Supplementary Protection Certificates
The European Parliament defines its negotiating position.
UM – 02/2024
When the European
Parliament meets in Strasbourg on 27 February, it will also adopt its
position on most of the dossiers enshrined in the legislative package for the protection
of intellectual property. These include the two dossiers on protection
certificates for medicinal products. The decision in the plenary meeting will be
based on the reports by Tiemo Wölken (S&D, DE) on the unitary Supplementary Protection Certificate and the revision
of the Regulation on the Supplementary Protection Certificate for medicinal
products, which were voted on by the responsible European Parliament's
Committee on Legal Affairs (JURI) on 24 January.
Competition vs. innovative ability
Even if further amendments are possible in
the plenary meeting, the JURI reports show the negotiating priorities with
which Parliament's negotiators will enter the trialogue. The guiding principle
for the MEPs in the committee was that, as with the reform of pharmaceutical
legislation, it is crucial to maintain a healthy balance between the timely
entry of generics and biosimilars and thus competition on the one hand, and the
preservation of the innovation and competitiveness of European pharmaceutical manufacturers
on the other.
Market presence via licence
Protection certificates act like patents
and protect an original preparation from competition. Their purpose is to
compensate the manufacturer for the sometimes long and complex procedures
required to obtain marketing authorisation for a product through additional
protection periods of up to five years. MEPs want to use the introduction of a unitary
European protection certificate as an opportunity to develop it into an
instrument that helps to ensure that new medicinal products are available on as
many markets as possible. To this end, the certificate holder should be able to
grant the rights from it by licence if there is no own interest in marketing
it.
Equal rights for all
However, in order to protect European manufacturers from competitive disadvantages, it should also be possible to restrict the rights arising from protection certificates. Namely, in cases where the medicinal product is to be manufactured exclusively for export to third countries. After all, the property rights would not apply to competitors from third countries either way. In these cases, it should be possible to manufacture the medicinal product without the consent of the certificate holder.
For more process efficiency
The JURI is also of the opinion that in
certain cases it may be necessary to bring about decisions on the granting of
supplementary protection certificates more quickly. An accelerated review
procedure is to be set up for this purpose. All applications, statements,
complaints and other administrative processes must be carried out
electronically to ensure procedural efficiency. The competent offices - the
European Union Intellectual Property Office (EUIPO) based in Alicante in the
case of the unitary European certificate and the national patent offices in the
case of national Supplementary Protection Certificates - shall be obliged to
decide on the applications within six months, or four months in case of an accelerated
procedure. The deadlines were apparently so important to the MEPs that they did
not want to leave their definition up to the implementing acts of the European
Commission.
Transparency is a must
The European Commission's draft regulations
already contained requirements for the establishment of registers - both for
the unitary supplementary certificate and for the certificates to be issued
nationally. In addition to the basic details of the application, these should
also summarise certificate validity periods and procedural information. JURI
urges that these registers be made publicly accessible and that they also
include information on direct public financial support for the development of
the product. However, the committee does not go as far as the Green MEPs did
with the pharmaceutical reform. The Green shadow rapporteurs had suggested that the dates of expiry of patent protection and regulatory protection be made transparent together. A demand that would see generic competition fostered, and which the DSV fully agrees on.
Perhaps this idea could be taken up in the trialogue on the reform of
intellectual property protection?