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

A Review of Recent Developments at the Multilateral Level with Respect to Intellectual Property and the Pharmaceutical Industry

2009 ◽  
Vol 6 (4) ◽  
pp. 323-331
Author(s):  
Maximiliano Santa Cruz ◽  
Pedro Roffe
Keyword(s):  
Public Health ◽  
Intellectual Property ◽  
Patent Protection ◽  
Pharmaceutical Products ◽  
Global Strategy ◽  
World Intellectual Property Organization ◽  
World Health ◽  
Compulsory Licensing ◽  
The World ◽  
Recent Developments

The adoption in 1994 of the World Trade Organization's Agreement on Trade Related aspects of Intellectual Property Rights (TRIPS) meant the incorporation of intellectual property as an important component of the international trading system. It meant also an end to the exclusive treatment of intellectual property issues in the World Intellectual Property Organization (WIPO). TRIPS meant also, the end of the accepted practice of excluding pharmaceutical products and or processes from patent protection, a practice that was particularly important for developing countries. This note reviews recent developments at the multilateral level after the adoption of TRIPS, namely the adoption of the Declaration on the TRIPS Agreement and Public Health in 2001 and the subsequent decision to amend the TRIPS for the effective use of the compulsory licensing system; the adoption of the Development Agenda by the WIPO General Assembly in 2007 and related recent developments in WIPO; and finally the adoption of the Global strategy and plan of action on public health, innovation and intellectual property by the 61st World Health Assembly in 2008. One common feature of these developments is the attempt to bring some balance to the international intellectual property system that has been characterised by an upward tendency to strengthen private rights and their enforcement to the detriment of public interest considerations.

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.

scholarly journals Comment: Compulsory Licensing of Patented Pharmaceutical Inventions: Evaluating the Options

2009 ◽  
Vol 37 (2) ◽  
pp. 247-263 ◽  
Author(s):  
Jerome H. Reichman
Keyword(s):  
Intellectual Property ◽  
Patent Protection ◽  
Uruguay Round ◽  
World Intellectual Property Organization ◽  
International Convention ◽  
Compulsory Licensing ◽  
Multilateral Trade ◽  
The World ◽  
The One ◽  
Patented Inventions

Few topics in international intellectual property law have been as controversial in recent years as the one we are about to examine. In the 1980s and early 1990s, a Diplomatic Conference attempted to revise the oldest international convention providing some protection for patented inventions outside of the domestic laws. Those efforts broke down, largely because developed and developing countries could not agree on the powers that governments should retain to issue compulsory licenses or on the grounds for which these powers could be exercised. The failure of this Conference, held under the auspices of the World Intellectual Property Organization (WIPO), persuaded the technology-exporting countries to link future negotiations concerning international intellectual property protection to the Multilateral Trade Negotiations, known as the Uruguay Round, which got underway in 1986. The end result was Annex IC of the Agreement Establishing the World Trade Organization of 1994, which incorporated a new, comprehensive and relatively elevated set of international minimum standards of patent protection into the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement).

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.

Product Patent in Pharmaceuticals and Compulsory Licensing

2017 ◽  
pp. 108-123
Author(s):  
Jatinder Maan ◽  
Dinesh Kumar
Keyword(s):  
Intellectual Property ◽  
Compulsory License ◽  
Developed Countries ◽  
Developing Nations ◽  
Trips Agreement ◽  
Intellectual Property Protection ◽  
Political Pressure ◽  
Compulsory Licensing ◽  
Contentious Issue ◽  
History Of

The issue of patenting is a contentious issue. Different stakeholders hold opposite views. The pharmaceutical giants demand for stricter and longer Intellectual Property Protection for the promotion of research and development. They contend IP protection to be the “bedrock of their business”. While the health activists and governments of developing nations want greater flexibility in intellectual property protection and shorter patent period protection. Article 31 of the TRIPs agreement provides certain flexibilities to cater to certain situations. The countries are free to determine the grounds to issue provisions like compulsory licensing. But despite the provisions very few countries have used them. Pharmaceuticals giants with the backing of developed countries always try to denounce the practice of compulsory licensing with economic and political pressure. This chapter explains the concept and significance of Intellectual Property with reference to Pharmaceuticals. It also traces the little history of TRIPs agreement and explains the concept of Compulsory Licensing with trends in its use. It also discusses the few instances where compulsory License has been issued in different countries and tries to find the reasons of non issuance of Compulsory License.

Optimal Policy for Biopharmaceutical Drugs Innovation and Access in India

2011 ◽  
pp. 74-114
Author(s):  
Rakhi Rashmi
Keyword(s):  
Developing Countries ◽  
Optimal Policy ◽  
Patent Protection ◽  
Trips Agreement ◽  
Public Access ◽  
The Public ◽  
Transfer Of Technology ◽  
The People ◽  
The Right ◽  
Government Initiative

In theory, patents work by providing the inventor an incentive to invent in the first place and then to disclose. Disclosure to the public is rewarded by giving the inventor a monopoly. As product patent and higher patent protection has been advocated by Art 27.1 of the TRIPs agreement on the basis that for greater innovation through transfer of technology is a necessity in developing countries like India as it provides capital to fund expensive innovations, who are otherwise not be able to fund expensive innovations on its own. On the other hand, at the same time drugs are also related with the health of the people and to take care of the health of the people is the utmost priority of any Government and there are issues like accessibility with regard to strong patent protection to biopharma products and data exclusivity. Also as per Art 7 of the TRIPs transfer of technology has to occur to the developing countries in order to promote technological innovations, which is conducive to social and economic welfare. Therefore, striking the right balance between incentive and public access creates a tension is essential. This study suggests optimal policy (Patent and other regulations) to have a balance between biopharma drugs innovation and their access in India while complying with the provisions of the TRIPs agreement by broadly categorising variables such as (1) patent policy such as the scope of biotech patents and the extent of the right in terms of breadth and length; and (2) regulatory environment such as the taxation incentive, Investment policy, Government initiative for the development of this sector etc.

scholarly journals On Protection of Intangible Cultural Heritage in China from the Intellectual Property Rights Perspective

2018 ◽  
Vol 10 (12) ◽  
pp. 4369 ◽  
Author(s):  
Qing Lin ◽  
Zheng Lian
Keyword(s):  
Intellectual Property ◽  
Cultural Heritage ◽  
Copyright Protection ◽  
Patent Protection ◽  
Intangible Cultural Heritage ◽  
The Third ◽  
Current State ◽  
The World ◽  
Protection Mode ◽  
Ipr Protection

With the development of globalization, intangible cultural heritage (ICH) has come under increasing threat, making the safeguarding of ICH a crucial task for the governments and peoples of the world. This paper examines China’s current state of intellectual property (IPR) protection for ICH and proposes that ICH be placed under China’s legislative protection as intellectual property. Due to the immense diversity and complexity of ICH and the difficulty in reconciling various interests involved, the existing IPR protection mode faces many obstacles in practice. We present two case studies and three sets of recommendations on improving the protection of ICH in China. The first set relies on improving copyright protection for ICH, the second set relies on improving trademark and geographical protection for ICH, and the third set relies on improving patent protection for ICH.

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.

scholarly journals The Tiger Awakens: The Tumultuous Transformation of India’s Patent System and the Rise of Indian Pharmaceutical Innovation

2007 ◽  
Vol 68 (3) ◽  
Author(s):  
Janice M. Mueller
Keyword(s):  
World Trade Organization ◽  
World Trade ◽  
Global Economy ◽  
Patent Protection ◽  
Turning Point ◽  
Pharmaceutical Products ◽  
High Quality ◽  
The World ◽  
History Of ◽  
Drug Manufacturing

The first day of January 2005 marked a dramatic turning point in the history of India. By deliberately excluding pharmaceutical products from patent protection for the previous 34 years, India became a world leader in high-quality generic drug manufacturing. But India’s entry into the global economy at the end of the 20th century, as evidenced by membership in the World Trade Organization (WTO), compelled the nation to once again award patents on drugs. Moreover, India henceforth would have to apply internationally-accepted criteria for granting patents, and the term of its patents would have to extend twenty years beyond filing.

Biotechnological Patents and Morality

2011 ◽  
pp. 141-151
Author(s):  
Jakkrit Kuanpoth
Keyword(s):  
Developing Countries ◽  
Intellectual Property ◽  
World Trade Organization ◽  
Intellectual Property Rights ◽  
World Trade ◽  
Patent Protection ◽  
Patent Law ◽  
Legal Analysis ◽  
The World ◽  
Micro Organisms

The chapter deals with ethical aspects of patent law and how the global patent regime helps or hinders the development of a developing country such as Thailand. More specifically, it discusses Article 27.3 of the World Trade Organization (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), which states that countries may exclude methods of medical treatment, plants and animals (but not micro-organisms) from patent protection. It also provides legal analysis on the issue of whether developing countries can maximize benefits from the TRIPS morality exception (Article 27.2) in dealing with biotechnological patenting.

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