Compulsory licensing in favor of patentholders of dependent pharmaceutical inventions

Abstract

The article analyzes the conditions for issuing a compulsory license in favor of the patent holders of dependent pharmaceutical inventions on the basis of Paragraph 2, Article 1362 of the Russian Civil Code. The criteria for the relevance of a dependent invention to important technical advancements with significant economic advantages are disclosed. An analysis of the emerging Russian court practice on the issuance of compulsory licenses in the pharmaceutical market, meanwhile, showed that Russian courts lack a clear understanding of when a patent holder can and cannot apply for a compulsory license. The author proves that compulsory licensing is an effective mechanism to prevent abuse of the right (first of all, to standard-essential patent) in the markets of complex innovations (IT, electronics and telecommunications). At the same time, its implementation on the pharmaceutical market can lead to negative consequences: discourage pharmaceutical companies to invest in the development of new drugs, register breakthrough drugs in Russia; reduce foreign investment in the pharmaceutical sector. In this case, the provision of compulsory licenses should be interpreted as an exceptional tool. The issuance of a compulsory license in favor of the owner of the dependent invention can be justified only if such an invention represents a genuine innovation, an important step in the development of pharmaceuticals. The licensee must offer the market a new drug with improved characteristics: increased therapeutic efficacy and (or) safety, which has no available alternatives.