European Bolar Provisions in Croatia

The Bolar exemption was introduced in the Croatian Patent Act in 2003. Hence, it existed in Croatian patent law even before it was introduced by Article 10(6) of Directive 2001/83/EC (as amended in 2004). The Bolar exemption is set out in Art 98, paragraph (1) point (2) of the Patent Act  that reads as follows: 

“The patent holder’s exclusive right of exploitation of the invention shall not apply to:

…..

(i)    acts done for the purposes of research and development and for experiments relating to the subject-matter of a patent or a supplementary protection certificate, including where such acts are necessary for obtaining authorisation for placing on the market a product that is a medicinal product intended for human and/or animal use.”

The Croatian wording of the Bolar exemption refers only to an exemption from infringement of patent rights (or supplementary protection certificates) for a medicinal product for human use. “Medicinal product for human use” has the meaning given by Article 1 of Directive 2001/83/EC. Therefore, there is a risk that the scope of the Bolar exemption under Croatian law would only extend to infringement of patents for medicinal products and not for the device or the combination product that (itself) does not qualify as a “medicinal product”. As far as we are aware, this point has not been tested in the Croatian or EU courts.

There are no procedural rules governing the application of the Bolar provision. 
The MAH applicant (or a third party acting on its behalf) can resort to the Bolar exemption provided that statutory requirements set out in Article 98, Paragraph (1), Point (2) of the Patent Act have been met. The statutory requirements are threefold:

1. The MAH applicant’s acts (or a third party’s acts) must be done for the purposes of research, development and/or for experiments;
2. The MAH applicant’s acts (or a third party’s acts) must be necessary for obtaining a marketing authorisation of a medicinal product; and
3. The medicinal product must be a medicinal product for human use (or animal use).

The Croatian wording of the Bolar exemption is not restricted to exempting studies for generic marketing authorisations but rather extends to (any) marketing authorisation for a human use medicinal product. In our view it also includes a marketing authorisation for an innovative human use medicinal product. However, under EU law, a Croatian court is required to construe Croatian law in light of the wording and the purpose of the Directive. Therefore, there is a risk that the scope of the Bolar exemption under Croatian law would only extend to infringement of patents for medicinal products authorised pursuant to Article 10(1) of Directive 2001/83/EC (and not for innovative medicinal products). As far as we are aware, this point has not been tested in the Croatian courts.

The Bolar exemption has not been litigated in our jurisdiction. 

The Croatian wording of the Bolar exemption does not define in which country regulatory approval should be ultimately sought. We are of the view that exempted activities should be covered by (local) Bolar exemption even if a regulatory approval is sought in an EU country other than Croatia. 

There is still uncertainty as to whether third party carrying out acts on behalf of the ultimate marketing authorisation applicant qualify for protection under this exemption. We are of the view that the wording of the Croatian Bolar exemption is sufficiently neutral in the sense that there is no explicit suggestion that only the marketing authorisation applicant may avail itself of this exemption. But, as far as we are aware, this point has not been tested in the Croatian courts.