Today many countries either fail to provide protection or the protection that they provide falls below the levels required by Trade Related Aspects of Intellectual Property Rights (TRIPS). Data exclusivity is one of the most interesting issues in the current discussion on pharmaceutical intellectual property policy making on the global pitch. Data exclusivity, also known as marketing exclusivity, refers to a practice whereby, for a fixed period of time, drug regulatory authorities do not allow the registration files of a pioneer company to be used to register a therapeutically equivalent generic version of that medicine. Only with a clear understanding of the data exclusivity issue and a concerted effort by governments and industries, such as the pharmaceutical industry, that are required to provide registration data to governments have the assurances that their extensive efforts to research, develop, and bring new, innovative products to market will not be subject to unfair business use. Data exclusivity also plays a key role in the development and marketing of new biologics.
All Science Journal Classification (ASJC) codes
- Pharmaceutical Science