EU supplementary certificates should cut red tape and costs related to protection of patented medicinal and plant protection products.
To help patent holders cover the costs invested into research of innovative substances, MEPs of the Legal Affairs Committee approved their position on EU and supplementary protection certificates for medicinal products such as medicines and vaccines and plant protection products, such as innovative pesticides. These tools extend the 20-year term of patent by up to 5 years to compensate for the lengthy testing requirements before these products are placed on the EU market.
Just one application to EUIPO
Without EU certificate, patent holders of plant protection and medicinal products have to apply for extended protection in each member state separately. Since examination procedures differ between member states, so do the results. EU protection certificate should solve this problem thus cutting related costs and administrative burden and making the process more efficient. EU patent holders would be able to apply for EU certificate at the European Union Intellectual Property Office (EUIPO) and it would be applicable equally in all countries that have joint the EU patent system. Applicants could also lodge a combined application, which would allow them to ask not only for EU protection certificate but also for additional national certificates in countries, which are not part of the unitary patent system.
A centralised application can be filled in any official EU language and it would be examined by one member of the EUIPO and two examiners from the national patent offices. MEPs proposed several provisions clarifying requirements on examiners who should have sufficient expertise and experience. They would issue an examination opinion on granting the certificate or refusing the application. New rules also clarify procedures related to appeals, opposition and remedies and MEPs further specify their particular steps, strengthen their transparency and set related time limits.
Differing authorisation procedures for medicinal and plant protection products
For medicinal products, there is a centralised procedure for obtaining marketing authorisations which will become basis for application for unitary protection certificate. MEPs also insist that application and related exchanges on protection certificate for medicinal products should be electronic by default while EUIPO should make public the format of submissions. To protect innovation, MEPs also foresee expedited examinations for medicinal products in some situations.
Since marketing authorisations for plant protection products are granted at a national level at different times, MEPs suggest that application for EU certificate should be possible where a marketing authorisation in at least one EU country have been granted in which that basic patent has unitary effect. MEPs also suggest that the Commission should evaluate after five years whether the creation of a central authorization procedure for plant protection products under the European Food Safety Authority would not be appropriate and necessary.
Following the committee vote, rapporteur Tiemo Wölken (S&D, DE) said: “The new rules will benefit the European industry by reducing the costs and burden of obtaining or maintaining a supplementary protection certificate. Furthermore, thanks to the unitary nature we will remove the fragmentation that currently exists between member states when it comes to the implementation of the regulatory framework. This will provide predictability for both the innovative and generic industry.”
The Legal Affairs Committee approved its position on unitary supplementary protection certificate for plant protection products unanimously with 20 votes in favour and on supplementary protection certificate for plant protection products also unanimously with 20 votes in favour. Its position on unitary supplementary certificate for medicinal products was also approved unanimously with 23 votes in favour and on supplementary protection certificate for medicinal products also unanimously with 23 votes in favour.
If the Parliament as a whole adopts its position on these files, it will be ready to start talks with EU countries on the final shape of the legislation.
These proposals are part of the ‘EU patent package’ announced in 2023 which, besides the revision, modernisation and introduction of a system for unitary supplementary protection certificates includes a new initiative on compulsory licensing and legislation on standard-essential patents. These proposals also complement the unitary patent system, which is a major step towards the completion of the single market for patents.