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

  1. Heya i’m for the first time here. I came across this board
    and I find It really useful & it helped me out a lot.
    I am hoping to provide something back and help others like
    you aided me.

  2. Nice post. I learn something more challenging on totally different blogs everyday.
    It is going to always be stimulating to learn content from
    other writers and follow somewhat something from their store.
    Id choose to make use of some with the content on my weblog whether or not you dont
    mind. Natually Ill provide you with a hyperlink in your net blog.
    Thanks for sharing.

  3. Nice post. I used to be checking constantly this blog and I’m inspired!
    Extremely helpful information particularly the remaining
    phase 🙂 I take care of such info much. I was seeking
    this particular information for a very long time. Thanks and best of luck.

  4. Do you mind if I quote a few of your posts as long as I provide
    credit and sources back to your webpage? My blog site is
    in the exact same area of interest as yours and my
    visitors would certainly benefit from some of the information you present here.
    Please let me know if this ok with you. Regards!

  5. Hi! I know this is kinda off topic however , I’d figured I’d ask.
    Would you be interested in exchanging links or maybe guest writing a blog post or vice-versa?
    My blog covers a lot of the same topics as yours and I believe we could greatly benefit from each other.
    If you’re interested feel free to send me an email. I look forward to hearing
    from you! Terrific blog by the way!

  6. Wow that was unusual. I just wrote an incredibly long comment but after I clicked submit
    my comment didn’t show up. Grrrr… well I’m not writing all that over again. Anyway, just wanted to say wonderful blog!

    • Thank you so much Fernando for your comment. I am so sorry your long comment was not uploaded. Do you want to share what you said? Thanks so much for reading the blog! Best, Lisa

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out / Change )

Twitter picture

You are commenting using your Twitter account. Log Out / Change )

Facebook photo

You are commenting using your Facebook account. Log Out / Change )

Google+ photo

You are commenting using your Google+ account. Log Out / Change )

Connecting to %s