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.
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Posted in: FAQ-PATENTS
