Patent and License
The basis for Karessa’s business model is its right to the Film patent in respect of certain critical molecules. The Film patent’s validity lasts until 2026 (in the US, 2028) and has been approved in the most important markets in the world, setting the stage for global distribution.
The Film patent
The Film patent (Swedish patent no. 0502900-4 and European patent no. 1976562) covers the right to composition and production of an orally dissolving alginate based film that clings to the oral mucosa and effectively deliver an active substance to the blood stream. The Film patent is owned by Uppsalagruppen Medical AB. The PCT application (PCT/SE2006/050626) was made in 2006.
Patent applications are made in 51 countries and have so far been approved in 50. Approvals have been received in all for Karessa important markets, including the EPC member countries (European Patent Convention) and among others the USA, Canada, China, India, Russia, Japan, Australia, South Africa, South Korea and Mexico. The scope of the protection for the invention is governed by the patent application and patent approval in each country. In the countries in which the patent has been approved, protection until 2026 or in some cases longer is obtained.
The rights of Karessa
The Film patent is exclusively, and for the remainder of the period of validity of the patent, and without restrictions, licensed to Karessa regarding critical molecules in the area of sexual dysfunction (all current known PDE5 inhibitors) in which erectile dysfunction is included. Karessa will pay no royalties or any type of future milestone payments for the license but must pay its part of the costs related to maintaining the patent.
When developing new therapy areas and/or substances, Karessa has the right to initiate negotiations with the patent owner regarding increases in the license scope and the terms of it.
Karessa's own patent(s)
For using and manufacturing the Film together with vardenafil, Karessa filed an own patent application to the EPC at December 20, 2017, in order to strengthen and prolong its IP protection.
Karessa will submit additional patent applications concerning the Film in combination with other active substances in line with future development.