U.S. Sup. Ct.
10-844
The Food and Drug Administration (FDA) regulates the manufacture, sale, and labeling of prescription drugs. A brand-name drug manufacturer seeking FDA approval for a drug submits a new drug application (NDA) containing, among other things, a statement of the drugs components and proposed labeling describing the uses for which the drug may be marketed. See 21 U. S. C. §§355(b)(1), (d). Once the FDA has approved a brand manufacturers drug, another company may seek permission to market a generic version by filing an abbreviated new drug application (ANDA). See §§355(j)(2)(A)(ii), (iv). But the FDA cannot authorize a generic drug that would infringe a brand manufacturers patent. To facilitate the approval of generic drugs as soon as patents allow, the Hatch-Waxman Amendments require a brand manufacturer to submit its patent numbers and expiration dates, §355(b)(1); and FDA regulations require a description of any method-of-use patent, known as a use code, see 21 CFR §§314.53(c)(2)(ii)(P)(3), (e). The FDA does not attempt to verify the accuracy of the use codes that brand manufacturers supply. Instead, it simply publishes the codes, patent numbers, and expiration dates in a large volume known as the Orange Book.
