ARCSA Outlines Role of Manufacturers and Public in Controlling Counterfeits

The National Agency for Health Inspection, Regulation, and Monitoring (ARCSA), has recently issued a regulation relating to the control of counterfeit, adulterated, and altered products in Ecuador. ‘Adulterated’ products are defined through the regulation as those that have had their characteristics changed knowingly in some way, whereas ‘altered’ products are those products whose characteristics are […]

Landmark Criminal Action Initiated Against Counterfeiters

At the end of 2015, the District Attorney’s Office in Quito received an anonymous complaint alerting them to the sale of counterfeit pharmaceutical products. Following this complaint, on December 2, 2015 the National Police of Ecuador conducted several raids on various locations. These locations included a site where counterfeit pharmaceuticals were being manufactured, a site […]

Andean Community Issues Ruling on Patent Fees in Ecuador

The Andean Community Secretariat has issued a resolution rejecting the action brought on behalf of the Bolivarian University from Medellin, Colombia, seeking to lower patent official fees based on them being considered discriminatory and excessively high. [...]

Re-branding as Generics upon Expiration of Ecuadorian Patent

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. [...]