On December 11, 2018, FDA issued final guidance on interpreting the "Deemed to be a License" provision of BPCIA. The guidance provides FDA's interpretation of the provision and its recommendations to sponsors of proposed protein products.
According to the guidance, an approved NDA for a biological product shall be deemed to be a BLA for the product as of the transition date, March 23, 2020. Examples of such products are provided in the guidance's appendix. As of the transition date, the approved NDA will no longer exist, FDA will remove the product from the Orange Book, and FDA will no longer consider any listed patents as relevant for the timing of approving a 505(b)(2) application or ANDA for the product.
Regarding regulatory exclusivities, the guidance indicates that any unexpired period of exclusivity related to the approved NDA other than orphan drug exclusivity and pediatric exclusivity will cease to have any effect as of the transition date. In addition, the guidance indicates that the approved products will not be eligible for the 12-year exclusivity period for reference products first licensed as BLAs.
After the transition date, FDA will not approve any pending or tentatively approved NDAs for biological products subject to the provision. Instead, sponsors may withdraw these applications and resubmit them as BLAs or aBLAs, as appropriate.
FDA recommends that sponsors of proposed protein products intending to submit an NDA consider submitting a BLA instead. FDA recommends a sponsor intending to submit a 505(b)(2) application consider modifying their development program as appropriate to support submission of a BLA or aBLA.
More information about the provision can be found in FDA's draft guidance on questions and answers about the provision and Finnegan's related IP FDA Blog post.
Comments on the final guidance by FDA Commissioner Scott Gottlieb can be found here. Readers are encouraged to read the final guidance, also available on FDA's website.
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