scholarly journals Similar Biologics: Global Opportunities and Issues

2017 ◽  
Vol 19 (4) ◽  
pp. 552 ◽  
Author(s):  
Prasanta Kumar Ghosh
Keyword(s):  
Intellectual Property ◽  
Human Health ◽  
Intellectual Property Rights ◽  
Comparative Evaluation ◽  
Market Competition ◽  
Regulatory Agencies ◽  
Regulatory Guidelines ◽  
The World ◽  
Chronic Disorders ◽  
Different Parts

The invention and use of a large number of biologics during the last three decades for treating various deficiencies and chronic disorders has resulted in great benefit to human health. Abundant use of these biologics has been considerably constrained due to the reasons of their increased prices, charged by the inventors up to the time up to which their use were/are protected by intellectual property rights (IPR).Some of these biologics are presently being manufactured by the existing and newer companies as “similar biologics” after the IPR on these products have expired and as a result the prices of several such medicines are coming down.“Similar biologics” are also referred to as “biosimilars” and other related names in different parts of the world. The regulatory authorities of different countries have authorized use of “similar biologics” based on comparative evaluation of each of such medicines with the inventor’s biologics; these are approved when considered to be closely similar to the inventor’s biologics in properties, quality and efficacy. By 2020, a dozen of “inventor’s biologicals” having estimated market sale-value of over USD 79 billion are going out of protection of IPR. This would drive entrepreneurs to enter in to the field and the prices are going to crash considerably due to market competition. In course of time more “biosimilars” would go out of IPR. Different proactive governments and the regulatory agencies all over the world are trying to harness the existing and future opportunities by creating regulatory guidelines to ease faster authorization for use of “similar biologics” in their territories. Up to the present time, a small number of “similar biologics” have been approved for use in different countries all over the major parts of the world. More efficient technologies for manufacture of “similar biologics” are also getting developed. Together, these efforts are anticipated to ease the availability of “similar biologics” at more affordable prices to the users/ payers the world over. This article is open to POST-PUBLICATION REVIEW. Registered readers (see “For Readers”) may comment by clicking on ABSTRACT on the issue’s contents page.

scholarly journals Effective factors to encourage the foreign direct investment in Iraq

2018 ◽  
Vol 162 ◽  
pp. 02038
Author(s):  
Shahla Mohammad Ali
Keyword(s):  
Foreign Direct Investment ◽  
Intellectual Property ◽  
Property Rights ◽  
Intellectual Property Rights ◽  
World Bank ◽  
Direct Investment ◽  
Banking System ◽  
Effective Factors ◽  
World Bank Report ◽  
The World

Foreign direct investment in Iraq cannot take its complete role for different reasons, such as: Lack of security, Corruption, Lack of Transparency, Unequipped banking system, undeveloped arbitration law, Intellectual Property Rights (IPR) issue, and internal disputes over oil rights. It was found that Iraq rates as one of the worst places in the world to do business, languishing at 166 out of 183 countries, according to a World Bank report and for starting a business Iraq ranks even lower

scholarly journals The COVID-19 Vaccine and the Future of International Laws in Business, Travel, and Trade

2021 ◽  
Vol 8 (2) ◽  
pp. 183-198
Author(s):  
Melanie Lane
Keyword(s):  
Intellectual Property ◽  
Property Rights ◽  
Intellectual Property Rights ◽  
Business Travel ◽  
The World ◽  
The Future ◽  
International Laws ◽  
New Challenges ◽  
Current Systems

Since COVID-19, the world has been constantly evolving to adapt. Finding a cure quickly became the focus worldwide which altered set approaches to intellectual property rights. Additionally, creating a controversial vaccine has led to several more questions for the future. With varying vaccines and standards throughout the world, travel, business, and trade may face new challenges which change the current systems.

scholarly journals Not Tripping over TRIPS: An Analysis of Necessity and Legality of the COVID-19 TRIPS Waiver Proposal

2022 ◽  
Vol 10 (5) ◽  
pp. 61-65
Author(s):  
Ahan Gadkari ◽  
◽  
Sofia Dash ◽  
Keyword(s):  
South Africa ◽  
Intellectual Property ◽  
Property Rights ◽  
World Trade Organization ◽  
Intellectual Property Rights ◽  
World Trade ◽  
Vaccine Development ◽  
Pharmaceutical Manufacturing ◽  
The World ◽  
Fair Distribution

The availability of vaccinations against COVID-19 provides hope for containing the epidemic, which has already claimed over 2.84 million lives. However, inoculating millions of individuals worldwide would need large vaccine manufacturing followed by fair distribution. A barrier to vaccine development and dissemination is the developers' intellectual property rights. India and South Africa have jointly sought to the World Trade Organization that certain TRIPS rules of COVID-19 vaccines, medicines, and treatments be waived. This piece argues for such a waiver, highlighting the unique circumstances that exist. It believes that TRIPS's flexibilities are inadequate to cope with the present epidemic, particularly for nations without pharmaceutical manufacturing competence.

Implementing the Global Biodiversity Convention: IPR for Public Good

1995 ◽  
Vol 20 (4) ◽  
pp. 3-10
Author(s):  
M S Swaminathan
Keyword(s):  
Intellectual Property ◽  
Public Good ◽  
Intellectual Property Rights ◽  
Rural Women ◽  
World Trade ◽  
Trade Agreement ◽  
The World ◽  
Global Biodiversity ◽  
Biodiversity Convention ◽  
Conservation Of Biodiversity

Transparent and implementable methods of recognizing and rewarding the contributions of tribal and rural women and men in the conservation of biodiversity have become exceedingly urgent in the context of the provisions of the Trade Related Intellectual Property Rights (TRIPS) under the World Trade Agreement. In this paper, M S Swaminathan points out how considerations of equity can be integrated with those of ecology and economics in recognizing and rewarding informal innovations in genetic conservation and enhancement.

IV. Intellectual Property

2001 ◽  
Vol 50 (3) ◽  
pp. 714-724
Author(s):  
Joe McMahon ◽  
Catherine Seville
Keyword(s):  
Intellectual Property ◽  
Property Rights ◽  
World Trade Organization ◽  
Intellectual Property Rights ◽  
World Trade ◽  
Trips Agreement ◽  
Global System ◽  
The World

This Journal's previous piece on current developments in EC intellectual property noted that this area of law is dominated by the drive towards harmonisation.1 This drive continues, and its success has been such that it can now begin to be seen in an overarching context of globalisation. The idea of a unified global system for the protection of intellectual property now seems at least conceivable, even if not immediately achievable. It is even possible to state that some stages have been achieved on the journey, most notably the TRIPs Agreement. Since adherence to this is a requirement of World Trade Organization (WTO) membership, the arguments in its favour have suddenly become “persuasive”. It represents a tremendous achievement in terms of the protection and enforcement of intellectual property rights throughout the world. The World Intellectual Property Organisation's contribution here and elsewhere has been immense.

Compulsory Licensing in Canada and Thailand: Comparing Regimes to Ensure Legitimate Use of the WTO Rules

2009 ◽  
Vol 37 (2) ◽  
pp. 222-239 ◽  
Author(s):  
Kristina M. Lybecker ◽  
Elisabeth Fowler
Keyword(s):  
Developing Countries ◽  
Intellectual Property ◽  
Intellectual Property Rights ◽  
World Trade ◽  
Trips Agreement ◽  
Essential Medicines ◽  
Compulsory Licensing ◽  
The World ◽  
Aids Crisis ◽  
Doha Declaration

The tension between economic policy and health policy is a longstanding dilemma, but one that was brought to the fore with the World Trade Organization’s (WTO) Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement in 1994. The pharmaceutical industry has long argued that intellectual property protection (IPP) is vital for innovation. At the same time, there are those who counter that strong IPP negatively impacts the affordability and availability of essential medicines in developing countries. However, actors on both sides of the debate were in agreement that something needed to be done to address the HIV/AIDS crisis, especially in developing countries. In response to sustained and significant pressure from civil society groups, members of the World Trade Organization agreed to the Declaration on the TRIPS Agreement and Public Health (the Doha Declaration) in 2001. The Declaration clarified that countries unable to manufacture the needed pharmaceuticals could obtain more affordable generics elsewhere if necessary.

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