Intellectual
property rights

Isofol works continuously and proactively to protect the intellectual property rights of arfolitixorin. The patent portfolio consists of several different types of patents, for example substance patents, formulation patents protecting how arfolitixorin is used clinically in treatment.

The intellectual property protection for arfolitixorin currently consists of a combination of patents protecting the substance  (for example substance patents owned by Merck to which Isofol has an exclusive, global license) and clinical use patents (for example use and dosing patents owned by Isofol), which together provide robust protection and market exclusivity in key global markets. In parallel with arfolitixorin’s clinical development, efforts continue to further expand the scope and extent of intellectual property protection. The substance arfolitixorin is patent-protected until 2037 in the U.S. and until 2034 in other markets. Additionally, an International Searching Authority has issued a positive preliminary opinion regarding a new international substance patent that could extend protection until 2043, pending approval by national patent authorities. Furthermore, the new dosage regimen currently being trialled is expected to lead to additional patents providing exclusivity until 2045 if granted, and potentially beyond if patent term extensions are approved.

Working with leading patent experts, the company continuously evaluates opportunities to file new patents based on potential discoveries emerging from ongoing development work, which could further extend exclusivity protection and potentially increase the value of the company’s pharmaceutical projects even more.