In September 2019, the Ministry of Health of the Russian Federation updated the draft amendments to the Law On the Circulation of Medicines, proposing to create a unified register of pharmacologically active substances protected by patents.
Rospatent will maintain the register. Participation in the register will be self-imposed, but paid. Information from the registry will be in the public domain.
Pharmaceutical companies will be able to file for inclusion in the register information on existing patents for active substance. Rospatent will verify documents and the characteristics of the active substance in the patent and registration certificate, and make an expert opinion.
Thus, the applicant will be issued a registration certificate for the drug, but if information on its protection is contained in the register, registration will become valid only after the expiration of the patent protection of the original.
Earlier, the Ministry of Health has already published amendments to the law that introduce the norm that the applicant must indicate the patent protection of the original product and the validity period of such patents when applying for the registration of a new drug.
Nowadays, the legislation also restricts the introduction of a generic into circulation if there is a valid patent for the original drug, but the procedure for this restriction is not clearly regulated.