This document is an excerpt from the EUR-Lex website
Supplementary protection certificates for medicines and plant protection products
- Date of last review:
- 10/10/2019
- Initial creation date:
- 24/09/2009
- Summary code:
-
- 03.10.00.00 Pesticides & fertilisers
- 24.03.03.00 Pharmaceutical and cosmetic products
- 24.06.03.08 Inventions, trade marks & designs
- 29.13.01.00 Medicines for human use
- 03.10.00.00 Pesticides & fertilisers
- EUROVOC descriptor:
- Directory code:
- Summarised document(s):
- Author:
- Publications Office of the European Union
- Responsible entity(ies):
- Directorate-General for Internal Market, Industry, Entrepreneurship and SMEs
Supplementary protection certificates for medicines and plant protection products
SUMMARY OF:
Regulation (EC) No 1610/96 — supplementary protection certificate for plant protection products
Regulation (EC) No 469/2009 — supplementary protection certificate for pharmaceutical products
WHAT IS THE AIM OF THESE REGULATIONS?
- They provide additional protection for specific patented pharmaceutical and plant protection products that have been approved for sale.
- Amending Regulation (EU) 2019/933 introduced a manufacturing waiver to the protection given by a supplementary protection certificate (SPC)1 for pharmaceutical products that allows EU-based companies to manufacture a generic or similar version of an SPC-protected medicine during the term of the certificate:
- either for exporting to a non-EU market; or
- for stockpiling during the final 6 months of an SPC, ahead of entry into the EU market.
- This European Union protection is designed to even out any disparities and shortcomings in national pharmaceutical and plant protection product patent systems.
KEY POINTS
- Any pharmaceutical or plant protection product may receive an SPC, where:
- it is protected by a national patent (the basic patent);
- it must have national or EU authorisation before it may be sold (marketing authorisation); and
- it does not already have a certificate.
- The SPC confers the same rights as those provided by the basic patent, apart from the limitations of the manufacturing waiver explained above.
- The SPC application must be lodged with the relevant national industrial property office:
- within 6 months of the marketing authorisation being granted; or
- where the marketing authorisation is granted before the basic patent is granted, within 6 months of the date on which the patent is granted.
- The SPC takes effect when the basic patent expires, and is valid for up to 5 years. The overall protection a patent and an SPC can provide may not be more than 15 years from the granting of the first marketing authorisation.
- The SPC may be extended once for 6 months for pharmaceutical products for children where a paediatric investigation plan has been prepared. The overall protection provided is then 15,5 years.
FROM WHEN DO THE REGULATIONS APPLY?
- Regulation (EC) No 1610/96 has applied since , except in those countries whose national law did not cover the patentability of plant protection products, where it has applied since .
- Regulation (EC) No 469/2009 codifies Council Regulation (EEC) No 1768/92. It has applied since .
- Amending Regulation (EU) 2019/933 has applied since .
BACKGROUND
- The time between applying for a patent for a new pharmaceutical or plant protection product and receiving authorisation to place it on the market reduces the effective period of patent protection. The SPC aims to offset that reduction in the effective patent protection in these fields of research to encourage innovation and prevent these industries moving away from EU countries.
- For more information, see:
- Supplementary protection certificates (European Commission).
KEY TERMS
- Supplementary protection certificate: an intellectual property right for a specific product that acts as an extension of a patent.
MAIN DOCUMENTS
Regulation (EC) No 1610/96 of the European Parliament and of the Council of concerning the creation of a supplementary protection certificate for plant protection products (OJ L 198, , pp. 30-35)
Successive amendments to Regulation (EC) No 1610/96 have been incorporated into the basic text. This consolidated version is of documentary value only.
Regulation (EC) No 469/2009 of the European Parliament and of the Council of concerning the supplementary protection certificate for medicinal products (codified version) (OJ L 152, , pp. 1-10)
See consolidated version.
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