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Serbia

European Bolar Provisions in Serbia

Table of contents
  1.  How is Bolar implemented?
  2. How does the Bolar provision work?
  3.  Is Bolar restricted to exempting studies for generic marketing authorisations?
  4.  Has Bolar been litigated in your jurisdiction?
  5.  Are exempted activities covered by a local exemption regardless of where regulatory approval is ultimately sought? 
  6.  Does Bolar extend to a third party who assists the MAH in carrying out the activities? 
Serbia
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1. How is Bolar implemented?

The Bolar provision is implemented in Article 21 of the Serbian Law on Patents (“Law”). This Article stipulates that exclusive rights of the patent holder shall not apply to research and development activities relating to the subject matter of protected invention, including activities that are necessary for obtaining an authorisation from the competent authority for placing on the market a product which is a drug intended for use on humans or animals, or a medicinal product or plant protection products defined by the law regulating plant protection products. 

How does the Bolar provision work?

This exemption shall apply only if they do not conflict with normal exploitation of the patent or petty patent, and do not unreasonably prejudice the legitimate interests of right holders, taking into account the legitimate interests of third parties. 

3. Is Bolar restricted to exempting studies for generic marketing authorisations?

The Law contains no such exemption and does not differentiate between marketing authorisations for branded and generic medicines.

4. Has Bolar been litigated in your jurisdiction?

We are not aware of any dispute regarding this provision.

5. Are exempted activities covered by a local exemption regardless of where regulatory approval is ultimately sought? 

This exemption is applicable only for patents registered in Serbia. In that case the local exemption should cover research for submission to a body of a foreign country or placing a drug/ medicinal product or plant protection product on the market of a foreign country.

6. Does Bolar extend to a third party who assists the MAH in carrying out the activities? 

Bolar should extend to a third party because such party is acting on behalf of MAH in carrying out the activities.