Test Data Exclusivity in Ecuador: SENADI Confirms Its Scope Following a Legal Inquiry by M&Z
In response to a legal inquiry submitted by Meythaler & Zambrano Abogados (M&Z), Ecuador’s National Service for Intellectual Rights (SENADI) issued Legal Opinion No. SENADI-DAJ-PJ-2026-015 in September 2026. The opinion confirms that new combinations, new indications and new dosage forms of previously registered medicines may qualify as new chemical entities for purposes of test data protection.
In practice, a medicine that already holds a marketing authorization may qualify for a separate five-year period of data exclusivity. This applies when a new combination, indication or dosage form is approved and the data supporting that approval meet the applicable legal requirements.
This opinion builds on M&Z’s earlier work, which contributed to modernizing Ecuador’s regulatory framework for test data exclusivity. Learn more about this earlier achievement.
What Is the Legal Basis?
Article 266 of Andean Community Decision 486 requires the protection of test data or other undisclosed information whose generation involved considerable effort. This protection applies where such data are required to obtain marketing approval for products containing new chemical entities.
Decision 632 allows this protection to be implemented through periods of exclusivity. Ecuador adopted this mechanism in Article 509 of the Organic Code on the Social Economy of Knowledge, Creativity and Innovation (the Ingenios Code).
In its preliminary rulings, the Court of Justice of the Andean Community (TJCA) has established that new chemical entities include “new combinations, new indications or new dosage forms.” SENADI applies this interpretation together with the Ingenios Code and confirms that a medicine’s existing marketing authorization does not preclude protection for these subsequent developments.
What Does This Mean for an R&D-Based Pharmaceutical Company?
Consider a medicine already registered and marketed in Ecuador. Its marketing authorization holder invests in further research, including additional safety and efficacy studies, to secure approval for a new therapeutic indication.
If the new indication is approved and the supporting data meet the legal requirements, those data may qualify for their own five-year exclusivity period. That period runs from the date of marketing approval for the new indication. The same principle applies to new combinations and dosage forms.
Protection can therefore extend throughout a medicine’s lifecycle: each approval of a new combination, indication or dosage form that meets the legal requirements may give rise to a separate exclusivity period for the supporting data, beginning on the date of that new approval.
What Requirements Must Be Met?
Eligibility for exclusivity depends on three elements established under Andean Community law and addressed by SENADI:
New chemical entity. The medicine must qualify as a new chemical entity under the TJCA’s interpretation, which includes new combinations, indications and dosage forms.
Considerable effort. Generating the data must have involved a significant investment of physical, financial and human resources.
Undisclosed information. The data must retain their undisclosed status. Submission to the health authority does not, in itself, alter that status.
Documenting the research process is therefore strategically important. Study traceability, resources invested, ownership of the data or authorization to submit them, and confidentiality measures are
key to supporting an application.
What Does Exclusivity Protect?
Under the Regulations on Knowledge Management, during the five-year exclusivity period, third parties may not market, sell or offer for sale a product whose approval relies on test data or other undisclosed information generated or submitted by another party and protected under this regime.
For pharmaceutical companies, this provides tangible protection for the investment made to obtain approval for a new combination, indication or dosage form.
How Can We Help?
M&Z’s work before SENADI secured a significant legal confirmation for Ecuador’s pharmaceutical industry: new combinations, indications and dosage forms may qualify for five years of test data exclusivity, even where the medicine already holds a marketing authorization, provided the applicable legal requirements are met.
This achievement reflects Meythaler & Zambrano Abogados’ expertise in intellectual property and pharmaceutical regulation and creates opportunities to protect your investment in research and development throughout a medicine’s lifecycle.
Contact us to assess how this legal interpretation can support the protection of your pharmaceutical portfolio in Ecuador.
For informational purposes only. Protection in each case is subject to the applicable legal requirements and assessment by the competent authority.
