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Despite not being as high as other parts of the world, the reported numbers of COVID-19 cases in Mexico are increasing and has doubled the number this past weekend. Like we did back in 2009 when Mexico was battling the AH1N1 disease, we consider it important to remind clients and friends now of the regulations for compulsory licenses in Mexico.
Compulsory license regulations
Article 77 of the Industrial Property Law establishes that for emergency or national security reasons, including serious diseases declared as such by the General Health Council, IMPI will determine that certain patents can be exploited through a compulsory license for reasons of “public benefit”, when the lack of a license would hinder or overvalue the production, supply or distribution of basic goods to the population. In cases of serious diseases, in order for IMPI to make such determination, the General Health Council must publish a declaration of national emergency in the Official Gazette. Although, the General Health Council has finally met, after several petitions by various sectors, there is no publication of the declaration of emergency in the Official National Gazette, as requested by the law.
AH1N1 in 2008/09 and COVID-19 now
In the 2008 AH1N1 crisis, there were facts that could have led to the grant of compulsory licenses for public benefit. In April 2009, the WHO raised its alert level for the, signaling that a pandemic was imminent. The government quickly responded and imposed strict measures. At that time, there were already two available patented treatments for the AH1N1 disease OSELTAMIVIR and ZANAMIVIR.
Nonetheless, the requirements for compulsory licenses were not met, as there was nothing that indicated that pharmaceutical companies were unable to supply to drugs, that they had set prices too high or that they were blocking distribution. The General Health Council although published the state of emergency, it had never published a final declaration for compulsory licenses in the Official Gazette.
The COVID-19 disease we are fighting now has already been declared a pandemic by the WHO. Currently, there is no universally accepted treatment or cure. It is also apparent that the Mexican government’s actions are much less stringent, slower and much more disordered than they were in 2009.
COVID-19 treatments and patents
Some pharmaceutical products have been shown to help combat the COVID-19. These products are already being marketed for other diseases, and some are either patented or in the process of being patented. Also, there have been some efforts to develop a vaccine, which is already in the early stages of clinical trials.
As mentioned above, compulsory licenses were not necessary for the AH1N1 disease in 2009. If a universally accepted treatment does become available for COVID-19 and if it is protected by a patent, we hope that, similarly, the treatment will not be in short supply (for various reasons such as compassionate use, pandemic prices and free licenses), and therefore we all desire that the conditions for compulsory licenses will never met.
By Alejandro Luna
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