On 11 June 2019 has been published in the Official Journal of the EU the Regulation (EU) 2019/933 of 20 May 2019, regarding the SPC manufacturing waiver.
The manufacturing waiver provisions will enter into force on the 20th day after publication, i.e. on 1 July 2019.
The introduction of an SPC manufacturing waiver had been endorsed in the EU’s single market strategy adopted in 2015 with the aim of boosting the competitiveness of Europe’s generics and biosimilar industry.
Accordingly, for SPCs that are applied for in the EU member states on or after 1 July 2019, it will be legal:
– the manufacturing of active ingredients and corresponding medicinal products for the purpose of export to third countries outside of the EU during the entire period of validity of the SPC;
– the manufacturing and stockpiling for day-1 entry to the EU market immediately after SPC expiry, during the last 6 months before SPC expiry.
Under the transitional regime, the manufacturing waiver will not affect SPCs that are already granted on 1 July 2019.
For SPCs that were applied for before 1 July 2019 but will be granted only afterwards, the manufacturing waiver will become applicable only after 3 years, i.e. from 2 July 2022 onwards.
To safeguard the SPC holders against abuses of the manufacturing waiver, generics and biosimilar producers wishing to rely on the manufacturing waiver must notify not only the national patent offices of those member states where production should take place but also to directly inform the SPC holder.