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 noPatentTypeValidRegionStatus
US 10,059,710 B2
US 10,336,758 B2
Arfolitixorin
(6R-MTHF)
Substance/

Formulation/Treatment method

2037

2037

USAGranted

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

Enzyme inhibition, measurement of biomarker in bloodTreatment method2038

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