European Bolar Provisions in Poland

1. How is Bolar implemented?

The Bolar provision was introduced in Poland before such exemption was introduced into EU law. It has been implemented into the Act of 30 June 2000 – Industrial Property Law and reads as follows: 

“A patent is not infringed by the use of an invention in making, using, keeping, storing, offering, placing on the market, exporting or importing, in order to carry out acts which by law are required in order to obtain, including by a third party, registration or authorisation as required for placing on the market certain products by virtue of their intended use, in particular medicinal products, within the European Economic Area or in another country.”

2. How does the Bolar provision work?

As a rule, the Bolar provision enables third parties (e.g. manufacturers of generic medicinal products) to carry out activities required to obtain a marketing authorisation. 

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

The Bolar exemption is restricted to generic MAs, but the Polish provision implementing Bolar indicates different exemptions beyond just studies, i.e.:

  • making,
  • using,
  • keeping,
  • storing,
  • placing on the market,
  • exporting, or
  • importing a product

under the condition that the said activities are carried out to obtain a marketing authorisation. Because of such a broad catalogue of permissible activities – a third party (e.g. manufacturer of generic medicinal products) can conduct studies, clinical trials or manufacture an active substance. Technically, an innovator company may also be able to use the Bolar exemption provided that they are using it for the purposes of a generic MA only.

4. Has Bolar been litigated in your jurisdiction?

Yes. Bolar has been litigated in Poland since its implementation. To the best of our knowledge, there have only been a few cases based on this provision.(all of them before the Bolar exemption was amended in 2019). Despite that some points presented in case law are still up-to-date, including that:

  • The essence of the exception is that it allows a generic manufacturer to conduct bioequivalence testing while the patent is still in force.
  • The national legislature is only empowered to regulate events that fall within its jurisdiction. In view of this, it may authorize the use of an invention without the consent of the patentee within the scope of the Bolar exception only with respect to acts relating to registration or authorization that would be granted within its jurisdiction.

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

Since the amendment in 2019, the Polish Bolar provision directly states that it is permissible to carry out activities required to obtain a registration or an authorisation within the European Economic Area or in another country.

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

The Polish Bolar provision does not directly limit entities that can carry out activities within this exemption. The provision only generally refers to “third parties”. This could potentially cover various entities, including a generic manufacturer itself, a third-party contractor or even a subcontractor.