Although two different areas of Law, each with its particularities and differing objectives, Intellectual Property Law and Regulatory Affairs Law converge at a certain point during its practice. This is because each of these branches of Law protects aspects of high relevance and impact in commerce. Knowing both areas of Law, as well as identifying the points in which both meet, could mean an advantage when protecting our clients’ rights, by using Intellectual Property tools to obtain authorizations typically obtained via Regulatory Law and vice-versa.
It is in the mutual recognition of pharmaceuticals in El Salvador, that we have identified the first situation where Regulatory Law and Intellectual Property Law converge. Resolution 333-2013 (COMIECO LXVI) for the Mutual Recognition of Pharmaceuticals in Central America and applicable to El Salvador, establishes that, “No recognition to the registration will be granted when there is confusion or identity in the commercial name of a pharmaceutical product previously registered.” What is known in Regulatory Law as “commercial name” is what in Intellectual Property Law is known as a “trademark”. The above mentioned contradicts the established by EL Salvador`s Trademark Act, as having a previous sanitary registration of a pharmaceutical products with a certain trademark or commercial name (as it is named in Regulatory Law), does not grant the titleholder property over the same.
If the Regulatory Authority of El Salvador denies someone with a registered trademark, the recognition of a pharmaceutical registration due to a previous sanitary registration with that “trademark” or “commercial name”, the exercise of that person’s Property Right would be obstructed. How is this solved? In case of a decision of this type by the regulatory authority, proving ownership of the trademark before the regulatory authority of El Salvador should suffice.
In a subsequent delivery, we will analyze the convergence between these two areas of Law, applied to the registration of other regulated products.
We are at the service of our clients to provide assessment on regulatory affairs, where we have experience managing sanitary registration of all types of products, from human consumption to pharmaceuticals, agrochemical and veterinary products.
Associate
García & Bodán
El Salvador