Previously we have already mentioned that a draft law “On amendments to the Federal Law “On drugs circulation” was prepared by MoH to bring the Russian legislation in line with the Eurasian Union legislation.
According to the first version of the draft law, all patents and trademarks relevant to a new drug as well as evidence of their non-infringement shall be indicated by a company seeking to register this new drug.
In September the draft law was amended with a new provision on the creation of Register of pharmacologically active substances. Under this provision, Rospatent will keep the publicly available Register of pharmacologically active substances protected by patent.
A company seeking to register a new drug may apply for the inclusion of information on the pharmacologically active substance used as a component of a drug and protected by patent. If active substance characteristics in a patent claim and marketing authorization are determined after the expertise of documents, this active substance will be recorded to the Register.
Moreover, following the draft law marketing authorizations for generic drugs may enter into force only after the expiration date of a patent protecting an active substance.
If the current version of the draft law will be passed, the introduction of generic drugs to the civil circulation before the expiration date of a patent to an original drug will be restricted, which allows minimizing patent infringement and claims against unfair competitors.
Meanwhile, there are still some unsettled issues. The new version of the draft law does not specify the liability of an applicant provided unreliable information on patents and trademarks or did not provide such information during drug registration. Furthermore, the procedure of amendments to the Register in case of patent prolongation, annulment or partial invalidation is not regulated by the draft law as well. Additionally, it is not regulated whether a marketing authorization to a generic drug may be obtained earlier in case a patent to active substance was regarded as invalid or canceled.