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.

Embedding Human Dignity Standards into Biotechnology Patents: The Role of Morality Clauses

This paper proposes an approach to the debate on how to reconcile international trade and human rights, explaining the minimum content of the ordre public and morality clauses (OPMCs) as the recognition of international human rights law (IHRL) standards in trade law and intellectual property law. Within the context of a multicultural and globalised society, in which trade and economic interests are protected worldwide and morality seems to be a culture-based concept, the primary considerations of IHRL embedded in these pivot clauses serve as a universal defence for human beings and a safeguard to the coherence of the human-centred international system. In particular, this study argues that the OPMCs allow for the enforcement of three standards derived from human dignity in the wider spectrum of biotechnology and scientific research, even constituting legitimate limits to the economic exploitation of biotechnological inventions.

Synthetic Biology: Old and New Dilemmas—The Case of Artificial Life

This article aims to examine some of the ethical questions emerging from the use of already existing biotechnological tools and the issues which might occur by synthetic biology’s potential future possibilities. In the first part, the essence of synthetic biology and its relation to the contemporary biotechnological research is analyzed. In the second part, the article examines whether the new biotechnological inventions pose new or revive old moral questions about the ethics of science, engineering, and technology in general. After briefly addressing some of the various issues which are raised by experts, philosophers, but also the general public, concerning synthetic biology in general, it focuses on the topic of “artificial life creation” and presents moral reasons which may or may not allow it. The topic is approached by referring to consequentialist, deontological, but also, virtue theory arguments for and against it and the possibility of a partial permission of “artificial life” experiments, asking whether the benefits outweigh the risks and moral implications is explored. Finally, it proposes an argument in favor of the future exploration of biological innovation, underlying the need for a more balanced access to its beneficial results.

Experience of EU countries on ethical aspects of patenting biotechnologies in the field of medicine and pharmacy

Keywords: patenting, ethics, biotechnological inventions, medicine, pharmaceuticals,health The progress ofmodern biotechnological achievements poses new ethical and social challenges to society.Research using biotechnology in medicine and pharmacy leads to more in-depthknowledge of diseases. With the help of biotechnology, it becomes possible to treatpreviously incurable diseases. It is worth noting that today with the possibility ofusing biotechnological developments, the scientific community in a very short timewas able to successfully invent vaccines against COVID-19.During clinical trials, the safety of study subjects should be unneglected for therapid introduction of the product to the market. Ethics and innovation in modern societyalways go hand in hand, especially in the field of health care. The worldwidespread of COVID-19 underscores the importance of maintaining a balance betweenethics and intellectual property rights when human lives are in mortal danger.Society is concerned about the ethics of patenting life, namely, the possibility ofpatenting genes, cell lines and human tissues. The Directive states that the humanbody cannot be invented at certain stages of its formation and development, includinggerm cells, as well as the simple discovery of one of its components, including the sequenceor partial sequence of a gene.Patents that relate to the human gene are particularly critically examined ethically.Ethics, morality, and law are interrelated components and are extremely importantfor society to accept the invention. EU patent law is based on ethical principles. Thus, theadoption of the Directive was envisaged for the development of the EU economy, the abilityto regulate controversial issues regarding the patenting of biotechnological inventionsby criteria of ethics and morality and to harmonize EU legislation.Owners who run biotechnology institutions (organizations) must protect the results ofresearch, and obtaining patents is the most effective way. After all, long-term researchand development of new products or processes require significant financial costs. The intellectualproperty product must be protected by a patent, including biotechnological inventions.

Mejoramiento vegetal moderno, inteligencia artificial y derechos de propiedad intelectual

The modern plant breeding to obtain new plant varieties is based on genomic and phenomic selection generated through big data with millions of information points. In the face of such a quantity of data, it is necessary to use artificial intelligence to combine a complete vision and analysis of the problem through a human-computer interaction never addressed.The use of artificial intelligence has already created interpretive challenges in patents and copyrights. To a greater extent, modern plant breeding with the assistance of artificial inte-lligence is exposing major disarticulations and anachronisms in the Plant Breeder’s Rights and patent systems for biotechnological inventions. The challenges may even extend to the question of who would be entitled to the right in the case of products obtained without human intervention.The analysis of the situation indicates, on the one hand, that it would be necessary a review of the international framework of intellectual property rights in plant living matter which is based on independent treaties and conventions that apply to an indivisible organism as is a new plant variety. A more logical proposal would be to have a single, modern, and up-to-date compre-hensive sui generis protection system for all types of plant germplasm. On the other hand, it is proposed that, even in the case of products obtained through complete artificial intelligence processes, there must always be a human person legally responsible of the consequences of their actions, whether positive or negative

REVIEWING INTERNATIONAL PATENT POLICY ON BIOTECHNOLOGICAL INVENTIONS AND THE ADEQUACY OF EQUITABLE BENEFIT SHARING PRINCIPLE

The purpose of this study is to review international patent policy related to biotechnological inventions, particularly from the Venetian Patent Law to the TRIPs Agreement. It closely examines whether such inventions fulfill the patentability thresholds and analyses the reason why such patents are regarded as having the potential to cause facility misappropriation of biodiversity, which is considered unfair. The most important part of this study is the adequacy analysis of the principles of equitable benefit sharing of the Convention on Biodiversity (CBD), including disclosure requirements and prior informed consent (PIC), to prevent misappropriation of biological resources in this era of fourth industrial revolution. This study is based on normative legal research method and uses primary and secondary legal resources. The analysis conducted for this study employed several approaches, which are: statute, conceptual, and historical approaches. This study found that patent protection for biotechnological inventions has received justification since the Paris Convention. However, the current international patent policy has a potential to facilitate misappropriation of biodiversity and it is regarded as unfair. On the other hand, equitable benefit sharing principle is still inadequate in dealing with such misappropriation. It advises the requirement of mandatory disclosure of origin to be regulated under national law as a legal basis for implementing equitable benefit sharing principle.

THE PATENTABILITY OF BIOTECHNOLOGICAL INVENTIONS IN THE EU: AN IMPACT ON THERAPEUTIC PRACTICE

The aim: To identify the spheres in which it is forbidden to patent the results of medical researches and as a consequence there is no legal protection of biotechnological inventions. Materials and methods: The research material is a modern European regulatory framework that establishes the basic principles for patentability of biotechnological inventions. The methods of information retrieval, analysis, systematization, and generalization were used in this article. Conclusions: The Court of Justice has categorically stated that inventions that use human embryonic cells cannot be used for industrial or commercial purposes and therefore cannot be patented. In connection with this prohibition, the Court of Justice provided a unified definition of “embryo” and determined that it could be considered a dividing human egg, but only if it had a real ability to develop into a human. That is, the determining factor is not the beginning of the process of cell proliferation, but their real ability to become human. These decisions have become crucial for the development of research and the use of their results in therapeutic activities in the EU.

11. Patentability

This chapter explores the criteria that are applied by an intellectual property office in examining a patent application. These applies to all forms for innovation and are novelty, inventive step, and industrial applicability. The chapter also explores additional requirements and barriers which apply in relation to biotechnological inventions, which has proved to be a particularly controversial issue in Europe, and the patentability of computer software and related inventions, such as business method patents. The chapter demonstrates the evolution in legal and policy thinking in these two fields, which provide a means to an understanding of developments in patent law in general.