The abuse of patentability conditions in the sphere of pharmacy in Ukraine and the EpO: upon the Example of polymorph sofosbuvir

Abstract

The author analyzed regulation of the patenting of polymorphs for medicinal products in Ukraine, the European Patent Office, and in countries with stringent application of patentability criteria in pharmaceutical field (Argentina and India). The author described the analysis of the decisions of the Ukrainian patent office and the Appeals Chamber of the Ministry of Economic Development and Trade concerning the refusal of issuing a patent for the polymorph of sofosbuvir, and the impact of this judgment on access of sofosbuvir for the Ukraine’s population. The author also conducted a brief comparative analysis of Ukraine with the approach of the European Patent Office as opposed to «stringent» patent offices and IGOs patentability guidelines regarding the patenting of polymorphs. It is proposed that polymorphs should be excluded from patentability in Ukraine in order to prevent the abuse of patentability conditions by the industry using polymorphs of known chemicals. Such changes should be introduced either by more precise wording in the patent law in order to correct the deficiencies regarding new forms of known medicines in the Article 7(7) of the Law of Ukraine «On Protection of Inventions and Utility Models» or by introducing relevant provisions by development of patentability guidelines for pharmaceuticals on a sub-legislative level.