Regulation (EU) 2019/933 on Supplementary Protection Certificates (SPCs) entered into force on 1 July 2019. It amended Regulation (EC) No 469/2009 on SPCs by introducing a manufacturing waiver for generics and biosimilars within the EU.
A few observations to begin:
- The market has evolved significantly and the manufacture of generics and, in particular, of biosimilars, as well as the manufacture of their active ingredients, has grown considerably in countries outside the European Union (EU), where protection does not exist or has expired, to the detriment of companies within the EU;
- Regulation (EC) No 469/2009 prevents companies established within the EU from manufacturing generics and biosimilars, even for export to ‘third country’ (i.e. non-EU) markets where protection does not exist or has expired, and storing generic products and biosimilars before expiry of the SPC;
- Regulation (EC) No 469/2009 also makes it more difficult for European companies to enter the EU market immediately after the expiry of the SPC, unlike companies located in third countries where protection does not exist or has expired.
These circumstances have placed generic and biosimilar manufacturers established in the EU at a significant competitive disadvantage compared to manufacturers established in third countries that offer less or no protection.
Levelling the playing field
Regulation (EU) 2019/933 aims, through the manufacturing waiver, to restore a level playing field between manufacturers, while ensuring that the exclusive rights of SPC holders are guaranteed within the EU. The manufacturing waiver is part of a wider objective to strengthen the competitiveness of the European generic and biosimilar medicines industry.
As a result of this waiver the SPC no longer confers protection against certain acts, which would otherwise require the consent of the certificate holder. In particular, as of 1 July 2019, SPCs will no longer be allowed to ban:
- the manufacture of the active ingredients and medicinal products it covers for products intended for export to third countries, ie outside the EU, throughout the life of the SPC;
- during the last six months preceding the expiry of the SPC, the manufacture of the active ingredients and medicinal products it covers for products intended for marketing within the EU at the earliest the first day immediately after expiry of the SPC.
This regulation is applicable for all SPCs filed as of 1 July 2019. However, this Regulation does not have an impact on SPCs already in force on 1 July 2019, and for SPCs submitted before that date, the manufacturing waiver will only become applicable after three years, ie from 2 July 2022.
Safeguards for licensees
At the same time, safeguards for SPC licensees have been provided to prevent potential abuses of this manufacturing waiver, including requiring generic and biosimilar producers who wish to use this manufacturing exception to inform both the national patent offices of the EU member states in which the manufacture and the first related acts are to take place, and also the holder of the SPC directly. This information must reach the national office and the holder no later than three months before the date of the start of manufacture in the member state concerned, or at the latest three months before the first related act prior to that manufacture, which shall be otherwise prohibited under the protection conferred by the SPC, whichever is the earlier.
Further, the following new “EU export” logo must be affixed to the outer packaging and, where feasible, the immediate packaging of products made for the purpose of export to third countries outside the EU:
The European Commission is planning to assess the impact of this new exception by 1 July 2024 and every five years thereafter. In the meantime, we will closely monitor news on the implementation of this exception and its effects, and keep you informed of any event that may affect your company's strategies.