New SENADI Precedent Strengthens Protection of Test Data | Success Case

Meythaler & Zambrano Abogados
Oct 21
3 min read

SUCCESS CASE • TEST DATA EXCLUSIVITY

We strengthen legal certainty for Ecuador’s pharmaceutical sector

Logro destacado: Segundo precedente favorable del SENADI obtenido por nuestro equipo

Regulatory context of the exclusivity regime in Ecuador

With the entry into force of the Organic Code on the Social Economy of Knowledge, Creativity and Innovation, Ecuador incorporated a test data exclusivity regime:

Five years for pharmaceutical products, and
Ten years for agrochemical products.

Within this framework, Meythaler & Zambrano Abogados led a comprehensive legal strategy to secure recognition and effective protection of safety and efficacy studies before SENADI.

Favourable SENADI decision: What did we achieve?

We obtained a second favourable resolution from SENADI that reinforces protection of test data exclusivity and sets key precedents for the pharmaceutical industry. This milestone provides a solid framework for future decisions by the Authority and greater predictability for rights holders in their product launch and defence strategies.

Independent protection from patents	Clarification of the “novelty” criterion in test data	Legal boundaries between preparatory and infringing acts
Our arguments prompted SENADI to reaffirm that test data protection is independent from patent rights, avoiding restrictive interpretations.	We achieved the dismissal of the argument that molecules registered abroad void local protection, thereby strengthening legal certainty within the regime.	A clear boundary was established: reasonable preparatory acts are permitted up to two years before expiry, but offering or marketing during the exclusivity period constitutes infringement.

Significance of the “novelty” criterion in Ecuador

One of the most common defences by infringers is to argue that the active ingredient is “not new” because it has been known or registered elsewhere. The binding opinion of the Office of the Attorney General served as a basis for SENADI to reject this argument and to confirm that new molecules enjoy test data protection in Ecuador even if registered in other jurisdictions.

This clarification strengthens the regime, enhances legal certainty, and reduces litigation stemming from misinterpretations of “novelty.”

Legal strategy developed by M&Z Abogados

The first precautionary measures we initiated in Ecuador demonstrated that defending test data requires a robust, results-oriented legal strategy.

In the absence of precedents and within an evolving framework, we designed a comprehensive service that:

Identifies and certifies the applicable exclusivity period in a timely manner.
Implements regulatory monitoring and extensive evidence collection.
Structures both preventive and reactive defences, activating precautionary and sanctioning proceedings before SENADI when appropriate.
Develops persuasive legal arguments on autonomy, novelty, and preparatory acts.
Follows through to resolution and issues compliance guidelines, deterring infringements through reinforced legal positioning and documented evidence.

Benefits for pharmaceutical companies

Greater legal certainty and predictability for product launches and portfolio defence.
Clear parameters to activate precautionary and sanctioning measures before SENADI.
Solid foundation for internal compliance and risk-management protocols.

Recommendations for pharmaceutical rights holders

The defence of test data exclusivity should not be limited to reactive measures. It requires prevention, continuous monitoring, and timely action to ensure effective protection.

Our recommendations for current and potential rights holders:

Request official certification of the exclusivity period for each new medicine.
Maintain ongoing regulatory oversight to detect infringements or misuse.
Have an early-response plan (precautionary measures + SENADI actions).
Work with regulatory and IP specialists to develop an effective strategy.

These actions mitigate risks and strengthen the capacity to prevent, detect, and swiftly contain any attempt to appropriate intangible assets. Our team is prepared to assist at every stage of the process with the highest efficiency and confidentiality.

Request an exclusivity assessment and regulatory monitoring plan for your portfolio