Help Print this page 

Summaries of EU Legislation

Title and reference
Supplementary protection certificates for medicines and plant protection products

Summaries of EU legislation: direct access to the main summaries page.
Multilingual display
Text

Supplementary protection certificates for medicines and plant protection products

 

Regulation (EC) No 469/2009 — supplementary protection certificate for pharmaceutical products

Regulation (EC) No 1610/96 — supplementary protection certificate for plant protection products

WHAT IS THE AIM OF THESE REGULATIONS?

  • They provide additional protection for specific pharmaceutical and plant protection products which have a national patent and have been approved for sale.
  • This European Union protection is designed to remedy any disparities and shortcomings in national pharmaceutical and plant protection product patent systems.

KEY POINTS

  • Any product that is protected by a national patent and subject to national authorisation before it may be sold, and does not already have a certificate, may receive a supplementary protection certificate (SPC)*.
  • The SPC confers the same rights as those provided by the basic patent.
  • The SPC application must be lodged with the relevant national industrial property office within 6 months of the marketing authorisation being granted.
  • The SPC takes effect when the basic patent expires, and is valid for up to 5 years. In the case of pharmaceuticals, the SPC may be extended once for 6 months if a paediatric investigation plan has been prepared.
  • 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.

FROM WHEN DO THE REGULATIONS APPLY?

  • Regulation (EC) No 469/2009 codifies Council Regulation (EEC) No 1768/92. It has applied since 6 July 2009.
  • Regulation (EC) No 1610/96 has applied since 8 February 1997, except in those countries whose national law did not cover the patentability of plant protection products where it has applied since 2 January 1998.

BACKGROUND

  • The time between filing for a patent for a new medicinal or crop protection product and receiving authorisation for its sale reduces the effective period of patent protection. The SPC aims to offset that reduction in the effective patent protection for these 2 fields.
  • For more information, see:

* KEY TERMS

Supplementary protection certificate: a distinct (sui generis) intellectual property right that acts as an extension of a patent.

MAIN DOCUMENTS

Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products (codified version) (OJ L 152, 16.6.2009, pp. 1-10)

Successive amendments to Regulation (EC) No 469/2009 have been incorporated into the basic text. This consolidated version is of documentary value only.

Regulation (EC) No 1610/96 of the European Parliament and of the Council of 23 July 1996 concerning the creation of a supplementary protection certificate for plant protection products (OJ L 198, 8.8.1996, pp. 30-35)

See consolidated version.

last update 14.03.2017

Top