European Bolar Provisions in Austria

1. How is Bolar implemented?

Austria has implemented Bolar with a specific provision in Section 22, Paragraph 1 of the Patent Act 1970 which governs: 

“(...)The effect of the patent does not extend to studies and trials as well as the related practical requirements, insofar as they are necessary for obtaining a marketing authorization, approval or registration under pharmaceutical law.”

The Austrian Bolar provision became effective in November 2005 and implemented the EU Directives 2004/27/EC and 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 the related practical requirements which are necessary to obtain marketing authorisation, approval or registration in connection with the marketing of pharmaceuticals. However, the studies and trials must be necessary for the pharmaceutical regulatory approval process. Thus, there must be a direct connection between the studies/trials conducted and the market authorisation to be obtained. Trials/studies which are “nice to have” but not absolutely necessary do not benefit from the Bolar provision. 

The term “practical requirements” related to the trials and studies means any use of the patented invention which is necessary to create the conditions for carrying out the required studies or trials. This could, for instance, be production of the active ingredient to carry out the related trials and studies.  

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

No. Even though the background idea was to privilege companies developing generic pharmaceuticals, Section 22, Paragraph 1 of the Patent Act 1970 does not govern this as a restriction. Thus, Bolar privileges are applicable on trials and studies to obtaining marketing authorisation for any pharmaceutical. 

4. Has Bolar been litigated in your jurisdiction?

No, there are no Higher Regional Court or Supreme Court decisions in Austria on the Bolar provision. However, please note that the Court of First Instance decisions, in the present case the Vienna Commercial Court, are only available to the public in exceptional cases. 

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

The Austrian 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. 

The Austrian Bolar provisions do not govern any geographical limitations. As these provisions are based on EU Directives, the activities are privileged irrespective of whether the regulatory approval is sought in Austria, the EU or another EU member state. In respect of non-EU countries, there is currently no case law, scholarly opinion or guidance as to whether the Austrian Bolar provisions are applicable where marketing authorisation is sought in a non-EU country. The corresponding Bolar provision under German law explicitly states that obtaining marketing authorisations in non-EU countries is covered by German Bolar provisions, and it is likely that the Austrian courts would follow this direction.

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

There is no Austrian case law in this regard. 

However, under German case law, the Higher Regional Court Düsseldorf has ruled in its decision dated 5 December 2013 (I 2 U 68/12) that third parties’ conduct may be privileged by Bolar, but only if the third party may reasonably assume that his assistance is solely to be used for Bolar privileged trials and studies. Besides, the third party must take its own measures to prevent their assistance being used for non-privileged trials and studies. 

We note that the Higher Regional Court Düsseldorf has originally initiated a CJEU preliminary ruling procedure to further clarify the extent of a third party’s conduct when it comes to the Bolar provision. However, the Higher Regional Court Düsseldorf itself has informed the CJEU by letter of 2 April 2014 to withdraw the application to initiate a preliminary ruling procedure. Therefore, the CJEU has not decided in substance on this case (CJEU 7 May 2014, C-661/13). 

Since the above-described Higher Regional Court Düsseldorf decision is currently the only case law in the region relating to Bolar provisions, it is likely that Austrian Courts will adopt a similar position