Drug Repositioning and Repurposing

The Drug Repurposing & Repositioning Inventions Boardroom provided a deep dive on this important topic with industry experts from NLO, 3D-PharmXchange and the Repo4EU consortium. Major topics concerning the regulatory framework and patent opportunities were covered to provide a comprehensive foundation for a successful drug repurposing program.

The discussion focused on off-patent products – products that have run out of exclusivity, with generic versions already being marketed – and on new indications for such products, for which regulatory approval is sought. In this report, methods are covered on how to protect the results of such repurposing programs, with the ultimate aim of being able to recoup investments made in the development of the new indication. This requires effective means to prevent others from benefiting from the new indication, also through off-label use, as well as effective pricing and reimbursement of the repurposed product.

Since regulatory rewards (in the form of data exclusivity or market protection) are virtually non-existent for repurposed drugs, IP plays a decisive role in any drug repurposing program. Human data is often required to support drug repurposing IP. At the same time, it is often very challenging to properly align clinical trial related disclosures and IP filings. Close cooperation between regulatory and IP experts is therefore often key to success.

Drug repurposing is an attractive option for finding new treatments to meet unmet medical needs relatively quickly and it can present attractive opportunities for new ventures. Whether the primary aim is to benefit patients or to create economic value, a key to success is to stay in control of the results of the program by exploiting available means to establish exclusivity.