Patent term extension (PTE) is a valuable benefit to developers of patented small molecule pharmaceutical products that exists within the Hatch Waxman framework.  Nevertheless, the PTE statute, 35 U.S.C. § 156, embodies limitations that are quite stringent and mean that most patent holders need to strategize carefully in order to maximize the potential extension to term that can be afforded.  Although there has been only a small amount of litigation to test the language of 35 U.S.C. § 156, the cases that have been decided have had an important impact on defining the scope of the extension.

Patent term extension in the U.S.

256th National Meeting (2018)

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