Supplementary Protection Certificates and Pediatric Extensions in Croatia

On July 1, 2013, Croatia became the 28th member of the European Union (EU). With a view to its accession to the EU, Croatia amended its laws to provide for Supplementary Protection Certificates (SPCs) for medicinal (human and animal) and plant protection products as well as pediatric extensions.

The requirements for obtaining an SPC in Croatia are:

1. The medicinal or plant product must be protected by a “basic” patent that is still in force;

2. A valid marketing authorization has been granted in Croatia and is the first authorization to market the product as a medicinal or plant product in Croatia; and

3. The product has not already been the subject of a certificate in Croatia.

The length of an SPC is calculated from the filing date of the “basic” patent until the date of grant of the first marketing authorization in the EU, minus five years. The maximum duration of an SPC is five years.

A “basic” patent is any patent which, in the country where the SPC is applied for, protects an active ingredient (AI) forming the subject-matter of the marketing authorization and of the SPC. The patent may claim the AI as such. Alternatively, it may claim a formulation comprising the AI, a process for preparing the AI or the formulation, a medical or agrochemical use of the AI or of the formulation, etc. The “basic” patent to be used as the basis for an SPC can be designated by its holder; in other words, if a company owns more than one patent for a certain AI in Croatia, that company will be able to choose which of such patents to designate as the “basic” patent (provided that the grant date of such “basic” patent still allows for the filing of an SPC in Croatia).

An application for an SPC must be filed six months from the date of grant of the local marketing authorization or, if the marketing authorization has been granted before the grant of the “basic patent”, within six months from the date of the publication of the mention of grant of the patent. Additionally, there is a six month transition period that expires on January 1, 2014. During this transition period, the owner of a “basic” patent in Croatia can apply for an SPC provided that the relevant first marketing authorization was granted on or after January 1, 2003. Patent owners with patents in Croatia covering medicinal and plant products should review their products to see whether any marketing authorizations were received on or after January 1, 2003 which may allow for an SPC to be filed before the deadline of January 1, 2014.

An application for an SPC in Croatia should include the following information and enclosures:

1. Information on the requester and its representative;

2. The patent number of the “basic” patent and the title of the invention;

3. The number and date of the first authorization to place the product on the market in Croatia; and if the authorization in Croatia is not the first authorization to place the product on the market in the EU, the number and date of that authorization; and

4. Proof of payment of the prescribed fee.

Additionally, it is possible to apply for a pediatric extension of an SPC for an additional six months. A request for a pediatric extension can be filed simultaneously with an SPC application if the applicant has received notice of compliance with a pediatric investigation plan or up to two years before the expiration date of the SPC.

This post was written by Lisa Mueller and Micaela Modiano of Modiano & Partners

12 thoughts on “Supplementary Protection Certificates and Pediatric Extensions in Croatia

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