Revision of EU rules on pharmaceuticals, SPCs, SEPs and compulsory licensing during crises
On 26 and 27 April 2023 the European Commission published proposals revising current EU provisions, or introducing new ones, in the areas of pharmaceuticals, supplementary protection certificates (SPCs), standard essential patents (SEPs) and compulsory licensing of patents for crisis management.
The first proposal, published on 26 April, revises pharmaceutical legislation of the EU with the aim of making drugs more accessible and affordable.
Proposed amendments to current rules include a reduction, under certain conditions, of the protection term for data on patent-protected drugs, with the aim of enabling generic manufacturers to start marketing their immediately upon expiry of exclusive rights.
On 27 of April a package of proposals was presented on the following topics.
Supplementary protection certificates
In view of the unitary patent beginning operations on 1 June 2023, the European Commission has proposed the creation. of a unitary supplementary protection certificate (SPC), by introducing a single procedure and examination, to be carried out by the European Union Intellectual Property Office (EUIPO), for the granting of a national SPC for each state designated in the patent application, or of a unitary SPC with uniform validity in all states covered by the European patent with unitary effect.
Standard essential patents
Patents covering technology that has been declared essential to implement a technical standard (for instance 5G, Wi-Fi or Bluetooth) are known as standard essential patents (SEPs).
Since manufacturers of devices that comply with technical standards must necessarily make use of patented technology, agreements are in place to grant licenses on fair, reasonable and non-discriminatory (FRAND) terms.
The proposal aims to create a balanced system to make the mechanism for SEP licensing more transparent and equitable, aiming also to reduce litigation. One of the tabled solutions is the creation of a Competence centre at the EUIPO.
Compulsory licensing for crisis management
Compulsory licensing enables national authorities to legitimise the use of a patent without permission from the patent holder under certain conditions. Currently the 27 member states of the European Union each apply their own national laws on the subject.
The European Commission’s proposal aims to create an EU-wide instrument to be used during crises (for instance a new pandemic) to authorise the use of patented solutions, should voluntary licensing prove impossible.
All of the above proposals must now be examined by the European Parliament.