MEPs adopt their first reading position about EU supplementary certificates enabling longer protection of patented medicinal and plant protection products
These proposals on revision, modernisation and introduction of a system for unitary supplementary protection certificates complement the unitary patent system, which is a major step towards the completion of the single market for patents. They were announced as part of the ‘EU patent package’ in 2023, which also includes a new initiative on compulsory licensing and legislation on standard-essential patents.
Innovative medicines and pesticides should enjoy 5-year longer EU-wide patent protection on top of 20-year protection of patent to compensate for lengthy testing requirements before these products are placed on the EU market. Unitary supplementary protection certificates aim to cover costs invested into research of innovative substances at the EU level.
Single procedure
The unitary character of certificate should ensure that EU patent holders do not have to apply for extended protection in each member states separately, but can save costs and time by applying for an 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. Combined application would allow them to ensure protection of their patents at the national level in those EU countries, which have not joined the EU patent system. MEPs want the centralised application to be examined by one EUIPO member and two examiners from national patent offices with sufficient expertise and experience, who would be able to grant the certificate or refuse the application.
Easier procedure for plant protection products
Plant protection products can only be placed on the EU market with valid marketing authorisation and these are provided nationally at different times. MEPs thus want manufacturers of innovative plant protection products to be able to apply for EU certificate as soon as a marketing authorisation was granted in at least one EU country, which is part of the common patent system. MEPs also suggest the possibility of centralised authorisation procedure for plant protection products. They want the Commission to assess after five years whether such a procedure under the European Food Safety Authority would not be necessary and appropriate.
Electronic process for medicinal products
Manufacturers of innovative medicinal products already enjoy centralised procedure for obtaining marketing authorisations. It will therefore become basis for application for unitary protection certificate. MEPs want the manufacturers to be transparent in the process about public financial support received for development of their patented products. Given the importance of innovative medicines and vaccines in crises in particular, MEPs foresee the need for expedited examinations of medicinal products in some situations which should last four instead of the usual six months.MEPs also want certificate application and related exchanges on appeal to be electronic while the format of submissions should be provided by EUIPO.
Following the plenary vote, rapporteur Tiemo Wölken (S&D, DE) said: “The new rules will benefit Europeans Industry by reducing the cost 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 and hence granting an SPC, providing predictability for both the innovative and generic industry.”
MEPs approved their position on unitary supplementary protection certificate for plant protection products with 516 votes in favour, 26 against and 74 abstentions and on supplementary protection certificate for plant protection products with 523 votes in favour, 26 against and 69 abstentions. European parliament position on unitary supplementary protection certificate for medicinal products was approved with 518 votes in favour, 29 against and 70 abstentions and on supplementary protection certificate for medicinal products with 526 votes in favour, 23 against and 70 abstentions.
Parliament is now ready to start talks with EU countries on the final shape of the legislation. The file will be followed up by the new Parliament after the European elections on 6-9 June.
