Russian government again extends its authority over pharmaceuticals
On 11 May 2021 the provisions on the government’s extended powers to use a patented solution without the right holder’s consent within the country came into force.
Federal Law No. 212-FZ dated June 11, 2021 has gone into effect on 22 June 2021 (hereinafter the Law). The new Law empowers the government to decide whether an invention can be used to produce a medicinal product for export without the patent owner’s consent.
The draft law is intended to organize the production of reproduced medicinal products in the Russian Federation using the patent for the invention for the medicinal product to provide assistance to other states.
The Law enables the government to decide whether an invention can be used to produce a medicinal product in Russia for export without the patentee’s consent. The cases and conditions of international treaties apply, and the patentee must be notified as soon as possible and be paid appropriate compensation.
The international treaties include, for example, the Agreement on Trade-Related Aspects of Intellectual Property Rights, concluded in Marrakesh on 15 April 1994 (hereinafter the Agreement). The Protocol amending the Agreement, signed in Geneva on 6 December 2005 (hereinafter the Protocol), adds Article 3 Ibis and an annex allowing members of the World Trade Organization (WTO) to issue compulsory licences for the production of medicines for subsequent export.
The text of the government decree should state the amount of drug production, which is determined by the needs of the foreign state to which the drug is to be exported. The medicinal product’s packaging should have a special label.
The Russian government must approve a number of details pursuant to the treaty to which it is a party. These include: the procedure for notifying the right holder, the grounds and procedure for making a decision on using the invention to produce a medicinal product in the Russian Federation for export and termination of the decision, the procedure for determining the duration of the decision and the method of determining the compensation and payment procedure.
The international treaties include, for example, the aforementioned Protocol, Article 31 of whose Annex describes the obligation of remuneration of the right holder.
The adoption of the Law is particularly important for the development of the pharmaceutical market. The mechanism can be applied in complex epidemiological situations when states need assistance with providing the population with the necessary drugs.
However, this new development could negatively impact the right holders of patented solutions: they could lose the market advantage for a particular medicinal product.