On November 24, 2023 Circio Holding ASA (OSE: CRNA), a biotechnology company developing novel circular RNA and immunotherapy medicines, reported that the European Patent Office (EPO) board of appeal has moved to revoke the EU Patent 3140320 "Peptide vaccine comprising mutant RAS peptide and chemotherapeutic agent" during proceedings held on 22 November 2023 (Press release, Circio, NOV 24, 2023, View Source [SID1234637959]).

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EU Patent 3140320 is a method of use patent covering the combination of TG01 with the chemotherapeutic gemcitabine (and similar agents) in pancreatic cancer. The EPO board of appeal ruled that the patent should be revoked due to a lack of sufficient inventive step based on prior publications relating to TG01 clinical studies. Method of use patents are known to be challenging to uphold due to mandatory public disclosures surrounding trial design and treatment regimen. The EPO ruling applies only in European countries.

Dr. Lubor Gaal, Chief Financial Officer of Circio Holding ASA, said: "We are disappointed by and disagree with the EPO´s ruling to revoke our TG01/gemcitabine patent for pancreatic cancer. However, this chemotherapy combination was discontinued in 2019, and the ruling has no impact on ongoing clinical studies where TG01 is being tested with novel immunotherapies and in other cancer forms outside of this patent. Moreover, TG01 remains covered by orphan drug designations in pancreatic cancer and data protection as a biologic in both the EU and USA, which provides market protection for up to 12 years."