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Even with recent steps taken by the FDA to “fast track” the new drug application and approval process, the period between application and approval remains lengthy. As a result, patent holders may be deprived of the full benefit of their patent. To remedy this loss of patent protection, many countries have adopted patent term extension laws allowing patent holders to recover the vital time lost to the regulatory review process. Even one additional day of patent protection can mean over a million dollars in revenues on a blockbuster drug product. This article describes the patent term extension process in the United States, Europe and Japan, summarizes two recent judicial decisions interpreting the laws and suggests strategies for drafting patent claims and licenses to take advantage of patent term extensions.