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.
Marketing Authorization (MA) process in Mexico involves the direct or indirect participation of IP authority.
While it is true that each stage of the Marketing Authorization process includes particular steps, most of them have well-stablished guidelines; however, the stages related to IP rights are still under refinement.
In order to understand the relationship between actual IP rights and the MA prosecution process, Clarke Modet & Co offers wide range solutions from the IP point of v
Directed to in-house patent and legal professionals of pharmaceutical companies and their subsidiaries, to understand the relationship between IP rights and the market authorization prosecution process for a drug in Mexico.
IP services during Marketing Authorization (MA) process in Mexico:
Background: Search of patent documents related to a drug, Linkage system
Processing: Filling response to office actions from COFEPRIS related to IP matters
Monitoring: Importations and exportations vigilance
El 27 de diciembre de 2016, fue publicado en el Diario Oficial de la Federación un Acuerdo que modifica lineamientos para el uso del Portal de Pagos y Servicios Electrónicos (PASE) del Instituto Mexicano de la Propiedad Industrial (IMPI), en trámites de solicitudes de marca y aviso comercial.
Recently the Nice International Classification of Products and Services, a system used to categorize trademark applications, has been updated once again, with the entry into force of the 11th Edition on January 1, 2017.
Under the Mexican Trademark Law there is no obligation to use a trademark until renewal time is reached in the 10th year as of the filing date of the registration to be renewed and when filing the application for renewal it is only necessary to declare under oath that the mark has been used during a term of the last three years.
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