FDA addresses ANDA conversion to tentative approval 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.
The new MAPP lays out the policy for converting a paragraph IV ANDA’s final approval to tentative approval (TA) status when FDA receives a federal district court judgment that the patent is infringed and the ANDA approval becomes effective after expiration of the infringed patent. “FDA will consider the judgment and will also consider any documents showing (1) that the district court judgment has been stayed or (2) that there is a pending motion for stay of the district court judgment,” according to the policy.
The MAPP also outlines the responsibilities of the various OGD offices in the conversion of ANDA approval to TA because of a court order.
The Office of Generic Drug Policy patent and exclusivity team, which receives the patent infringement information, verifies that subject patents are listed in the Orange Book, assesses court orders and motions and then notifies the office’s Division of Legal and Regulatory Support (DLRS) and Deputy Director, to whom it provides a recommendation on approval status. Finally, this office drafts the “Conversion to ANDA Tentative Approval” letters.
After a secondary review by the DLRS director or designee, the Division of Product Management updates the status to TA, including updating Orange Book staff.
The procedures accompanying the policy and workflow make clear that submissions related to patent infringement can be made by or on behalf of either the owner of the patent or NDA, or the holder of the ANDA.
Guidelines for triage of submissions related to patent infringement lawsuits are also outlined in the MAPP’s procedures.