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News From the Food and Drug Administration
December 4, 2002

Proposed Change of Patent Rules

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JAMA. 2002;288(21):2678. doi:10.1001/jama.288.21.2678

The FDA has proposed amending its requirements regarding patents for brand-name drugs. If finalized, the proposed rule would (1) clarify that certain types of patents—including those claiming packaging, metabolites, or intermediaries—may not be listed by brand-name drug manufacturers; (2) revise the required patent declaration to help ensure that it includes only appropriate claims; and (3) limit to one a brand-name manufacturer's opportunity to secure a 30-month stay of FDA approval of an application for the marketing of a competing generic drug.