Ecuador will publish in the coming days its first Personal Data Protection Law in the most European style after a long time working on it.  Our senior associate Rafael Serrano writes about it in LexLatin.

This great advance for Ecuador, although the right was guaranteed since 2008 but without a norm that would regulate it, will allow companies to have a refined database with globally homogenized standards and, above all, to have greater protection of the personal information.

In the words of Rafael Serrano, “it is about establishing a framework of parameters to process correct information”.

All those people who store information that identifies or makes any individual identifiable, directly or indirectly, and in any type of support, will be affected by this rule.

To review whether the law is being complied with, a personal data protection authority has been created. “If the president does not veto the project, this authority, the Superintendency, will be independent and with overseeing power in both the private and the public sectors,” adds Serrano.

In addition, this law has established parameters for international communications and transfers with personal data. It has also stablished rights so that consultation, digital education, and girls, boys and adolescents would not be the subject of a decision based solely or partially on automated valuations.

Serrano points out, “one of the most discussed issues was whether or not there was a need to create a record of the databases in the possession of those responsible. This does not mean that this information is delivered to the Superintendency to create a large database, but rather that what is delivered responds to statistical purposes: for example, what data is being processed and how many databases are there”.

The law establishes that the consent for a person to be registered in a database will only be valid when it is manifested freely, specifically, informed and unequivocally.

Information from companies to the owner of personal data

As Serrano explains, the information required by companies is “the purpose of the data treatment, the legal basis, the types of treatment that exist, the time of their conservation, the existence of a database , the purposes, a contact person in charge, the transfers that are intended to be made and the existence of automated evaluations and decisions, among others”.

“Those responsible for the processing of personal data are obliged to sign confidentiality contracts and proper handling of personal data with the person in charge and the staff in charge of the processing of such personal data or whoever has knowledge of the personal data, in addition to using technologies to mitigate and evaluate the performance or the violations that their protection mechanisms may have ”, concludes Serrano.

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Pharmaceutical patent licenses are generally granted by means of agreements freely executed between the patent holder and the person authorized to exploit the invention. However, this is not always the case, since in some exceptional cases, they are granted by order of the authority under the conditions set forth in the Law. Our partner, María Cecilia Romoleroux, and our professional technician, Gabriel Kuri, write about this for AIPPI Ecuador.

The Commission of the Andean Community of Nations -CAN- provides for the granting of compulsory licenses for reasons of public interest, emergency or national security, if there are practices that affect free competition, and when requested by the holder of a patent, provided that it necessarily requires the use of another patent. This requires the prior notice to the licensee, whenever possible, and a specification of the period for which it is granted, the object of the license, the amount, and the conditions of the financial consideration. 

In 2009, the Ecuadorian Government declared access to medicines used in the treatment of certain diseases that affect the population and that are a priority for public health, as a matter of public interest. As a consequence, it declared the possibility of granting compulsory licenses. “In addition, it declared that, in principle, all medicines and agrochemicals would be subject to compulsory licensing as there are basic concepts that prevail over commercial interests,” add our experts.

For this reason, while recognizing the right of each country to order compulsory licenses for patent-based medicines under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), Ecuador declared access to medicines used in the treatment of priority diseases to be in the public interest.

Last March 2021, the Andean Court of Justice issued a preliminary ruling (interpretación prejudicial) stating that ” among the situations in which the competent national offices have the power to grant compulsory licenses, are those related to reasons of public interest, emergency, or national security “, they add. Therefore, the granting of a compulsory license does not affect the right of the patent holder to continue exploiting the patent.

Our experts, based on their experience, state that “the granting of a compulsory license requires that the competent authority of the Member Country evidences, explains and adequately and sufficiently substantiates the reasons of public interest, emergency or national security, as well as the need to adopt such measure, which must meet three reasonableness requirements”. “It must also substantiate the reasons that justify that, under these circumstances, it is essential to grant a compulsory license.”

“The preliminary ruling clearly establishes that it is not enough to simply state one or more  conditions included in Article 65 of Decision 486, but that these must be explained, detailed and even individualized for each case,” they conclude.

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Our associate Andrea Miño, specialist in Intellectual Property, has published a new article in  World Trademark Review on the contradictory criteria for the examination of trademarks in similar cases in the Andean Community.

In the words of our expert, “It’s the principles of primacy and direct effect on the obligation of member states to optimize the specialized legal system to ensure strict and uniform compliance with Andean community regulations. At the same time, the principle of autonomy empowers the competent offices to issue resolutions without affecting the decisions adopted by other member countries or their own; however, the decisions must be issued in strict adherence to what is established in the regulations and jurisprudence that governs the trademark area at the community level”.

Taking this context into account, the decisions issued by the IP offices of Ecuador, Colombia and Peru should be analyzed, since the criteria given are contradictory for the registrability of the same trademark intended to cover identical products.

Our associate also states in this publication that “In the case of Ecuador, Resolution No. 0004531, the National Industrial Property Directorate of the National Intellectual Rights Service (SENADI), determined that the same trademark, which protected class 5 products, did not meet the requirements for registration, since it was included in one of the grounds for refusal of registration provided for in the Andean Community regulations; that is, the trademark made direct reference to the products it intended to identify”.

SENADI, however, ignored the mixed nature of the trademark and only established that the trademark applied for “was not distinctive because it was a generic and descriptive term, and commonly used.”

If you want to see the article (under registration), click here