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Create, Copy, DisruptIndia's Intellectual Property Dilemmas$
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Prashant Reddy T. and Sumathi Chandrashekaran

Print publication date: 2017

Print ISBN-13: 9780199470662

Published to Oxford Scholarship Online: March 2017

DOI: 10.1093/acprof:oso/9780199470662.001.0001

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PRINTED FROM OXFORD SCHOLARSHIP ONLINE (oxford.universitypressscholarship.com). (c) Copyright Oxford University Press, 2021. All Rights Reserved. An individual user may print out a PDF of a single chapter of a monograph in OSO for personal use. date: 01 March 2021

Novartis Trips Over Section 3(d)

Novartis Trips Over Section 3(d)

(p.84) 4 Novartis Trips Over Section 3(d)
Create, Copy, Disrupt

Prashant Reddy T.

Sumathi Chandrashekaran

Oxford University Press

One of the first high-profile patent cases after 2005 was the patent application filed by Novartis for the protection of Glivec, a sensational new drug which dramatically increased the survival rate of patients with a rare form of cancer called chronic myeloid leukaemia (CML). A patent application filed by Novartis for a certain salt form that was marketed as Glivec was rejected by the Indian patent office on the grounds that it was barred by Section 3(d). Not only did the rejection sparked a series of appeals by Novartis but it also led to Novartis challenging the constitutionality and TRIPS compatibility of Section 3(d) before the Madras High Court. Novartis lost both the cases. This chapter starts with the story of how Glivec was invented and explains the various legal issues raised by Novartis in its long battle to patent Glivec.

Keywords:   Glivec, Novartis, Section 3(d), Imatinib, chronic myeloid leukaemia (CML), patent infringement, pre-grant opposition, Intellectual Property Appellate Board (IPAB), Madras High Court, Supreme Court

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