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Original vs. generic drug disputes in Russia: recent practice and the steps towards Russian patent linkage system

News by Liapunov and Co.

We would like to bring to your attention some notable court cases completed in Russia in 2018, as well as their potential impact on the legal positions of generic manufactures and the opportunities of the holders of the original drug patents to monitor the activity of generic companies.

Since the year 2009, when the resolution of the Presidium of Supreme Commercial Court No. 2578/09 with regards to the case No. А40-65668/08-27-569 had been adopted, there was well-established practice in Russia that the registration of a drug in the Ministry of Health as well as the actions relating strictly to said registration are not considered to infringe a patent.

However, in the recent case No. А41-85807/2016 (Novartis vs. Nativa), courts’ position was that the actions involving developing and conducting bioequivalent studies of a generic drug, applying for and granting a registration of the drug and establishing the market price constitute a threat of infringement, especially if the above steps are taken long before the expiry date of the patent in question.

By way of contrast, in another recent case No. А40-170151/2017 (Celgene Corporation vs. Pharmsynthez and Bratskhimsyntez) quite similar actions of the generic companies were not considered a threat of infringement of a patent.

In view of this controversial practice the head of Rospatent Grigory Ivliev has recently stated that it might be reasonable to amend the Russian Law on Circulation of Medicines by adding a direct indication of that a generic drug may be registered during the validity of the patent protecting the original drug however the validity period of said registration shall begin, and any actions relating to introducing said generic drug into civil circulation shall be allowed, only after the expiration of said patent.

In order to enable the Ministry of Health to correlate the drug specifications submitted for registration with existing patents and to apply the delay in registration validity period where necessary Mr. Ivliev advocates establishing a patent linkage system in Russia. Such system will also help patent holders to monitor generic drug registrations. This proposal is also supported by the Ministry of Health.

Given the importance of the above mentioned proposals for drug originators and generic companies we are monitoring the situation and will be glad to answer to your questions on the matter.

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