Patent och varumärken
Intellectual property rights
Intellectual property rights, including market protection through orphan drug market exclusivity,
regulatory data protection rights and patents, are of great importance to the Company’s operations. Egetis
has an active patent strategy aimed at protecting tiratricol (the active pharmaceutical ingredient) in the
Emcitate® product and calmangafodipir (the active pharmaceutical ingredient) in the Aladote® product.
This strategy has been developed in close collaboration with the Company’s external patent attorneys.
The Company has filed patent applications for Emcitate® in the US and other regions listed in Table 1. In
April 2026, the United States Patent and Trademark Office (USPTO) granted Patent No. US 12611383B1
for the Company’s patent application Family 2 entitled “Pharmaceutical Compositions for Treating MCT8
Deficiency”. This patent provides protection for a novel composition, which contains tiratricol as the
active ingredient, designed to correct the disrupted thyroid hormone signaling characteristic of MCT8
deficiency. The claims cover, among other things, a method of treating MCT8 deficiency with the claimed
pharmaceutical composition that encompasses tiratricol, dosing regiments, and tiratricol compositions
with specific excipients. This patent represents a significant milestone in strengthening the Company’s
intellectual property portfolio. Egetis expects the granted patent will be Orange Book-listable.
The Patent Cooperation Treaty (PCT) patent application for Patent Family 1 was published in March 2026.
The company plans to strengthen its ability to safeguard innovation and maintain exclusivity in the market
by taking the PCT case forward into the national phase in the usual way in March 2027. The Company has
filed a PCT application for the Patent Family 2 invention and that will publish in early 2027. The Company
also plans to take that case forward into the national phase in various jurisdictions in due course.
In parallel with this patent protection, the Company also benefits from additional regulatory exclusivities
in both the United States and the European Union. In the US, these include orphan drug exclusivity of 7
years. In the EU, the Company benefits from orphan market exclusivity of 10 years and regulatory data
protection.
The Company’s strategy is to seek strong patent protection both through patents covering the tiratricol
and calmangafodipir drug candidates, and to formulation and treatment methods, and also by regulatory
data protection and orphan market exclusivity derived from orphan drug designation. The Company
aims to obtain broad geographic patent coverage in jurisdictions considered to be key markets for its
drug products, including major markets such as the United States, China, Japan, France, Spain, Italy, and
the United Kingdom. The Company is actively working to add to the patent protection for its current and
future drug products. Furthermore, Egetis Therapeutics closely monitors developments related to its
intellectual property in all relevant areas and keeps track of competing technologies and companies.
Trademark
The Company maintains trademark protection for Emcitate® and Aladote® in major markets worldwide,
including registrations in the EU, UK, US, Canada, Japan, Switzerland, and with additional applications
pending in other jurisdictions.
Table legend
Table 1: Patent Families 1 and 2 protect Emcitate®; family 1 covering a high purity composition of
tiratricol and ways of preparing it, and family 2 covering a formulation containing tiratricol with beneficial
properties.
Table 2: Patent Families 2, 3, and 5 are relevant to Aladote®. One of the Company’s most significant
patent families (Patent Family 3) is a composition-of-matter patent for calmangafodipir, which is the
active pharmaceutical ingredient in Aladote®. The Company’s other patent family covers a method and
formulations for treatment of acute liver failure and other hepatotoxic conditions (family number 5).
