The pharmaceutical industry of Ukraine: problems of intellectual property rights security

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1 230 Romaniuk Elena Ivanovna, PhD, Associate Prof., Pichugina Sabina Andreevna, Student, Institute of Economics and Management Donetsk National University of Economics and Trade named after Mykhailo Tugan-Baranovsky E mail: websabina@mail.ru The pharmaceutical industry of Ukraine: problems of intellectual property rights security Abstract: The key issues of intellectual property rights protection in the Ukrainian pharmaceutical industry. The legislative aspects of the Ukrainian Law are analyzed for the purpose of its harmonization with WTO requirements. Keywords: The pharmaceutical industry, medicines, TRIPS Agreement, intellectual property rights, the law of Ukraine. The pharmaceutical industry is one of the most popular in terms of patent owners attempts to protect their rights. Moreover, the existence of effective mechanisms of protection is one of the applied grounds, of scientific researchers, for the development of new medicines. Medicines are very specific objects of intellectual property rights. Without the consumption of pharmaceuticals none of us are immune, so the life of the entire population depends on them. It is essential to be sure that we do not consume counterfeit and substandard medicines. There are only two solutions, on the one hand, to ensure adequate protection of the rights of inventors and other subjects of intellectual property rights, and the other, to ensure strict control over the quality of all medicines, in circulation, within the territory of the country. All systems of protection of intellectual property are significantly different, in all of the countries, all over the world; however, lately there is a tendency for harmonization of these standards and to aligne them with unified international standards. Therefore, there is a need to ensure that these standards are reflected, and at what place in the process, to be so applied within Ukraine. In order to evaluate the features of intellectual property rights protection within the pharmaceutical industry, there is a need to request, and consider, the legal aspects relating to the pharmaceutical industry of Ukraine. In addition, to analyze the requirements for the regulation of intellectual property issues, which were put forward in the framework of the WTO Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS). The regulatory framework within Ukrainian pharmaceutics is a set of complex laws and regulations, some of which were inherited from the old USSR system, and part also introduced after Ukraine became independent. Many of the recent regulations

2 Секция 7. Юриспруденция have been developed for political reasons, specifically to join the EU, and to start the process of regulatory harmonization in this sphere of WTO rules. Article 418 «the Concept of intellectual property rights» of the Civil Code of Ukraine notes that the right of intellectual property is the person s right for the result of intellectual activity or other object of intellectual property rights defined by this Code and other laws. The main result of such activity in the pharmaceutical industry is the medicament. According to article 2 of the Law of Ukraine On medicaments, 1996 (last amended by the laws of Ukraine in 2009 and 2010) medicinal products are substances or their mixtures, of natural, synthetic, or biotechnological origin which are applied to pregnancy prevention, disease prevention, diagnostics and treatment diseases of people or changing the condition and functions of the organism. Medicines can be created by enterprises, institutions, organizations and citizens [1]. In the pharmaceutical industry the following objects of intellectual property protection are highlighted: 1. The copyright objects: reports on scientific research/development works on new chemical substances, medicines; reports on the preclinical and clinical study of medicines; development of the analytical normative documentation materials on methods of quality analysis of the medicinal product, other documentation (pharmacopoeias articles), which gives a possibility to control quality; projects of instructions for medical use. 2. The inventions: substance (connection), auxiliary substance connection; pharmaceutical composition of the medicinal product (pharmaceutical composition); method of obtaining the substance, or a new biologically active compound, group of new compounds, pharmaceutical compositions; the way to use (treatment) for known substances; use of the famous medicinal product for a new purpose. 3. Utility models: equipment, equipping of pharmaceutical factories. 4. Industrial designs: form of pills; type of packaging. 5. Commercial designations: trade name of medicinal product; brand name of the manufacturer; logo. 231

3 The Ukrainian patent law contains the following provisions, which are fundamental for the pharmaceutical industry: the patent validity is 20 years from the date of filing of the application to the State service of intellectual property, but it can be increased for the period required for obtaining a registration certificate for medical use of medicines, maximum for 5 years; the patented inventions and modus supposed to be used, whereas every sign of the independent feature of the invention, or feature equivalent to it is used; infringement of the exclusive right of the patent owner is unlawful manufacture, sale, use, offer and other introduction into the economic turnover, the use of a process protected by a patent without obtaining a license or introduction into the economic turnover of a product manufactured by the patented method, because the effect of a patent on the method applies to the product itself, made this way [1]. The law of Ukraine On protection of rights to inventions and utility models provides the following cases of rights restriction of the patent owner by the violation of rights that are granted by a patent shall not include: single preparation of medicines prescribed by a doctor who has been justified by the need to save a patient s life in a particular case; the use of patented medicines with a scientific purpose in case of the experiment; the use of medicines in case of disasters, accidents, emergencies, etc.; the use of patented medicines for personal purposes which are not connected with the receipt of benefits. The essential entrance condition for Ukraine in WTO was signing of the Agreement on trade-related aspects of intellectual property agreement (TRIPS), which establishes the required standards in the sphere of intellectual property and obliges countries-members of WTO to ensure full patent protection (either the production processes or products) for a period which is not less than 20 years, especially in the case of pharmaceutical products [2]. Presently, in case of Ukraine s accession with the WTO, Western organization partners are paying more attention to the fulfillment in Ukraine of the TRIPS requirements. Moreover, Ukraine s fulfillment of its commitments became the subject of close observation. For example, United States Trade Representative (USTR) Ukraine was included in the priority list of countries that require monitoring. Each new candidate to the WTO membership, during signing of bilateral agreements with countries-members of this organization, particularly with the United States, faced increasingly stringent requirements which pass into subsequent agreements with other candidates. Thus, the requirements to the new members are constantly increasing. Signing agreements with developing countries, where legal intellectual property rights protection is not particularly hard, developed countries insist on the adoption 232

4 Секция 7. Юриспруденция of the unique interpretation of the TRIPS Agreement, despite the fact that the «base» document doesn t contain specific statements on types of rights violations and or measures against violators. Also it is limited by more general formulation: protection against inappropriate commercial use. For example, the US offered the rules TRIPS-plus, which contain more stringent requirements in respect of medicines, and in addition to exclusivity of protected medicines, they require patent term extension, as well as determining the relationship between the patent protection of pharmaceutical products and the granting of permission for its patent/regulatory linkage [2]. It should be noted that compensation of short-effective term of a patent (the exclusive right to commercial use of innovation) became possible in the United States since 1984, in Japan since 1988, in the EU countries since In some European countries the effect of Supplement Protection Certificate (SPC) may not last more than 5 years, effective term of patent protection must not exceed 15 years [2]. In general, the TRIPS Agreement requires from owners and actors in the international trade full and effective implementation set out in it standards for the protection of intellectual property rights and acceptance of the necessary measures to ensure the adequate level of protection of these rights. The Agreement also stated that the governments of the countries-wto members must ensure that these requirements were provided with measures of responsibility and penalties for offences were adequate. All the required procedures must be fair and based on the principles of equality, simplicity, inexpensive price, and not lead to delays but fulfill in real deadlines. The Agreement includes enough details on how should be organized the effective implementation of rights, including rules of evidence collection, interim measures, the pronouncement of judicial decisions on application of measures, introduction of penalties and other measures of judicial protection. Governments of interested countries should provide the establishment of efficient customs mechanisms to prevent import of counterfeit goods. The TRIPS Agreement stipulates a transitional period, during which countries must align their national legislation and practice into conformity with the provisions of this agreement. As soon as this agreement applies in certain state, the owner of the patent is granted by certain means for protection of patented medicines from copying. If some country fails to bring its legislation into conformity with the TRIPS Agreement, it may be presented to the complaint within the system of the WTO dispute settlement and after the negative decision, it does not abandon the relevant practices against it trade sanctions may be imposed [3]. World legal practice shows that the number of cases in the field of intellectual property rights in the pharmaceutical industry is continuously growing, including Ukraine. This fact should accelerate the adoption of legislative decisions for early settlement of the problems and filling in gaps in its legislation in particular. General 233

5 legislation of Ukraine in the sphere of intellectual property is sufficiently developed, and corresponds to the world standards, but it is not enough to ensure the adequate protection of all types of intellectual property rights in the pharmaceutical industry. There are many issues relating concretization of those or other definitions, establishing the borders of patent protection, the ratio of the rights of holders of patents and rights to health protection. The problems of approximation of Ukrainian legislation to European and world standards in this field require a separate study. It is important to protect the rights of holders of patents and inventors, to establish the state on the global pharmaceutical market, as a state with great scientific potential in this area, to reach the highest level of control over production, to prevent and punish manufacturers of counterfeit products and, thus, to protect its image and national producers. As a consequence, it is necessary to find the right balance between the observance of intellectual property and population provision with high-quality, accessible, effective medicines. References: 1. Закон Украины «О лекарственных средствах» от /96 ВР. Ведомости ВРУ ст Кириченко І. Проблемні питання правового регулювання фармацевтичної галузі у зв язку зі вступом України до СОТ/І. Кириченко//Юридичний журнал Украина ЕС. Защита прав интеллектуальной собственности в фармации. [Електронний ресурс]. Режим доступа: Prikhodko Michael Anatolievich, Die Moskauer Staatliche Juristische O. E. Kutafin-Universität, Dr.iur, Lehrer, Institut für Geschichte der Staat und Recht E mail: mprihod@list.ru Das moderne Konzept der Ministerregierungssystemsentwicklung im Russischen Reich am Anfang des XIX Jahrhunderts Abstrakt: Im Herzen dieses Artikels ist die neueste Konzept der Trennung der beiden wichtigsten Etappen bei der Schaffung der ministeriellen Steuerung: Bühne der ministeriellen Reform gg. (Unterteilt sich wiederum in der Anfangsphase ( gg.). Und final ( gg.). Perioden Ministerebene Reform) und