Law of Ukraine «On Indigenous Peoples of Ukraine»: declaration of rights and their further implementation»

Keywords: Indigenous peoples, Crimean Tatars, Karaites, Krymchaks, Gagauzpeople, representation, legal status, self-determination, language, culture, traditions,people, identity The article analyses indetail the legal status and certain types of rights as signed to indigenous peoples ofUkraine under the recently adopted Law of Ukraine «On Indigenous Peoples of Ukraine». The criteria of belonging of separate communities to the indigenous peoplesof Ukraine, features of realization by these peoples of their collective rights, and alsorealization by separate representatives of indigenous peoples of their individualrights in the corresponding spheres are defined. The study also defines the characteristicsof the indigenous people, which distinguish this concept from other related concepts,in particular, the concept of national minority. Also, the article, based on theaforementioned Law, determines why only the indigenous peoples of Crimea:Crimean Tatars, Karaites and Krymchaks can be recognized as indigenous peoples ofUkraine, in contrast to the Gagauz people, who currently in Ukraine’s Odessa region.The study also highlights the peculiarities of the representation of indigenous peoplesof Ukraine at the local, national and international levels. A detailed interpretation ofthe provisions of the Law clarifies its role and significance, as well as prospects for theimplementation of its provisions in the future. The specifics of the representation ofindigenous peoples in Ukraine have been studied, in particular through the functioningof separate representative bodies of indigenous peoples, as well as the representationof the aforementioned communities within public authorities and local governments.The process and peculiarities of interaction of the representative bodies of theindigenous peoples of Ukraine with the bodies of state power and local self-governmentin Ukraine are analysed, along with the specifics of the legal status of such bodiesof the indigenous peoples. The publication proves the need for further the legislativeprocess to implement the requirements of the law, as well as the development ofdetailed and transparent mechanisms for such implementation.

Criminal liability for committing crimes in the sphere intellectual property under the laws of foreign countries

Keywords: intellectual property, copyright and related rights, objects of industrialproperty, means of individualization, criminal liability, crimes against intellectualproperty The article providesan overview of individual articles of the criminal codes of Ukraine, the Republic ofLatvia, Georgia and the People's Republic of China. These articles have constituted crimes against intellectual property. Statistics on the number of sentences in cases ofinfringement of intellectual property rights in Ukraine for 10 years.The rapid development of science and technology in the 21st century is creatingnew impetus for scientific research. There is a need to update national legislation.New approaches to intellectual property protection continue to be sought around theworld. Issues of crime in the field of intellectual property are becoming relevant anddiscussed among scientists, authors, inventors.The author gives examples of the Criminal Codes of Ukraine, the Republic ofLatvia, Georgia, and the People's Republic of China. The experience of the People'sRepublic of China is logical, correct in legal terms.Intellectual property provides economic benefits. Ago crimes against intellectualproperty should be classified as economic. According to the author, the Ukrainian authoritieswill be faced with new demands from foreign partners, including the EU, tostrengthen the fight against crime in this area under the threat of significant internationaleconomic sanctions. The proposed changes are aimed at eliminating gaps inlegislation and avoiding errors in the application of the Criminal Code of Ukraine bylaw enforcement agencies.

Key issues of legal regulation of the supplementary protection of inventions in the field of pharmacy in the national legislation of Ukraine

Keywords: supplementary protection certificate, basic patent, procedure for obtainingsupplementary protection certificate Key issues of legal regulation of the supplementary protection of inventionsin the field of pharmacy in the national legislation of UkraineThe article is devoted to the study of key issues of legal regulation of supplementaryprotection of inventions after the adoption of the Law of Ukraine «On Amendmentsto Certain Legislative Acts of Ukraine on Patent Legislation Reform» in the absenceof bylaws to regulate the procedure for issuing supplementary protection certificates.The study also highlights the main shortcomings and gaps in the regulation ofcertain issues of application of supplementary protection certificates in the currentLaw of Ukraine «On protection of rights to inventions and utility models.»The author in details analyses European Union approaches to definition of thesubject matter of the supplementary protection, providing criteria which are recommendedto use in order to decide whether the product is covered by the basicpatent in force. Also, the paper is focusing on the issues related to verification ofdata and materials provided together with the application for a certificate — suchas whether the requirement that the medicinal product must be submitted formarketing authorization in Ukraine no later than during one year after it’s first marketing authorization in the world, whether the authorization provided is thefirst authorization in Ukraine, etc.Another problem which is highlighted in the study is the application of the rule tosubmit the petition for obtaining supplementary protection to those patents and marketingauthorizations which were issued before the amendments to the Law came inforce, as this question remained unresolved due to the lack of transitional provisionsin the Law. Also author points out the necessity to align the provisions of the Article271 of the Law of Ukraine «On Protection of Rights to Inventions and Utility Models»regarding the definition of the subject matter of supplementary protection in accordancewith patent legislation by excluding application of the medicinal product fromthe list as it is not patentable according to Ukrainian law. In addition, the author emphasizedthe urge to adopt relevant bylaws (procedure) regulating the issue of certificatesof supplementary protection.

Keeping the balance of public interests and the interests of the subjects of patent rights in the codification of legislation in the field of intellectual property

Keywords: intellectual property, codification, human rights, private interests, publicinterests, exclusions, medicines, patents The article concerns the expediency of codificationof legislation in the field of intellectual property on the basis of the principles ofpolicy development of pharmaceutical nationalism or pharmaceutical independence ofthe state. Modernity encourages to determine the principles of intellectual propertylaw on the basis of «collective knowledge», to put the intellectual property right toserve the interests of society and provide appropriate incentives for scientific activity.The new spirit of intellectual property dictates the policy of introducing exceptions tointellectual property rights for objects used in the fight against COVID-19.Special attention should be paid to the formation in the world, on the one hand, ofa policy of «pharmaceutical nationalism», which provides for protectionism in relationto the national producer, and on the other — the policy of priority of public interestsover intellectual property rights. Today, this issue is particularly acute in the contextof limited access to vaccines against the background of free production sites of genericcompanies. Therefore, when determining the conceptual approaches to the codificationof legislation in the field of intellectual property, the international experience ofmaintaining such a balance should be taken into account.The path of harmonization of human rights and intellectual property rights hascertain social and economic obstacles, overcoming which requires significant efforts ofpublic organizations, rethinking the established paradigms of the scientific communityand the political will of international organizations. The pandemic has only strengthened our sense that modern science is supranational,it has long been beyond the geographical and beyond the human imagination.That is why the monopolization of its results has become a dangerous phenomenon fora society that has lost the ability to control the processes within itself and has becomedependent on external processes, which are controlled by a small percentage of intellectualproperty market participants.Today, Ukraine has become an Eastern European hub in the field of harmonizationof private and public interests in the field of health care with the mechanisms ofintellectual property rights, and the ongoing patent reform is a breakthrough success.It should be noted that although it is extremely important for Ukraine to be able touse the flexible provisions of the TRIPS Agreement, both for the production of vaccinesand over time for drugs for specific treatment KOVID, the Government shouldkeep in mind the need to clarify the production capacity of domestic producers. , toallow the production of such vaccines and drugs exclusively for the national market,at least at the first stage, as the priority is to meet the needs of the national patient.And, of course, compulsory know-how licenses (trade secrets) should contain provisionslimiting the time and number of doses produced by analogy with compulsory licensesfor inventions.

Protection of intellectual property rights in the field of biotechnology

Keywords: intellectual property rights, biotechnologies, patenting, legal protection,legislation Current trends of globalization and the process of European integrationof Ukraine necessitate the creation of an effective mechanism of legal regulationof intellectual property rights in the field of biotechnology, due to the constitutionalprovisions according to which human life and health are the highest value inthe state. The purpose of the study was to determine the legal regulation of protection of intellectual property rights in the field of biotechnology. Empirical and theoreticalmethods of scientific cognition are used for comprehensive consideration of the topicof the article. It has been found that modern biotechnological advances require inventorsnot only to secure monopoly rights to use them, but also to comply with the moraland ethical criteria for the perception of inventions created by genetic engineeringand living matter. It is determined that the legal system of intellectual property protectionin the field of biotechnology is based on the provisions of the Constitution ofUkraine, the Civil Code of Ukraine, regulations in the field of health and agriculture,international treaties and special legislation in the field of intellectual property. It isestablished that the system of legal protection of biotechnological inventions consistsof the acquisition of intellectual property rights to these inventions (establishment ofthe object of patenting and compliance with patentability, state registration of inventions)and the use and disposal of intellectual property rights to such inventions. Alegislative support of legal protection of biotechnological inventions is seen in furtherempirical research and theoretical and methodological substantiation in order to determinethe legal mechanisms of their practical implementation.

European’s Union Open Science Policy as a global benchmark for Ukraine: legal environment

Keywords: Open Science, EOSC, intellectual property, scientific researches, COVID-19 pandemic, UA-EU Association, Digital Europe The article provides an analysis of the EU practices inthe field of development and implementation on the Open Science Policy, elaboration ofthe European Open Science Cloud (EOSC), employment of the FAIR principles and theirenhancement with CARE-principles. The European Commission activities are reviewedin the area of the Open Science roll-out as well as its ability to withstand the emergingglobal challenges like COVID-19. The EOSC concept is overviewed on the backdrop ofsuch EU policies as unified Digital Market Strategy and European Cloud Initiative, EuropeanResearch Environment, and Industrial Digitalization, as a part of those. EOSCconcept integration is considered through the development and interaction of Europeanand national research and e-infrastructures and data arrays, services and knowledgewithin the EU and globally.Steps are analyzed taken by Ukraine towards its integration to European researchenvironment and EOSC in the legal field, taking into account the State Authorities activityand implementation of the Ukraine-EU Association Agreement. It is highlighted thatthe innovations’ development of Ukraine is bound, both in timelines and meaningfully,with digital economics and the society development, intellectual property area, and should align the Ukrainian science initiatives with the European Cloud initiative as wellas further steps to joint the EOSC. It is consequently proven that consistent and meaningfulimplementation of the UA-EU Association commitments via the conceptual andstrategic regulations adopted by the state authorities is essential for Ukraine integrationto the EU’s Digital Market and Digital Environment so that to enhance its science potential.It is concluded that consistent efforts on implementing the goals and objectives asfor regulatory environment with their consequent enforcement creates the vital groundsfor successful enrollment of the national policy in this area.

Review of the theoretical approaches regarding the legal protection of objects generated by artificial intelligence systems in the field of copyright and related rights

Keywords: artificial intelligence, copyright, related rights, sui generis The publication provides a descriptive review of existingtheoretical approaches regarding the legal protection of objects generated byartificial intelligence systems in the field of copyright and related rights, namely.1) The inexpediency of legal protection of computer-generated objects. It is concludedthat the absence of legal regulation and free circulation of generated objects isconsidered the easiest option. Still, hardly fair and justified, as the creation of artificialintelligence systems requires large and significant investments in their development.2) The possibility of protecting computer-generated objects by copyright as originalworks. It has been established that extending the concept of «originality» to computergeneratedobjects seems unjustifiable.3) The introduction of the latest iteration of the fiction theory and establishing aspecial legal status for artificial intelligence systems. It is noted that such an approachseems premature because the existing artificial intelligence systems are amanifestation of «narrow» or «weak» artificial intelligence and not artificial generalintelligence.4) Protection of specific generated objects through related rights. It is concludedthat the objects generated by AI systems may be protected in Ukraine through theprism of related rights, under the condition that the relevant object can be attributedto a phonogram, videogram, or broadcast (program) of broadcasters respectively.5) Protection of generated objects through a special legal regime under copyrightlaw. It is described that this approach cannot be considered a universal example forimitating the legal protection of objects generated by computer programs because itsapplication leaves more questions and inconsistencies than solving the problem onthe merits.6) Protection of generated objects through sui generis law. It is assumed that applyingsuch an approach to the protection of objects generated by computer programswill not lead to significant changes in copyright and will protect the interests and investmentsof developers of artificial intelligence systems.

Role of intellectual property as key element of innovation activities: legal grounds

Keywords: intellectual property, intellectual property rights, innovation activities,innovation activity companies (entities), open innovations concept, open innovationplatforms The article determinates that, on the background of a digitaleconomics actively development, the open innovations become a key source of digitalbreakthrough. The author states that within such a concept, the entities carryinginnovation activity, keep focus on monetizing both the internal research results aswell as the external ideas. Such approach, enhanced with external partners involvementinto the innovations process, helps the innovative technologies to move remarkablyfaster through the lifecycle. It is also emphasized that the approach enabling externalaccess to the companies’ innovations, need a concept to be set up, with focus onintellectual property rights protection. The author draws attention that the key roleof legal instruments for intellectual property protection, is to minimize the risk forthose companies which contribute to the innovations market development. It is clarifiedthat within such a concept, the innovation activity companies provide their partnersthe right to use the intellectual assets, which may be either already in use bysuch companies or idle to use. Thus, the companies providing legal protection of theintellectual property, have more favourite conditions to come into a strategic partnership.The author highlights that the innovations-industry companies make profitfrom getting access to science-research and related production outputs which areowned by their partners, as well as from further development of their own productsresulting from the intellectual property under the strategic agreement. The articlealso proposes creation of digital platforms which will facilitate the effective partnershipof the business, state organizations and innovation teams within the developmentprocess of innovation products.

The distribution of economic rights to intellectual property rights objects, created in higher education institutions of Ukraine on order

Keywords: the distribution of economic rights; economic intellectual property rights; intellectualproperty rights objects, created on order; higher education institutions; intellectualproperty rights of higher education institutions; intellectual property rights objects;agreements for the creation on order and the use of intellectual property rights objects The article investigates the procedure for the distribution of economic rights to IPR objects,created in higher education institutions of Ukraine on order. In the course of researchgeneral requirements of the current legislation of Ukraine concerning possiblevariants of distribution of economic rights to IPR objects, created on order, have been defined.Based on this analysis it has been found that the legislator departed from the previouslyexisting unified approach to the distribution of economic rights to IPR objects,created on order, therefore, there are currently several legally enshrined approaches tothe distribution of economic rights to such objects. At the same time, the choice of one oranother option will depend on the type of the IPR object, created on order (work or anotherIPR objects), and in some cases from the purpose of its creation (has been createdspecifically as a piece of software or not).In addition, the author discovered the existence of a legal conflict between the provisionsof Part. 4 Art. 440 and Art. 1112 of the Civil Code of Ukraine, Part 6 of Art. 33 ofthe Law of Ukraine «On Copyright and Related Rights» regarding the approach to thedistribution of economic rights, in particular, to works, created on order (except for worksof visual art). Also, it has been established that Art. 430 and Art. 1112 of the Civil Codeof Ukraine contain a different approach to determining the list of IPR objects, that can becreated on order.The article also disclosed the consequences of the existence of these inconsistencies forthe law enforcement practice, including for resolving the issue of choosing an appropriateform of agreement for the settlement of legal relations regarding the creation of IPR objects,other than a work, which are included in the concept of "an object, created on order"today. The fundamental importance of solving this issue for the educational sphere hasbeen revealed.Based on the results of the study, a general vision of possible options for the distributionof economic rights to IPR objects, created in higher education institutions of Ukraineon order, has been outlined. Also, suggestions to improve the legislation of Ukraine havebeen made.

Ensuring the confidentiality of patient information obtained during a clinical trial of a medicinal product

Keywords: clinical trial, confidential information, personal data, patient Clinical trials are conductedin accordance with legal norms, subject to human rights and in accordance with internationalethical principles. Each clinical trial for the patient (subject) begins on a voluntarybasis and with acquaintance of the patient (subject) about the features of the study, itspurpose and purpose, explanation of possible risks, in addition, the patient is informedabout innovative drugs and access to free treatment during research. The patient participatesin the study of the drug of his own volition, signing a voluntary informed consent.It is important to ensure that the rights of the patient (subject) in the clinical trial of themedicinal product to privacy and the protection of personal data, which is confidential informationabout the person who is the subject of the study, are respected. During clinicaltrials, researchers and all persons involved in the research process should treat responsiblythe person participating in the study of the medicinal product as the object of study,namely with respect for the human right to privacy and its secrecy. Individuals and legalentities should be able to protect information legally under their control from disclosure,acquisition or use by others without their consent in a manner contrary to fair commercialpractice, if such information is confidential in the sense that it is as a whole or in theexact configuration and combination of its components, commonly known or available topersons in the circles normally involved with the information in question. It is importantto note that any information that becomes known about the patient (subject) during theclinical trial of the drug should be carefully protected by the party conducting the study.Therefore, it is important to note that the right of a patient not to disclose confidentialinformation about him is guaranteed by the Constitution of Ukraine. The right to medicalsecrecy is enshrined in the Law of Ukraine "Fundamentals of Health Legislation". Incases where the rights of the patient (subject) have been violated, the legislator providesfor criminal liability for intentional disclosure of medical secrets to a person who becameknown in connection with the performance of professional or official duties, if such an actcaused serious consequences and for illegal collection, storage, use, destruction, disseminationof confidential information about a person or illegal change of such informationcomes criminal liability.