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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.

Patents are not granted uniformly across nations as the standards for patentability varies across nations. This chapter analyses standards of patentability, specifically nonobviousness and the enhancement of efficacy, for pharmaceutical patents. The new definition of nonobviousness laid down by the Patents Act has serious ramifications in terms of raising the bar on inventions that can be patented. A further significance of the new definition is that it places the burden of disclosure squarely on the patent applicant. This chapter then examines the threshold requirement of enhancement of efficacy. The provision itself has been introduced to curb any initiative to patent bioequivalents. The judicial determination of the meaning of the term ‘efficacy’ and the legislative intent behind the provision are explained herein.

Indian reforms to patent law have drawn polarized reactions, however, the reforms have been in the making since India gained Independence and can hardly be classified entirely as a response to the TRIPS Agreement. Indeed, the Indian model shows that there can be an alternative to patent systems propounded by developed nations that favour the public and adhere to socio-democratic principles. This chapter highlights the transition of the patent model in India and describes the rationale for its current patent system. Further, this chapter examines the amendments brought forth to comply with the TRIPS and the amendments meant to ameliorate such compliances. The provisions of the Patent Act that were amended following the TRIPS and the manner in which they affect the Indian public are examined.

The signing of the World Trade Organisation (WTO) Agreement at Marrakesh in 1994 marked the beginning of a new international IP regime. As per Article 27 of the Agreement on Trade-Related Intellectual Property Rights (TRIPS), no member could discriminate among different technologies under their domestic patent law. India was, therefore, under an obligation to amend its domestic patent law to once again recognize pharmaceutical patents. After an initial failure to amend its domestic law, India was sued by the US and EU before the Dispute Settlement Body (DSB) of the WTO. Under the threat of WTO-authorised trade sanctions, India began the process of amending its patent law over three phases. This chapter explains the stormy decade between the signing of the Marrakesh Agreement and the enactment of the Patent (Amendment) Act, 2005 which finally recognized pharmaceutical patents with the caveat of Section 3(d).