Regulation 2009/469 - Supplementary protection certificate for medicinal products (Codified version) - Main contents

Supplementary protection certificates for medicines and plant protection products

REGULATION (EC) NO 1610/96 — SUPPLEMENTARY PROTECTION CERTIFICATE FOR PLANT PROTECTION PRODUCTS

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?

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  They provide additional protection for specific patented pharmaceutical and plant protection products that have been approved for sale.
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  Amending Regulation (EU) 2019/933 introduced a manufacturing waiver to the protection given by a supplementary protection certificate (SPC)* 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:

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    either for exporting to a non-EU market; or
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    for stockpiling during the final 6 months of an SPC, ahead of entry into the EU market.

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  This European Union protection is designed to even out any disparities and shortcomings in national pharmaceutical and plant protection product patent systems.

KEY POINTS

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  Any pharmaceutical or plant protection product may receive an SPC, where:

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    it is protected by a national patent (the basic patent)
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    it must have national or EU authorisation before it may be sold (marketing authorisation); and
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    it does not already have a certificate.

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  The SPC confers the same rights as those provided by the basic patent, apart from the limitations of the manufacturing waiver explained above.
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  The SPC application must be lodged with the relevant national industrial property office:

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    within 6 months of the marketing authorisation being granted; or
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    where the marketing authorisation is granted before the basic patent is granted, within 6 months of the date on which the patent is granted.

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  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.
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  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?

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  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.
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  Regulation (EC) No 469/2009 codifies Council Regulation (EEC) No 1768/92. It has applied since 6 July 2009.
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  Amending Regulation (EU) 2019/933 has applied since 1 July 2019.

BACKGROUND

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  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.
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  For more information, see:

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    Supplementary protection certificates (European Commission).

MAIN DOCUMENTS

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)

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 6 May 2009 concerning the supplementary protection certificate for medicinal products (codified version) (OJ L 152, 16.6.2009, pp. 1-10)

See consolidated version.

RELATED DOCUMENTS

Regulation (EU) 2019/933 of the European Parliament and of the Council of 20 May 2019 amending Regulation (EC) No 469/2009 concerning the supplementary protection certificate for medicinal products (OJ L 153, 11.6.2019, pp. 1-10)

last update 14.03.2017

This summary has been adopted from EUR-Lex.