Pharmaceutical companies are a step closer to being able to obtain new unitary supplementary protection certificates (SPCs) that have direct effect across large parts of the EU after MEPs endorsed plans for their introduction.
At a plenary session late last month, the European Parliament adopted its negotiating position on legislative reforms that, if implemented, would provide the underlying legal framework for unitary SPCs in the EU. The move is just the latest step in a legislative process that began with proposals tabled by the European Commission last year and which requires the MEPs to strike a deal with the EU’s other law-making body, the Council of Ministers, on the text proposed.
SPCs are intellectual property rights that extend patent protection normally 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.
In April 2023, the European Commission published two draft new EU regulations seeking to establish the legal basis for unitary SPCs for medicinal products and plant protection products respectively, as well as a further two draft ‘recast’ regulations which would permit national SPCs to be filed and examined centrally. The Commission has said its plans would enable unitary SPC rights holders to 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.
Publication of the proposals represented the culmination of a programme of work that the Commission had undertaken in relation to potential reforms to the existing SPC legislation: it commissioned studies by the Max Planck Institute, published in 2018 and 2022; contemplated reforms as part of its November 2020 IP action plan and pharmaceutical strategy, which were published alongside an evaluation of the SPC Regulation; and 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”.
The Committee on Legal Affairs (JURI) has led the European Parliament’s scrutiny of the Commission’s proposals. In January, it approved proposed amendments to the Commission’s texts. Those proposed amendments have now been endorsed by all MEPs, providing rapporteurs from the JURI Committee a mandate to open negotiations with the Council and Commission with a view to reaching agreement on the final wording of the texts.
The central filing and examination procedure for unitary SPCs would be administered by the EU Intellectual Property Office (EUIPO). The Commission proposed that if the owner of a patent seeks to obtain a unitary SPC on the basis of a marketing authorisation held by a third-party, they must obtain the consent of that marketing authorisation holder to be eligible for the new right. The MEPs have now further proposed that the applicants should provide details of the consent they obtain within their application.
The MEPs have also proposed to adapt Commission proposals that would prevent multiple companies within the same pharmaceutical group each obtaining a unitary SPC in respect of the same medicinal product. The Commission proposed that the restriction apply to “economically linked” companies. The MEPs have proposed to define ‘economically linked’ as meaning “in respect of different holders of two or more basic patents protecting the same product, that one holder, directly or indirectly through one or more intermediaries, controls, is controlled by or is under common control with another holder”.
Other amendments proposed by the MEPs would introduce the potential for an “expedited procedure” for the EUIPO to issue its examination opinion in respect of a unitary SPC application. That procedure could be triggered “whenever duly justified for reasons of urgency”, under the MEPs’ plans.
The Kluwer Patent Blog has listed a range of other amendments that have been put forward by the JURI Committee.
Patent and life sciences experts Judith Krens and Marc Holtorf of Pinsent Masons, who are based in Amsterdam and Munich respectively, said the plans for new unitary SPCs in the EU would complement the existing framework for obtaining unitary patents, which is operational in 17 EU countries currently.
Krens said: “The unitary SPC would provide equivalent rights as the basic unitary European patent across all member states where the European patent is applicable, with uniform restrictions and obligations. Any alterations, transfers, cancellations, or invalidations of the unitary SPC would affect all member states collectively. Consequently, multiple patents for the same product couldn't secure several SPCs or unitary SPCs within the same member state.”
“The coverage would align with the European patent with unitary effect, encompassing only the 17 member states that have ratified the agreement on the unified patent jurisdiction. To address member states not covered by the European patent with unitary effect, the proposal introduces the option of a ‘combined centralised application’, merging national SPCs into the unitary SPC,” she said.
Holtorf added: “The centralised application procedure and the unitary SPC will address issues of legal uncertainty stemming from differing decisions of national offices. Another advantage could be the quicker market entry of generic or biosimilar products through easier access to information on existing SPC protection across the EU, facilitating strategic planning for product launches. The simplified SPC procedure is expected to reduce costs and administrative burdens as well – the European Commission’s own impact assessment suggests EU-wide SPC would cost 55% less than the existing system, resulting in savings of around €137,000 per product.”
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