Legal aspects of the implementation of the “Bolar exception” in Russian legislation

The article discusses the problem of applying the principle of “Bolar exception” in the context of Russian patent legislation. The subject of the study is a comparative analysis of foreign legal approaches to the regulation of this exception and an assessment of its potential implementation in the legal field of the Russian Federation to ensure a balance of interests of patent holders and society. Based on the study of international experience (EU countries, USA, Switzerland, Andean Community countries, etc.) and contradictory domestic judicial practice, it is concluded that it is necessary to legislate the “Bolar exclusion” in Russia. A specific version of the amendments to Article 1359 of the Civil Code of the Russian Federation is proposed, which will eliminate legal uncertainty, legalize the registration of generics during the patent period and ensure their entry into the market immediately after its expiration. This will contribute to the fulfillment of the objectives of the pharmaceutical strategy of the Russian Federation, the development of competition, reducing dependence on imports and increasing the availability of medicines for the population.