Applications for FDA Approval to Market a New Drug: Patent Listing Requirements and Application of 30-Month Stays on Approval of Abbreviated New Drug Applications Certifying That a Patent Claiming a Drug Is Invalid or Will Not be Infringed

Résumé

The Food and Drug Administration (FDA) is proposing to amend its patent listing requirements for new drug applications (NDAs). The proposal would clarify the types of patents that must and must not be listed and revise the declaration that NDA applicants must provide regarding their patents to help ensure that NDA applicants list only appropriate patents. The proposal would also revise the regulations regarding the effective date of approval for certain abbreviated new drug applications (ANDAs) and certain applications submitted under section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act (the act) (505(b)(2) applications). In certain situations, Federal law bars FDA from making the approval of an ANDA or 505(b)(2) application effective for 30 months if the applicant certified that the patent claiming a drug is invalid or will not be infringed, and the patent owner or NDA holder brings suit for patent infringement. The proposal also would state that there will be only one opportunity for a 30-month stay in the approval date of each ANDA or 505(b)(2) application. The proposal is designed to make the patent listing process more efficient and to enhance the ANDA and 505(b)(2) a