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Slovenia

European Bolar Provisions in Slovenia

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? 
Slovenia
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1. How is Bolar implemented?

Slovenia has implemented Bolar in the Medicinal Products Act (Zakon o zdravilih Official Journal 17/14 and 66/19), which stipulates in Art. 45 Paragraph 9 (and thereby implements EU directive 2004/27/EC) “Notwithstanding the provisions of regulations governing the patent rights or the rights of a supplementary protection certificate for a medicinal product, the implementation of studies necessary to comply with the  requirements of this Act and other requirements related to the acquisition of marketing authorisation shall not be  deemed to be a violation of patent rights or the rights arising from a supplementary protection certificate for a  medicinal product.”. The same wording is used in Art. 46 Paragraph 10, which thereby implements EU directive 2004/28/EC

2. How does the Bolar provision work?

The background of the Bolar provision is to offer pharmaceutical companies the possibility to research and start preparatory acts to seek regulatory approval for (generic) pharmaceuticals even when patent protection for the original pharmaceutical (or the original active ingredient) is still active. 

Thus, patent protection does not extend to studies and trials as well as other requirements which are necessary to obtain marketing authorisation, approval or registration in connection with the marketing of pharmaceuticals. 

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

No, Bolar privileges are applicable on trials and studies to obtaining marketing authorisation for any pharmaceutical.

4. Has Bolar been litigated in your jurisdiction?

So far there have been no cases published regarding this matter.

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

The Slovenian Bolar provision does not differentiate where the regulatory approval is ultimately sought. Thus, privileged activities by Bolar may be carried out irrespective if regulatory approval is sought on EU or national level.

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

There is no Slovenian case law in this regard.