Book review: Pilicheva A. V. (2016) Drugs as subjects of patent rights
Journal: Science Governance and Scientometrics (Vol.11, No. 3)Publication Date: 2016-07-13
Authors : Maya V. Sotnikova;
Page : 176-179
Keywords : Drugs; health care; patenting of drugs; pharmaceuticals; Bolar legislation;
Abstract
Discovery and development of new medicines are among S&T priority areas of Russia. The importance of medicines for the individual, society and the state as a whole is difficult to underestimate. In accordance with the Constitution of the Russian Federation, the state is the guarantor of health protection and health care. In frame of the federal health-care programs the government encourages research and innovations in pharmaceutics and pharmacology. The problem of patenting of medicines is poorly covered in Russia's civil law. There are many unresolved issues in law enforcement practice and many provisions of legislative acts often contradict each other. The author explores medicinal product as an object of patent rights. She gives a general description of legal protection of medicines in the Russian Federation and abroad and analyzes the latest changes in Russian legislation. A special focus is placed on generics, which can not be protected with patents. The author suggests to apply so called Bolar provisions β a practice where generic manufactures are allowed to complete regulatory requirements prior to the expiry of original molecule's patent.
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