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'We can offer better drug access to developing countries'

Demonstration in South Africa against drug companies preventing cheap access to HIV drugs.

DG Shah, secretary general of the Indian Pharmaceutical Alliance, has taken up the cudgels on behalf of domestic generic companies. He tells TOI-Crest that if the government wins the battle Indian pharmas can be at a commercial advantage

What is your take on the case of Novartis versus the government on Glivec?

Ego seems to have overcome reasoning in this case. All countries, including the Swiss Government, have conceded India's right to determine patentability criteria. Yet Novartis is arguing that it has been granted patents in 35 countries and refuses to recognize the unique feature of Indian patents law.

The argument used against Novartis is that the company is 'evergreening' the patent, and it's a case of patent extension, and not a new drug. Your comments.

The intent of the Section 3(d) and purpose of late stage insertion of Explanation to Section 3(d) are well documented in legislative history. The Parliament was conscious of the undesirable effects of allowing patents for minor modifications without any significant benefits. This is unambiguously defined by the Madras High Court as 'therapeutic efficacy'. The Parliament took this position only to protect the public health and ensure access to medicines at affordable prices. It did not do so to safeguard the domestic industry. The Indian patent law has incorporated several flexibilities that are consistent with the Agreement on Trade Related Intellectual Property Rights (TRIPS). These include pre- and post-grant opposition, compulsory licensing, early working for non-commercial use, etc. They are all essential to ensure quality of patent and access to medicines.

What, according to you, are the implications if Novartis loses the battle?

The domestic industry will be able to better serve patients not only in India but also in many developing countries. It would have the advantage of an early mover in the global market because going forward patent protection will expire in India ahead of the developed countries. This could be a significant commercial advantage.

If Novartis does win the case?

The domestic industry will lose early mover advantage, besides slowing down in its future growth.

The domestic generic industry is facing roadblocks because of measures taken by governments globally and the big pharmas. How will it be able to overcome these?

The domestic industry has fought these battles in the past. It will continue to do so in the future. The media, the civil society organizations and some academics have extended helping hand for the sake of public health and to save lives of people. - RM

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