Intellectual proporty rights

Patent portfolio

Isofol has entered into a global, exclusive supply and licensing agreement with Merck KGaA and Merck & Cie for the development and commercialisation of arfolitixorin in cancer treatment. Isofol’s supply and licensing agreement with Merck remains in force as long as any of Isofol’s or Merck’s patents remain valid – a term which currently extends, at a minimum to 2038 (and potentially longer in the light of patent applications subsequently submitted). This agreement regulates both the price that Isofol pays for the API (Active Pharmaceutical Ingredient, i.e. the active substance) and future royalties on sales. The patent portfolio comprises several types of patent: substance, formulation, and how they shall be used in the treatment process.

Isofol´s main patent

Patent noPatentTypeValidRegionStatus
US 10,059,710 B2
US 10,336,758 B2
US 10, 570,134 B2
Arfolitixorin
(6R-MTHF)
Substance/
Formulation/Treatment method
Pharmaceutical compositions
2037
2037
2037
USAGranted
Granted
Granted
WO 2015/022407
EP 3033344 B2
Arfolitixorin
(6R-MTHF)
Substance2034
2034
Europa,
Japan,
Canada, etc.
Granted in Europe (36 countries), Japan, China, Australia, Mexico, Israel, South Africa, Singapore and Hong Kong.
Patent pending in 5 other countries
US 9,180,128 B2Citrate compositionFormulation/Treatment method2029USAGranted
EP 1641460 B2Citrate compositionFormulation/Treatment method2024Europe (12 countries), Japan, Canada, Australia, China, India, South Korea, Mexico, Russia, South AfricaGranted in all countries
WO 2018/065445
US 10,328,078 B2
Dosage regimesTreatment method2038
2038
USA, Europe, Japan + 10 countriesGranted in US
WO 2018/065446Dosage regimesTreatment method2038USA, Europe, Japan + 10 countriesPatent pending
WO 2018/150264
US 10,292,984 B2
US 10, 639,311 B2
Enzyme inhibition, measurement of biomarker in bloodTreatment method2038
2038
2038
USA, Europe, Japan + 10 countriesGranted in US
WO 2019/135157Dose regimen for ongoing clinical studyTreatment method2039USA, Europe, Japan + 10 countriesPatent pending
WO 2015/114099
US 10,487,364 B2
Measurement of gene expression before clinical treatmentTreatment method2035
2035
US, Europe
+ 2 other countries
Granted in US