Insights: Proposals for reform of the EU’s SPC system

On 27 April 2023 the European Commission published proposals concerning supplementary protection certificates (SPCs) for medicinal products and plant protection products. SPC protection is currently only available at national level. The proposals would introduce the option of obtaining a unitary SPC, as well as a new centralised procedure for obtaining a bundle of national SPCs.

In addition, the proposals contain provisions that, if adopted, may also impact on certain substantive aspects of the SPC regimes.

Unitary SPC

To complement the Unitary Patent (UP) system which came into force on 1 June 2023, the EU Commission proposes to introduce a Unitary SPC system. Unitary SPCs would be examined and granted by a central examination authority. Only a UP could serve as the basic patent on which the unitary SPC would be based, and the unitary SPC would have the same territorial scope as the underlying UP. It is proposed that only a centralised marketing authorisation (MA) could serve as a basis for an application for a unitary SPC for a medicinal product (there are no centralised MAs for plant protection products).

Centralised procedure for examining SPCs

Inspired by the European Patent Office’s centralised procedure for granting a European patent that (if no unitary effect is requested) gives rise to a bundle of national patents, the EU Commission proposes to introduce a centralised procedure for SPCs. A ‘centralised SPC application’ would be filed, which could be based on a non-unitary European patent or on a UP.  The centralised application would undergo a single centralised examination procedure before a central examination authority. Whilst the national offices of the designated EU member states would be responsible for the national grant stage, a positive opinion from the central examination authority would be binding upon the national offices.  Under the proposal only a centralised MA could serve as a basis for a centralised SPC application for a medicinal product.

Notably, it is proposed to close the ‘national route’ where the conditions are fulfilled for the centralised procedure, i.e., it would no longer be possible to file an SPC application at the National Office of an EU member state if a relevant centralised MA has been obtained. The proposal explains that this is intended to drive harmonisation by avoiding divergent approaches by different offices.

Further details

Given that UPs do not (at least for the foreseeable future) cover all EU member states, it is envisaged that a centralised SPC application and a unitary SPC application may be filed together in a “combined” application to request both a unitary SPC (covering the member states participating in the UP) and national SPCs (in any remaining designated member states). Such a combined application would undergo a single examination procedure.

The central examination authority would not, as some had expected, be the EPO, but would instead be the European Union Intellectual Property Office (EUIPO), with examination handled by a panel comprising an EUIPO Examiner and two Examiners from different national offices.

The proposals also include provisions regarding third party observations, oppositions and appeals.

Whilst the EU Commission is adamant that the “proposal will have no impact on fundamental rights, especially since it is not proposed to alter the substantive features of the existing SPC regimes (e.g. conditions for grant, scope, effects)”, the proposals nevertheless include a number of new recitals that could potentially have a substantive impact.  In particular, a new recital is proposed that would require the SPC applicant to have the consent of the MA holder. There are also some new recitals concerning the interpretation of Articles 3(a) and 3(d) of the current SPC Regulation (EU Regulation No 469/2009) that warrant close scrutiny.

Outlook

The proposals will be discussed by the European Parliament and Council and may thus undergo changes before they are ultimately adopted.

The proposals assert that the new regimes would not replace national SPCs, instead providing alternative routes to obtaining SPC protection across the EU. However, as mentioned above, it is in fact proposed to make the national route in relation to medicinal products available only where the MA is not a centralised MA.

As the UK is no longer a member of the EU, the UK’s SPC regime will not be affected by the proposed new regimes. However, if the new regimes do indeed end up introducing substantive changes, it is conceivable that this may ultimately drive corresponding changes in the UK.

If you have any questions, please do not hesitate to contact the author or your usual Boult Wade Tennant adviser.