European Bolar Provisions in Belgium

1. How is Bolar implemented?

The Bolar provision of Article 10 of EU Directive 2004/27 is implemented by Article 6bis §1 of the Medicinal Products Act of 25 March 1964, the last paragraph of which reads:

“Performing the necessary studies, tests and trials to comply with the requirements and rules  meant in  paragraphs 1 to 7 [i.e. requirements for obtaining a marketing authorization] and all practical consequences thereof are not considered to constitute an infringement of the patents and the supplementary protection certificates for medicinal products for human use.”

2. How does the Bolar provision work?

Under the Bolar provision, pharmaceutical companies seeking regulatory approval for their generic pharmaceuticals are allowed to prepare the actions required to obtain the marketing authorisation, even if the patent protection for the original pharmaceutical or the original active ingredient is still active. The patent owner cannot prevent pharmaceutical companies from preparing the launch of their generic pharmaceuticals.

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

Yes, but the Code of Economic Law contains an additional, more general exemption: the exclusive rights of the patent owner do not include the right to prevent activities with or on the patented subject matter for scientific purposes (Art. XI.34 §1.b). 

4. Has Bolar been litigated in your jurisdiction?

There is only one reported case. In his decision of 11 July 2014, the president of the Enterprise Court of Mons ruled that a successful defence on the basis of the Bolar exemption requires the availability on the market of the reference medicinal product. If it is not available, the Bolar exemption cannot be used, but the general “for scientific purposes” exemption of the patent act can be used (Art. XI.134§1.b of the Code of Economic Law).  (President of the Enterprise Court of Mons, 11 July 2014, docket number A/14/501, Henogen versus Theravectys, not published)

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

The activities are only covered by the exemption if the regulatory approval is ultimately sought in Belgium or in another EU member state.

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

Legal scholars have responded positively to this question, but there is no case law confirming this view.