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Ministry of Health: registration of a generic will be possible after the expiration date of the original patent

 

The Ministry of Health of Russia updated the draft amendments to Law No. 61-FZ “On Circulation of Medicines” developed in February 2019, adding to the document the Regulation on the Unified Register of Patented Active Pharmaceutical Ingredient. Rospatent will host the Register. The originator will be able to file the information on an existing patent for an active ingredient that will be recorded in the Register. Rospatent will be responsible for documents verification, comparison of the active ingridient characteristics in the patent with the registration certificate, and then make a decision. According to Dmitriy Travnikov, Director of the Department for the Provision of State Services of Rospatent, participation in the Register will be absolutely voluntary. The Federal Institute of Industrial Property will conduct an examination on a fee basis to cover relative expenses. The fee will be determined later, but taking into account circumstances of the industry under concern it will not be burdensome. Current legislation does not prohibit registration of a generic when the original patent is in force, but limits introduction of a generic into circulation. However, this particularrestriction is not clearly regulated.

 

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