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Pharmaceuticals: Entry into force of the EU regulation 2019/933 introducing an SPC manufacturing waiver

24/06/2019

Supplementary Protection Certificates (SPC) in the European Union extend the market exclusivity provided by patents by up to five years.  


In the last few weeks, the European Parliament and the Council of the European Union adopted the controversial new regulation introducing an SPC manufacturing waiver for export and stockpiling.

  
This new regulation has been published in the Official Journal of EU on June 11, 2019 and will come into force on July 1st, 2019.


The main features of the SPC manufacturing waiver can be summarized as follows: 


- throughout the entire SPC lifetime, SPC will not confer protection against manufacturing of SPC-protected active ingredients and corresponding medicinal products for the purpose of export to third countries outside the EU;

  
- during the last six months before SPC expiry, SPC will not confer protection against stockpiling of SPC-protected active ingredients and corresponding medicinal products in order to place them on the EU market after SPC expiry; 


- a generics or biosimilar producer intending to benefit from the manufacturing waiver will have to notify the national patent office in which that manufacturing is to take place and inform the SPC holder no later than three months before the intended start of manufacture;  
- in the case of a product made for the purpose of export to third countries, the “EU export” logo will have to be affixed to its outer packaging and, where feasible, to its immediate packaging; 


- the SPC manufacturing waiver will apply to all SPCs filed on or after July 1st, 2019 but will not apply to a SPC  that has already taken effect at this date; for SPCs that were filed before, but take effect only after, the entry into force of this legislation, the manufacturing waiver will become applicable from July 1st, 2022 onwards. 


We thus advise for authorized products with a basic patent expiry date before July 1st, 2022 to file for the SPC application before July 1st this year. In the future, it may also be appropriate for SPC holders to implement systems for handling manufacturing notifications and to coordinate with Marketing Authorization holders if these are different entities. 
 

Eric BILHERE and Stijn LAGAERT

 

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