The European Commission has presented a regulation in which it proposes amendments to Regulation 469/2009 on Supplementary Protection Certificates for medicinal products. In parallel, in a separate regulation, it also proposes the creation of a Unitary Supplementary Protection Certificate for these products. Both regulations will complement the currently existing Regulation for obtaining SPCs for pharmaceutical products before national patent offices.
It is relevant to recall that, despite the existence of the European Patent, no centralised system currently exists that allows the owner of a patent granted by the European Patent Office to obtain a Supplementary Protection Certificate through a single examination procedure. On the contrary, SPC prosecution and examination must be carried out on a country per country basis, resulting in disparities among the respective decisions.
Centralized examination at the EUIPO
The regulation proposal now unveiled by the European Commission aims to open new paths that are better aligned with the European Patent System and with the new Unitary Patent System.
In particular, what is proposed is the establishment of a centralised examination procedure that will be compulsory in order to obtain an SPC when the underlying patent is a European Patent and the commercialization authorization is also a centralised authorization, that is, one granted by the European Medicines Agency (EMA). The existing national examination procedure is reserved only for cases where the basic patent is not European or where the marketing authorisation is not centralised.
The new regulation suggests that the European Union Intellectual Property Office (EUIPO) shall conduct the centralised examination, which will be carried out by a panel consisting of two qualified examiners from the member states as well as a member of the EUIPO.
Following the publication of the SPC application, third parties will have three months to submit observations, after which the EUIPO will issue an opinion on the grant of the SPC and third parties will then have two months to submit an opposition.
If either party is dissatisfied with the ruling, it may appeal to the Boards of Appeal of EUIPO, then to the General Court, of the European Union and finally to the Court of Justice of the EU.
If the opinion of the EUIPO is positive, the Member States will be obliged to grant the SPCs which may, nevertheless, still be revoked in national courts.
A similar procedure for acquiring a European Unitary SPC has also been planned by the European Commission, taking into consideration that the Unitary Patent system will enter into force on 1 June. Only pharmaceutical patents that have opted to apply for unitary protection will have access to this new path.
Other suggested modifications for SPCs
The regulation also includes the following other significant changes:
- the requirement to obtain the owner of the marketing authorization’s permission when that person is not the SPC applicant
- the restriction of the possibility to obtain two SPCs for the same product based on two different patents only to the case where said patents are held by parties with no financial ties.
For the implementation of this system, the Regulations proposed by the European Commission have to be discussed and approved by the European Parliament and the Council of the European Union, but their current content can be consulted by clicking here.