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Bosnia and Herzegovina

European Bolar Provisions in Bosnia and Herzegovina

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? 
Bosnia and Herzegovina
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1. How is Bolar implemented?

Bolar is implemented in Article 73 of the Patent Law (“Official Gazette of BiH,” No. 53/10).

2. How does the Bolar provision work?

The Bolar provision provided in the Directive 2001/83EC is implemented in Article 73 (Exceptions from the Exclusive Rights) of the Patent Law (“Official Gazette of BiH,” No. 53/10) as follows:
The patent holder’s exclusive right shall not apply to: 

  1. acts in which an invention is exploited for private and non-commercial purposes, 
  2. acts performed for research and development purposes, and for experiments relating to the subject matter of the protected invention, including the acts necessary for obtaining registration or marketing authorization for the product which is a medicine intended for humans or animals or a medicinal product, 
  3. direct or individual preparation of a medicine in a pharmacy on the basis of an individual medical prescription and procedures relating to the medicine so prepared. 

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

No, Bolar is not restricted to generic marketing authorisations. Please refer to answer under question number 2. 

4. Has Bolar been litigated in your jurisdiction?

We are not aware of any viable practice regarding respective Bolar provisions in Vosnia and Herzegovina.

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

To the best of our knowledge, the issue whether exempted activities are covered by a local exemption regardless of where regulatory approval is ultimately sought has not been addressed by the applicable law and case law in Bosnia and Herzegovina. 

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

To the best of our knowledge, the issue of whether exempted activities are covered by a local exemption regardless of where regulatory approval is ultimately sought has not been addressed by the applicable law and case law in Bosnia and Herzegovina. We are of the view that Bolar should extend to a third party because such party is acting on behalf of MAH in carrying out the activities. However, as there is no case law in this respect, this interpretation has not been confirmed yet.