European Bolar Provisions in France

The EU Directives  were implemented at the French national level through the Law n°2007-248 of February 26th, 2007 containing various provisions for adapting to Community law in the field of medicines (1). French Bolar exemption is now provided for by Article L. 613-5 (d) of the French Intellectual Property Code (“FIPC”).

The French legislator decided to broadly implement the Bolar exemption. The point is further developed below.

Article L. 613-5 FIPC has been supplemented by Subparagraph d) that has inserted the Bolar provision:

1. acts done privately and for non-commercial purposes;
2. acts done for experimental purpose relating to the subject-matter of the patented invention;
3. the extemporaneous preparation for individual cases in a pharmacy of a medicine in accordance with a medical prescription nor acts concerning the medicine so prepared;
4. studies and trials necessary for obtaining a marketing authorisation for a medicine, as well as to acts necessary to carry out such studies and trials and to obtain the authorisation;
5. bis) Acts necessary to obtain the advertising visa mentioned in Article L. 5122-9 of the French Public Health Code;
6. Objects intended to be launched into Outer space introduced into French territory.”

On the basis of this legal exemption, a defendant to an infringement action (including in the scope of summary proceedings) can obtain the dismissal of the claims of the patentee. 

No. According to Article L. 613-5 FIPC, it appears that the French Bolar exemption is not limited to generic products. The exemption is broader and applies to any act (studies and trials) required to obtain a marketing approval for any medicine product including bio-similar  and princeps products.
Moreover, the French exemption is also broader than the EU Directives with respect to:

• The concerned Marketing Authorizations: the French provision does not limit the application of the exemption to MA “in the territory of the EU”.
• The acts entitled to exemption which are “studies and trials required … as well as the acts necessary for their performance and for obtaining the authorization marketing”. Hence, it was decided in the scope of PI proceedings that compassionate use should fall within the scope of Bolar exemption (see TGI Paris, March 15th, 2016, Ono Pharmaceutical, Mr. Honjo, BMS v. MSD France, Schering Plough, RG 16/51152).

Yes. The Bolar exemption has been the subject of a few Court decisions in France, most of which have been mentioned throughout this section. 

Yes. Contrary to the EU Directives which only refer to MAs applied in the EU, French law does not include any restriction as to the considered country. 

• Given this general wording, part of the doctrine considers that the French Bolar exemption should cover the studies and trials made with the view of obtaining a MA inside as well as outside the EU.
• This interpretation is compliant with the French legal principle according to which one should not make a distinction where the law does not.
• Case law supports this interpretation. In an Order dated 7 October 2014 (case Sanofi-Aventis Deutschland v. Lilly France, RG 14/12276), the Court expressly recognised that the Bolar exemption may also apply when trials aim at obtaining marketing authorisations outside the EU (in Brazil in this case).

This question is not settled by French case law. This being said, we tend to consider that the Bolar exemption should apply to subcontractors that carry out studies and tests upon the MAH’s behalf and a few French Court decisions which were taken before the implementation of the Bolar exemption have rejected infringement claims made against a third party who assisted the MAH (cf. TGI Paris, January 25th, 2002, Science Union et Compagnie and Servier v. Biophelia, Agi Pharma and Pharma developpement, RG 00/11702; TGI Paris, October 12th, 2001, Science Union et Compagnie and Servier v. AJC Pharma and Expanpharm International, RG 00/11698).