Intellectual property and orphan drug designation

Oncopeptides has an active patent strategy encompassing all major geographic markets, including the U.S., Europe, Canada, Japan, and China.

Patent protection

Melflufen, and its formulations and uses are protected by patents and patent applications in many territories around the world. Oncopeptides has also patent and patent applications relating to our manufacturing processes and has invested significant know-how in our proprietary freeze-dried formulation.

The possibility exists to extend the patent term for one selected patent by up to five years, at least in the U.S., EU and Japan, if the product candidate receives marketing authorization prior to the expiration of such patent.

Orphan designation

Melflufen has been granted orphan designation in both the US and Europe, which may provide benefits such as market exclusivity for seven and ten years respectively. Orphan designation is granted to treatments that target rare diseases where it’s unlikely that the costs of developing such treatments would be recovered through sales.

On July 2022 the company decided to withdraw Pepaxti from the European Union register of orphan medicinal products.