Open Access. Powered by Scholars. Published by Universities.®
Articles 1 - 1 of 1
Full-Text Articles in Law
Protection Of Test Data Under Article 39.3 Of The Trips Agreement: Advancements And Challenges After 25+ Years Of Interpretation And Application, Eric M. Solovy
Protection Of Test Data Under Article 39.3 Of The Trips Agreement: Advancements And Challenges After 25+ Years Of Interpretation And Application, Eric M. Solovy
Northwestern Journal of International Law & Business
Among the types of intellectual property rights covered by the TRIPS Agreement, WTO Members must, pursuant to Article 39.3, protect certain test and other data submitted “as a condition of approving the marketing of pharmaceutical or of agricultural chemical products.” Such protection provides the incentives necessary for the biopharmaceutical industry to conduct the lengthy, expensive multi-phased clinical testing that is required to demonstrate the safety and effectiveness of a new drug or vaccine.
Test data protection has become increasingly more important to the development of new medicines in the past several years. That is in significant part because biologics (i.e., …