As a World Trade Organisation member, Ecuador is a signatory of the Agreement on Trade-Related Aspects of Intellectual Property Rights, the Paris Convention for the Protection of Industrial Property and the Common Industrial Property Regime of the Andean Community. At a national level, IP rights are governed by the Organic Code on Social Economy of Knowledge and Innovation, which is based on the above agreements, but with certain limitations.
Against this background, certain regulations allow rights holders to protect their IP rights and file actions against infringing third parties. However, there is a significant blind spot regarding IP rights for pharmaceutical patents due to a lack of knowledge surrounding the norms that protect such rights – especially by health and public procurement authorities. This lacuna is mainly due to the absence of a so-called 'linkage system' that would grant entities in Ecuador information on the patent rights granted to rights holders.
As a result, the most relevant patent infringement cases are the result of the health and public procurement authorities allowing third parties to market and obtain registries of phramaceutical products protected by patents without rights holders' authorisation.
However, in a landmark case, the National Service for Intellectual Rights (SENADI) – the national entity that grants patents – used an administrative tutelage process to penalise the improper and unauthorised use of a pharmaceutical patent.
In 2019 a rights holder was concerned about a third party selling its patented pharmaceutical product without authorisation. In response, the rights holder submitted:
- warning letters to any companies that had infringed its IP rights;
- reports to the public procurement entities about the IP rights infringements and the entities' duty to prevent them from continuing; and
- an administrative action (called an 'administrative tutelage') to SENADI to stop the immediate violation of its IP rights.
During the administrative tutelage process, all evidence was heard and precautionary measures were requested and granted, prohibiting the third party from producing, importing, offering or selling the infringing product.
For the first time in Ecuador, SENADI granted precautionary measures to prevent the infringement of a pharmaceutical patent and penalised the offender.
The case set a precedent by establishing a new IP protection strategy for the SENADI to prevent future IP rights infringements.
Notably, the administrative tutelage process tackled the problem much quicker than it would have taken using common legal action. The strategy also allowed health and public contracting entities to acquire greater knowledge of patent rights and infringements. Although the IP linkage system has not been established in Ecuador, SENADI's recent action is a step in the right direction.
