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

2021 ◽  
pp. 174-190
Author(s):  
Ludmila A. Novoselova ◽  
◽  
Arina S. Vorozhevich ◽  
Keyword(s):  
Industrial Application ◽  
Patent Protection ◽  
Gene Sequence ◽  
Science And Technology ◽  
Patent Application ◽  
Genetic Research ◽  
Compulsory License ◽  
Legal Framework ◽  
Civil Code ◽  
Diagnostic Methods

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.

scholarly journals Self-Regulation of Genomic Studies and Prospects of Personified Medicine

Lex Russica ◽  
2020 ◽  
pp. 54-61
Author(s):  
K. V. Mashkova ◽  
M. V. Varlen ◽  
A. Yu. Shirokov
Keyword(s):  
Self Regulation ◽  
Genetic Research ◽  
Personal Data ◽  
Professional Associations ◽  
Legal Framework ◽  
State Regulation ◽  
Personal Genomic ◽  
Demographic Situation ◽  
Genomic Studies

A secular trend of the development of medicine in the 20th century was on the ways of strengthening the foundations of public health, formation of systems of affordable medical care. Human genome deciphering opens wide prospects for using the obtained data in medicine. In recent years commercial medical organizations have been developing genetic research and personal genomic testing services. The paper is devoted to the analysis of the importance of legal self-regulation in the field of genomic counseling in the Russian Federation. The authors investigate the prospects of the introduction of personalized medicine and limitations that arise today in one of the areas of the approach under consideration, namely: forecasting predisposition to diseases of mixed nature, which is related to the peculiarities of development of medical and demographic situation in the world. The question is raised about the need for broad population studies to verify the risk values for diseases with low genetic determinacy. The authors conclude that it is impossible to predict what medicine of the future will be, but the results of genome decryption and increasing availability of personal data represent a unique social phenomenon that should be developed within the legal framework. In the coming years, the debate on the role of legal mechanisms in the self-regulation of genetic research and genetic services will become increasingly important. At the international level, this discussion will be focused on the fundamental issue of respect for individual rights in the interpretation of the data received. As genetic advice evolves, the issue of responsibility for the information provided and the availability of national regulatory mechanisms within the framework of state regulation or self-regulated professional associations will become a key concern.

scholarly journals THE NEW BRAZILIAN LEGAL FRAMEWORK OF SCIENCE & TECHNOLOGY

2020 ◽  
Vol 8 (6) ◽  
pp. 39-50
Author(s):  
Dercio Luiz Reis ◽  
Marcelo Albuquerque de Oliveira ◽  
Sicy Rusalka Goes de Melo Barreto ◽  
Gabriela De Mattos Veroneze ◽  
Ana Nubia dos Santos de Oliveira
Keyword(s):  
Cost Reduction ◽  
Scientific Community ◽  
Science And Technology ◽  
Legal Framework ◽  
Productivity Cost ◽  
Research And Innovation ◽  
Innovation Activities ◽  
Brazilian Legislation ◽  
Science Technology ◽  
Support Seeking

The recognition of science and technology as a risk activity, focusing on results rather than procedures, means that researchers are more effectively engaged in activities involving innovation. The purpose of this article is to analyze the applicability of law known as the Legal Framework of Science and Technology, and it was constructed with bibliographical support seeking to contribute to a different view of the control organs regarding the research. The new Brazilian legislation brings with it the expectation that research and market have a process of approximation, reducing the distance between the knowledge produced in universities and their transformation into wealth. The possibilities arising from the new legislation tend to have effects in solving problems of quality, productivity, cost reduction, with the possibility of incorporating benefits to production and competitiveness, with the introduction of technology, methods and processes aligned with lean production. It concludes that the Legal Framework for Science and Technology, with its specific purpose of reducing bureaucracy in the country's research and innovation activities in general, is an important instrument in the integration of the academic and scientific community at all levels, and companies, representing a new path to boost the process of education.

scholarly journals A személyiségi jogok szabályozása a hatályos román Polgári törvénykönyvben

2021 ◽  
Vol 4 (2) ◽  
pp. 65-81
Author(s):  
Zsolt Kokoly
Keyword(s):  
Civil Law ◽  
Legal Framework ◽  
Civil Code ◽  
Fundamental Rights ◽  
Personality Rights

The new Romanian Civil Code (adopted in 2009, in effect since 2011) comprises a section dedicated to personality rights, as a novelty element compared to the previous Code. Their incorporation into the form of juridical norm follows both naturally from the historic evolution of some fundamental rights, both from the intention of the Romanian lawmaker to offer a comprehensive legal framework in the field of civil law.

scholarly journals Chromosome instability in Alzheimer’s disease

2011 ◽  
Vol 63 (3) ◽  
pp. 603-608 ◽  
Author(s):  
B. Spremo-Potparevic ◽  
L. Zivkovic ◽  
B. Plecas-Solarovic ◽  
V.P. Bajic
Keyword(s):  
Alzheimer’S Disease ◽  
Early Detection ◽  
Chromosome Instability ◽  
Genetic Research ◽  
Diagnostic Methods ◽  
Telomere Shortening ◽  
Premature Centromere Division ◽  
The World ◽  
Different Types ◽  
Potential Parameters

Alzheimer?s disease (AD), as the most common form of dementia, has for many years attracted the attention of researchers around the world, primarily because of the problems of reliable diagnostic methods that could help in the early detection of this devastating disease. One of the important aspects of genetic research related to AD is the analysis of chromosome instability which includes: aneuploidies of different chromosomes, telomere shortening and the phenomenon of premature centromere division (PCD). The aim of this study was to describe specific biomarkers in different types of cells as potential parameters for the diagnosis of AD in order to promptly recognize pre-symptomatic stages and prevent the development of disease and/or slow down its progression.

scholarly journals Right to access science and technology information in scientific research and innovation activities in Vietnam

2021 ◽  
Vol 63 (4) ◽  
pp. 50-55
Author(s):  
Tung Son Le ◽  
◽  
Thi Hoang Yen Thach ◽  
Van Hong Tran ◽  
◽  
...  
Keyword(s):  
Information Society ◽  
Legal Status ◽  
Science And Technology ◽  
Scientific Research ◽  
Legal Framework ◽  
Research And Innovation ◽  
Innovation Activities ◽  
Technological Information ◽  
The Right

Science and technology information has been an important driving force in the information society and knowledge economy. Access to scientific and technological information for scientific research becomes an essential need and a factor affecting the quality of scientific research and innovation, thereby posing a problem to establish a legal framework for recognising and enforcing the right to access scientific and technological information. Based on identifying and evaluating the current legal status on the right to access to science and technology information, this study proposes solutions to improve the legal framework to ensure the enforcement of the right to access science and technology information in Vietnam.

The method of fundamental harmonic frequency determination

2021 ◽  
Vol 63 (1) ◽  
pp. 38-42
Author(s):  
Tomasz Szczepański ◽  
Stanisław Traczyk ◽  
Paweł Dziedziak
Keyword(s):  
Fundamental Frequency ◽  
Patent Application ◽  
Diagnostic Methods ◽  
Main Process ◽  
Harmonic Frequency ◽  
Frequency Determination ◽  
The Subject ◽  
Mechanical Devices ◽  
Vibroacoustic Signals ◽  
Better Than

Analysis of vibroacoustic signals is one of the more frequently used mechanical devices diagnostic methods occurring among others in car diagnostics. Often, it happens that the most important element of the recorded course is the fundamental harmonic frequency of vibrations. Fundamental frequency indicates the main process related to the operation of the device and allows to follow its course. In the article the author's method of determining the fundamental frequency in the signal will be presented which is the subject of a patent application. Its theoretical basis and application examples were discussed comparing the accuracy of its use with the accuracy of other methods. The frequency range where the method finds application is shown. That is, where its accuracy turns out to be better than the accuracy of popular used methods to fundamental harmonic frequency determination.

National Report for Spain

2012 ◽  
Keyword(s):  
19Th Century ◽  
21St Century ◽  
Legal System ◽  
Satisfactory Result ◽  
Legal Framework ◽  
Civil Code ◽  
Procedural Law ◽  
National Report ◽  
The 19Th Century ◽  
The Eu

The current insolvency legislation is the result of a long and cumbersome evolution. It was approved on 7 July 2003 (Ley 22/2003, the Insolvency Act 2003 (‘IA’)) and came into force on 1 September 2004, putting an end to one of the most embarrassing situations that the Spanish legal system has ever had to endure: coming into the 21st century with an insolvency legislation dating back to the beginning of the 19th century. The previous insolvency system was composed of as many as five different legal instruments: the Commercial Codes (Codigo de Comercio) of 1885 and 1829 (only partially in force) and the Law on Suspension of Payments of 1922 (Ley de Suspension de Pagos), which regulated some procedural aspects and all material aspects of commercial insolvency; the Civil Code of 1889, which regulated the insolvency of the general—non-commercial—debtor; and the Civil Procedural Law, dating from 1881 (Ley de Enjuiciamiento civil ). It can then be said that the insolvency of a large business in a developed European economy (the fifth largest in the EU) had to be solved with laws that dated from two centuries before. The reform has been a relief and it has greatly modernised Spain’s economic legal legal framework. However, this process was neither easy nor did it produce a fully satisfactory result.

10 Czech Republic

2018 ◽  
Author(s):  
Schweigelová Dana
Keyword(s):  
Czech Republic ◽  
Capital Markets ◽  
Legal Framework ◽  
Civil Code ◽  
The Czech Republic ◽  
Cross Border ◽  
Statutory Law ◽  
Regulatory Regimes ◽  
The Cross

This chapter provides an overview of the legal framework of set-off in the Czech Republic both outside and within the context of insolvency. In the Czech Republic, set-off rights are regulated exclusively by statutory law. General regulations on set-off arrangements are laid down in Sections 1982–1991 of the Czech Civil Code. Other laws relevant to set-off are the Business Corporations Act, the Capital Markets Act, the Financial Collateral Act, and the Act on Insolvency. The chapter first examines set-off between solvent parties, taking into account general regulations, specific regulations under the Business Corporations Act, contractual set-off involving multiple parties, and special regulatory regimes governing set-off in the Czech Republic. It then considers set-off between insolvent parties before concluding with an analysis of set-off issues arising in the cross-border context.

scholarly journals Compulsory Licenses for Cancer Drugs: Does Circumventing Patent Rights Improve Access to Oncology Medications?

2016 ◽  
Vol 2 (5) ◽  
pp. 292-301 ◽  
Author(s):  
Cinthia Leite Frizzera Borges Bognar ◽  
Brittany L. Bychkovsky ◽  
Gilberto de Lima Lopes
Keyword(s):  
Cancer Control ◽  
Compulsory License ◽  
Legal Framework ◽  
Essential Medicines ◽  
Cancer Drugs ◽  
Middle Income ◽  
Middle Income Countries ◽  
Life Saving ◽  
Poor Outcomes ◽  
Improve Access

Worldwide, there are enormous inequities in cancer control that cause poor outcomes among patients with cancer who live in low- and middle-income countries (LMICs). One of the biggest challenges that oncology faces today is how to increase patient access to expensive, but life-saving, therapies in LMICs. Access to cancer medications in LMICs is a major problem, especially in recent years, as the costs of these therapies continue to rise exponentially. One mechanism available to LMICs to improve access to cancer medications allows a country to pursue a compulsory license for a given drug. Here, we will review how the legal framework in the World Trade Organization's Trade-Related Aspects of Intellectual Property Rights Agreement and the Doha Declaration supports countries to circumvent patent laws and acquire compulsory licenses for essential medicines. We will also discuss the current and future role of compulsory licenses in oncology and how compulsory licenses may improve access to cancer drugs in LMICs.

Which Types of Bioinformatics Inventions Are Eligible for Patent Protection?

2015 ◽  
Vol 21 (2) ◽  
Author(s):  
Trent Ostler ◽  
Michael Gollin
Keyword(s):  
Patent Protection ◽  
Patent Application ◽  
Trade Secret ◽  
General Purpose ◽  
Patent Law ◽  
Step Test ◽  
Copyright Laws ◽  
The Supreme Court ◽  
General Purpose Computer ◽  
Purpose Computer

The field of bioinformatics is flourishing, and strong growth is only projected to continue. Like any cutting edge technology, bioinformatics requires an integrated IP strategy involving patent, trade secret, and copyright laws. The patent system in particular can be a powerful protection for commercializing bioinformatics inventions as long as a corresponding patent application meets certain patent law standards. Recently, the most rapidly evolving of these patent law standards—patent eligibility—came to a crescendo last year when the Supreme Court in Alice v. CLS Bank introduced a two-step test for determining whether computer-implemented inventions are patent-eligible. Since then, other courts and the USPTO have applied the test on inventions implemented on a computer and/or using the Internet with fact-dependent results. Here, we discuss how these decisions relate to bioinformatics inventions. We then analyze bioinformatics patents that have recently issued post-Alice. While the law remains relatively underdeveloped, it becomes clear that relying on a general purpose computer to perform routine or conventional steps in a claim will not infuse patent-eligibility into a claim. However, bioinformatics inventions remain patentable, especially when the patent prosecution team properly and persuasively presents the technical improvements and commercial embodiments.

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