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Supplementary protection certificate for medicinal products

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The European Union intends to provide sufficient protection for the development of medicinal products in the interest of public health and also to encourage pharmaceutical research. In view of the above, this Regulation creates a supplementary protection certificate for medicinal products at Community level which makes it possible to rectify disparities in the national systems.

ACT

Council Regulation (EEC) No 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products [See amending acts].

SUMMARY

The purpose of the supplementary protection certificate for medicinal products * is to remedy the disparities and shortcomings in national patenting systems for pharmaceutical research. It aims in particular to guarantee sufficient protection for the development of medicinal products in the European Union (EU).

Indeed, the period between the filing of a patent application for a new medicinal product and authorisation to place it on the market constitutes one of the factors which actually reduces the effective protection afforded by the patent and can compromise the amortisation of investment in research. The lack of sufficient protection can also lead research centres based in the Member States to relocate to countries offering better protection.

In order to also guarantee the free movement of medicinal products, the supplementary certificate for the protection of medicinal products also aims to prevent the development of too many disparities in national legislation.

The certificate is issued if the product for which it was requested, as a medicinal product and at the time when the application was filed in a Member State, meets the following conditions:

  • the product * is protected by a basic patent * in force;
  • the product, as a medicinal product, has been granted a marketing authorisation;
  • the product has not already been the subject of a certificate;
  • the marketing authorisation is the first authorisation to place the product on the market as a medicinal product.

Furthermore, the certificate applies to the product in the same way as the patent from which it benefits. The Regulation also specifies the arrangements relating to application for and granting of the certificate and likewise the conditions for lapse, invalidity and publicity of the certificate.

The certificate cannot be granted for a period exceeding five years. Furthermore, the duration of protection afforded by a patent and by the certificate cannot exceed 15 years overall for the holder's first marketing authorisation.

From 6 July 2009, this Regulation was repealed by Regulation (EC) No 469/2009.

Key terms in the Act
  • Medicinal product: any substance or combination of substances presented for treating or preventing disease in human beings or animals and any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in humans or animals.
  • Product: the active ingredient or combination of active ingredients of a medicinal product.
  • Basic patent: a patent which protects a product, a process to obtain a product or an application of a product, and which is designated by its holder for the purpose of the procedure for grant of a certificate.

REFERENCES

ActEntry into forceDeadline for transposition in the Member StatesOfficial Journal
Regulation (EEC) No 1768/92

2.1.1993

-

OJ L 182 of 2.7.1992

Amending Act(s)Entry into forceDeadline for transposition in the Member StatesOfficial Journal
Act of Accession of Austria, Finland and Sweden

1.1.1995

-

OJ C 241, 29.8.1994

Act of Accession of the Czech Republic, Estonia, Cyprus, Latvia, Lithuania, Hungary, Malta, Poland, Slovenia and Slovakia.

1.5.2004

-

OJ L 236 of 23.9.2003

Act of Accession of Bulgaria and Romania.

1.1.2007

-

OJ L 157 of 21.6.2005

Regulation (EC) No 1901/2006

26.1.2007

-

OJ L 378 of 27.12.2006

Last updated: 24.09.2009
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