Сompulsory Licensing of Medicines: Some Issues of Regulation and Enforcement

The article is devoted to the topical problems of protecting the intellectual rights of companies that are manufacturers of medicines and drugs, taking into account the need to maintain a balance of interests of pharmaceutical companies, patients and the state, as well as the role of the patent system in this mechanism. Almost all medicines and medication created in different countries are initially registered today as objects of intellectual property and are protected by patents. In world practice, exclusive rights to the results of intellectual activity are among the most investment-attractive corporate assets. Therefore, the creativity of innovators who create new technical solutions should be properly stimulated for the purpose of subsequent organization of production in Russia for the production of new medical products on an industrial scale, including the latest medicines and medication. In addition, the regulatory framework should ensure the attraction of investments in the research activities of innovators and the subsequent commercialization of patented developments, in order to provide consumers with highly effective medicines at affordable prices. One of the ways to reduce the selling value of medical products demanded by the market is the use of legal mechanisms for compulsory licensing of patentable drugs, which is implemented in the civil legislation of Russia. It is generally accepted that these mechanisms can reduce the cost of medicines created on the basis of the latest developments. At the same time, the author draws attention to the complexity of the legal relationship arising between the copyright holder who owns the innovation and the licensee. If the patentee does not agree with the loss of the monopoly right to the created drug, he can overcome the legal monopoly on the patented product in court. The article considers such concepts as the conditions for issuing, features, positive and negative aspects of compulsory licensing, as well as an analysis of the established judicial practice in the field of granting a license and the possibility of subsequent development of the practice of concluding contracts of this type.