Supplementary protection certificate for medicinal products

Supplementary protection certificate for medicinal products

Outline of the Community (European Union) legislation about Supplementary protection certificate for medicinal products

Topics

These categories group together and put in context the legislative and non-legislative initiatives which deal with the same topic.

Internal market > Pharmaceutical and cosmetic products

Supplementary protection certificate for medicinal products

Document or Iniciative

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) (Text with EEA relevance).

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.

This Regulation codifies and repeals Regulation (EEC) No 1768/92.

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

Act Entry into force Deadline for transposition in the Member States Official Journal
Regulation (EEC) No 469/2009

6.7.2009

OJ L152 of 16.6.2009

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