Global Insight Perspective | |
Significance | This is the first instance in which the Indian political setup has reacted so strongly against the patent litigation, and points credence to health activists' contention that a potential change in intellectual property (IP) laws would result in a dearth of essential cheap generics. |
Implications | The aggressive stance taken by both sides is in danger of making the situation extremely polarised. |
Outlook | Novartis is unlikely to back down, prompting the potential for a long, drawn-out litigation. |
India's health minister, Anbumani Ramadoss, turned up the heat on Novartis and the multinational lobby in general by issuing a direct threat of invoking the compulsory licensing options for the Swiss pharma major's cancer drug Glivec/Gleevec in the event that it does not withdraw its patent litigation. Media reports across the board have reported the development, quoting the Ramadoss as stating that, ”India is very concerned” by the challenge and particularly, when questioned about the link between ”affordable” drugs and the outcome of the litigation. Further, the minister rued the fact that there was no company representation to the ministry before approaching the courts, hinting at a potential negotiation.
India has so far not taken the compulsory licensing route that allows the government to overrule patent protection in the event of an epidemic citing public interest. The minister's threat comes in the wake of a wave of compulsory licences issued by the Thai government over the past five months, namely Merck & Co's Efavirenz, Sanofi-Aventis's Plavix (clopidogrel), and Abbott's Kaletra (lopinavir/ritonavir ), among others. There is concern that the domestic industry, being one of the largest sources of cheap generics, would be forced to cut down in the event of a tightening of intellectual property (IP) laws if the litigation goes in favour of Novartis. International aid agencies such as Medicine Sans Frontiers have successfully garnered support from the European parliament, as well as from some U.S. political quarters, to back their campaign to get Novartis to withdraw its patent litigation.
The status of the litigation now actually rests on an independent patent appellate board (IPAB) set up by the Indian government to tackle the flood of pre- and post-grant patent litigations. It was preceded by both the government and Novartis completing arguments at the Madras High Court last week. It is interesting to note here that the Swiss firm submitted that its Glivec patent application is a ”selection patent”, extremely mindful of the fact that its earlier patent application was rejected on the basis of section 3(d) of the Indian Patent Law, mandating that any new use/variant of an old substance cannot be patented unless you could demonstrate significant efficacy (source: Daily News & Analysis report). A selection patent is outlined as an innovation that one or more members of a known class of products possess, leading to an advantage for a particular purpose, which could not be predicted before the discovery was made.
Outlook and Implications
The Indian government’s stance on the litigation has with this aggressive statement increased the stakes a notch higher. Although Novartis has so far not reacted, it can be assumed that the company would not consider withdrawing from the lawsuit at the current juncture, given the earlier statements by Novartis's CEO, Daniel Vasella, that the company will continue its patent challenge, hoping to provide more clarity and instil tighter norms. The government has its own pressures to deal with: one the one hand, the strong indigenous generics industry and health activists hope to maintain the tide in their favour; on the other hand, as noted by the Business Standard, the United States India Business Council, a key lobby group, promised to open the ”floodgates” for foreign direct investment (FDI) into the country if intellectual property rights (IPRs) are strengthened.
Despite being dangled as a potential threat, compulsory licensing is considered a country's last resort in its bid to increase access of essential drugs. However, in the backdrop of the Thai government's latest resolve, the Indian government would be certainly emboldened to issue such a threat, but it remains to be seen whether it will go ahead with implementation. On the positive side, the fact that Ramadoss regretted the lack of negotiation between the two indicates that there could still be a neutral ground for other multinationals to count on before adopting Novartis's approach. The larger issue of whether this could affect the supply of AIDS treatments from India's generic producers is somewhat skewed since multinationals have issued compulsory licences for their patented AIDS drugs. However, whether these companies would have done so if not for the threat of generic firms flooding the market with their cheap versions is open to debate.
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India: 5 April 2007: Glivec Case Referred to Appellate Board
Thailand: 22 March 2007: Increasing International Concern Follows Abbott's Decision to Withdraw New Medicines from Thailand
India: 6 March 2007: Novartis Image Shaken with GIPAP Scandal, Remains Undeterred on Patent Litigation Front
India: 21 February 2007: Novartis Goes On the Defensive, Denies Glivec Parallel to HIV/AIDS South Africa Case