In the review discussed the unique properties of the Russian pharmaceutical market and the factors and conditions that affect to development of it. Thus, today the market is characterized by a presence of original drugs as well as a large number of generic drugs. This results to granting evergreen patents to drugs, except patents to original preparations. Moreover, amendments in laws, including patent law changes for avoiding evergreen patents contribute into over-regulation in the drug stream of commerce overall. Based on the above, a launch of drugs into the Russian pharmaceutical market is very complex challenge, and an IP protection strategy is needed to be developed for any types of drugs
Keywords: evergreen patents, public purchase, pharmaceutical market, drug patents, generic patents
- RNC Pharma: ABD import of drugs into Russia. «Import of finished drugs in Russia in 2019 shows a record dynamic in rubles»//GMP News. 06.03.2020.
- DSM Group: Drug sales in 2019 fall in the first time for 4 years//Pharmasevticheskiy vestnik. 11.02.2020.
- The Rules for registration and examination of the drugs for medical use. The EEC Decision № 78 of 3.11.2016 (ed. of 30.01.2020).
- The Russian Government Executive Order of 5 September, 2020 under № 1360«The order for determination of a drug for medical use».
- The Russian Government Executive Order of 4 September, 2020 under № 1357 «The Rules for using information about interchangeable drugs for medical use and explanations on interchangeability quiestions».
- The Federal Law № 61-FZ of 12.04.2010, in the edition 27.12.2019.
- S. Mentyukova. «Manturov: in Russia drugs for treating Covid-19 are produced in sufficient volume»//The Russian newspaper. 16.10.2020.
- Quintiles IMS Institute. Medicines Use and Spending in the U.S.A. Review of 2016 and Outlook to 2021.
- The Russian Government Executive Order of 1 August, 2020 under № 2015-r «On amendments in the Russian Government Executive Order of 6 July, 2010 under № 1141-r».
- O. V. Chelysheva. Patents for chemical compounds: right scope, violation. М.: INFA-М, 1996.