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Compulsory Licensing: Precedent

The issue of effects on copyright holders, abusing the dominating regulation and refusing to supply  socially required drugs and devices to the Russian Federation is on agenda.

The federal antimonopoly service proposes to include the corresponding amendments in the civil code and law “On protection of competition”. The corresponding project was published at the website of legal information disclosure.

The amendments were caused by abuse by proprietors of the dominating statement, causing them to refuse under different pretexts and for different reasons (economical, political) to market drugs protected with patents, and manufacture or supply to Russia drugs required for treatment of socially significant disorders. No effective mechanisms of public measures instituted in case of such violations are existent in the Russian legislation. However, international acts provide for a possibility of compulsory actions of the public on unfair proprietors. According to Clause 31 of TRIPS agreement the use of patent object without the copyright holder is possible if national legislation of the WTO member permits such use. International jurisprudence is aware of cases, when government issued a compulsory license for import (manufacture) of a drug as required in the interest of the national security.

According to the document it is proposed to amend clause 1360 of the Civil Code (Use of invention, useful model or industrial sample in the interests of national security, protection of life and health of citizens of the Russian Federation) as follows:

“The Government of the Russian Federation has the right in the interests of national security, protection of life and health of citizens, to approve the use of an invention, useful model or industrial ample without consent of the patent holder, with notification about that in the shortest term and payment of proportionate compensation”.

Public discussion of the proposed document will continue to February 2, 2017.

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