(2002; 77 pages) [Spanish]
1. Data necessary for marketing approval
A basic premise for the application of Article 39.3 is that test data must only be protected if national authorities require their submission for obtaining marketing approval of pharmaceuticals or agrochemical products. The first sentence of this article states:
"Members, when requiring, as a condition of approving the marketing of..."
Given the territoriality of the intellectual property system - a feature that the TRIPS Agreement has not altered - the obligation to protect test data only arises in the Member countries where national regulations require the submission of such data. If a Member country opts not to require those data, Article 39.3 will be not apply.
In addition, the submission of data must be necessary to obtain approval. Data voluntarily submitted by an applicant, or in excess of what is required for approval, are not subject to protection under Article 39.3.