Glivec sold by MNC Novartis for Rs 1.2 lakhs will now be available for Rs 8,000
Gopal is affected by Cronic Myeloid Leukemia (CML), a blood cancer. His annual treatment at the All India Institute of Medical Sciences (AIIMS) will cost anywhere between Rs 10 to 40 lakhs and will certainly add to his life. Wonder drug Glivec will make it possible.
But the sad part is Glivec’s astronomically high price - a burden for a majority of three lakh CML patients in India. The Swiss drug giant justifies it on account of its $1 billion investment into the research of the molecule. Such tall claims by multinational companies (MNCs) have been refuted by the Public Health Foundation which says that MNCs are overstating their investment to make heavy profits. In a landmark judgment, the Supreme Court ruled out a plea filed by Novartis for patenting this anti-cancer drug Glivec, saying, ``there is no novelty, no invention’’. Novartis’ claim for patent was earlier rejected by the Indian Patent Appellate Board (IPAB), after which the MNC had moved the apex court.
The overall implication of this judgment is this: Glivec which is sold by Novartis for Rs 1.2 lakhs, will be available for Rs 8,000 to patients marketed by Glenmark, an Indian generic producer. The decision has come as a great relief to patients, generic drug manufacturers like Cipla, Ranbaxy, GlenMark etc and bad news for MNCs who thrive on exclusive marketing like Pfizer, Glaxo Smith Kline, Novartis and Aventis.
This historical development underlines a stark reality: Indian judicial and quasi-judicial bodies will not allow MNCs to exploit the 2005 April amendment of the Indian Patent Act which provides them exclusive marketing rights for 20 years, provided the drug is a new invention. The 2005 amendment was in tune with global practices as dictated by the World Trade Organisation (WTO). Needless to add, the process patent regime of the Patent Act 1970 has been made redundant. But law makers did provide enough teeth in the act to stop ever greening - which means extending the patents duration by minor modulations in the molecule. The Supreme Court did use this particular legal provision in this case.
The MNC pharma body, Organization of Pharmaceutical Producers of India (OPPI) spokesman reacted strongly saying that India is discouraging invention and research. He also pointed out that MNCs not getting their due may shun this country. On the face, it is a commercially motivated propaganda to pressurise India. What are the points of rebuttal? One, this molecule was not new and existed in the public domain the world over and tried to enter India after 2005 to take advantage of the changed patent regime; two, Indians have walked the extra mile for promoting genuine inventions in 2005; three, the threat to India rings hollow because the sheer size of the Indian market will force the MNCs to adjust accordingly.
The bottom line here is not recovering costs incurred in research but the greed for big money. Pharma products are killing poor people. Even the world’s most developed country USA, has resorted to generic drugs, saving roughly $ 1 trillion in health care. There is a similar clamour in the European Union (EU). To handle this dire situation, a compulsory licensing (CL) clause was added to Trade Related Intellectual Property Rights (TRIPS ).
Cynics may argue otherwise but the fact is India has used this so-called death warrant (CL) only once while it has been often resorted to by the USA, Canada, China, Indonesia and Malaysia. In a bid to provide for affordable kidney anti-cancer drug Nexavar, the IPAB upheld the CL in favour of Natco Pharma against MNC Bayer, the original patent holder. Natco Pharma reduced Nexavar prices by 97 percent although they were asked to pay 6 percent royalty to Bayer. Remember Bayer was granted the patent in 2008 but exorbitant prices became unaffordable for cancer patients. Hence a fourth CL was granted in 2011. In contrast, US Presidents through executive orders have invoked CL time and again to sort out issues of shortages and affordability. Interestingly, the executive order of the US President cannot be challenged in court. What is the way out? In case of essential and life saving drugs, governments, the World Health Organisation (WHO) and Unicef can join hands to promote research in the larger interest of humankind, something like the Gene Pool research where the USA and UK have joined hands.
Gopal is affected by Cronic Myeloid Leukemia (CML), a blood cancer. His annual treatment at the All India Institute of Medical Sciences (AIIMS) will cost anywhere between Rs 10 to 40 lakhs and will certainly add to his life. Wonder drug Glivec will make it possible.
But the sad part is Glivec’s astronomically high price - a burden for a majority of three lakh CML patients in India. The Swiss drug giant justifies it on account of its $1 billion investment into the research of the molecule. Such tall claims by multinational companies (MNCs) have been refuted by the Public Health Foundation which says that MNCs are overstating their investment to make heavy profits. In a landmark judgment, the Supreme Court ruled out a plea filed by Novartis for patenting this anti-cancer drug Glivec, saying, ``there is no novelty, no invention’’. Novartis’ claim for patent was earlier rejected by the Indian Patent Appellate Board (IPAB), after which the MNC had moved the apex court.
The overall implication of this judgment is this: Glivec which is sold by Novartis for Rs 1.2 lakhs, will be available for Rs 8,000 to patients marketed by Glenmark, an Indian generic producer. The decision has come as a great relief to patients, generic drug manufacturers like Cipla, Ranbaxy, GlenMark etc and bad news for MNCs who thrive on exclusive marketing like Pfizer, Glaxo Smith Kline, Novartis and Aventis.
This historical development underlines a stark reality: Indian judicial and quasi-judicial bodies will not allow MNCs to exploit the 2005 April amendment of the Indian Patent Act which provides them exclusive marketing rights for 20 years, provided the drug is a new invention. The 2005 amendment was in tune with global practices as dictated by the World Trade Organisation (WTO). Needless to add, the process patent regime of the Patent Act 1970 has been made redundant. But law makers did provide enough teeth in the act to stop ever greening - which means extending the patents duration by minor modulations in the molecule. The Supreme Court did use this particular legal provision in this case.
The MNC pharma body, Organization of Pharmaceutical Producers of India (OPPI) spokesman reacted strongly saying that India is discouraging invention and research. He also pointed out that MNCs not getting their due may shun this country. On the face, it is a commercially motivated propaganda to pressurise India. What are the points of rebuttal? One, this molecule was not new and existed in the public domain the world over and tried to enter India after 2005 to take advantage of the changed patent regime; two, Indians have walked the extra mile for promoting genuine inventions in 2005; three, the threat to India rings hollow because the sheer size of the Indian market will force the MNCs to adjust accordingly.
The bottom line here is not recovering costs incurred in research but the greed for big money. Pharma products are killing poor people. Even the world’s most developed country USA, has resorted to generic drugs, saving roughly $ 1 trillion in health care. There is a similar clamour in the European Union (EU). To handle this dire situation, a compulsory licensing (CL) clause was added to Trade Related Intellectual Property Rights (TRIPS ).
Cynics may argue otherwise but the fact is India has used this so-called death warrant (CL) only once while it has been often resorted to by the USA, Canada, China, Indonesia and Malaysia. In a bid to provide for affordable kidney anti-cancer drug Nexavar, the IPAB upheld the CL in favour of Natco Pharma against MNC Bayer, the original patent holder. Natco Pharma reduced Nexavar prices by 97 percent although they were asked to pay 6 percent royalty to Bayer. Remember Bayer was granted the patent in 2008 but exorbitant prices became unaffordable for cancer patients. Hence a fourth CL was granted in 2011. In contrast, US Presidents through executive orders have invoked CL time and again to sort out issues of shortages and affordability. Interestingly, the executive order of the US President cannot be challenged in court. What is the way out? In case of essential and life saving drugs, governments, the World Health Organisation (WHO) and Unicef can join hands to promote research in the larger interest of humankind, something like the Gene Pool research where the USA and UK have joined hands.
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