The Legal Challenges Faced by the Pharmaceutical Industry Particularly in India: An Analysis of the Compulsory Licensing System and Section 3(D) of the Patents Amendment Act 2005

2012 ◽  
Author(s):  
Kamini Shan Shanmugaiah
Keyword(s):  
Pharmaceutical Industry ◽  
Compulsory Licensing ◽  
Legal Challenges

scholarly journals THE IMPACT OF TRIPS AGREEMENT ON ACCESS TO MEDICINES IN DEVELOPING COUNTRIES: LEGAL CHALLENGES FACED BY THE PHARMACEUTICAL INDUSTRY PARTICULARLY IN INDIA

2012 ◽  
Author(s):  
Kamini Shanmugaiah
Keyword(s):  
Public Health ◽  
Developing Countries ◽  
Intellectual Property ◽  
Pharmaceutical Industry ◽  
Intellectual Property Rights ◽  
Access To Medicines ◽  
Trips Agreement ◽  
Compulsory Licensing ◽  
Legal Challenges ◽  
The Impact

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

scholarly journals Determinants of Merger and Acquisition: An Indian Pharmaceutical Industry Perspective

2019 ◽  
Vol 8 (2S11) ◽  
pp. 3081-3088
Keyword(s):  
Pharmaceutical Industry ◽  
Mergers And Acquisitions ◽  
Competitive Advantage ◽  
Secondary Data ◽  
Merger And Acquisition ◽  
Company Performance ◽  
Compulsory Licensing ◽  
The Impact ◽  
Negative Factors ◽  
Indian Pharmaceutical Industry

Mergers and acquisitions (M&A) have gained prominence across the globe as a way of gaining competitive advantage and boosting the profit of the companies. The Indian pharmaceutical industry has readily embraced M&As in the recent times and has witnessed a number of profitable deals materialize, while some indeed failed. The success of M&As is contingent upon a variety of factors and eventually has a bearing on how the acquiring and target companies perform. This study intended to identify the various factors that either lead to or impede M&As and to measure their impact on company performance. The factors that motivate and discourage M&As were identified and the importance of factors such as deal size and compulsory licensing requirement in M&A success was assessed and the impact of the all these factors on the performance of the companies was assessed using both primary and secondary data. The encouraging and discouraging aspects of M&A were found to impact company performance significantly, so did the deal size and compulsory licensing requirement. The findings implied that the success of M&As depends on a variety of positive and negative factors and the participating companies need to balance these factors judiciously in order to obtain realistic profits from M&As

scholarly journals Compulsory licensing in pharmaceutical industry: current state of affairs and prospects

2021 ◽  
Author(s):  
TY Gaydin ◽  
SA Rozhnova
Keyword(s):  
Pharmaceutical Industry ◽  
Pharmaceutical Drugs ◽  
Ongoing Debate ◽  
Compulsory Licensing ◽  
Current State ◽  
Pharmaceutical Patent ◽  
Economic Balance ◽  
State Of Affairs ◽  
Political Economic

The problem of compulsory licensing (CL) in the pharmaceutical industry is being discussed worldwide. The aim of this paper was to analyze the effects of using CL for pharmaceutical drugs (PD) as part of competitive policies aimed at safeguarding the life and health of the population. Using PEST-analysis, we identify the main political, economic, social and technological problems associated with using CL in the pharmaceutical industry. We demonstrate the potential of CL as a tool for countering the threats to public health caused by the abuse of market dominance by pharmaceutical patent holders. At present, both developers of pharmaceutical innovations (patent-holders) and other entities involved in drug circulation are protected by law. There is ongoing debate about the efficacy of CL as a tool ensuring the implementation of competitive policies aimed at safeguarding the rights to life and health. However, in Russia CL is applied only under exceptional circumstances. An economic balance should be sought between the incentives for innovation, long-term profits from selling PDs and PD accessibility.

scholarly journals PELAKSANAAN COMPULSORY LICENSING PATEN OBAT-OBATAN BIDANG FARMASI DI INDONESIA DIKAITKAN DENGAN DOHA DECLARATION ON THE TRIPS AGREEMENT AND PUBLIC HEALTH

2017 ◽  
Author(s):  
Samariadi
Keyword(s):  
Public Health ◽  
Pharmaceutical Industry ◽  
Research Methods ◽  
Legal Research ◽  
Compulsory Licensing ◽  
Legal Reforms ◽  
Patent Medicines ◽  
The Government ◽  
Formulation Problem ◽  
Doha Declaration

Purpose of this study is firstly to find out implementation of compulsory licensing patent medicines in Indonesia’s pharmaceutical field linked Declaration DOHA, secondly to know resistance implementation of compulsory licensing to access drug in Indonesia, thirdly to know efforts should be done in implementation compulsory licensing as to support access public health. Author used legal research methods to get the result. Results of formulation problem, it can be concluded that, firstly implementation of compulsory licensing in Indonesia is still not maximized because only implement patent by the government alone, secondly obstacles in the implementation of covering obstacles in juridical aspect and non-juridical, thirdly attempts that should be done is to implement both compulsory licensing program which has been legalized by Indonesian patent legislation. Advice from author, firstly there should be legal reforms in Act Patent to enhance the article fully support access to public health, secondly their efforts to optimize pharmaceutical industry through appointment of other pharmaceutical industry to produce drugs Antiretroviral besides chemical pharma, thirdly government should enhance further technical provisions of compulsory licensing programs such as compulsory licenses, in order to assist the government to implement the mandate of the 1945 task in fulfilling rights of all people.

scholarly journals Opportunities for Parallel Import in China (Shanghai) Pilot Free Trade Zone: Evidence from the Automobile Industry and the Pharmaceutical Industry

2018 ◽  
Vol 14 (10) ◽  
pp. 344
Author(s):  
Maoguo Wu ◽  
Siyuan Yan
Keyword(s):  
Intellectual Property ◽  
Pharmaceutical Industry ◽  
Free Trade ◽  
Automobile Industry ◽  
Rapid Development ◽  
Free Trade Zone ◽  
Grey Zone ◽  
Compulsory Licensing ◽  
Parallel Import ◽  
Long Time

Parallel import, as a pattern of international trade, is often under criticism because of infringement of intellectual property. However, the establishment of China (Shanghai) Pilot Free Trade Zone has contributed to the rapid development of parallel import, which has existed in the “grey zone” in China for a long time. Generally speaking, parallel import not only minimizes damages to related intellectual property owners, but also maximizes flow of goods and promotes formation of a unified market, which is beneficial to free trade and economic integration as well as the welfare of consumers. This paper investigates two industries most affected by parallel import, namely the automobile industry and the pharmaceutical industry. Two cases, “Peugeot Unfair Competition” and “Compulsory Licensing of the Indian Pharmaceutical Industry”, are analyzed. This paper draws the conclusion that the general welfare of society must be considered and a clear boundary of intellectual property rights should be established in the development of trade policies on parallel import. Effective use of parallel import can ultimately promote social development.

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