Compulsory licences and swine flu

March 22, 2010

BY YURI VAZQUEZ, MANAGING INTELLECTUAL PROPERTY, INTERNATIONAL BRIEFINGS, JULY/AUGUST 2009.

Mexico is closer than it ever has been in history to granting compulsory licences due to a national emergency.

According to Article 77 of the Industrial Property Law (IPL), the declaration of compulsory licensing by cause of emergency is not automatic, as it requires inter alia compliance with specific conditions:

·        When lack of compulsory license would prevent, hinder or increase expenses related to the supply, distribution or access to the patented product.
·        A declaration of emergency justifying priority attention should be issued by the General Health Council.

·        One the declaration of priority attention is published, third party pharmaceutical companies are allowed to request a compulsory license from the Mexican Patent Office (IMPI).
·        IMPI will call the patent holder and after hearing both parties, IMPI shall grant the licence with a term no longer than 90 days after the filing of the petition.
·        The Ministery of Health will establish the production conditions, quality control, duration and scope of application of the license.

 

On May 2, the General Health Council published in the Mexican Federal Journal a declaration of priority attention to the outbreak of A(H1N1) human influenza virus.

This publication was the first stage of the process established in Article 77 of the IPL. However, on May 19, a second decree was published specifying that, for the moment, the necessary conditions for granting a compulsory licence were not met.

From this experience emerges the necessity to review the regulation, specifically to ensure that the compulsory licence proceeding is sufficiently rapid and effective to overcome an emergency situation.  It is equally important to avoid the granting of compulsory licences only to fulfil some private interests, especially when the conditions are not met.