Product Patent in Pharmaceuticals and Compulsory Licensing

Author(s):  
Jatinder Maan ◽  
Dinesh Kumar

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.

2019 ◽  
pp. 135-147
Author(s):  
Jatinder Maan ◽  
Dinesh Kumar

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.


2020 ◽  
Vol 9 (2) ◽  
Author(s):  
Junaid Subhan

The World Trade Organization's (WTO's) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) of 1994 seeks to implement a uniform set of intellectual property protection across member nations to provide greater stability in international economic relations. Critics argue that the TRIPS agreement provides unnecessarily strong protection of intellectual property rights which serves to prevent the ill in developing nations from having access to affordable essential medications. The first recommendation that this paper makes is to provide two sets of intellectual property protection, one that applies to essential medications such as AIDS drugs and certain antibiotics and another that applies to drugs that treat non-life threatening conditions. The second recommendation builds upon the first recommendation: if two sets of intellectual property protection legislation are enacted, patents on essential medications should be restricted to patents on processes rather than the product itself. The third recommendation seeks to amend the language of the TRIPS agreement to make it obligatory for member nations to implement provisions on compulsory licensing within their domestic legislation.


2009 ◽  
Vol 37 (2) ◽  
pp. 222-239 ◽  
Author(s):  
Kristina M. Lybecker ◽  
Elisabeth Fowler

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.


2020 ◽  
Vol 28 (1) ◽  
pp. 197-225
Author(s):  
Rahamatthunnisa Mohamed Nizamuddin

This study analyses the provisions of the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement with respect to the various intellectual property protection mechanisms. The main purpose of this study is to demonstrate that Malaysia is a TRIPS compliance country and have established intellectual property laws including the incorporation of data exclusivity laws. This study also illustrates that data exclusivity and patent are two different intellectual property protection mechanisms required under the TRIPS Agreement. Moreover, this study clarifies the misconception that data exclusivity and patents are somehow related; such that data exclusivity is an extension of patent rights and that it is often regarded as a TRIPS-plus provision. The study is conducted based on qualitative research, predicated on primary sources such as the TRIPS Agreement and the various laws with respect to intellectual property in Malaysia. It is further supported by secondary sources from journals and information provided on relevant authorities’ websites. The results of the study show that Malaysia is a TRIPS compliance country and that data exclusivity is an intellectual property protection mechanism that is established pursuant to Article 39.3 of the TRIPS Agreement. Hence, this study concludes that member countries of the TRIPS Agreement that have established data exclusivity protection mechanism to protect undisclosed data submitted to their respective authorities for the purpose of marketing approval of pharmaceutical or agricultural chemical products, including Malaysia, are indeed in compliance with the obligation set under Article 39.3 of the TRIPS Agreement.


Author(s):  
Sandeep K. Rathod

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.


Author(s):  
Correa Carlos Maria

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.


Author(s):  
Kamini Shanmugaiah

The impact of intellectual property rights in particular patent relating to public health has posed numerous challenges faced by developing countries who are members of World Trade Organisation (WTO). This paper examines the impact of TRIPS Agreement (Trade Related Intellectual Property Rights) in relation to developing countries in general with specification made to India. Significant changes brought about by the TRIPS flexibilities in particular usage of compulsory licensing and Bolar provision have to a certain extent benefited the developing countries in the field of public health during national emergency. The TRIPS flexibilities by way of amendment have helped countries that (do not possess manufacturing capacities) to import medicines. Some developing countries even utilised TRIPS flexibilities in an aggressive manner to enforce their right to have access to medicines from other countries for the benefit of their citizens. Further, TRIPs flexibilities have helped developing countries to manufacture generic products to make it affordable to the people. This paper specifically examines the impact of the TRIPS Agreement on Indian generic pharmaceutical industry and the legal challenges faced by Indian pharmaceutical industry after the implementation of product patent regime effective from 1 January 2005. The Patent Amendment Act 2005(India) will be looked into especially on the controversy in respect of Section 3(d) of the Patent Amendment Act 2005(India) on the requirement of patentability. The new Section 92A of the Patent Amendment Act 2005(India) on the grounds to invoke compulsory licensing will be analysed to see whether Indian government has applied restrictive or broad approach, as compulsory licensing is certainly an important legal


1969 ◽  
Vol 15 (4) ◽  
Author(s):  
Yali Friedman

The intellectual property protection differences between countries is a contentious issue. Countries with strong innovation systems (technology producers) often favor strong intellectual property protection because it motivates innovation by granting innovators temporary market exclusivity for their new, nonobvious and useful inventions; countries with less-developed innovation systems (technology consumers) often prefer weaker patent protection, as it enables them to access inventions developed elsewhere without having to pay licensing or manufacturing fees that may be beyond their capacity (or desire) to pay. Although the World Trade Organization's TRIPS agreement does provide governments the right to use patented technologies without authorization, this compulsory licensing is limited to cases of ‘national emergency or other circumstances of extreme urgency’. Furthermore, there is often disagreement on what constitutes a national emergency or circumstance of extreme urgency. The central question underlying TRIPS claims or unauthorized use of patents is that of their greater impact on a country's industry and economy.A common rationale for unlicensed patent use is that improving their citizen's health is a national priority, so governments ought to produce high-value drugs domestically, without license if necessary, to serve their national interests. Price controls can be seen as a less-extreme version of unlicensed use as, instead of denying innovators profits from domestic sales, price controls give governments greater power in dictating terms. The downside of these strategies, however, is that they can deprive countries of patented technologies; several years ago AstraZeneca responded to pressures from the New Zealand government to lower prices for Zoladex by announcing that they would simply stop selling the drug in that market. Domestic industries can also be affected; Novartis recently bypassed the appeals courts in India and responded to the Indian patent office's decision not to grant its patent for Glivec (sold as Gleevec in the United States) by announcing that it would redirect hundreds of millions of dollars of R&D investments to other countries.India and New Zealand are not alone. There are plenty of other examples of drug companies threatening to withdraw drugs or R&D investments from other developed and developing countries. The common theme in these battles is that these decisions can have broader impacts than the individual products or patents involved. While licensing decisions are often based on individual drugs or individual diseases, they can signal to companies that a given country represents a poor market and can discourage a company from domestic R&D investments or developing of drugs for endemic conditions. The result is that near-term benefits are exchanged for long-term deficits.Although simple logic suggests that all countries – developing and developed – should offer the strongest intellectual property protection possible, that solution is rarely practical for economic reasons, and it deprives government-backed health-care systems a valuable bargaining tool. So, the battle between countries and drug manufacturers will likely continue, using patents, price controls, R&D investment and other levers. What is of particular interest is how the dynamics change as countries transition from being technology consumers to technology producers (or, possibly, the reverse). As countries that were once broad technology consumers develop technology-innovation capacity and find it increasingly favorable to strengthen their patent laws, how can they strengthen these laws while protecting legacy companies and their domestic interests in areas in which they are still net technology consumers? Additionally, as low wage-cost countries face competition from each other, how can they motivate foreign investment in a way that promotes the growth of domestic companies? Furthermore, how much leverage can countries with large markets wield?


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