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European Bolar Provisions in Italy

Table of contents
  1.  How is Bolar implemented?
  2.  How does the Bolar provision work?
  3.  Is Bolar restricted to exempting studies for generic marketing authorisations?
  4.  Has Bolar been litigated in your jurisdiction?
  5.  Are exempted activities covered by a local exemption regardless of where regulatory approval is ultimately sought? 
  6.  Does Bolar extend to a third party who assists the MAH in carrying out the activities? 
Italy
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1. How is Bolar implemented?

The Bolar exception provided for by Art. 10 of Directive 2001/83 has been implemented in Italy by means of Art. 68(1)(b) of Legislative Decree No. 30 of 2005 (the “IP Code”) and by means of Art. 10(9) of Legislative Decree n. 219 of 2006 (the “Pharmaceuticals Code”).

2. How does the Bolar provision work?

Article 10(9) of the Pharmaceuticals Code replicates the content of Art. 10(6) of Directive 2001/83 as amended by Directive 2004/27/EC. It provides that the carrying out of studies and experiments necessary for obtaining a generic marketing authorisation (i.e. the activities referred to in Article 10 Paragraphs 1, 2, 3, and 4 of the Directive 2001/83) shall not be regarded as contrary to patent rights.

Similarly, Article 68(1)(b) of the IP Code, provides that the patent owner’s exclusivity rights do not cover the studies and experiments aimed at obtaining, even in foreign countries, a marketing authorisation for a medicinal product and the consequent practical requirements, including the preparation and use of the pharmacologically active raw materials strictly necessary for this purpose.

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

Although the exception provided by the Pharmaceuticals Code is, as that provided by Article 10 of Directive 2001/83/EC, only referred to generic marketing authorisations, the research use exemption provided by the IP Code is not literally restricted to studies for generic marketing authorisations. 

4. Has Bolar been litigated in your jurisdiction?

Bolar has occasionally been litigated before the Italian Courts. The disputes mainly concerned the interpretation of the limits of the exemption, such as the amount of API that could be manufactured to fall under the exception without infringing the other party's patent right.

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

As literally specified by Art. 68(1)(b) of the IP Code, the clause extends to studies and experiments aimed at obtaining a marketing authorisation for a medicinal product in any foreign countries. Therefore, exempted activities are covered regardless of where regulatory approval is ultimately sought.

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

In Italy there is a lack of case law concerning this interpretation of the rule. However, it is well possible to assume that the exemption also extends to third parties, on the basis of the literal wording of the provisions of the IP Code.