On January 15, 2015, Presidential Decree No. 522 amended the Regulations for the Application of the Law on Import, Commercialization and Sale of Generic Medicines for Human Use (the “Regulations”). The “New Rules” alter the practice in relation to the branding and trademarking of patented medicines after expiration of the patent.
The new wording added to the Regulations read as follows:
“Once the patented invention has lapsed, medicines shall be mandatorily registered and sold as generics, and the label shall primarily contain the International Common Denomination (ICD) and the reference to “Generic Medicine”, above the name of the manufacturer.
Once the patent has lapsed reference medicines shall be registered as such and shall be sold as generics. Reference medicines are understood to be those which had originally obtained a patent that has afterwards lapsed.
It is prohibited for generic medicines to be sold exclusively with a certain brand”.
At the time of its drafting, it was unclear as to exactly what the provision meant in practice. The National Agency for Health Regulation, Control and Surveillance (ARCSA in Spanish), has now issued more detailed information as to how this amendment will work.
The changes will involve owners of previously patented drugs in effect re-registering the product with the relevant authorities once the patent expires, this process being obligatory, although ARCSA itself will notify owners once the patent has expired as to this requirement. It is worth noting that the transition from patented drug to generic medicine does not prevent the product being used with a trademark.
The owner must complete a Marketing Authorization modification through the website “Ventenilla Unica Ecuador” (VUE), which will involve completing the following fields:
- Name of the Product: This will be the International Common Denomination
- Trademark: that previously used with the patented product
- Type of product: “Generic”
- Reason for modification: the suggested text translates as “issuance of a new certificate following modification of a health registration after expiry of a patent”.
The draft label must then also be submitted for approval by ARCSA, and must feature the ICD, or in its absence, a general denomination recognized internationally, as well as “Medicamento Genérico”.
Labels must contain legible and indelible characters and “Medicamento Genérico” must be in red capital letters (Pantone Red 032) and both this and the ICD must each be of a size at least 20% larger than that of the name/trademark as applied to the product.
The owner must also sign and submit an “exhaustion of stock” request, which will detail the quantity of product under the old labelling, as well as the corresponding inventory (and the invoice for the purchase of the labels in the case of national pharmaceutical laboratories).
ARCSA will then review the request, which will then either be approved or the owner will be notified accordingly.
As is evident, the re-registration process is not in itself particularly onerous, but the new regulations are interesting from a branding perspective, since simultaneously with brand holders losing their patent and the downsides associated with that, the branding “power” of the product, at least in so far as it concerns the product packaging, will also be somewhat diminished by the re-branding requirements.
6th July 2016