SATYANARAYANA, Kanikaram

Abstract: This chapter describes the current status of IP (intellectual property) management in the areas of health and agriculture in India with a focus on post-2005, at which time India became fully complaint with the Agreement on TRIPS (Trade-Related Aspects of Intellectual Property Rights). The major policy trends existing in India include (1) public sector expenditure for R&D is on the rise and is currently about US$5.0 billion (one US$ equals about 4 Rs); (2) pharma industry R&D expenditures were on the rise and had reached Rs 15.0 billion, or close to 4.0% of their turnover; (3) several major policy initiatives had been undertaken by the government, including the National Health Policy (2002), National Policy on Indian Systems of Medicine and Homeopathy (2002), and National Biotechnology Policy (2005). Other major initiatives to promote IP generation include the creation of a Central Drug Administration, a new national body for the registration of medical devices, a National Registry for Clinical Trials, and a law similar to the Bayh-Dole Act that provides for the sharing of IP with inventors. The Departments of Science and Technology and Biotechnology, the Council of Scientific & Industrial Research, the Indian Council of Medical Research, the Indian Council of Agricultural Research, and so forth, have initiated large R&D programs in the health sector for the generation of new diagnostics, vaccines, and drugs largely focused on current health problems of India. A few indigenous products are being tested for safety and efficacy before use in the public health system. A new thrust and focus are being given for public–private partnerships involving both national and international partners. In agriculture, besides a substantial allocation of funds for R&D, two new initiatives—the National Agricultural Innovation Project (NAIP) and the Indo-U.S. Agricultural Knowledge Initiative (AKI) were started in 2005. The NAIP is a World Bank-supported project worth approximately Rs 11.7 billion that is expected to strengthen basic and strategic research in agriculture in India. The AKI is expected to address a large number of issues including education, research services, and commercial linkages in agriculture.

Abstract: This chapter provides an overview of the current and potential impact of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) on low- and middle-income countries. The chapter also summarizes the findings of a meeting in New Delhi, India and explores the legitimacy of concerns about TRIPS. Access to health products relies on many factors, including the successful innovation of new technologies. Innovation, in turn, is a complex process, involving many factors (intellectual property [IP] is just one) that influences product availability and price.

Pointing to the growth of global and national public–private product-development partnerships (PDPs), the chapter highlights one way these countries are seizing opportunities—and reveals how important effective IP management has become for them. Focused on high-priority diseases such as AIDS, malaria, and TB, PDPs require the development and implementation of sophisticated IP management policies and practices in both developed and developing countries in which PDPs operate. Finally, the chapter discusses the possible role of compulsory licensing and parallel trade. The value of these flexible options, provided by TRIPS, is yet undocumented and successfully implementing them represents a significant challenge. Crucially, countries have considerable freedom to control the effects of TRIPS on the availability of new health technologies. The countries can do this most effectively by building capacity for IP management and by formulating policies and practices, for courts, patent offices, and other institutions, that favor the poor.

Abstract: In the past, it was possible for some countries to ignore IP (intellectual property) management while pursuing economic development and improved public health. Globalization, however, has brought the world closer and closer together, and with the advent of the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS), no country can afford to be isolated from the global IP system. This chapter explains how developing countries can use this new system to their advantage through in-licensing technologies (that is, bringing technology into the public sector through patent license agreements). Offering an overview of the usual requirements of a license agreement, the chapter also considers issues that are uniquely relevant to public-sector institutions in developing countries as they negotiate such licenses.