Patent term extensions: issues, challenges and implications for pharmaceuticals

The standard term of a patent is 20 years from the date of filing. However, the time required for a pharmaceutical product to pass through research and development, and clinical trials to obtain regulatory approval can often be more than 10 years. This effectively shortens the life of the patent leaving the patentee with little or no monopoly over the pharmaceutical product by the time it reaches market. The solution to this loss of patent monopoly in many countries is to provide an extension to compensate for loss of patent term due to obtaining regulatory approval of a product. This article provides a summary of some of the issues, challenges and implications of patent term extensions in various countries.