Data Protection: The New IP Frontier — An Overview of Existing Laws and Regulations

Abstract

The paper provides an overview of laws and regulations for the protection of data submitted by pharmaceutical companies for the purposes of obtaining marketing approval for a drug in Member States of the World Trade Organization, which must comply with intellectual property provisions set in the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS). Article 39.3 of the agreement requires countries to protect undisclosed test or other data against unfair commercial use but not the adoption of exclusivity periods to protect such data. In general terms, today all developed countries have implemented an array of data exclusivity provisions with specific periods of protection, whereas most developing and least developed countries have often adopted language similar to that of Article 39.3. There are exceptions to this, mainly those countries that have negotiated free trade agreements with the United States such as Chile, Morocco and Jordan, and others that have agreed to adopt periods of exclusivity under pressure from other governments and industry groups. Furthermore, trade agreements have gradually broadened the scope of the protection thus undermining generic competition and therefore consumers' access to more affordable drugs.