Maxim Ali has talked about the draft law on the release of drugs

Maksim Ali Senior Associate

The Government of the Russian Federation introduced a draft version of Article 1360 of the Civil Code, allowing compulsory licensing without the consent of the copyright holder “in case of emergency, connected with… protecting the life and health of citizens.” At the same time, it is assumed that the patent holder will be notified as soon as possible that Russia wants to release its medicines, and will receive a right to “proportionate compensation”.

As Maxim Ali, Head of the IP/IT practice, told Advokatskaya Gazeta, the bill presumes that there is a general methodology for determining the amount of compensation, which will be approved by the Government of the Russian Federation. “For comparison: the amount of compensation is determined ad hoc, the development of a common methodology for determining compensation in any case will be a difficult task, because the application of Article 1360 of the Civil Code should be carried out only in extraordinary cases. Therefore, it will be extremely difficult to predict all of the cases and immediately figure out how to consider proportionate compensation”, he said.

Maxim expressed the hope that the methodology of the government will be quite general and to a greater extent suggest some general guidelines for determining compensation (such as duration and volume of use), “otherwise there is a risk that the compensation will be unfair and far from reality”, he cautioned. Maxim added that Article 1360 of the Civil Code still remains a reserve instrument in the hands of the state and has not actually been used. “If the situation changes, it is quite possible that the methodology for calculating compensation and the procedure for its payment will be challenged in court, where the final amount of compensation can be checked for its proportionality”, Maxim summed up.

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