SENADI’s Intellectual Property Board Sets Precedent on Test Data Exclusivity

The Intellectual Property Board of SENADI has issued a landmark resolution in the field of intellectual property and test data protection.

This ruling not only represents the first case of its kind in Ecuador but also establishes a key precedent for strategic industries such as pharmaceuticals, agrochemicals, and biotechnology, which rely heavily on innovation and research investment.

Below, we share the most relevant points and the role of Meythaler & Zambrano Abogados in this case.

1. Applicable Legal Framework

In Ecuador, test data are considered intangible intellectual property. They are protected as trade secrets due to the economic value of undisclosed information they contain and are safeguarded against unfair practices seeking to exploit them without authorization.

2. Legal Regulation

Articles 507 to 509 of the Organic Code of the Social Knowledge Economy (COESC+i) expressly regulate this exclusivity, which is recognized only when the data meet three conditions:

• Required by the national competent authority.

• Possess commercial value due to their secret nature.

• Have been subject to reasonable confidentiality measures and require considerable effort to be developed.

3. Dual Protection of Test Data

The regime provides two dimensions of protection:

• Positive protection: exclusive right of the holder to benefit from the innovation for a specific period (5 years for pharmaceutical products and 10 years for agrochemical products).

• Negative protection (ius prohibendi): right of the holder to prevent third parties from using their data to obtain marketing authorizations during that period. Although reasonable preparatory acts are permitted, the direct use of the data is prohibited.

In Ecuador, test data exclusivity constitutes a sui generis form of intellectual property with both commercial and regulatory implications. Compliance is mandatory for the competent authority and for all market participants.

4. Competent Authority

According to the opinion of the Attorney General, SENADI is the national competent authority on intellectual property, with regulatory, administrative, and enforcement powers.

Additionally, Ecuadorian regulations recognize exclusivity for new chemical entities entering the country for the first time, which:

• Ensures safe and effective access for consumers.

• Protects the commercial value of innovation holders.

• Complies with Ecuador’s international commitments, including the Trade Agreement with the European Union and the Andean Community framework.

5. The Case at Hand

In this case, it was proven that a third party had used another company’s test data to obtain a sanitary registration and subsequently marketed a copycat product during the exclusivity period.

Based on this evidence, SENADI:

• Recognized the violation of the exclusivity regime.

• Confirmed the precautionary measures requested, including the prohibition of sales of the copycat product and the imposition of sanctions on the infringer.

Once the resolution becomes final, the illegitimate sanitary registrations will be cancelled, and claims for damages will proceed in favor of the test data holder.

6. Role of Meythaler & Zambrano Abogados

• We designed and executed the legal strategy that secured the first resolution of its kind in Ecuador.

• Our arguments were fully upheld by the authority, consolidating a pioneering precedent in the region.

• This outcome reflects our commitment to the strategic defense of innovation, protecting critical investments in the pharmaceutical, agrochemical, and biotechnology industries.

Conclusion

This precedent strengthens legal certainty surrounding test data in Ecuador and reinforces the confidence of productive sectors that invest in innovation.

In this historic case, Meythaler & Zambrano Abogados reaffirms its leadership in intellectual property, ensuring tangible value for its clients and consolidating a framework that promotes investment in innovation in the country.

Does your company develop innovation in regulated sectors? At Meythaler & Zambrano Abogados, we have extensive experience in the strategic defense of test data, intellectual property, and regulatory compliance in Ecuador.

If you need to protect your investment, prevent the unauthorized use of your information, or secure your market position, contact us today. We are ready to legally safeguard your developments and ensure the enforcement of your rights before SENADI and other competent authorities.

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