Under the Federal Law “On drugs circulation&” (Law), information on state registration of drugs in Russia shall be publicly available.
Pursuant to Art. 37(1) of the Law, MoH-s obligation is to disclose information regarding all filed applications for drug registration on its official website.
For a long period, MoH used to turn a blind eye to this obligation, keeping this information confidential. It used to be a negative factor and raised public concerns among professionals. Moreover, absence of this information used to pose additional risks for patent holders lacking information on the upcoming launches of generic drugs.
However, in April 2019, MoH finally launched the section on Information related to state registration on its website. This section has disclosed information on recently filed applications for registration of drugs currently pending before MoH.
Access to this information is particularly significant in harsh competitive conditions on the market and significant increase of patent disputes in Russia between originators and generics.
Russian law does not recognize registration of generic drugs during the patent validity term as an act of infringement (Para. 2, Art. 1359 of the Russian Civil Code, Decision of the Presidium of the Supreme Commercial Court in case No. A40-65668/08, dated 06.16.2009).
However disclosure of information on filed applications will allow patent holders to keep control of any threat of infringement coming from generic registrations. Under the current jurisprudence, “threat of infringement” takes place when a generic drug obtains a market authorization in Russia over 3 years before the patent expiry (case No. А41-85807/2016).
Moreover, MoH has prepared a draft version of the Law “On amendments to Art. 18 of the Federal Law “On drugs circulation”. It says that any company seeking to register a new drug (original or generic) shall indicate all patents and trademarks relevant for this new drug. Another obligation is to warrant that registration of this new drug would not infringe any third party’s intellectual rights, under the risk of penalties.
We believe that disclosure of information on filed applications as well as initiatives to formalize IP compliance in the process of registration of drugs will strengthen legal protection of patent holders against malicious practices.