Compulsory licences on pharmaceutical patents in India: A short article

2017 ◽  
Vol 13 (3) ◽  
pp. 108-113 ◽  
Author(s):  
Sandeep K. Rathod
Keyword(s):  
Compulsory License ◽  
Developed Countries ◽  
Pharmaceutical Products ◽  
Historical Background ◽  
Short Article ◽  
Pharmaceutical Patents ◽  
Compulsory Licensing ◽  
Compulsory Licence ◽  
License Application ◽  
Media Reports

Over the last few years, multiple media reports have commented on compulsory licensing of pharmaceutical patents in India. A majority of these reports painted a doomsday scenario and were devoid of facts. The grant of India’s sole compulsory licence in March 2012 (to Natco for Bayer’s patented drug – Sorafenib) spawned a series of media reports theorising that the grant of this compulsory license was ‘… a major blow to global pharmaceutical firms’ and speculating a beginning of compulsory licensing era for pharmaceuticals patents. However, this simply has happened and India till date has rejected all subsequent compulsory licence applications filed after the Natco/Sorafenib compulsory license application. The purpose of the present article is to collate the present information around the various compulsory licences in India and provide some historical background at a time when even developed countries are beginning to issue compulsory licences for pharmaceutical products.

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.

scholarly journals The TRIPS Article 31 Tug of War Developing Country Compulsory Licensing of Pharmaceutical Patents and Developed Country Retaliation

2018 ◽  
Author(s):  
Lucas Volman
Keyword(s):  
Developing Countries ◽  
International Law ◽  
Free Trade Agreements ◽  
Developed Countries ◽  
Access To Medicines ◽  
Developed Country ◽  
Pharmaceutical Patents ◽  
Compulsory Licensing ◽  
The Right ◽  
Restrictive Measures

My dissertation examines compulsory licensing under Article 31 of the TRIPS Agreement by looking at the use of such licensing by developing countries, as well as retaliatory and restrictive measures imposed by developed countries. In doing so, it looks at the right to health, and price and intellectual property considerations for access to medicines in developing countries. It further explores the TRIPS compulsory licensing rules themselves to present compulsory licensing as a legitimate, and at times necessary, policy measure under international law. Then, it examines how compulsory licensing has been used and restricted since TRIPS, and how the compulsory licence relates to voluntary licensing and international free trade agreements, both of which are factors for the development of compulsory licensing strategies in developing countries.

Recent Developments in Compulsory Licensing of Pharmaceutical Patents in India

2016 ◽  
Vol 22 (2) ◽  
Author(s):  
Viren Konde
Keyword(s):  
Pharmaceutical Products ◽  
Economic Consequences ◽  
Business Strategies ◽  
Compulsory Licensing ◽  
Compulsory Licence ◽  
Doing Business ◽  
Controller General ◽  
Recent Developments ◽  
Domestic Companies ◽  
Licensing Laws

On March 9, 2012, under Section 84(1) of the Indian Patents Act, Controller General of Patents granted country’s first and only compulsory licence to Natco Pharma to sell Bayer AG’s patented oncology drug Nexavar (Sorafenib Tosylate). Since then, India has not issued any other compulsory licence even though two more such applications have been received. India has also implemented a special compulsory licence regime under Section 92A(1), for the manufacture and export of patented pharmaceutical products to any country having insufficient or no manufacturing capacity to address public health needs. In view of the recent developments, and given the economic consequences of compulsory licensing, it has become important for multinational pharmaceutical companies procuring patents and doing business in India to understand the country’s compulsory licensing laws and reevaluate their business strategies, while domestic companies pursue alternate options to access patented lifesaving medicines within the legal system.

Product Patent in Pharmaceuticals and Compulsory Licensing

2019 ◽  
pp. 135-147
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.

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

scholarly journals THE LEGAL IMPLICATION OF COMPULSORY LICENCE PHARMACEUTICAL PRODUCTS IN THE TRIPs AGREEMENT TO THE PROTECTION OF THE RIGHT TO HEALTH IN DEVELOPING COUNTRIES

2018 ◽  
Vol 18 (1) ◽  
pp. 1
Author(s):  
Sri Wartini
Keyword(s):  
Developing Countries ◽  
Compulsory License ◽  
Right To Health ◽  
Pharmaceutical Products ◽  
Pharmaceutical Product ◽  
Trips Agreement ◽  
Human Right ◽  
Compulsory Licence ◽  
The Right ◽  
Legal Implication

Compulsory license of pharmaceutical products in the Trade Related Aspects of Intellectual Property Rights (TRIPs) Agreement attempts to balance the interest of patent holders and The right to health. The access of medicines in developing countries for the epidemic diseases, such as, HIV/AIDS  medicine is crucial to  protect The right to health. The objective of the research is to analyze comprehensively the legal implication  of compulsory license for the pharmaceutical product to the protection of The right to health in developing countries. It is  a normative juridical research by applying conceptual and  comparative approaches. The results of the research  shows that: first, the implementation of compulsory licence is in accordance with the international human right law: second, the legal implication of the compulsory license  causes the adoption of policy and regulations regarding the protection of the right to health in developing countries, such as Indonesia, Malaysia, Brazil, India and  South Africa.  Keywords : Compulsory license, pharmaceutical products, legal implication and The right to health

Experiences in Water Resources Management in Developed Regions

1987 ◽  
Vol 19 (9) ◽  
pp. 217-223
Author(s):  
Leo Weaver ◽  
Peter A. Tennant
Keyword(s):  
Water Resources ◽  
Water Resources Management ◽  
Engineering Application ◽  
Resource Planning ◽  
Developed Countries ◽  
Historical Background ◽  
Science And Engineering ◽  
Resources Management ◽  
Quality Of Water ◽  
The Right

The science and engineering of water resources in developed countries has undergone profound changes in less than a professional lifetime. This has radically influenced education and research and essentially revolutionized water resource planning. Fundamental uses of water to fulfill society's needs continue. These include domestic and industrial supplies, waterways for transport, fire protection, waste carriage, recreation, irrigation, and in general, an adequate quantity and quality of water in the right place at the right time to fulfill human and aquatic needs. The complexities of water resources no longer may be measured largely in terms of science and engineering challenges alone, but must include economics sensitive to the political and social sciences. What has evolved is what is now best described as water management. This paper reviews the evolvement of water resources management in developed counties in terms of historical background, and national policies and institutions, particularly as this evolvement impacts scientific research and engineering application.

EXPERTS MEET, DRAW UP MODEL LIST OF ESSENTIAL DRUGS

PEDIATRICS ◽  
1978 ◽  
Vol 62 (2) ◽  
pp. 165-165
Keyword(s):  
Health Care ◽  
Communicable Disease ◽  
Developed Countries ◽  
Pharmaceutical Products ◽  
Expert Committee ◽  
Least Developed Countries ◽  
Communicable Disease Control ◽  
Essential Drugs ◽  
Preliminary Model ◽  
Selection Of

In the light of present scientific knowledge, approximately 200 drugs are indispensable for the health care of the vast majority of the world's population. This was the conclusion of the WHO Expert Committee on the Selection of Essential Drugs, which met in Geneva from 17 to 22 October. The committee's full report will be submitted, together with other Expert Committee reports, to the Executive Board of WHO during its 11-27 January 1978 session. In its deliberations the Committee benefited from the worldwide response to a preliminary model list issued after a consultation held in Geneva in October 1976. Comments and suggestions were received from the six regional offices of WHO, more than 100 experts from over 40 countries, and nongovernmental organizations in official relations with WHO. The Committee drew attention to the fact that drug costs account for up to 40% of the total health budget in some developing countries. In affluent nations as well, governments appear to be increasingly worried by the rising expenditure for pharmaceutical products. In the least developed countries, where communicable disease control and elementary health care are the major concerns, large segments of the population are in urgent need of essential drugs and vaccines. For their limited financial resources to be put to optimal use, the drugs available must be restricted to those proven to be therapeutically effective, to have acceptable safety, and to satisfy the health needs of the population.

Role of the national regulatory authority for vaccines

2017 ◽  
Vol 22 (3) ◽  
pp. 128-137 ◽  
Author(s):  
Norman W. Baylor
Keyword(s):  
Regulatory Authority ◽  
Developed Countries ◽  
Pharmaceutical Products ◽  
World Health ◽  
Expert Committee ◽  
Content Type ◽  
Mortality And Morbidity ◽  
Expert Review ◽  
Regulatory Authorities ◽  
National Regulatory Authority

Purpose Before vaccines are marketed and used, they must be evaluated and approved by a national regulatory authority (NRA). The Food and Drug Administration (FDA) is the NRA in the USA responsible for overseeing and regulating the manufacturing, marketing, and distribution of vaccines. The paper aims to discuss this issue. Design/methodology/approach Expert review. Findings Developed countries have established governmental regulatory agencies to review and determine the safety and effectiveness of vaccines to ensure that the manufacture, sale, and use of vaccines are adequately regulated. However, even today, many developing countries do not have established NRAs. Furthermore, despite similarities, there are still substantial differences in how regulatory authorities in different countries perform minimum functions required for effective regulation of pharmaceutical products, including vaccines. The World Health Organization (WHO), although not a governmental NRA, uses a consultative approach involving its Expert Committee on Biological Standardization and Biologicals Unit to develop regulatory criteria and identify and consolidate current consensus opinions on key regulatory issues. It is through this approach that WHO informs NRAs on the necessary scientific background required to assess and advise on optimal regulatory approaches and methodologies. This paper will focus on the evolution of the US FDA and its role in regulation of vaccines to illustrate the function of a vaccine NRA. Originality/value Vaccines are an important resource for protecting people and communities from the mortality and morbidity associated with many infectious diseases. The assessment, licensure, control and surveillance of vaccines are the responsibilities of government regulatory authorities.

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