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Одобрено на заседании секции частного права ученого совета Института законодательства и сравнительного правоведения при Правительстве Российской Федерации

Рецензенты:

Л.А. Трахтенгерц – главный научный сотрудник отдела гражданского законодательства и процесса Института законодательства и сравнительного правоведения при Правительстве Российской Федерации, кандидат юридических наук;

А.С. Ворожевич – старший преподаватель кафедры интеллектуальных прав Московского государственного юридического университета имени О.Е. Кутафина (МГЮА), кандидат юридических наук

© Институт законодательства и сравнительного правоведения при Правительстве Российской Федерации, 2019

The Institute of Legislation and Comparative Law under the Government of the Russian Federation

PROTECTION OF EXCLUSIVE RIGHTS TO INVENTIONS USED IN MEDICINES:

PROBLEMS OF LEGAL REGULATION AND DIRECTIONS FOR IMPROVING LEGISLATION

Monograph

Executive editors O.V. Gutnikov, S.A. Sinitsyn

Moscow

LAW FIRM CONTRAKT

2019

Approved at the Private Law Section of the Academic Council of the Institute of Legislation and Comparative Law under the Government of the Russian Federation

Reviewers:

L.A. Trakhtengerts – PhD in Law, Chief Researcher of the Department of Civil Legislation and Process of the Institute of Legislation and Comparative Law under the Government of the Russian Federation;

A.S. Vorozhevich – PhD in Law, Senior Lecturer of the Department of Intellectual Rights of the University. O.E. Kutafina (MSLA)

Protection of exclusive rights to inventions used in medicines: problems of legal regulation and directions for improving legislation: monograph / О.V. Gutnikov, S.A. Sinitsyn, F.V. Tsomartova, A.A. Ayurova; ex. ed. O.V. Gutnikov; The Institute of Legislation and Comparative Law under the Government of the Russian Federation. – M.: LAW FIRM CONTRACT, 2019. – 208 p.

The growth of innovation and scientific and technical progress, the improvement of the quality of health care and the life of the population as guidelines for the social policies of developed countries created conditions for the development of national and international markets for medicines while preserving the imperfections and gaps in the legal regulation of their turnover. In modern conditions of commodity turnover, the results of intellectual activity are one of the most liquid objects of civil rights, however, in Russian legislation and law enforcement practice, registration of drugs is now possible with violation of the rights to the results of intellectual activity used in such drugs, which does not meet the criteria of legal certainty, creating the prerequisites for violating the rights and legitimate interests of innovators.

The present book assesses to the reader the state of the current legal regulation of state registration of drugs and the protection of exclusive rights of third parties to inventions used in them, an analysis of law enforcement practice in the field of identifying violations and protection of exclusive rights of manufacturers of original drugs when released into circulation of reproduced drugs, investigated the international experience in the regulation of drug registration and protection you have the exclusive rights of third parties to inventions used in them; solutions are identified and proposed to address key scientific and practical problems of patent protection of drugs in modern Russian and foreign law; in the conclusion, they formulate and justify ways to improve the regulatory framework for the protection of exclusive rights to inventions used in registered medicinal preparations for medical use.

For researchers, teachers, graduate students, undergraduates, students, practicing lawyers, government officials and all interested in contemporary issues of exclusive rights in the pharmaceutical field.

© The Institute of Legislation and Comparative Law under the Government of the Russian Federation, 2019