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Unitary SPCs law proposed to complement unitary patents

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Pharmaceutical companies will be able to apply for supplementary protection certificates (SPCs) centrally before the European Union Intellectual Property Office (EUIPO) and obtain new unitary SPCs in future to complement new unitary patents granted, under proposals outlined by the European Commission.

The centralised procedure and unitary SPCs would be available alongside national procedures under the plans, though the Commission said the centralised procedure before the EUIPO would be mandatory when the basic patent is a European patent and the underlying marketing authorisation was granted centrally. This applies to the vast majority of SPC applications. In addition, the Commission said unitary SPC rights holders would make savings on the annual renewal fees they would be liable for if they alternatively obtained individual national SPCs in all the countries that the new unitary SPC could apply to.

The proposals form part of a new package of intellectual property (IP) legislative reforms set out by the Commission on Thursday and follow a separate package of reforms to the EU’s general pharmaceutical legislation that the Commission published on Wednesday.

SPCs are intellectual property rights that extend patent protection by up to a maximum of five years for specific medicinal and plant protection products. While existing EU law provides a harmonised framework for granting SPCs, SPCs are national rights which must be registered in individual EU member states for them to have effect there.

The Commission has been considering updating the existing SPC legislation for years. It commissioned studies by the Max Planck Institute, published in 2018 and 2022 respectively, and reforms have also been considered in its November 2020 IP action plan and pharmaceutical strategy, which were published alongside an evaluation of the SPC Regulation. It subsequently held a call for evidence on establishing a unitary SPC or a single, unified procedure for granting national SPCs with a view to making SPCs “more accessible and efficient”.

With its new proposals, the European Commission is seeking to introduce two new EU regulations to establish unitary SPCs for medicinal products and plant protection products respectively, as well as a further two ‘recast’ regulations which would permit national SPCs to be filed and examined centrally.

Jules Fabre of Pinsent Masons said: “The ‘recast’ regulations do not seek to change the substantive rules for obtaining SPCs, which is likely to be welcomed by the industry given any further changes would have had the potential of creating new questions in an area that has already led to numerous referrals to the Court of Justice of the EU (CJEU). That said, the recitals of the proposed regulations do seek to incorporate some of the recent case law of the CJEU and there are also a few changes or clarifications of substantive rules, such as a provision aimed at clarifying that so-called ‘third-party SPCs’ – where the owner of a patent seeks to obtain an SPC on the basis of a marketing authorisation held by a third-party – are not permitted without the consent of the marketing authorisation holder.”

Proposed conditions for obtaining unitary SPCs are set out in the draft legislation and closely reflect the existing conditions that apply for obtaining national SPCs. However, it is proposed that availability of unitary SPCs for medicinal products be limited to instances where the underlying product is protected by a unitary patent in force.

A new regime for obtaining new unitary patents will take effect from 1 June this year across an initial 17 participating EU member states, though others, like Ireland, are expected to participate in due course. Pinsent Masons has developed an action plan, checklist and series of guides to help businesses prepare for that change, which will bring with it a new court system, the Unified Patent Court (UPC), for litigating unitary patents and European patents that are not opted-out of its jurisdiction.

Like with the unitary patent regime, where patent protection across the 17 states will be able to be obtained via a single, centralised application process, the Commission’s SPC reforms envisage the establishment of a new centralised procedure under which the European Union Intellectual Property Office (EUIPO) would be responsible for examining and, if appropriate, granting applications for unitary SPCs.

The centralised procedure would also become the main route through which national SPCs are applied for in future. In those cases, the EUIPO would issue a binding opinion on whether the conditions for protection have been met in each EU member state designated in the application, but it would remain up to national patent offices to formally grant national SPCs.

Provision is also made in the proposals for third-party observations and opposition proceedings to be raised against centralised or unitary SPC applications before the EUIPO pre-grant, with an obligation for the EUIPO to issue an opposition decision within six months, unless there is a particular complexity. An appeals process is also provided for, with a dedicated Board of Appeal and further appeals possible to the EU General Court and ultimately to the CJEU, which could raise concerns in terms of the timing for such a judicial review, while in the meantime SPC applications remain pending.

Additionally, the EUIPO would have jurisdiction to hear revocation actions against unitary SPCs that have been granted, with again a six-month deadline to issue a decision on validity, unless there is a particular complexity. Fabre said: “To me, this is the most surprising provision of the new regulations. This was not anticipated and raises questions as the Unified Patent Court, which is about to open its doors, would seem the natural forum for these actions and this seems to contradict the objective to address fragmentation.”

Provision is made in the proposals for representatives of national patent offices to be involved in the panel responsible for examination, opposition and invalidation before the EUIPO.

Charlotte Weekes of Pinsent Masons said: “The UK’s SPC legislation is currently the same as the EU Regulation. Whilst the basis on which SPCs are granted is not set to change, in light of the EU’s new proposals there is the potential for divergence and for the development of UK case law which differs even to those matters that have been incorporated into the recitals of the recast regulations for clarification purposes. The UK will not be obliged to implement changes proposed by these draft regulations and there could be a requirement for entirely new law to be required if the Retained EU Law Bill proceeds in such a way as to sunset EU derived legislation. How aligned the UK will seek to be remains to be seen.”

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