Manufacture of patented drugs in Russia in special circumstances without the consent of the patent owner

On the 22nd of June, 2021, the Federal Law No. 212 as of June 11, 2021 entered into force, introducing an additional Article 1360.1 into part IV of the Civil Code.

According to Article 1360.1 of the Civil Code the Government of the Russian Federation may now allow to use a patented invention for the production of a medicinal product by any party for export purposes without the consent of the patent owner with the immediate notification of the patent owner and payment of the proportionate compensation for such a use.

The notification must disclose the information about a volume of production of a medicinal product defined by the needs of a foreign state where the medicinal product is to be exported, while the packaging of such a medicinal product should have a special designation «for export purposes» or the like.

On top of that according to earlier amendments to Article 1360 of the Civil Code of the Russian Federation introduced by the Federal Law No. 107 of April 30, 2021, the Government of the Russian Federation may allow to use an invention, utility model or industrial design without the consent of the patent holder, not only in the interests of the defense and security of the state, but also to protect the life and health of citizens in case of emergency.

The Government has once again expanded its powers and capabilities to use patented medicines in cases where the patent owner cannot fulfill the need of Russia’s and the Eurasian Economic Union’s (EAEU)* pharmaceutical markets with the required amount of medicines, especially with vital and essential drugs in difficult epidemiological situations and other undesirable circumstances.

Following this new provision the Russian company Pharmasintez has been recently given a permission to manufacture Remdesivir (used the treatment of COVID-19) without the consent of the originator company, Gilead Science. The decision is currently under court appeal submitted by the patent owner.

The adoption of the above-mentioned amendments clearly indicates the intention of the Russian Government to expand the application of the administrative procedure for authorizing the use of patented drugs over the whole territory of the Eurasian Economic Union and replace what is believed to be a controversial and widely criticized approach of issuing compulsory licenses in accordance with Article 1362 of the Civil Code of the Russian Federation.

While these provisions are clearly beneficial to generic manufacturers they also give an additional clear message to the originator companies about the importance of obtaining Eurasian patents covering not only Russia but the rest of the EAEU contracting states and other neighboring import-oriented countries.

Should you have any questions in this regard or need additional information please do not hesitate to contact PATENTICA’s patent attorneys at info@patentica.com.

*EAEU Contracting States: Russia, Armenia, Belarus, Kazakhstan, Kyrgyzstan