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Hungary

European Bolar Provisions in Hungary

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? 
Hungary
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1. How is Bolar implemented?

The present form of the Bolar exemption in Hungarian law was implemented in the Hungarian legal system by the amendment of Article 19 of Act XXXIII of 1995 on the Patent Protection of the Inventions (the “Patent Act”) in 2002, upon the adoption of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use. In addition, there are two government decrees of the Minister of Health covering the Bolar exemption.

2. How does the Bolar provision work?

The Bolar provision is regulated by the Patent Act. According to Article 19 of the Patent Act, on the basis of patent protection, the patentee has exclusive rights for use of the invention. However, the exclusive right of use shall not cover any experimental procedures relating to the subject of the invention, including any experimental procedures and research, which are needed for the licensing/obtaining the MA for generic products. The Bolar provision in the Patent Act is a rather loosely worded version of the exemption: it does not state any explicit restrictions regarding the personal, territorial and material scope of the provision, giving opportunity to a wide range of interpretation for courts and authorities.

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

No, the wording of Article 19 of the Patent Act states that any experimental procedures relating to the subject of the invention shall be exempt from the exclusive right for use of the invention. The afore-mentioned provision of the Patent Act only mentions as an example that such experimental procedures include experiments and studies for generic marketing authorisations but are not limited to those.

4. Has Bolar been litigated in your jurisdiction?

As of now, we have no information of the Bolar exemption being or having been the subject of a litigation procedure in Hungary.

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

Neither the Patent Act nor its ministerial reasoning is dealing with the issue of geographical location of the marketing authorisation. Therefore, according to our understanding, tests and experiments are falling within the scope of the Bolar exemption, irrespective of the location of the marketing authorisation to be obtained. However, as there is no case law in this respect, this interpretation has not been confirmed yet.

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

Although there is no established case law in this topic, we are of the view that Hungarian courts are likely to consider the Bolar exemption as an exemption personal to the party carrying out activities for experimental purposes such as conducting experiments, tests, studies or trials (“Testing Entity”). In summary, we are of the view that the Testing Entity can rely on the Bolar exemption, however other parties, like e.g., manufacturers, importers, etc. will probably not be covered by the Bolar exemption.