Intellectual proporty rights

Patent portfolio

Isofol has entered into a global, exclusive supply and licensing agreement with Merck KGaA 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 2037 (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 no Patent Type Valid Region Status
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
USA Granted
Granted
Granted
WO 2015/022407
EP 3033344 B2
Arfolitixorin
(6R-MTHF)
Substance 2034
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 B2 Citrate composition Formulation/Treatment method 2029 USA Granted
EP 1641460 B2 Citrate composition Formulation/Treatment method 2024 Europe (12 countries), Japan, Canada, Australia, China, India, South Korea, Mexico, Russia, South Africa Granted in all countries
WO 2018/065445
US 10,328,078 B2
Dosage regimes Treatment method 2038
2038
USA, Europe, Japan + 10 countries Granted in US
WO 2018/065446 Dosage regimes Treatment method 2038 USA, Europe, Japan + 10 countries Patent pending
WO 2018/150264
US 10,292,984 B2
Enzyme inhibition, measurement of biomarker in blood Treatment method 2038
2038
USA, Europe, Japan + 10 countries Granted in US
WO 2019/135157 Dose regimen for ongoing clinical study Treatment method 2039 USA, Europe, Japan + 10 countries Patent pending
WO 2015/114099
US 10,487,364 B2
Measurement of gene expression before clinical treatment Treatment method 2035
2035
US, Europe
+ 2 other countries
Granted in US