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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

On June 8, 2021, an order of the Ministry of Economic Development of the Russian Federation No 155 will come into force introducing significant clarification amendments to the patent regulations governing the assessment of the inventive step and sufficiency of disclosure of the inventions relating to new forms and derivatives of the known chemical compounds.

In particular, Rule 77 of the Rules (inventive step) has been amended to include the paragraph as follows:

Inventions are not acknowledged as meeting the inventive step criterion if they are based, in particular:

“- on the creation of a chemical compound, which is a form of a known chemical compound (in particular, an isomer, stereoisomer, enantiomer, amorphous or crystalline form) or its derivative (in particular, a salt, solvate, hydrate, complex compound or ether/ester), if such a compound does not exhibit new properties from qualitative or quantitative perspectives as compared to the known compound, which do not follow to a specialist explicitly from the prior art.”

Rule 47 of the Requirements was supplemented by a new subclause 6, specifying that:

“6) if the invention relates to a chemical compound, which is a form of a known chemical compound (in particular, an isomer, stereoisomer, enantiomer, amorphous or crystalline form) or its derivative (in particular, a salt, solvate, hydrate, complex compound or ether/ester), the information about its new qualitative or quantitative properties as compared to the known compound, which do not follow to a specialist explicitly from the prior art, as well as information that reliably supports the existence of such new properties shall be provided.”

These legislative amendments are essentially aimed at legalizing the actual patent office and court practice that has developed in recent years, according to which, in order to acknowledge the non-obviousness of new forms and derivatives of a chemical compound, it must exhibit new unexpected properties as compared with the known forms and derivatives of the compound, while such properties must be supported by the reliable experimental data.

In view of the above-mentioned amendments, whenever a patent application pertains to a new derivative or form of a known chemical compound applicants are recommended to disclose the experimental support of any advantageous properties of such a new derivatives and/or forms in the specification, or at least be ready to submit the additional experimental data during substantive examination.

We at PATENTICA will be happy to answer any further questions you may have on this or other news and insights published on our website. Please feel free to contact us for more details at info@patentica.com

Since early 1995 the Eurasian Patent Convention (the EAPC) has been effectively used to obtain Eurasian patents for inventions in up to eight former USSR countries via single prosecution procedure conducted by the Eurasian Patent Office. The popularity of this unified patenting system has been recongnized by many professionals from the EAPC contracting sates suggesting to generilize the system with respect to other objects of the intellectual property.

As a result of this process the Protocol on the Protection of Industrial Designs under the EAPC was adopted during international diplomatic conference on September 9, 2020 in Nur-Sultan, the capital of Kazakhstan. The Protocol was singned by six out of eight of the EAPC Contracting States including Azerbaijan, Armenia, Kazakhstan, Kyrgyzstan, Russia and Tajikistan.

According to the established procedure the Protocol will come into force with respect to the first free countries, which are going to ratify the Protocol (Kyrgyzstan, Azerbaijan and Armenia) on March 17, 2021. In Russia the Protocol was ratified on November 10, 2020 and will come into force on April 11, 2021.

The Eurasian Patent Office is going to announce a starting date of the Eurasian system for the industial designs during the fist half of 2021.

Similarly to inventions the Protocol establishes the Eurasian system for the protection of industrial designs, which will allow to obtain a legal protection for an industrial design simultaneously in all of the Contracting States based on a single application submitted to the Eurasian Patent Office. Once a Eurasian patent on industrial desing is granted it can be made valid in any of the EAPC Contracting States upon payment of annuties fees.