PATENT ANALYSIS IN INDIA (original) (raw)
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Technological Forecasting & Social Change, 2012
Recent patent-law changes in India's pharmaceutical industry provide opportunities to study changes of institutional and regulatory environments on innovation and social welfare in low-income markets. From 1972 to 2004 under its process-patent regime, India's pharmaceutical industry grew to become the world's fourth largest. Indian companies were becoming globally competitive in generics and clinical testing, and moving into product R&D. Researchers have debated the effects of India's new product-patent laws' effects on these trends. The authors cover the domestic characteristics and global competitiveness of India's pharmaceutical industry. They contrast data (from 2001 to 2004) on patents in India's process-patent regime with preliminary data (from 2005 to 2008) on patents in the country's new product-patent regime. They argue that Indian pharmaceutical companies have changed their decision-making in response to changed patent laws by moving from process to product research. However, the preliminary results indicate that these changes may have hurt domestic innovation. They conclude with strategic implications for the Indian pharmaceutical industry and highlight the need for research and public policy to establish optimal social returns from product-patent regimes.
The effects of patent-law changes on innovation: The case of India's pharmaceutical industry
Technological Forecasting and Social Change, 2012
Recent patent-law changes in India's pharmaceutical industry provide opportunities to study changes of institutional and regulatory environments on innovation and social welfare in lowincome markets. From 1972 to 2004 under its process-patent regime, India's pharmaceutical industry grew to become the world's fourth largest. Indian companies were becoming globally competitive in generics and clinical testing, and moving into product R&D. Researchers have debated the effects of India's new product-patent laws' effects on these trends. The authors cover the domestic characteristics and global competitiveness of India's pharmaceutical industry. They contrast data (from 2001 to 2004) on patents in India's process-patent regime with preliminary data (from 2005 to 2008) on patents in the country's new product-patent regime. They argue that Indian pharmaceutical companies have changed their decision-making in response to changed patent laws by moving from process to product research. However, the preliminary results indicate that these changes may have hurt domestic innovation. They conclude with strategic implications for the Indian pharmaceutical industry and highlight the need for research and public policy to establish optimal social returns from product-patent regimes.
ARCIALA Series on Intellectual Assets and Law in Asia, 2019
Article 21 of the Indian Constitution guarantees every person and citizen of India the right to life and the right to personal liberty. Further, Article 47 of the Indian Constitution declares that it is the duty and obligation of the Indian state to improve public health. In addition, Article 12 of the International Covenant on Economic, Social and Cultural Rights (ICESCR) adopted by India asserts that nations have an obligation to facilitate the right to health. Thus, the Indian government operates under the premise that medicines critical to the important healthcare needs of India's population must be both available and affordable. Indeed, this paradigm is the foundational basis for India's vision for the right to health under the Article 21 of the Indian Constitution. Thus, the Indian policy makers strive to meet India's constitutional obligations for the right to health while promoting its innovation ecosystem and safeguarding the legitimate business interests of MNCs. Indeed, this powerful undercurrent has been shaping the evolution of the Indian patent regime since India's independence in 1947, through the 1970s, the economic liberalization era initiated in the 1990s, through the membership of WTO and TRIPs Agreement in 1995, post-TRIPS in 2005 and all the way up to today. In this context, this chapter analyzes how the Indian patent regime has been leveraging the flexibilities afforded under the TRIPS Agreement for the prevention of evergreening, award of compulsory licenses, retention of pre-grant opposition, and introduction of post-grant opposition and discusses how these dynamic changes are having a global impact.
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Utilizing both qualitative and quantitative analyses, this article intended to analyze (1) whether a special article inserted in the Indian Patent Law 2005 had a role in reducing the negative impact on the Indian Pharmaceutical Industry from the introduction of product patents based on analysis of a variety of data and on-site interviews with stake holders, and (2) whether change of the business model of the Indian pharmaceutical industry helped the industry to continue to develop through 2005 by avoiding negative impact from the introduction of product patents. It is believed that this study may be valuable when considering such developing countries as they plan to set up a patent system that would be suitable to the situation of each country.
Information & Communications Technology Law, 2014
India's TRIPS compliant Patent (Amendment) Act 2005 saw the transformation of its laws from a process patent regime to a product patent regime. The amendments have had a direct impact on India's generic drugs manufacturing sector, which was developed through the process patent regime introduced under the 1970 Act. The knock-on effect will soon be felt both domestically and globally, as a number of developing countries have come to rely strongly on Indian generics. This article seeks to study the effectiveness of the Act of 2005, and if it can be seen as an instance of success of the TRIPS provisions in Articles 7 and 8 read along with the Doha Declaration. It will be queried if developing countries in the WTO can possibly benefit from the model set-up by India for the issuance of compulsory licenses, and to check the practice of 'evergreening' by pharmaceutical patent holders. Recent decisions from the Indian judiciary and the quasi-judicial authorities, along with the procedures and policies put in place will be used to carry out the study.
The Indian Pharmaceutical Patent Regime: Protection of Innovation Vis-À-Vis Access to Medicines
The Indian pharmaceutical industry is a prime example of an industry that is being forced to revisit its long-term strategies and business models as India opens its markets to global trade. Factors such as protection of intellectual property are increasing in significance due to the growing recognition of the need to ensure protection of valuable investments in research and development (R&D). Efforts are being made to curb problems of weak enforceability of existing intellectual property legislations, and the Indian government is moving towards establishing a patent regime that is conducive to technological advances and is in keeping with its global commitments including the Trade-Related Aspects of Intellectual Property Rights (TRIPS). Patents on medicines have been one of the most hotly-debated topics since the adoption of the TRIPS Agreement because patents grant exclusivity for the duration of the patent term and result in patent holders having control over the production, suppl...