Legal Forum: Drug Product, Active Ingredient, and Patent Term: ARecipe for Confusion

The Drug Price Competition and Patent Term Restoration Act (1984), more commonly known as the Hatch-Waxman Act (herein "the Act"), seeks to give a patent owner at least partial restoration of the patent term period lost while obtaining regulatory approval for a patented article or method, typically a drug, medical device, or therapeutic method.

Limitations on patent-term extension under the Act are neatly summarized by the "rule of ones:" one patent extension per product, one patent extension per patent, and one product per patent extension.1 "One patent extension per product" refers to the statutory requirements that no other patent has been extended for the product,2 and that "in no event shall more than one patent be extended for the same regulatory review period of any product."3 "One patent extension per patent" reflects the requirement that the term of the patent has never been extended."4 The third rule, "one product per patent extension," derives from the goal of the Act to allow a restoration of patent term only for the product for which regulatory approval was sought. That is, only the product that served as the basis of the extension is exclusively covered by the patent during its extended term.

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