European Bolar Provisions in Portugal

1. How is Bolar implemented?

In Portugal, the Bolar provision was implemented through Article 18º, No. 4, Article 19º, No. 1 and implicitly in Article 25º, No. 1 of Decree-Law No. 176/2006 [Medicines Act], in force since 31 August 2006, as provided by Article 10, No. 6 of Directive 2004/27/CE.

Considering that high level of litigation concerning the effective implementation of the Bolar provision in Portugal, Article 19, No. 8 of the Medicines Act was amended through Law No. 62/2011 of 12 December, which expressly transposed Article 10, No. 6 of Directive 2004/27/CE.

2. How does the Bolar provision work?

Article 19, Paragraph 8 of the Medicines Act states that without prejudice to the provisions of Article 103 of the Industrial Property Code, approved by Decree-Law No. 110/2018 of 10 December, the necessary trials and studies required to be undertaken for the application of the (previous) numbers 1 to 6 and the consequential practical requirements shall not be regarded as contrary to patent rights or to supplementary protection certificates for medicinal products.

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

The Bolar exemption is restricted to activities relating to marketing approval of generic medicines, bioequivalents and biosimilars. Some doctrine also defends Portuguese law broadly exempt any act required for marketing approval, as well as acts relating to innovative medicines

4. Has Bolar been litigated in your jurisdiction?

In Portugal, the enforcement of the Bolar provision, as provided by Article 19, No. 8 of Decree-Law no. 176/2006 has never been litigated.

Previous implementation of the Bolar provision was heavily litigated in Portugal and its applicability was finally decided by the Supreme Administrative Court in a decision issued in January 2019 in a case taken to the Supreme Administrative Court by CMS Portugal.

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

To the best of our knowledge, the issue whether exempted activities are covered by a local exemption regardless of where regulatory approval is ultimately sought has not been addressed by the Portuguese applicable law and case law. 

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

To the best of our knowledge, the issue whether Bolar provision extends to a third party who assist the MAH in carrying out the activities and under what conditions has not been addressed by the Portuguese applicable law and jurisprudence.