Granted patents for Foxy-5

WntResearch has three granted patents on Foxy-5. Product patents are fundamental where the drug substance Foxy-5 is patent protected, in the US until 2028 and in the EU until 2026. Product patent protection can be extended by up to five years as compensation for long development time, called SPC, Supplementary Protection Certificate. In addition to patent protection, local authorities in many countries also offer extra protection in the form of market exclusivity from the time the drug is registered. This means that Foxy-5 can obtain exclusivity for at least eight years in the EU and up to seven years in the US, regardless of the expiry of the product patent. In addition to the product patent, Foxy-5 has been granted a patent for the treatment of prostate cancer and a manufacturing patent for Europe has now been granted with patent protection until 2039.

Patent applications in several areas

WntResearch is actively working to complement the existing patent portfolio by further broadening and extending the patent protection for Foxy-5. In addition to the granted patents, WntResearch has a number of patent applications, based on the company’s ongoing research and development.

There are patent applications for Foxy-5 and checkpoint inhibitors as well as an application on the ability of Foxy-5 to reduce the number of cancer stem cells. These applications are categorised within medical indications and a patent application for the use of Foxy-5 in the treatment of AML (acute myeloid leukaemia) was filed in November 2021. The patent is based on Foxy-5’s ability to counteract several oncogenic processes that occur in AML by inhibiting cell growth. AML is a disease area where WntResearch will continue to study Foxy-5.

Applications for two different synthesis routes have been submitted to achieve low raw material costs, simpler processes, higher purity and adaptation for scaling up to commercial volumes. Ultimately, the new method provides a significantly lower production cost and strengthens the company’s patent portfolio, which is an important aspect of commercialisation. Patents are granted for Europe until 2039 (see Authorised patents for Foxy-5).

Over the past year, WntResearch has been working on different approaches to address the limited solubility of Foxy-5. In December 2021, a patent application was filed covering new stable compositions of Foxy-5 with improved solubility and excellent stability. After granting the patent, this means that Foxy-5 has patent protection until 2041.

Briefly about the patent process

The patent process is briefly as follows – an initial patent application is made, which in itself means international protection as no one else can apply for a patent for the same thing after the application is registered. The uniqueness of the patent application is assessed by an international examiner and you normally have one year to complete your application. After 1.5 years, the application becomes public. After 30 months, it is decided in which specific countries the patent application will be filed. Once authorised, the patent is valid for up to 20 years, depending on the country, from the date of the initial application.

Granted patents

Patent familyCountry*Date of applicationExpiry date
A peptide ligand to impair cancer cell migrationBE, DK, FI, FR, DE, IT, NL, ES, SE, CH/LI, TR, UK, US, IN, CN, AU, CA, JP2005-05-30 2026**  
A peptide ligand to impair cancer cell migration (Foxy-5) (Divisional)BE, DK, FI, FR, DE, IT, NL, ES, SE, CH/LI, TR, UK2005-05-302026
Treatment of prostate cancer and a method for determining the prognosis for prostate cancer patientsAT, BE, CH/LI, DE, DK, EE, ES, FI, FR, GB, HU, IR, IS, IT, NL, NO, PO, SE, TR, US2011-07-012032
Use of Wnt5a peptide derivates for the treatment of melanoma and gastric cancer (Box-5)CA, CN, IN, JP, RU, US, BE, FR, DE, IT, NL, ES, SE, CH/LI, TR, UK2008-08-132029
Wnt5a peptides in reduction of cancer stem cellsSG, UP, CH, ES, UK, NO, UP, PL, TR, HK, CN2017-10-252038
Solution phase routes for Wnt hexapeptidesRU, HU, IS, IR, NO, PL, ES, CH/LI, TR, UP, UK, CN, US, HK, US (Divisional)2018-08-202039
Linear solution phase synthesis for Wnt hexapeptidesCL, JP, RU, SG, HK, AU, BE, DE, DK, ES, FR, UK, HU, IE, IS, IT, NL, NO, PL, TR, CH, CA, CN2018-12-142039
Stable compositions of Foxy-5 hexapeptide with high solubilityUP, CH, ES, UK, NO, PL, TR2021-10-122041
AT Austria, AU Australia, BE Belgium, CA Canada, CH/LI Switzerland/Lichtenstein, CN China, DE Germany, DK Denmark, EE Estonia, ES Spain, FI Finland, FR France, HU Hungary, IN India, IR Ireland, IS Iceland, IT Italy, JP Japan, NL Netherlands, NO Norway, PL Poland, SE Sweden, TR Turkey, US USA, UK United Kingdom.
** US adjusted by 789 days (base year 2028).