Prawo cywilne PRL — wybrane zagadnienia prawa autorskiego

The author, presenting in a limited way the results of research on the law of the Polish People’s Republic, discusses two institutions regulated in the 1952 Act on copyright — the compulsory license under art. 16 and 17 and the implementation of the Council of Ministers’s powers (resulting from art. 33 § 1) to determine the principles and rates of remuneration for authors and contract templates. In accordance with art. 33 § 2, in relation to the provisions of the contracts covered by them, they were absolutely binding. The first of them limited the protection of subjective “ownership” rights to works, enabling their specific, although limited by their function, “expropriation”, while the second resulted in a significant and real restriction of the freedom of contracts regarding the use and disposal of copyright to works. This analysis leads to the conclusion that adapting the law shaped in a different system and political realities — in this case, its specific “totalization” — does not require large-scale changes in the existing regulation. It is only enough to modify the institutions of fundamental importance for the implementation of the principles of a specific political order. At the same time, in the reality of the totalitarian state of the Polish People’s Republic, the acts issued on the basis of art. 33 of the Copyright Act of 1952 were the most important to fulfil the purpose of these principles.

Conditions for Granting Compulsory License for Dependent Invention Use

The paper deals with the institution of compulsory licensing for dependent inventions. Currently, its most important application is in the pharmaceutical industry. In order to launch generic drugs that are dependent inventions pharmaceutical companies have to enter into licensing agreements with the developers of original drugs. The law enforcement practice that began in 2018 in the Russian Federation showed that paragraph 2 of Art. 1362 of the Civil Code of the Russian Federation, which establishes the conditions for granting a compulsory license for the use of a dependent invention, needs to be harmonized and supplemented in order to protect and regulate the balance of private and public interests. To solve this problem, the author analyses the wording of the corresponding legal norm found in international agreements, in particular in the TRIPS Agreement, and in the national legislation of different countries as well as the effectiveness of its application. Based on the results of the study, possible clarifications are given to the conditions for granting a compulsory license for the use of a dependent invention under paragraph 2 of Art. 1362 of the Civil Code of the Russian Federation.

Compulsory licensing in favor of patentholders of dependent pharmaceutical inventions

The article analyzes the conditions for issuing a compulsory license in favor of the patent holders of dependent pharmaceutical inventions on the basis of Paragraph 2, Article 1362 of the Russian Civil Code. The criteria for the relevance of a dependent invention to important technical advancements with significant economic advantages are disclosed. An analysis of the emerging Russian court practice on the issuance of compulsory licenses in the pharmaceutical market, meanwhile, showed that Russian courts lack a clear understanding of when a patent holder can and cannot apply for a compulsory license. The author proves that compulsory licensing is an effective mechanism to prevent abuse of the right (first of all, to standard-essential patent) in the markets of complex innovations (IT, electronics and telecommunications). At the same time, its implementation on the pharmaceutical market can lead to negative consequences: discourage pharmaceutical companies to invest in the development of new drugs, register breakthrough drugs in Russia; reduce foreign investment in the pharmaceutical sector. In this case, the provision of compulsory licenses should be interpreted as an exceptional tool. The issuance of a compulsory license in favor of the owner of the dependent invention can be justified only if such an invention represents a genuine innovation, an important step in the development of pharmaceuticals. The licensee must offer the market a new drug with improved characteristics: increased therapeutic efficacy and (or) safety, which has no available alternatives.

EXCLUSIVE RIGHTS TO THE GENE ENGINEERING’S RESULTS: RUSSIAN AND FOREIGN EXPERIENCE

Well-balanced patent regulation is an important factor in the effective development of the biotechnology market. The possibility of establishing exclusive rights over the results of genetic research, including isolated genes and gene-based diagnostics, has been the subject of heated debate all over the world. Nevertheless, a unified approach to regulating these matters has not yet emerged. For example, in the US and India, patenting of isolated natural genes and diagnostic methods based on them is not permitted at all. Only synthetic genes and modified sequences are patentable. The EU and the UK generally allow such objects to be patented, but impose additional requirements. In China, diagnostic methods are generally not considered to be patentable, yet particular substances and instruments used for diagnosis may be recognised as protectable subjects. A cautious approach to the admissibility of patent protection for the results of genetic research is reflected, for example, in the requirement to provide additional data in order to prove that the solutions do meet the criteria of industrial applicability and non-obviousness. In countries which allow the patenting of a gene sequence (or a partial gene sequence with the structure identical to that of a naturally occurring one) as a substance, the law nevertheless mandates that the industrial application of such a sequence must be clearly indicated; it is also required that the patent application contains the information on the field for which the industrial application is specifically described. An unambiguous approach to biotechnology patenting has not yet emerged in the Russian legal sphere. Russian Civil Code does not directly prohibit the patenting of genes, gene-based therapies and diagnostics. Basic principles and approaches to the patenting of genetic engi-neering results and the protection of exclusive rights to them, including: the criteria for distin-guishing patentable and unpatentable results of genetic research, the limits of exclusive rights and the conditions for a compulsory license issuance have not yet been fully developed and introduced into the Russian legal framework and regulatory enforcement practice. The regulation is carried out at the level of by-laws: in accordance with the Rospatent Guidelines for Examination of Applications for Inventions, the approach used in the assess-ment of inventions relating to the field of biotechnology is the same as the one employed for inventions relating to other fields of science and technology. Given the potential importance of the biotechnology for the further progress in science and technology, these matters should be regulated at the Civil Code level. We propose that a broad public debate be held concerning 1) the principles for the regulation of these matters 2) the possibility of patenting, and 3) the extent of the exclusive rights of rightholders.

THE IMPACT OF COVID-19 ON INTELLECTUAL PROPERTY LEGAL SYSTEM RELATED TO PUBLIC HEALTH IN CONNECTION WITH TRIPS FLEXIBILITIES IN INDONESIA

In early 2020, countries in the world was shocked by a new virus called Coronavirus Disease 2019 (COVID-19) including Indonesia. The COVID-19 pandemic gives impact to the legal system, including intellectual property (IP). Trade Related Aspects of Intellectual Property Rights (TRIPS) flexibilities on public health in developing countries: Transition Periods, Compulsory License, Government Use, Parallel Imports, Exceptions to Patent Rights, Exemptions from Patentability, Limits on Data Protection, and Implementation of the Paragraph 6 of the Doha Declaration. Research problems: (1) what are the conditions for implementing the flexibilities of TRIPS in facing COVID-19 pandemic in Indonesia and (2) what are the issues that should be anticipated for future IP legal system relating to public health as a lesson from this COVID-19 Pandemic. Government Use is most effective to be used for encounter COVID-19 Pandemic, and voluntary license is recommended tobe promoted for future approach. The study is using a qualitative literature study.

Los fármacos como materia patentable y el encuadre del COVID-19 en la licencia del artículo 45 de la Ley 24481

At the beginning of 2020, the World Health Organization declared COVID-19 a Pandemic. It is not necessary to do an exhaustive analysis to notice the important health, economic and legal consequences that it has had.In particular, Patent Law plays an important role in this regard, the possibility of a vaccine being patented in the country with the current ordinance of Law No. 24,481 and its amendments, and that the human right of property that the holder has on it, has a strong impact on the incentive to technical and scientific development. A right that cannot be analyzed in isolation, but in the context of the health emergency that is prevailing worldwide today and the public interest in the protection of another human right such as public health.The aforementioned technical development encouraged by the patent system is part of the in-terest not only of the legal community, but of society as a whole. In this paper we will analyze the context of the pandemic and Intellectual Property Law, the historical evolution in Argentine legislation regarding the possibility of patenting pharmacological products and procedures, the requirements that the vaccine must meet to be considered patentable matter in terms of the law, the procedure to be followed before the INPI for its patenting, the rights that the law grants to the owner of the vaccine patent and its framing in the Compulsory License in the context of a health emergency of Art. 45 of the Patent Law.

Treatment Coverage and Drug Expenditure in Hepatitis C Patients From 2013 to 2019: A Journey of Improving Treatment Accessibility in Malaysia Through Government-led Initiatives

Background: Hepatitis C is a public health threat, affecting approximately 1.9% of the Malaysian population. Objectives: This study demonstrates how a series of initiatives taken by the Ministry of Health (MOH) of Malaysia have impacted the treatment coverage and drug expenditure for hepatitis C patients since 2013, the year in which the first direct-acting antiviral (DAA) was introduced in public health institutions. Methods: The data were obtained from all the 144 hospitals and 33 primary healthcare centers throughout the country, which were identified to have offered the pharmacological treatment to hepatitis C patients over the last seven years. Results: The total number of hepatitis C patients treated each year was shown to increase by more than 10 times, reaching 3,116 in 2019. However, the drug expenditure for hepatitis C relative to the overall health expenditure did not significantly increase over time (P = 0.094). The use of DAAs was once limited by its exorbitant cost. A remarkable elevation in the number of patients receiving the treatment only took place as of 2016, particularly following the engagement of the MOH in endeavors driven by non-profit organizations to enhance the accessibility of DAAs and the issuance of a compulsory license to sofosbuvir. Conclusions: Timely decisions of the MOH and the judicious use of policy tools were shown to have transformed the landscape of hepatitis C management in Malaysia without considerably raising the budgetary pressure. Yet, continuous efforts to massively upscale the screening and treatment of the disease are warranted going forward.

AMENDING SECTION 84 PATENTS ACT 1983 TO ENCOMPASS THE HEALTH FLEXIBILITIES LEVERAGE ACCORDED BY ARTICLE 31bis TRIPS AGREEMENT

The significance of this study lies in its proposal to insert an appropriate provision into the Patents Act 1983 to embody the provisions of Article 31bis TRIPS Agreement. The methodology adopted in this study is library-based, and relies extensively on primary sources such as the Paris Convention, TRIPS Agreement and Patents Act 1983. This is further supported through secondary sources such as articles, books, websites and newspaper reports. The research question posed in this study aims to identify the most appropriate provision that should be incorporated into the Patents Act 1983 in addressing the public health flexibilities provided under Article 31bis. The purpose of this study is to demonstrate that Article 31bis is best incorporated into the Patents Act 1983, under the right of the government mechanism rather than through the compulsory license mechanism. Furthermore, the scope of this study is limited to issues that address the abuse of monopoly, granted by the patent system, with respect to the dire needs of the public health. Hence, this paper discusses the mechanisms that address abuse of the patent system under Article 5(A) Paris Convention, Articles 31 and 31bis TRIPS Agreement, the relevant corresponding provisions under the Patents Act 1983, and subsequently formulates new proposed amendments to Section 84 Patents Act 1983 to buttress the public health flexibilities provided under Article 31bis. The outcome of this study proposes that the provisions of Article 31bis should be incorporated into the Patents Act 1983 under the right of the government mechanism, by replacing the current Section 84 Patents Act 1983 with a newly proposed Section 84.

Compulsory license to utilize the patent in accordance with UAE law and in light of the TRIPS Agreement

The study deals with legal texts dealing with compulsory licensing to exploit an invention, covered by legal protection in accordance with UAE law and TRIPS, the researcher follows the curriculum. Descriptive analysis and comparison of texts dealing with compulsory licensing in UAE Law. In the light of the TRIPS Agreement, the study focused on determining what is meant by compulsory licensing The right to grant a compulsory license in the event that they are available to the judiciary or cases where the UAE law permits the Minister to grant the license Compulsory with the conditions to be granted for the granting of compulsory license in each case of Cases in which UAE law and the TRIPS Agreement permit the compulsory licensing of third parties.The study examines the conditions for granting a license Compulsory and its legal effects, the study was divided into two subjects, and the section of each topic to two requirements, in addition to a conclusion containing the most important findings and recommendations.