European Union to implement a unitary SPC and centralised examination procedure for SPCs
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As already recalled in a previous article, the SPC system as it stands is based on a mix of national and European legislations. While the substantial conditions for the grant of an SPC are common to all EU Member States, based on European Regulation (EC) 496/2009 of 6 May 2009 for medicinal products and Regulation (EC) 1610/96 for plant protection products, SPC applications are filed with the national patent office of each Member State and have a national territorial effect, similar to the national designations of a European Patent.
With the Unitary Patent system and the UPC about to enter into force, it was time for the EU to think about a similar unified system for SPCs. As it stands, the relevant EU Regulations 1257/2013 and 1260/2012 do not provide for a unitary SPC but merely offer European patent holders (for which the basic patents would not have been opted-out) the opportunity to have the relevant national SPCs litigated before the UPC (which will then be mandatory for any SPC granted on the basis of a unitary patent). However, the grant procedure for such SPCs and their effects would still remain at the local level.
Several propositions had been submitted between 2018 and 2022 to consider a legislative review of the SPC system.
The European Commission itself first highlighted in 20181 the necessity to think through a revised SPC system in light of the fragmentation of the case-law with a consequential lack of legal certainty for the stakeholders, as well as a multiplication of proceedings which represent significant costs for the SPC holders.
The European Commission reiterated its criticism of the fragmentation and lack of transparency of the actual SPC system in its evaluation of the SPC Regulation published on 25 November 2020, together with the European Commission’s IP Action Plan. This led the European Parliament in November 2021 to adopt a resolution on the European Commission’s IP Action Plan which supports the implementation of a unified SPC system and called on the European Commission and the Member States to take the relevant measures.
A centralised SPC system was also suggested in the European Commission’s call for evidence for an impact assessment on proposals for a unitary SPC and/or a unified procedure for granting national SPCs, published on 8 March 2022, with the aim of adopting a proposal for a revised legislation by the end of 2022. Several models were also suggested by the Max Planck Institute in a second study published by the European Commission in September 2022, with a proper unitary SPC system however identified as the least preferred route in light of the uncertainties at the time surrounding the implementation of the unitary patent package.
These various suggestions eventually led the European Commission to publish today two different proposals for a revision of the SPC Regulation: a proposed brand new Regulation creating a “unitary SPC” and a recast of the current SPC Regulations for medicinal products and plant protection products to include a centralised examination procedure for some SPCs.
Centralised examination procedure for the grant of SPCs based on European patents and centralised marketing authorisations
The first set of proposals from the European Commission consist of introducing a centralised procedure for the grant of national SPCs, in line with the suggestions introduced in the Max Plank study of September 2022. Such a centralised procedure is described in a recast of the current SPC regulations on medicinal products (Regulation (EC) 469/2009) and plant protection products (Regulation (EC) 1610/96).
The aim would be to enable holders of European patents and centrally authorised medicinal products to file a single SPC application which will be examined through a centralised examination procedure and enable the simultaneous grant of national SPCs in all the EU Member States designated in the application. The central authority in charge of the examination would be the EUIPO, which would issue a binding opinion to the attention of the national IP offices of each Member State which will then grant or refuse the application (in accordance with their national formal rules). The relevant SPCs would have a national effect like current SPCs.
During the examination procedure, after assessing the formal admissibility of the SPC application, the EUIPO will entrust the substantive examination to a panel made of a member of the EUIPO and two SPC-qualified examiners drawn from two different national IP offices in the Member States.
Of note, the SPC applicant who would receive a negative opinion from the EUIPO panel can file an appeal before the Boards of Appeal of the EUIPO. Further appeals can be filed before the General Court and ultimately before the CJEU (for legal review).
As also suggested from the study of the Max Plank institute, third parties (such as generic companies or Member States) will be able to file third party observations during the examination of the centralised SPC application (within 3 months as from the publication of the SPC application) and file opposition briefs to challenge the validity of the SPC with a centralised effect (within 2 months after the publication of the examination opinion from the EUIPO panel).
The centralised procedure is however restricted to SPCs based on centrally authorised medicinal products, and expressly exclude national MAs (including those granted in the context of a decentralised procedure or a mutual recognition procedure). SPC applicants fulfilling the conditions to apply through the centralised procedure will be obliged to follow to this new procedure. Any SPC application filed with a national IP office while the conditions for using the centralised procedure are met shall be rejected by that national office.
National IP offices will thus remain competent to grant national SPCs based on national MAs (including MAs granted under the decentralised procedure and mutual recognition procedure).
The conditions for grant as provided for under the current SPC Regulation (under Article 3) remain unchanged, and the relevant CJEU case-law remains applicable. However, the European Commission noted the discrepancies amongst the Member States on the duration of European patents and thus on the starting date of SPCs (up to a one-day difference), and consequently suggested to clarify that rule at least for unitary SPCs.
The proposed Regulations also suggests to amend Regulation (EC) 1901/2006 to enable the application for SPC paediatric extensions through the centralised procedure (for national and unitary SPCs).
In its second set of regulations, the European Commission also suggests the parallel implementation of a “unitary SPC”, which would be applied for on the basis of European patents with a unitary effect (“unitary patents”). Such a new system is described in the proposal for a New Regulation for SPCs on medicinal products and plant protection products.
For such SPC application, the new centralised procedure described above also applies. The opinion of the EUIPO panel will thus lead to the grant of a unitary SPC with a uniform effect in all the EU Member States in which the basic patent has unitary effect (17 States to date).
Of note, holders of a European patent with a unitary effect will be able to file a ‘combined application' with a view to the grant of both a unitary SPC (which would have effect in the 17 Member States which have ratified the UPCA) and national SPC for additional Member States not covered by the unitary patent.
The new Regulation would thus be fully aligned with Regulation 1257/2012 and the UPCA, and unitary SPCs would be litigated in the UPC just like their basic patents. It is expected that the UPCA will be amended to include unitary SPCs in its scope.
After the grant of a unitary SPC, third parties will also be able to challenge the validity of the SPC by initiating an action for a declaration of invalidity before the EUIPO. Related decisions can also be appealed to the Boards of Appeal and eventually to the General Court. The Proposals also address the interplay with counterclaims for a declaration of invalidity that could be brought against a unitary SPC before the competent court (including the UPC provided that the UPCA is amended accordingly).
Expected benefits of the Proposals
In line with its IP Action Plan, the European Commission expects the implementation of the four proposals to “tackle the remaining fragmentation of the EU’s IP system”, and improve transparency and legal certainty by notably providing for a more consistent case-law on SPCs.
The Proposals also suggest to implement a central database with the EUIPO which would gather all the data collected and stored by the office from applicants and third parties (e.g. third party observations).
This improved harmonisation mostly aims at hastening generic/biosimilar entry by facilitating their information on the current SPC protection across the EU and planning their product launches.
The Proposals are also expected to involve cost reductions for SPC applicants, with estimated savings of 137,000 EUR for a 5-year protection in all 27 EU Member States.
In terms of next steps, the proposed Regulations will now be discussed by the European Parliament and the Council of the European Union in view of their potential adoption and entry into force.
1 As resulting from a Summary of the replies to the public consultation on SPCs and patent research exemption, a Study on the legal aspects of Supplementary Protection Certificates in the EU written by the Max Plank Institute, and a Study on the economic impact of supplementary protection certificates, pharmaceutical incentives and rewards in Europe