Open innovation for new drug research in Indian pharmaceutical sector

The national environment in India for the pharmaceutical sector recently underwent changes with The Patents (Amendment)Act 2005, to comply with the TRIPS agreement leading to product patent protection.This has led to Government initiatives to support R&D and promote interlinkages between industry and academia. Globally, innovation ecosystem in recent years has morphed and seen a paradigm shift from a closed innovation in-house R&D model to more open approaches. In this context, the study aspires to gain an understanding of how the institutional and regulatory factors influence adoption of open innovation strategies at firm level and enables formation of innovation networks between universities, public research labs and firms in India

Open innovation networks in Indian pharmaceutical sector

The Indian pharmaceutical sector grew spectacularly in a process patent regime, which enabled to entrench itself in the global market with generics and cost effective manufacturing processes. The legislative environment in India for the pharmaceutical sector underwent changes in 2005 leading to product patent protection. The sector was ready to embark on a smooth journey to path breaking innovation, equipped with enhanced process capabilities as well as expertise gained in modular aspects of drug innovation. Is innovation taking place in a manner as would have been expected? The aim of this paper is to understand how the changes in patent regime have influenced the scientific innovation networks, through the lens of national innovation system and open innovation. This study examines an important and unexplored facet of open innovation and the findings may have important implications for organizations to further their innovation agenda

Open innovation in new drug research : the Indian perspective

This article sketches open innovation strategies pursued by eight Indian pharmaceutical firms and provides an account of strategic flexibility charted by firms in the wake of changes in the legislative environment. The findings examined through the lens of open innovation and dynamic capabilities identifies ‘technological competencies’ and ‘funding’ as two very important reasons, which push the traditionally closed R&D firms to pursue open innovation. Within the dynamic capabilities framework, the findings suggest that resources and competencies play a vital role in enabling open innovation in the complex new drug research setting

Open innovation in new drug research, the case of the Indian pharmaceutical sector

The legislative environment in India underwent changes in 2005 leading to product patentprotection for pharmaceuticals. Equipped with superior process capabilities acquired forgeneric manufacturing, the pharmaceutical sector embarked on a journey to undertake radicalinnovation. The aim of the research is to explore how changes in the national environmentand asset profile of firms have influenced openness for research of novel drugs. The reviewof literature, synthesis of conceptual framework and data analysis is shaped by the theoreticalapproaches of national innovation systems (NIS), dynamic capabilities and open innovation.The theoretical lens of national innovation systems enables our understanding of what shapesinnovation behaviour of a firm, open innovation approach provides a description of howfirms adopt open innovation and dynamic capabilities concept supports the interpretation ofwhy firms differ in opening up their boundaries. The answers are examined through ninecases of established and start-up pharmaceutical firms in India.New drug research is challenging and requires collaborative effort predominantly at the drugdiscovery stage. However, in the Indian setting, research networks are minimal and there islittle cohesion within the ecosystem among firms, research institutes and universities. Firmsare opening up their R&D innovation process to foreign partners through open innovationstrategies; in-licensing, out-licensing and collaborative innovation that vary by stage of drugresearch. The open innovation pathways adopted by firms are influenced by four 4Rs -resource supplementation and risk mitigation that initiate open innovation, retention ofcontrol and revenue maximization that impel closed innovation. The insights into the strategictrends of these firms unveil an open innovation framework that is relevant to the openinnovation theory and praxis.The legislative environment in India underwent changes in 2005 leading to product patentprotection for pharmaceuticals. Equipped with superior process capabilities acquired forgeneric manufacturing, the pharmaceutical sector embarked on a journey to undertake radicalinnovation. The aim of the research is to explore how changes in the national environmentand asset profile of firms have influenced openness for research of novel drugs. The reviewof literature, synthesis of conceptual framework and data analysis is shaped by the theoreticalapproaches of national innovation systems (NIS), dynamic capabilities and open innovation.The theoretical lens of national innovation systems enables our understanding of what shapesinnovation behaviour of a firm, open innovation approach provides a description of howfirms adopt open innovation and dynamic capabilities concept supports the interpretation ofwhy firms differ in opening up their boundaries. The answers are examined through ninecases of established and start-up pharmaceutical firms in India.New drug research is challenging and requires collaborative effort predominantly at the drugdiscovery stage. However, in the Indian setting, research networks are minimal and there islittle cohesion within the ecosystem among firms, research institutes and universities. Firmsare opening up their R&D innovation process to foreign partners through open innovationstrategies; in-licensing, out-licensing and collaborative innovation that vary by stage of drugresearch. The open innovation pathways adopted by firms are influenced by four 4Rs -resource supplementation and risk mitigation that initiate open innovation, retention ofcontrol and revenue maximization that impel closed innovation. The insights into the strategictrends of these firms unveil an open innovation framework that is relevant to the openinnovation theory and praxis

Dynamics of appropriability regime and open innovation in the Indian pharmaceutical sector : an exploratory analysis

Appropriability regime in India has undergone a major change in 2005 legalizing product patent protection. Using empirical data from 50 semi-structured interviews with key players in the Indian pharmaceutical sector, we show that a strong appropriability regime favors outbound innovation but restrains inbound innovation in pharmaceutical innovation. We find three appropriability related issues which act as barriers to inbound open innovation - a) preference by public institution researchers to disseminate research results through publications b) poor infrastructure support and c) patent ownership issues. We find that low patenting trends in public institutions inhibits researchers to engage with firms for research collaborations and gives rise to paradox of disclosure. In contrast, the proclivity of firms to appropriate and enhance commercial potential for outbound innovation rather than engage in inbound sourcing of knowledge, for secrecy purposes, leads to paradox of openness. These two paradoxes inhibit open innovation between science and the industry

Patenting and the dynamics of innovation : the role of appropriability regime in pharmaceutical R&D

The appropriability regime in India changed with the implementation of Trade Related Intellectual Property Rights agreement and the ensuing Patent Amendments Act 2005, leading to product patent regime. When faced with a change from process patent regime to product patent regime in 2005, local firms could either continue with the generics business for patenting expired drugs or engage in research and development of incremental product innovations of existing drugs or new drug research. We analyze patent data and information from published sources for cases of five established and four startup Indian pharmaceutical firms to understand the influence of the change in the appropriability regime on the research and innovative activities of the firms. Our results show that firms have shown technological progression during both appropriability regimes and there is stepwise increment in nature of innovation. Furthermore, in the new appropriability regime, firms tend to file international applications for their high value inventions with greater commercial or out-licensing potential. We conclude that new appropriability regime offers distinct commercial opportunities and influences the research and development activities and propensity of firm to innovate

Navigating the open innovation paradox : an integrative framework for adopting open innovation in pharmaceutical R&D in developing countries

In this paper, we combine evidence from eight Indian pharmaceutical firms with extant literature and global best practices to conceptualize an integrative framework addressing the open innovation paradox (OIP), i.e., the tension between intellectual protection and openness. Firms in developing countries face additional challenges in the adoption of open innovation, such as the prevalence of open science norms, weak technology transfer systems, and mistrust between universities and industry; therefore, they employ open innovation selectively for pharmaceutical research. Prior research has examined the strategies to resolve OIP in the context of developed countries; the integrative framework proposed in this paper describes strategies for resolving the OIP in the context of developing countries. This framework illuminates the coping processes of the case firms and provides guidelines to uplift and accelerate the adoption of open innovation strategies in developing countries' pharmaceutical sectors, and thus provides value to both theory and praxis