As part of a sweeping package of proposals concerning Standard Essential Patents, Compulsory Licensing and Supplementary Protection Certificates (SPCs) announced on 27 April 2023, the European Commission has moved one step closer to the creation of a new unitary SPC system. The proposals include a centralised SPC application process to complement the new unitary patent and UPC system (which come into force on 1 June 2023), whereby a single application could result in the grant of a unitary SPC (covering those 17 Member States currently participating in the unitary patent system) and of national SPCs in further Member States.
It has been just over a year since the European Commission announced a consultation on a new unitary SPC system (see my previous article "Is there a future for unitary SPCs?"). The options considered at that time included both non-legislative and legislative options. With this announcement, it appears that the European Commission have favoured the latter, with a total of four proposed regulations to cover the new system, including:
- Two Regulations that introduce a centralised procedure for the grant of national SPCs, by recasting and repealing the existing EU regulations (one for medicinal products and the other for plant protection products), and
- Two completely new Regulations creating a new unitary SPC (with the same centralised examination procedure), one for medicinal products and one for plant protection products.
The regulations will rely on the same principles (in particular the same SPC eligibility criteria) and on the same centralised examination procedure. As mentioned above, applicants will also be able to file a ‘combined application' with a view to the grant of both a unitary SPC and national SPC for additional Member States not covered by the unitary patent..
The proposals are set out in four new Explanatory Memorandums. We have not had time to digest these new proposals in detail, but a few headline points include that:
- The unitary SPC system does not replace the existing national systems. However, a given product cannot be protected by both a national SPC and a unitary SPC in the same Member State.
- Applicants will be able to file a ‘combined application' with a view to the grant of both a unitary SPC and national SPC for additional Member States not covered by the unitary patent.
- The eligibility criteria for unitary SPCs remain the same as the existing SPC system.
The proposed Regulations have not been confirmed and will still need to be discussed and agreed by the European Parliament and the Council of the European Union in view of their adoption and entry into force. They are also open for public feedback for a period of 8 week(s).