What is the research exemption?

The “research exemption,” also known as the “safe harbor exemption,” is something within the patent laws which state that, for a limited period of time prior to the expiration of a patent, others are allowed to conduct research and testing which might otherwise infringe the patent if the purpose of that research is to gain regulatory approval related to the manufacture, use or distribution of drugs. For example, if the patent for a drug is shortly going to expire, people can begin preparing a generic version of that drug for FDA approval so that it can be sold shortly after the patent expires.