European Bolar Provisions in Czech Republic

In the Czech Republic, Bolar exemption is regulated by Act No. 527/1990 Coll., on Patents and Innovation Proposals, as amended (the “Patents Act”), and by Act No. 378/2007 Coll., on Pharmaceuticals, as amended (the “Pharmaceuticals Act”). The regulation under the Patents Act provides for a broader experimental exemption to which Bolar is only part of, whereas the Pharmaceuticals Act specifies the conditions of the Bolar exemption in relation to marketing authorisation of generic products.

The Patents Act expressly states that “the rights of the owner of the patent shall not be infringed by use of the protected invention in acts relating to the subject-matter of the invention done for experimental purposes, including necessary experiments and tests under the Pharmaceuticals Act before the pharmaceutical is introduced to the market.” This means, simply speaking, that the rights of the owner of the patent shall not be infringed if the invention (protected by the patent) is used for experimental purposes under which fall also experiments and tests of a pharmaceutical before the pharmaceutical is placed on the market. The purpose of this provision is to protect activities carried out for the purpose of obtaining new knowledge, development and technological advance.

The above mentioned “experimental purpose” in general includes experiments with a scientific purpose rather than business purpose, i.e. experiments to acquire new knowledge, or, in relation to pharmaceuticals, to identify adverse effects. As there is no case law in the Czech Republic, the commentary literature refers to e.g. decisions in cases “BGH Klinische Versuche I.”, “Klinische Versuche II” or “ICI v. Pharbila and Mediopharma”.

Under the Pharmaceuticals Act an applicant of the generic MA is not required to submit reports of pre-clinical trials, clinical trials and safety and residue test. In addition, the Pharmaceuticals Act further states that performing other test which are necessary for obtaining the MA (e.g. pharmaceutical trials) will not infringe industrial property rights and trade secrets.

The reasoning report of the Pharmaceuticals Act refers to the Bolar exemption only in relation to the marketing authorisation of generic products. On the other hand, the Patents Act does not limit the use of the Bolar exemption only to the generic marketing authorisations, but in general to any marketing authorisations. As there is no case law or guidance issued by state authorities on this topic, it is difficult to assess whether Bolar relates exclusively to generic marketing authorisations.

The Bolar exemption is not heavily regulated in the Czech Republic and there has not yet been any relevant case law in this respect.

Although the Bolar rules under the Patents Act and the Pharmaceuticals Act are not 100% consistent with each other, we are of the opinion that in relation to pharmaceuticals, the Bolar exemption will apply only for the purpose of placing a pharmaceutical on the Czech market, i.e. for the registration of the pharmaceutical by the State Institute for Drug Control (obtaining regulatory approval). 

Neither the Patents Act nor the Pharmaceuticals Act require that the tests need to be performed by the same entity that will apply for the MA. Therefore, we are of the opinion that the Bolar provision can extend also to a third party who assists the MAH.