USA – FDA releases MAPP for converting ANDA status for patent infringement

A new Manual of Policies and Procedures (MAPP) from the US Food and Drug Administration (FDA) addresses conversion of an abbreviated new drug application’s (ANDA) status from final to tentative approval following a court order for patent infringement.

The MAPP from the Office of Generic Drugs (OGD) describes policies and procedures for converting an abbreviated new drug application (ANDA) from final approval to tentative approval when a court order for patent infringement is issued under 35 USC 271 (e)(4)(A).

An applicant whose ANDA is submitted under so-called “paragraph IV certification” certifies that the patent for the reference listed drug (RLD) is invalid, unenforceable or will not be infringed by the manufacture, use or sale of the new drug for which the application is submitted…