Subsection 3: Compulsory licences for patents relating to the manufacture of pharmaceutical products for export to countries with public health problems

The application for an operating licence provided for in Article L. 613-17-1 shall be addressed to the Minister responsible for industrial property. It shall include the information mentioned in Article 6 of Regulation (EC) No 816/2006 of the European Parliament and of the Council of 17 May 2006 on compulsory licensing of patents relating to the manufacture of pharmaceutical products for export to countries with public health problems. The application…

The order granting the compulsory operating licence shall be issued after a reasoned opinion has been given by the committee referred to in Article R. 613-10 which shall give its opinion on whether the application complies with Articles 6 to 10 of Regulation (EC) No 816/2006. The procedure applicable is that set out in Articles R. 613-11, R. 613-12, R. 613-15 et R. 613-19 to R. 613-25. Orders granting or…

The holder of the compulsory exploitation licence may request the Minister responsible for industrial property to amend the conditions of the licence in order to be able to supply additional quantities of products, under the conditions set out in Article 16-4 of Regulation (EC) No 816/2006.

The arrangements for the identification of products manufactured under compulsory licence pursuant to Article 10-5 of Regulation (EC) No 816/2006 are established by a decision of the Director General of the National Agency for the Safety of Medicines and Health Products.