Novartis says that the decision touches Intellectual Property principles in all sectors of the country.

Everything seemed that the declaration of the Imatinib molecule to treat cancer as a matter of public interest, would be the third case of compulsory license in Latin America, after the governments of Brazil and Ecuador made use of this power in the past .

Remember that in 2007 the Brazilian government granted a compulsory license for the manufacture of antiretroviral efavirenz, whose patent belongs to Merck Sharp & Dohme. Meanwhile, in 2010 the Government of Ecuador issued a compulsory license allowing the import of ritonavir antiretroviral drug manufacturer Cipla Indian pharmaceutical generic drugs whose patent holder is Abbott.

Being a pre Compulsory license in most of the laws providing for caning law requirement, like what has happened in Colombia with the Imatinib molecule to treat cancer, both in the case of Brazil and Ecuador was negotiated previously and unsuccessfully with the holders of the respective patents, to lower prices, arguing facilitate drug access to most of the population, given its high price.

However, in this case, after failed negotiations with the Swiss drugmaker Novartis, the Ministry of Health of Colombia has decided not to grant compulsory license to another (s) manufacturer (s) of the drug or to allow the import of a generic of the same active ingredient of the drug to a foreign laboratory, but has decided to set the sales price of the drug through an administrative act for the National Commission on drug Pricing and devices define unilaterally the amount of the drug, simulating conditions of competition.

This government decision have not been controversy-free since, although we are against the use of flexibilities to patent protection, provided for in Article 31 of the Agreement on Aspects of Intellectual Intellectual Property Related Trade (TRIPS), this is an "exception" that must be given under certain conditions and if certain circumstances are referred to in the domestic laws of each country.

This is how the president of Novartis for the Andean region has been demonstrated in total disagreement with the measure, pointing out that the conditions are not pricing in this case. And the risk of such decisions, it can be seen by the owners of companies engaged in research as a bad sign, it is necessary to understand the exceptional nature should have pricing and / or compulsory licensing, and used by the current government, as a tool for saving medicines or intimidation when negotiating with patent holders.


Clarke, Modet & Co - CHILE

Santiago de Chile
Huérfanos, 835, piso 10
Tel: +562 2433 6830
Email: info@clarkemodet.cl


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