Like many questions there is a short and a long answer to your queries:What is the lifespan of a pharmaceutical patent?Short answer: 20 years.Long answer: The patent can effectively be extended by the "marketing exclusivity" or "data exclusivity" provided at the time of new drug approval because these periods (depending on the country and type of approval, lasting from 5-10 years) may be longer than the remaining patent life. There are also extensions granted for some of the length of time required for the regulatory review of the NDA and extensions can be granted for performing additional studies in children or additional studies that provide new clinical information.If a subsequent use for a drug is approved, does the patent "restart", or does the maker need a new patent.Short answer: The patent does not restart: there is a new 20 year patent, but only for that indication (assuming you can succeed in patenting the new indication).Long answer: This kind of patent, a "use patent", is obtainable in the US but not in most of the rest of the world. It provides very weak protection because if a generic product is out there for your drug for its original indication and you patent a new use there is nothing to stop physicians from using the generic for the new use. When companies follow this strategy they usually try to get the new use for a different dose or form of the drug (e.g. intravenous vs oral) that cannot be silently duplicated in the marketplace.We could go on for days about the variations on patent protection for pharmaceuticals and there are countless (expensive) law firms that do nothing but work out variations on these issues; we have only scratched the surface here.WCMinor
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