16-03-2021 16:02
by Fast

Russia: First compulsory pharmaceutical license issued by Russian Government based on “public security” clause

On 31 December 2020, the Russian government issued Decree No. 3718-p which allows the Russian generics company “Pharmasynthez” to make use of six Eurasian patents of Gilead over a period of 1 year with the aim of providing the population of the Russian Federation with pharmaceutical preparations comprising the active ingredient “Remdesivir” for the treatment of COVID-19 infections.

In the pharmaceutical area, beginning since Mid-2018, compulsory licenses for dependent patents have been granted by Russian Courts to the domestic Russian generic company “Nativa” to produce analogs of patent-protected Western drugs in Russia. In contrast to that, the above-mentioned Decree is based on Art. 1360 of the Russian Civil Code which entitles the government to grant compulsory licenses “in the interests of defence and national security” without the patentee’s consent, subject to “a fair compensation”. Said Decree No. 3718-p has triggered the mechanism of Art. 1360 of the Russian Civil Code for the first time and was issued specifically “in the interests of security”.

The generic Remdesivir version of Pharmasyntez is called „Remdeform“. The limitation of the compulsory license to 1 year is seemingly due to the fact that also the originator preparation Veklury® of Gilead received a conditional marketing authorization for the treatment of COVID-19 only, which expires 01.01.2022.

It remains unclear how said “fair compensation” to the patentee will be calculated, and to what extent this payment will correspond to the fair market value of the given compulsory license. The actual amount of said compensation is to be fixed by the Ministry of Industry and Trade within a three-month term.

As an aside, the Russian Parliament is currently working on draft law 842633-7, which shall even significantly simplify the above-mentioned mechanism of Art. 1360 of the Russian Civil Code under which compulsory licenses may be granted. Specifically, the grounds provided for by Art. 1360 “in the interests of defence and national security” shall be expanded by “in the interests of life and health protection of the population”.

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