

The proposal for a regulation aims at adjusting the current legislation to upcoming changes in the legislative context: as a matter of fact, starting from 2020, the protection granted by many SPCs will become increasingly ineffective, and several medicinal products will become public domain after the expiry of the relevant patent or SPC.

According to the Commission, although the SPCs are aimed at rewarding those investing in innovation and at protecting the intellectual property, they can adversely affect manufacturers of generic and biosimilar medicinal products established in the EU, if compared to the industry in third countries. During the protection period granted by an SPC to a medicinal product in the EU, the manufacturers of generic and/or biosimilar medicinal products established in the EU cannot manufacture the same for any purpose, including exporting them outside the EU to countries where there is no protection granted by the SPC or where the same has expired, while manufacturers established in third countries are not subject to any such prohibition: this situation creates a strong competitive disadvantage for the EU manufacturers.

The proposal is coupled with a number of safeguards aimed at ensuring transparency and at preventing that products violating intellectual property rights enter Member States’ markets.

Download here aside the Proposal for a Regulation