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
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
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.
En 45 minutos haremos un rápido repaso de todas las novedades relevantes que, en el mundo de la Propiedad Industrial e Intelectual, se han producido durante en el transcurso del 2016, junto a nuestra previsión de los principales hitos que nos depara este nuevo año.
Queremos que los temas propuestos sean sólo aquéllos que más les interesen. A tal fin, hemos incluido los siguientes a partir de las consultas recibidas durante este año. No obstante, estaríamos encantados de contar con sus sugerencias.
La participación de la autoridad mexicana en materia de Propiedad Industrial es crucial durante la tramitación del Registro Sanitario de un medicamento alopático.
Cada etapa del proceso de Registro Sanitario tiene directrices bien establecidas; sin embargo, las etapas que se relacionan con los derechos de Propiedad Intelectual continúan causando controversia.
Con el fin de entender la relación entre los derechos de Propiedad Intelectual y el proceso de Registro Sanitario, Clarke Modet & Cº ofrece una amplia variedad de soluciones desde el punto de vista de Propiedad Intelectual.
Decree Number 8,772 of May 11 2016 regulates Law Number 13,123 of May 20 2015, known as the Biodiversity Law, which provides for access to GH, protection and access to ATK...
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