Extension of the Transition Period under Article 66.1 of the TRIPS Agreement for Least-Developed Country Members for Certain Obligations with Respect to Pharmaceutical Products

2020 ◽  
pp. 414-415
Keyword(s):  
Transition Period ◽  
Pharmaceutical Products ◽  
Trips Agreement ◽  
Developed Country

The Influence of TRIPS Compliant Patent Laws on Indian Pharmaceutical Industry

2014 ◽  
Vol 4 (1) ◽  
Author(s):  
Rupesh Rastogi ◽  
Virendra Kumar
Keyword(s):  
Pharmaceutical Industry ◽  
Patent Protection ◽  
Uruguay Round ◽  
Pharmaceutical Products ◽  
Trips Agreement ◽  
Patent Law ◽  
Patent Laws ◽  
The Impact ◽  
First Time ◽  
Indian Pharmaceutical Industry

The first legislation in India relating to patents was the Act VI of 1856. The Indian Patents and Design Act, 1911 (Act II of 1911) replaced all the previous Acts. The Act brought patent administration under the management of Controller of Patents for the first time. After Independence, it was felt that the Indian Patents & Designs Act, 1911 was not fulfilling its objective. Various comities were constituted to recommend, framing a patent law which can fulfill the requirement of Indian Industry and people. The Indian Patent Act of 1970 was enacted to achieve the above objectives. The major provisions of the act, provided for process, not the product patents in food, medicines, chemicals with a term of 14 years and 5-7 for chemicals and drugs. The Act enabled Indian citizens to access cheapest medicines in the world and paved a way for exponential growth of Indian Pharmaceutical Industry. TRIPS agreement, which is one of the important results of the Uruguay Round, mandated strong patent protection, especially for pharmaceutical products, thereby allowing the patenting of NCEs, compounds and processes. India is thereby required to meet the minimum standards under the TRIPS Agreement in relation to patents and the pharmaceutical industry. India’s patent legislation must now include provisions for availability of patents for both pharmaceutical products and processes inventions. The present paper examines the impact of change in Indian Patent law on Pharmaceutical Industry.

scholarly journals Vaccine nationalism and equitable access to COVID-19 pharmaceuticals: TRIPS Agreement under trial (again)

2021 ◽  
Vol ahead-of-print (ahead-of-print) ◽  
Author(s):  
Boniface Chimpango
Keyword(s):  
Low Income ◽  
Empirical Studies ◽  
Pharmaceutical Products ◽  
Trips Agreement ◽  
Low Income Countries ◽  
Equitable Access ◽  
Content Type ◽  
Near Term ◽  
Procurement Strategies ◽  
The Impact

Purpose The purpose of this study is to contribute towards the debate about global access to COVID-19 vaccines, therapeutics and diagnostics. Design/methodology/approach The global scramble for COVID-19 vaccine and other related pharmaceutical products have once again exposed the limitations of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). High-income countries are claiming a lion’s share of the first available batches of the COVID-19 vaccine in total disregard of the consequences such approach would have on the low-income countries that lack both the manufacturing wherewithal and the financial resources to purchase the vaccine and other products needed to combat the pandemic. This paper reviews the existing TRIPS Flexibilities and analyses their limitations with respect to equitable access of pharmaceutical products in times of health emergencies. This paper then considers the unique challenges that have been brought to the fore by the COVID-19 pandemic. Finally, this paper analytically explores some options that have been proposed so far that the World Trade Organization (WTO) or governments can take in the immediate to near term to facilitate equitable access to COVID-19 pharmaceutical products and technologies. This research is non-empirical, desk-based research. It is, therefore, based on the literature review of existing body of work that is relevant to the topic under discussion. Mindful of the epistemological challenges that are always associated with desk-based research, part of the methodology of this work is to seek support from related empirical studies based on different philosophical underpinnings but that confirm the working hypothesis of this research. Findings This paper finds that there is still a need for a comprehensive reform of TRIPS Agreement to streamline the voluntary licencing system which is an important tool for low-income countries’ access to affordable pharmaceuticals. However, for purposes of dealing with COVID-19, WTO members should consider establishing pooled Licencing Facilities and procurement strategies via already existing political, economic or regional trade groupings. Originality/value This research is original. All sources have been acknowledged. This research synthesises different research papers and applies different viewpoints to the debate on the impact of the TRIPS Agreement on equitable access to COVID-19 vaccines, therapeutics and diagnostics.

INVESTMENT COOPERATION OF VIETNAM WITH FOREIGN COUNTRIES, INCLUDING RUSSIA AT TRANSITION TO THE NEW HIGH-TECH MODEL OF ECONOMICS IN THE XXI CENTURY

2020 ◽  
pp. 118-125
Author(s):  
Tatiana V. Lezhenina ◽  
Keyword(s):  
21St Century ◽  
Economic Model ◽  
Global Economy ◽  
Transition Period ◽  
High Volume ◽  
Developed Countries ◽  
High Tech ◽  
Developed Country ◽  
Trade Relations ◽  
The Usa

In the 21st century, a breakthrough in the global economy has come to transition to a new stage in the development of high technologies in the economy, social environment and strengthening the ties between countries along the path to new progress and cooperation. Vietnam has already emerged from the state of a medium-developed economy and gained experience for the transition to a highly developed economy, using the best practices and knowledge of the USA, Japan, the Republic of Korea, and China. Vietnam’s interaction with Russia has grown, using its experience in introducing into the economy and life new methods of using and transmitting information of universal scale and significance. For Vietnam, the transition to a new economic model will provide foreign direct investment, especially from highly developed countries. Tasks . Explore the factors and conditions of Vietnam's transition to a new economic model. Methodology. The methods of scientific knowledge of the main features and characteristics of the transition to a new high-tech model in the XXI century are used. Results. The high volume of Vietnam’s trade relations with highly developed countries of the world is proved, as one of the decisive factors for accumulating the resources for the transition to a new model, FDI received in Vietnam in the first two decades of the 21st century, its volume structure, investing countries, FDI, etc. are considered. Conclusions. Vietnam was able in a short historical time, passing the warriors and American aggression to create a solid foundation for the transition to a highly developed country in Southeast Asia. Vietnam received considerable assistance during this transition period from Russia.

Ch.14 Acquisition and Maintenance of Intellectual Property Rights, Dispute Prevention and Settlement, Transitional and Institutional Arrangements, and Final Provisions

2020 ◽  
Author(s):  
Correa Carlos Maria
Keyword(s):  
Intellectual Property ◽  
Property Rights ◽  
Intellectual Property Rights ◽  
Institutional Arrangements ◽  
Trips Agreement ◽  
Intellectual Property Protection ◽  
Developed Country ◽  
National Legislation ◽  
One Year

This concluding chapter looks at the acquisition and maintenance of intellectual property rights (IPRs), dispute prevention and settlement, transitional and institutional arrangements, and final provisions in the Trade-related Aspects of Intellectual Property Rights (TRIPS) Agreement. Different aspects relating to the procedures for the acquisition and maintenance of intellectual property rights are regulated in Article 62 of the TRIPS Agreement. Its main purpose is to ensure that the application of national legislation on this matter does not unjustifiably impair the access to and exercise of such rights. Meanwhile, Articles 63 and 64 contain rules aimed at preventing and settling disputes concerning the implementation of the TRIPS Agreement. Prevention of disputes is basically sought under the TRIPS Agreement through the rules on ‘transparency’ contained in Article 63. All WTO Members could avail themselves of one year after the date of entry into force of the WTO Agreement to comply with the obligations relating to intellectual property protection. The reason for this is quite obvious: most or all Members, including developed country Members, needed to introduce changes into their legislation in order to comply with the standards set out by the TRIPS Agreement, especially with those contained in Part II. A Council to specifically deal with TRIPS matters is established by Article 68.

The Use of Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health (2001): A Review of Implementation Experiences in the Developing Countries

2012 ◽  
pp. 186-209
Author(s):  
Alexandra Bhattacharya
Keyword(s):  
Public Health ◽  
Developing Countries ◽  
Transition Period ◽  
Access To Medicines ◽  
Trips Agreement ◽  
Compulsory Licensing ◽  
Trade Regime ◽  
Council Decision ◽  
Internal Barriers ◽  
Doha Declaration

Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public Health (2001) recognized the difficulty of some WTO member states in using the compulsory licensing flexibility allowed in the TRIPS Agreement due to their lack of local pharmaceutical manufacturing capacities. However, there has been almost no implementation by countries of the subsequent WTO General Council decision of 30th August, 2003 which was designed to resolve this Paragraph 6 issue. This is due to the existence of various impediments – generally in the form of external and internal barriers. A comparative analysis is undertaken of the implementation of the Council Decision in two countries with varying levels of development and with different obligations with regards to enforcement of the TRIPS Agreement. It is shown that external barriers such as proliferation of bilateral agreements have more impeding effect on developing countries such as South Africa which are already part of the full TRIPS compliance regime. Conversely, internal barriers such as institutional and structural drawbacks have more of an impact in Least Developing Countries (LDCs) such as Bangladesh which have been given a transition period for TRIPS compliance and are not yet fully susceptible to external pressures of the international trade regime. The increased preference of countries to use alternative innovative mechanisms such as the Medicines Patent Pool to improve access to medicine outside the framework of the global IP/Trade regime reiterates the unworkability of the Council Decision in promoting access to medicines.

Regulatory exclusivity protection for undisclosed test data in China: an innovative approach to implementing the TRIPS Agreement

2020 ◽  
Vol 10 (1) ◽  
pp. 115-127
Author(s):  
Zhiwen Liang
Keyword(s):  
Test Data ◽  
Orphan Drugs ◽  
Pharmaceutical Products ◽  
Trips Agreement ◽  
New Drugs ◽  
Trade Disputes ◽  
Data Exclusivity ◽  
Market Protection ◽  
Innovative Drugs ◽  
Weak Patents

Regulatory exclusivity, the TRIPS-plus protection for undisclosed test data, is considered as the principal means to extend market protection for brand-name pharmaceutical companies. When China joined the World Trade Organization in 2001, it promised to enact new laws or regulations that will comply with article 39.3 of the TRIPS Agreement. China's choice of implementing the TRIPS Agreement through regulatory exclusivity resulted mainly from intrinsic demands for China's strategy of innovative-driven development, and partly from the pressure of China-US trade disputes. There are two categories of regulatory exclusivities under China's laws. One is the market exclusivity for New Drugs and Traditional Chinese Medicine. The other is the data exclusivity for Innovative Drugs, Orphan Drugs, Paediatric Drugs, Innovative Biologics; and a ‘Generic Exclusivity’ for the first generic drug company that succeeds in challenging weak patents of pharmaceutical products.

scholarly journals Legal status of pharmaceutical industry secrecy In the UAE legal system

2021 ◽  
Vol 58 (1) ◽  
pp. 4377-4385
Author(s):  
Dr. Jihad Saleh Bani Younes
Keyword(s):  
Pharmaceutical Industry ◽  
United Arab Emirates ◽  
Legal Status ◽  
Negative Impact ◽  
Scientific Progress ◽  
Pharmaceutical Products ◽  
Trips Agreement ◽  
Local Market ◽  
Industrial Property ◽  
Pharmaceutical Industries

Facing the problem of matching growth and status, starting work, starting work, starting work, starting work, starting work, starting work, starting work, and the United Arab Emirates. This harmonization - by approving a set of exceptions of this nature has some of the effects and the secret idea behind it. As we see him, he relied on the idea of ​​public order in order to set some exceptions related to the inventions themselves by excluding some of them from the requirement to obtain a patent certificate, which is stipulated in Article 6 of the Law on the Organization and Protection of Industrial Property, and he also made exceptions related to the rights established for the inventor, which are It gives him the power to monopolize and dominate the invention if the inventor has what is in conflict with the objectives of scientific research, which is stipulated in Article 19 of the aforementioned law, and we see that the UAE legislator has organized the idea of ​​compulsory licensing contracts for pharmaceutical products in accordance with the interests of both the licensee and the licensee. Both. Research problem: considering that the pharmaceutical industry in the UAE is a strategic industry, and because of the fluctuation of drug prices in the global and local market. Therefore, the problem of this research will focus not on the extent to which the pharmaceutical industry in the Emirates can activate its role in the UAE national economy in light of the UAE pharmaceutical legislation, and whether these legislations were able to create a balance between secrecy in the pharmaceutical industry and scientific progress in this industry. research assumes: 1- There is no relationship between advances in the pharmaceutical industry in the UAE and the confidentiality imposed by the TRIPS Agreement. 2- The UAE’s accession to the TRIPS Agreement had a negative impact on the pharmaceutical industry. 3- The Emirati legislator was able to create a consensus between commitment to confidentiality and the manufacture of medicines. research aims: 1- Introducing confidentiality in the pharmaceutical industry. 2- Identifying the main obstacles to the pharmaceutical industry in the UAE. 3- Developing proposals to activate the role of local legislation to create a balance between confidentiality and the pharmaceutical industry. research importance: The importance of the research lies in focusing on the balance between confidentiality and the local pharmaceutical industry to have a developmental role. Thus, we will try to reveal the state of the pharmaceutical industry in the UAE. And how to stimulate the pharmaceutical industry through national legislation Research methodology: The researcher will rely on a descriptive approach to analyze and characterize the special industrial reality in medicine in the UAE and analyze private legislation Based on the foregoing, and in order to understand the position of the Emirati legislator on the idea of ​​secrecy in the pharmaceutical industries more, this requirement must be divided into two studies. In the first, we review the concept of confidentiality in the pharmaceutical industries. Second: the concerted attempts to mitigate the negative effects of confidentiality in the pharmaceutical industries.  

Compulsory Licensing under India’s New Model Bilateral Investment Treaty

2017 ◽  
Vol 9 (3) ◽  
pp. 139-154 ◽  
Author(s):  
Katarzyna Kaszubska
Keyword(s):  
Intellectual Property ◽  
Patent Protection ◽  
Pharmaceutical Products ◽  
Trips Agreement ◽  
Public Access ◽  
Compulsory Licensing ◽  
Bilateral Investment Treaty ◽  
Compulsory Licence ◽  
Investment Treaty ◽  
The World

The traditional lack of patent protection for pharmaceutical products allowed India’s generic sector to expand and become ‘the pharmacy of the world’ supplying affordable medicines to both developed and developing countries. With the entry into force of the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement in 2005, the mechanism of compulsory licensing was incorporated as a flexibility to ensure that the protection of intellectual property (IP) rights does not undermine the public access to affordable medicine. Following the issuance of the first compulsory licence by the India’s patent office to Natco for Nexavar in 2012, various domestic companies requested a licence for production of generic copies of patented drugs. The recourses and litigation over the compulsory licensing provisions under India’s Patent Act 1970 indicate the importance of the institution of compulsory licensing for ‘Indian pharma’ and its desire to rely on it in the future. This article attempts to assess the legal consequences of the new India’s Model Bilateral Investment Treaty providing investment tribunals with the jurisdiction to examine the compliance of domestic decision to grant compulsory licence with the World Trade Organization (WTO) TRIPS Agreement. JEL: K33, P45, F21, O34, O53, O19

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