WIPO to Discuss Protection of Pharmaceutical Test Data

On February 8, 2010, the World Intellectual Property Organization is holding a Symposium on test data protection in Geneva.

Under Article 39.3 of the WTO TRIPS Agreement, undisclosed test data submitted to gain marketing approval for a new drug is generally considered to be protected information. The US FDA and other nations' drug regulatory bodies keep such data secret for several years. However, generic pharmaceutical companies would like access to such data as early as possible, to facilitate generic drug entry into the marketplace.

The WIPO Symposium is meant to provide a forum for further discussion of this unique form of intellectual property protection.