Fed Regist. 2003 Jun 18;68(117):36675-712.
The Food and Drug Administration (FDA) is amending its patent submission and listing requirements for new drug applications (NDAs). The final rule clarifies the types of patents that must and must not be submitted and revises the declaration that NDA applicants must provide regarding their patents to help ensure that NDA applicants submit only appropriate patents. The final rule also revises the regulations regarding the effective date of approval for certain abbreviated new drug applications (ANDAs) and certain other new drug applications, known as 505(b)(2) applications, submitted under the Federal Food, Drug, and Cosmetic Act (the act). In certain situations, Federal law bars FDA from making the approval of certain ANDA and 505(b)(2) applications effective for 30 months if the applicant has certified that the patent claiming a drug is invalid or will not be infringed, and the patent owner or NDA holder then brings suit for patent infringement. The final rule also states that there is only one opportunity for a 30-month stay in the approval date of each ANDA and 505(b)(2) application. The final rule will make the patent submission and listing process more efficient as well as enhance the ANDA and 505(b)(2) application approval processes.
美国食品药品监督管理局（FDA）正在修订其新药申请（NDA）的专利提交和列名要求。最终规则明确了必须提交和不得提交的专利类型，并修订了NDA申请人必须提供的有关其专利的声明，以帮助确保NDA申请人仅提交适当的专利。最终规则还修订了有关某些简略新药申请（ANDA）和某些其他新药申请（称为505(b)(2)申请）根据《联邦食品、药品和化妆品法案》（该法案）批准生效日期的规定。在某些情况下，如果申请人已证明主张药品的专利无效或不会被侵权，而专利所有者或NDA持有人随后提起专利侵权诉讼，则联邦法律禁止FDA在30个月内使某些ANDA和505(b)(2)申请的批准生效。最终规则还规定，每个ANDA和505(b)(2)申请的批准日期只有一次30个月的延迟机会。最终规则将使专利提交和列名过程更加高效，并加强ANDA和505(b)(2)申请的批准过程。
