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What is a supplementary protection certificate?

A supplementary protection certificate may be granted where a basic patent has been granted for a medicinal product intended for humans or animals or for a plant protection product, the marketing of which requires prior authorization of the competent authority. A basic patent is the patent which has been designated by its holder for the purposes of the procedure for the grant of a supplementary protection certificate and which protects a product as such or the process for obtaining a product or the application of a product.

The subject-matter of the protection conferred by the certificate shall be only a product covered by the marketing authorization for a medicinal product intended for humans or animals or for a plant protection product, and for any use of such product as a medicinal product intended for humans or animals or as a plant protection product, that was authorized before the expiry of the certificate.

The effects of the certificate take effect immediately after the expiration of the lawful term of the basic patent. A supplementary protection certificate confers to a holder the same rights as are conferred by a patent and, analogously, such rights are subject to the same limitations.

What are the conditions for obtaining the certificate?

The certificate is granted at the request of the holder of a basic patent, if the following conditions are fulfilled on the day of filing the application for the grant of the certificate:

  • a medicinal product intended for humans or animals or a plant protection product is protected by a basic patent in force,
  • a marketing authorization has been issued for a medicinal product intended for humans or animals or a plant protection product and it is valid,
  • a basic patent for a medicinal product intended for humans or animals or a plant protection product has not already been the subject of the certificate,
  • the application for a basic patent was filed in Bosnia and Herzegovina after August 27, 2002,
  • the first market authorization for a medicinal product intended for humans or animals or a plant protection product was issued after the date 1st January 2011.

The application for the grant of a certificate is filed with the Institute for Intellectual Property of Bosnia and Herzegovina (IP Institute) within six months from the date of issuing the market authorization for a medicinal product intended for humans or animals or a plant protection product, and if the authorization is granted before the grant of the basic patent, within six months from the date of publication of the grant of the patent.

What is the term of protection of the certificate?

The rights conferred by the certificate may run for a period equal to the period which elapsed between the date of filing the application for a basic patent and the date of issuance of the first market authorization for a medicinal product intended for humans or animals or a plant protection product protected by such patent, reduced by five years. The certificate has a maximum time of five years from its coming into force.

The life time of the certificate is specified by the decision of the IP Institute.

Contact

Kerim Karabdic, LL.B.

Kerim Karabdic, LL.B.

Attorney At Law

  • Corporate, Commercial, M&A
  • Real Estate & Construction
  • Labor & Employment
  • Litigation/Dispute Resolution

kerim.karabdic@doklestic.law

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