Intellectual property and orphan drug designation

Patents and intellectual property

Oncopeptides has an active patent strategy, spanning from protection of the early pre-clinical portfolio to the commercial product Pepaxti. Part of the strategy encompasses protection in all major geographic markets, including the U.S., Europe, Canada, Japan, and China.

The company’s intellectual property portfolio of registered intellectual property rights consists of granted patents, patent applications in different stages, as well as trademarks. In addition, the company has important rights to clinical data and significant unregistered rights including trade secrets.

Melflufen is protected by different families of granted patents, including formulations, manufacturing processes and methods for treatment.

The market authorizations in EU and UK during the second half of 2022, may enable us to extend the patent protection for up to five years via the Supplementary Protection Certificates (SPCs), which have now been filed. The possibility to extend the patent term in selected countries will be investigated if new markets are entered.

Since the establishment of the drug development lab in 2020, pre-clinical R&D efforts have been intensified, resulting in an increase in filed applications over the last couple of years. These applications, some yet unpublished, provide protection of new innovations in the pre-clinical pipeline, including both the Peptide Drug Conjugate (PDC) platform and the Small Polypeptide based Killer Engagers (SPiKE) platform.

To secure high quality IP protection, Oncopeptides has a long-lasting relationship with Abel & Imray patent and trademark attorneys and their international network of attorneys around the world.

Orphan designation

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. An orphan designation may provide benefits such as market exclusivity but is only given to drugs that are proven better than all available therapies in that indication.

Melflufen was initially granted orphan designation in both the US and Europe, but at the time of marketing authorization approval of Pepaxti in EU, in Aug 2022, the company decided to withdraw Pepaxti from the European Union register of orphan medicinal products as other products have become available.

When relevant, orphan designation may also be applied for new compounds in the portfolio.