Data Exclusivity

Apart from patents, data exclusivity represents an additional form of intellectual property protection provided under Article 39.3 of the TRIPs Agreement. During the period of data exclusivity, the pharmaceutical registration data cannot be referenced in the regulatory filings of another company for the same drug substance. The data exclusivity provisions are still evolving and vary across geographies. This chapter deals with data exclusivity provisions in the United States, European Union, Japan, and other geographies. The United States, European Union countries, and Switzerland provide the highest level of protection to the pharmaceutical registration data though there are differences amongst these countries regarding the length of the period of data exclusivity. Most developed countries provide data exclusivity for new drug products, new therapeutic indication for existing drugs, orphan drugs, and pediatric studies. The United States also provides 180 days generic drug exclusivity and additional exclusivity for qualified infectious diseases.