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Not So Simple Math: Calculating the Regulatory Review Period for Patent Term Extension

This is the third article in our five-part series on PTE. Calculating a drug’s regulatory review period seems like it should be simple. The FDA even states that its regulatory review period determination is...more

Patent Term Extension for Drugs Not Limited to New Chemical Entities

Patent term extension is a valuable tool that drug manufacturers should consider, even when their products are not new entities. Recent decisions from the U.S. Patent and Trademark Office, coupled with various court...more

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