Introduction

On 27 April 2023 the European Commission released a raft of proposals on IP, with the lofty aim of “helping companies, especially small and medium-sized companies (SMEs), make the most of their inventions, leverage new technologies and contribute to the EU’s competitiveness and technological sovereignty”. There are proposals for Standard Essential Patents (SEPs), Compulsory Licensing, and Supplementary Protection Certificates (SPCs) both for medicinal products and plant protection products. This newsflash focusses on SPCs for medicinal products, where we have provided our initial thoughts on the proposals.

In the current SPC regime applications are filed at the national level, with individual SPC applications filed at each individual national patent office (NPO) where protection is sought. This is seen as leading to increased costs for SPC applicants, with legal and official fees multiplied per state, as well as leading to increased uncertainty due to the possibility of diverging decisions from NPOs on equivalent SPC applications. The Commission aims to deal with these issues in two ways:

(1) Introducing a centralised examination procedure for SPCs.

(2) Introducing a unitary SPC.

The proposals explicitly state that they are not intended to modify the substantive aspects of SPC law (e.g. the interpretation of Article 3(a) of Regulation (EC) No 469/2009). However, the proposals do include a number of revisions and additions to the statute, which could have far-reaching consequences.

Centralised examination for SPCs

The first part of the proposal is for examination of SPCs to be handled centrally by the EUIPO with assistance from the experienced examiners from NPOs. Once central examination has concluded a bundle of national SPCs will be granted (or refused) accordingly.

The conditions for filing a centralised SPC application are that the basic patent relied upon is a European Patent (i.e. granted by the EPO and including Unitary Patents) and that the marketing authorisation (MA) relied upon is a centralised one (i.e. granted under Regulation (EC) No 726/2004 or Regulation (EU) 2019/6). Indeed, the proposal is that when these conditions are met – which is the case for the majority of SPC applications filed today – then a centralised application must be filed. In other words, the proposal will close the “national route” where SPCs are filed at NPOs after receiving a centralised MA.

In terms of the practicalities, the proposals acknowledge that SPC examination requires specialised knowledge and experience which will not immediately be available to the EUIPO. Accordingly, examination at the EUIPO will be handled by a panel of three, including two examiners from different NPOs experienced in handling SPCs, along with a third examiner from the EUIPO.

The first stage of substantive centralised examination will be the issuance of an “examination opinion” on whether the SPC should be granted, which may be positive, negative, or partly so. Although termed an “opinion” it will be binding on NPOs, who must grant or refuse the SPC application accordingly. The applicant may appeal a negative (or partly negative) opinion, firstly before the Board of Appeal, subsequently before the General Court, and with an ultimate appeal possibly to the CJEU.

The centralised examination procedure provides the opportunity for third parties to file observations (TPOs) on the validity of the SPC application within a three-month window after the application has been published. It is not clear whether it will be permissible to file TPOs anonymously; however, given that the draft statute states that “any natural or legal person” may file TPOs, it might be that it is possible to use a strawman to hide the true identity of the party behind the observations. Third parties may also oppose a positive (or partly positive) examination opinion within a two-month window after it has been published.

National SPCs granted as a result of the centralised examination procedure may be enforced or challenged in the relevant national courts, and also in the Unified Patent Court (UPC) for states participating in the unitary patent system.

The proposed centralised SPC examination procedure outlined above bears a number of similarities with the familiar centralised patent examination procedure at the EPO. These include the use of a three-member examination panel, the ability to file TPOs and oppositions, and of course the binding nature of the centralised examination on NPOs.

A unitary SPC

The second part of the Commission’s proposal is to introduce a unitary SPC (USPC). In much the same way that the proposed centralised examination procedure seems familiar from traditional EPO procedure, the proposed USPC seems familiar from the new Unitary Patent (UP) about to come into being in Europe.

The conditions for obtaining a USPC are that the basic patent is a UP and that the MA is a centralised one. The same centralised examination procedure outlined above will be used for USPCs. So, again, third parties will be able to file TPOs and oppositions at the EUIPO. Given the current territorial scope of UPs, which do not span the full list of EU member states, the proposal is for a “combined” SPC application to be filed which will include both a request for the grant of a USPC and a request for the grant of national SPCs in states not part of the  unitary patent system.

One point of interest for a USPC is that, after grant, a third party may bring invalidity proceedings at the EUIPO, and also at the UPC as a counterclaim. However, the draft statute for the USPC states that a counterclaim for invalidity cannot be brought if the EUIPO has already made a decision on the same subject matter between the same parties. This seems to provide potential infringers with the choice of bringing pre-emptive invalidity proceedings at the EUIPO, or waiting and launching a counterclaim for invalidity at the UPC if the SPC holder brings enforcement proceedings in that court.

Will the proposals affect substantive SPC law?

The Commission is abundantly clear that it thinks that the answer to this question is “no”, in particular stating “it is not proposed to alter the substantive features of the existing SPC regimes (e.g. conditions for grant, scope, effects)”. However, the proposals do acknowledge the existence of pending referrals to the CJEU needed to clarify certain aspects of SPC law. Moreover, the proposals include recasting the statute to include a number of new recitals that could indeed affect the substantive law – for instance with new recitals intended to clarify the interpretation of Article 3(a) (whether the product is protected by the basic patent) and Article 3(c) (whether the product has already been the subject of a certificate). This does beg the question: if centralised examination is the way to avoid divergence, and if the intention is not to modify the law, then why are these new recitals necessary?

There is plenty to digest in the proposed new recitals, not least because they could be seen as the Commission’s interpretation of the current case law (particularly so if they are not intended to alter the law), and a full analysis is beyond the scope of this article.

Conclusions and next steps

Although it is likely that change is coming, that change is still some way off – the proposals need to be discussed and agreed by the European Parliament and Council before their adoption and entry into force. We will continue to review the proposals and their possible implications and will be ready, eager, and waiting to represent our clients in any new SPC regime that comes into force – in exactly the same way that we are looking forward to the UPC opening its doors shortly.