What is a supplementary protection certificate?
The protection conferred by a protection certificate is an extension of the duration of part of the basic patent. Despite being dependent on the basic patent, it is an industrial property right with a scope of protection of its own.
Who is entitled to apply for a protection certificate?
A protection certificate is granted to the holder of the basic patent or his/her successor in title.
What are the conditions for obtaining a protection certificate?
• the product is protected by a basic patent in force
• a valid authorization for placing the product on the market as a medicinal product has been granted in accordance with Directive 65/65/EEC or Directive 81/851 EEC (medicinal product) or in accordance with Article 4 of Directive 91/414/EEC (plant production products), respectively
• the applicant (proprietor of the basic patent) has not yet been granted a certificate for the product
What is “the first authorization for placing the product on the market”? And what about CH/LI?
If the above stated authorization for placing the product on the market is not the first authorization for placing the product on the market in the Community, the latter also needs to be stated in the application. The first authorization for placing the product on the market in a member state of the EEA is seen as the first authorization for placing the product on the market in the Community. This causes problems with respect to the authorization for placing the product on the Swiss market. In general, authorizations for placing the product on the Swiss market are also valid in Liechtenstein. Unlike Liechtenstein, Switzerland is not a member of the EEA. Because authorizations for placing the product on the Swiss market automatically also apply to Liechtenstein, they are regarded as first authorizations for placing the product on the market in the Community (ECJ C-207/03). Having taken this into account, Liechtenstein’s competent authority is now keeping a list that states medicinal products the authorization of which in Switzerland does not automatically apply to Liechtenstein. The authorization of medicinal products stated on this list in Liechtenstein is recognized after 12 months (additional agreement of 23 May 2006 concerning the validity of the Swiss law on medicinal products in Liechtenstein of 11 December 2001 on the authorization of medicinal products including novel active ingredients).
When and where must an application take place?
The application needs to be filed with the Austrian Patent Office. The application must be filed by no later than six months after the first authorization for placing the product on the Austrian market has been granted. However, if a patent was granted after the first authorization for placing the product on the Austrian market, the application must be filed by no later than six months after the patent has been granted.
What is the duration of the protection certificate? And how is it computed?
The period of protection of the protection certificate starts after the basic patent has expired. The period is computed from the period of time that passes between filing the application for the basic patent and the first authorization for placing the product on the market in the EEA minus a period of five years. The maximum period of protection is, however, five years. So, if the first authorization for placing the product on the market in the EEA is granted within five years after having filed the application for the basic patent, the period of protection of the protection certificate is negative, which means that it will not be granted.
May the duration of the protection certificate be extended?
If the product is authorized as a medicinal product for paediatric use, a six-month extension of the period of protection may be lodged (Article 36 of Regulation (EC) No 1901/2006). This application may be made when lodging the application for a certificate or when the application for the certificate is pending and the appropriate requirements are fulfilled. If a certificate has already been granted, the application for an extension is to be lodged no later than two years before the expiry of the certificate, unless Regulation (EC) No 1901/2006 has not been in force for five years, in which case the application for an extension must be lodged no later than six months before the expiry of the certificate.
How is the scope of protection defined?
The protection granted by the protection certificate applies to the product that is included in the authorization for placing the respective medicinal product on the market. If a basic patent is applicable to an active ingredient and its derivatives (salts and esters) the protection certificate grants the same protection (see ECJ C-392/97, “Idarubicin”).
With respect to derivatives of proteins as active ingredients that lie in the scope of protection of the basic patent it has to be clearly specified and thoroughly examined whether these derivatives may be regarded as minor modifications of the active ingredient, thereby falling into the scope of protection of the protection certificate (cf. decision taken by the Appeals Division of the Austrian Patent Office of 3 October 2002, B 22/1995).
Will the application be examined?
A protection certificate is granted without examining whether the product already is subject of a certificate issued by the Austrian Patent Office and whether the authorization presented is the first authorization for placing the product on the Austrian market.
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