scholarly journals Legal Aspects of the Balance of Interests: Pharmaceutical Companies Innovators and Generic Manufacturers

2021 ◽  
Vol 16 (10) ◽  
pp. 101-110
Author(s):  
E. I. Pazemova

The paper deals with the problems of entering the market of generic drugs in the light of protecting the interests of copyright holder-originators. It is emphasized that the main method of protection lies in the area of intellectual rights. The protection of patent rights by companies that are copyright holders of innovative medicines comes out on top. Attention is drawn to issues related to the data exclusivity regime that are especially important in the context of establishing a balance of interests not only between the copyright holders of original medicines and generic manufacturing companies, but also between representatives of the medical community. The paper considers individual rules of special normative legal acts regulating relations related to the circulation of medicines in Russia and abroad. The author draws attention to the fact that there is some terminological ambiguity, which creates difficulties in the implementation of legal regulation. Possible restrictions on the rights of companies that put into circulation generic medicines should act as a certain guarantor in the implementation of the proper legal mechanisms for the protection of the results of intellectual activity in the pharmaceutical sector and contribute to the stimulation of innovation.

Author(s):  
M.V. Kotenko

The author highlights and investigates the theoretical and legal aspects of the place of intellectual property in the system of legal values. It is noted that legal values ​​are a special phenomenon in which a wide range of ideas, ideas, provisions that reflect the peculiarities of society's perception of socially useful factors, which find their expression and manifestation in the legal sphere of society. In this regard, intellectual property is a special product of human intellectual activity, which is recognized as socially useful and subsequently acquired legal characteristics, ensuring the protection of intellectual property rights, their inviolability, as well as regulating relations in the field of intellectual property. Intellectual property is a special socio-cultural phenomenon, belonging to the system of socio-cultural values ​​is primarily due to its usefulness to society, the ability to ensure the interests of its subjects. At the same time, the multifaceted and complex nature of intellectual property, represented in various spheres of society, provides an opportunity to study intellectual property, including as part of a system of legal values ​​endowed with legal properties, provided by law, allows legal entities to achieve legally significant results. related to intellectual property. Based on the analysis of doctrinal and legal ideas about the value of intellectual property, the author identified the place of intellectual property in the system of legal values. It is concluded that intellectual property as a legal phenomenon has a multifaceted and multifaceted nature, which does not allow to unambiguously determine its place in the system of legal values. Therefore, it is proposed to determine the criteria according to which to classify legal values, which should cover and take into account all possible aspects (characteristics) of legal values, including taking into account the values ​​of intellectual property established above. The place of intellectual property in the system of legal values ​​is determined by the author according to the following criteria: 1) the state of legal support of intellectual property in Ukraine; 2) the method of legal regulation of relations in the field of intellectual property; 3) its functional purpose.


Author(s):  
Nikolay Kulakov ◽  
Mariya Saveleva

Introduction. Digital technologies are booming in the modern world. The resource economy is being replaced by the innovation economy. The results of intellectual activity occupy an increasing place in the economies of different countries. But any important invention must be properly protected. The purpose of this article is to study the problems of legal regulation of patent rights in the Russian Federation. Methodology. The work used General methods of cognition-comparison, analysis, synthesis, abstraction, system, structural and functional approach, ascent from the abstract to the concrete, etc. Results: the study allowed the authors to formulate a conclusion that administrative and legal liability as a means of legal protection of inventive rights, characterized by the presence of significant potential. However, a set of reasons prevents the realization of this potential to a sufficient extent. Among such reasons, the authors, among other things, rank the problems of legal regulation of administrative responsibility and civil liability in the field of patent law. The study of some of these problems allowed the authors to form several proposals for amendments to the current legislation.


Lex Russica ◽  
2020 ◽  
pp. 134-147
Author(s):  
B. A. Shakhnazarov

The paper examines the legal problems of protection and use of intellectual property in the context of fighting the pandemic. It is noted that the recommendations proposed by the World Health Organization to identify, diagnose and isolate, as well as to provide assistance to patients with suspected coronavirus infection in a pandemic can be effectively implemented only with proper legal regulation of the protection of intellectual property rights to the relevant results of intellectual activity, stimulating relevant developments while maintaining a balance between private and public interests. The paper examines the modernization of Russian legislation in the sphere of relations under consideration. Of vital importance are developments related to medicines and medical devices in preventing and overcoming the consequences of the spread of infectious diseases; flexibility of the legislator and the need to implement special-simplified, accelerated-legal regimes for the introduction of medicines and medical devices into trade. The author summarizes regulations at the interface of the legislation on circulation of medicines and intellectual property law in Russia and abroad (USA, Germany), as well as at the supranational level (EAEC). In modern conditions, the possible rapid spread of viral infections and pandemic threats it is essential to establish the legal basis for the balance between the public interest and the interests of patent holders in national legislations, based on a harmonizing international treaty provisions. The authors considers the restriction of patent rights in the extreme urgency with the obligatory non-exclusive and temporary nature of the use of objects of patent rights by a third party based on such restrictions and the mandatory payment of a just compensation to patent holders together with accelerated and simplified mechanisms for registration and introduction into the turnover of the relevant medicines, including vaccines, be a justified and necessary tool to combat the pandemic and the best means of overcoming its consequences.


2020 ◽  
Vol 15 (7) ◽  
pp. 76-90
Author(s):  
B. A. Shakhnazarov

The paper is devoted to the issues associated with the use of artificial intelligence (AI) technologies in intellectual property objects, in particular vaccines, in the context of fight against a pandemic. It is emphasized that AI technologies allow us to overcome similar problems at the national and international levels and to prevent their recurrence in the future. The author highlights that the most important requirements for observance of constitutional rights and freedoms of citizens consolidated in regulatory acts and impossibility of their restriction in AI technologies must be supplemented with clear rules regulating the legal framework of artificial intelligence, including intellectual activity, and responsibility of developers and AI users. At the same time, the AI legal personality also needs to be thoroughly elaborated with the focus on providing a reasonable balance of rights, responsibilities and eligibility among developers, AI users, and other addressees entering into legal relationships involving artificial intelligence. A key aspect in the context of the legal regulation of the results of intellectual activity created entirely or partially by artificial intelligence is represented by the balance between the interests of rights holders and the public interests. Possible restrictions of rights of copyright holders as established in international instruments (Para 31 of the 1994 Agreement on Trade-Related Aspects of Intellectual Property Rights) should be accepted as a harmonizing basis and adopted in national legal systems. At the same time, rights holders must be provided with appropriate guarantees of respect for their rights (In particular, the non-exclusive nature of the use of intellectual rights in the context of such restrictions, payment of reasonable remuneration, etc.).


Lex Russica ◽  
2019 ◽  
pp. 110-121 ◽  
Author(s):  
E. S. Boltanova ◽  
M. P. Imekova

In the last few decades, issues related to the legal regulation of genetic research and the legal regime of genetic information derived from it have become particularly relevant both at the international level and at the level of individual countries. However, Russia has only recently come to realize the need for legislative regulation of the relevant relations. At the same time, a distinctive feature of such regulation is the emphasis on public-legal aspects, and civil-legal aspects have been left without due attention.The distinction between genetic information and genetic data is essential for the determination of the civil law regime of genetic information. Genetic information is personified genetic (genomic) information (information), because it has an individual, personal character as relating directly or indirectly to a particular or identifiable person. Genetic data is non-personalized (anonymized) genetic data, which are characterized by a formalized species, often contained in the information system and in this regard — systematized. Genetic information is an element of such an intangible good as the secret of private life, genetic data are, as a rule, an element of such a result of intellectual activity as a database. In addition, it is concluded that there is no doctrinal or legislative basis for the recognition of genetic information as an independent object of civil rights. The necessity of additional legislative regulation of activity of the biobanks carrying out storage of biomaterials, respectively, genetic data is proved. Genetic information contained in such biobanks should be subject to the legal regime of privacy.


2021 ◽  
Vol 17 (1) ◽  
pp. 35-42
Author(s):  
ALEXEY N. Kirsanov ◽  
ALEXEY A. Popovich

Introduction. The article provides an overview of the legal regulation of copyright protection using technical means of protection. German law states that technical means of copyright protection are technologies, devices, and their components. Such technical means are created to prevent or impede illegal actions of users that are not authorized by the copyright holder in relation to the results of intellectual activity. At the same time the legislator pays special attention to the fact that the distinguishing criterion of a technical means of protection against other methods of protection is effectiveness. In the article the authors analyze the legal consolidation of the specified criterion as a distinctive feature of technical means of copyright protection, and also consider the concept and cases of bypassing technical means of protection provided for by German law. Materials and methods. The methodological basis of the research is formed by the following general scientific and special methods of cognition of legal phenomena and processes in the field of intellectual law: the method of system-structural analysis; method of synthesis of social and legal phenomena; comparative legal method; formal logical method. Results. As a result of the analysis it was revealed that according to German law the distinguishing feature of technical means of copyright protection from other methods of protection is the criterion of effectiveness. A technical protection device is recognized by the German legislator as effective if the technical protection device cannot be bypassed without the consent of the copyright holder. In the context of the effectiveness of a technical means of protection, German legislation broadly defines the concept of circumvention of technical means. German copyright law, unlike other foreign jurisdictions, contains provisions prohibiting the removal of a technical remedy.Discussions and Conclusions. The main criteria for technical means of copyright protection under German law have been studied, the fundamental of which is the criterion of the effectiveness of a technical means. Cases of circumvention of technical means of copyright protection provided for by German law have been identified. The legal regulation of the ban on the removal of technical means of protection has been explored.


2020 ◽  
Vol 2 (3) ◽  
pp. 90-96
Author(s):  
A. P. DROZDOVA ◽  
◽  
S. M. MOLCHANOVA ◽  

The article discusses information sources in assessing the effectiveness of innovations, types of cash inflows, cash outflows in the context of the organization's operational, investment and financial activities. The problem of insufficient relevance of accounting data in the analysis of the effectiveness of investment in innovation is reflected. The need for systematization of the current regulatory legal acts of the Russian Federation to integrate information on the results of intellectual activity into a single mechanism for effective management of the development of innovative potential of the Russian Federation is noted. The experience of foreign companies in the investment and innovation sphere is summarized. The factors influencing the development of the scientific potential of Russian companies and the need to introduce economic incentives for innovation entities are presented. The functions of the RF authorities in the field of legal regulation of innovations for the successful development of mechanisms for interaction between business entities and the state, the protection of intellectual property and the growth of the effectiveness of the practical application of innovative developments are generalized.


2020 ◽  
Vol 2 (2) ◽  
pp. 126-147
Author(s):  
A. N. Vashchekin ◽  
◽  
A. V. Dzedzinsky ◽  

Introduction. The era of digitalization sets for researchers the task of systematizing the essential features of digital space, identifying the essence of the “right to the Internet” and the legitimacy of limiting the digital rights of citizens. Theoretical Basis. Methods. The authors studied the peculiarities of the digital environment as a specific integral area of legal regulation, the doctrine and legislation of several countries on the topic which determines the basis for the regulation of digital space in Russia. The formal legal method, synthesis, analysis, induction and deduction were used as research methods. Results. The wording of the basic concepts in the area under study is proposed: digital space, digital region, digital platform, etc. The measures to eliminate “digital wells” are indicated. The main properties of the information space and its derivatives are considered. The effects of any contradictions in the legislation of the country are shown. Discussion and Conclusion. As the study showed, the latest innovations in the legislation contravene the principle of the balance of interests, fail to meet the requirements of observing the rights of a person and citizen, and contradict the Constitution and international treaties of Russia. When comparing these measures with their foreign counterparts, a search was made for their potential shortcomings and proposals were presented on possible directions for their correction, taking into account the particular characteristics of digital space.


Author(s):  
Ivanna Babetska

Purpose. The purpose of the scientific article is to establish the ratio of the meanings of the concepts "trademark", "brand" and "well-known" trademark and then to characterize their common and distinctive features. Indicate the gaps in current legislation and the need to refine certain rules in this aspect to determine the aspects of protection and protection of the brand. Methodology. The methodology includes a comprehensive analysis and generalization of the available scientific and theoretical material and the formulation of appropriate conclusions and recommendations. During the research, the following methods of scientific knowledge were used: terminological, dialectical, logical-semantic, logical-normative, system-structural. Results: in the course of the conducted study, the main and optional components of the brand are determined, which make it possible to determine the features of its legal protection. It has been proved that despite a fairly wide range of domestic and international regulations, there are certain shortcomings of the brand protection mechanism. Originality. The study found that a trademark differs from a brand in that a trademark is a designation that is only the basis of the brand, as for the trademark are not essential such properties of the designation as a certain level of information among consumers and quality as a basis. gaining a reputation; the concept of "brand" is an evaluative, conditional concept, and therefore its consolidation at the regulatory level is impractical. It is sufficient to establish the factors on the basis of which the trademark can be considered "well known". A "well-known" trademark is a designation that is familiar to a wide range of consumers through its use to designate certain goods. Practical importance. The results of the study can be used in law-making activities for the purpose of legal regulation of public relations in the sphere of legal protection of the brand.


2021 ◽  
Vol 6 ◽  
pp. 39-44
Author(s):  
I. G. Zhabinsky ◽  

The article raises the question of differentiating the legal regulation of legal relations arising from a pledge, depending on the object of the pledge. Of course, the pledge as a way of securing the fulfillment of obligations is characterized by common features and general approaches to regulation, regardless of the object, at the same time, the features of individual objects require the specification of the relevant rules. The ongoing debate in science regarding the ratio of objects of civil rights, as well as the lack of unity on the issue of the ratio of individual objects, gives rise to a discussion regarding certain types of collateral, classified depending on the object. The author pays special attention to the pledge of property rights and proposes an approach on the relationship between certain types of property rights, in particular, rights of obligation, rights of participants in legal entities and exclusive rights to the results of intellectual activity.


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