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How do the jurisdictions of India, Canada and the United Kingdom interpret the inventive step requirement for follow-on pharmaceutical innovation? Rainforth, George

Abstract

This paper looks at the three jurisdictions of the United Kingdom, Canada and India to determine how each interpret the inventive step, for follow-on pharmaceutical innovation. An analysis of domestic statutes and case law, allows the stringency of approach to the inventive step in each jurisdiction to be determined on a comparative basis. The paper provides the comparison by utilising two differing benchmarks as a means to establish a lenient, versus a stringent perspective. The stringent perspective is established from UN recommendations whilst the lenient perspective is provided by a critical analysis of the recommendations by Christopher Holman et al. The first three chapters detail the approach taken by each jurisdiction respectively. This is achieved through extensive literature reviews and case law analysis. Through a comparison of a dosage patent, which was challenged before both the Federal Court of Appeal and the UK Supreme Court this paper reveals the similarity in approach between the UK and Canada’s inventive step inquiries. The comparative nature of this paper further establishes the stringency of application in India, through a step by step, comparative analysis of the inventive step inquiries. The potential consequences of the stringent approach in India and the comparatively lenient applications in Canada and the UK, are established through summaries of key debates in this area. This includes ethical debates such as the vital ‘innovation v accessibility balance’, the controversial ‘lifecycle management plans’ and Erooms law. In order for these key concerns to be adequately accounted for, unnecessarily strict standards for the inventive should not be applied. It is established that an emphasis on flexibility in approach to the inventive step inquiry, as is beginning to emerge in the United Kingdom, is an appropriate first step towards an inventive step inquiry which is capable of accounting for these crucial concerns.

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