I just read the news that the Indian government has overruled Pharma giant Bayer and authorized Natco Pharma,an Indian generic drug manufacturer to manufacture and sell the Bayer-patented cancer drug Nexavar, (sorafenib). The decision requires Bayer to license the drug to Natco Pharma, which will then pay a royalty of 6% ofn net sales. Natco is required to sell the drug for Rs. 8,800 (US$ 176). Currently, Bayer charges $5,600 for the drug.
This is a great step for India, and may well lead other developing countries to follow the Indian model - one that will allow access to critical medicines to be manufactured and distributed by Indian generic drug companies.
It should, however, be noted that the Indian Supreme Court is on the threshold of hearing final arguments in the case of Novartis v. Union of India. This case involves Natco Pharma's Gleevec copycat drug (named Veenat). Gleevec has been patented by the Swiss Pharma company Novartis, but the Indian generic company was allowed to manufactured and sell it at highly discounted rates - which caused Novartis to file the aforesaid lawsuit.
India had stopped granting patents to drugs in 1970, but resumed it in 2005 under pressure from the WTO. However, drugs patented before 1995 did not qualify. Gleevec was patented before 1995, but Novartis claimed that a newer form of the drug was patented after that date. However, the Indian government argued that a newer patent on an older form of the drug would be recognized only if the newer form significantly improves the drug's efficacy. The Madras High Court heard and dismissed the case in August 2007. Novartis appealed to the Indian SC, and we'll know what transpires in a few weeks (or months).
While this case is being carefully observed by the (developed nations') Pharma companies and patent enforcers, today's new development - where the Indian Govt. has summarily authorized Natco to develop and sell Bayer's cancer drug - adds a new and interesting element to the drug patent fight.
I am sure that this will lead to more fights and pressures on India from the developed economies and big pharma which stand to lose big. But does this action mean that the Indian Govt. thinks it is likely to lose the battle with Novartis? We will have to wait and see...
This is a great step for India, and may well lead other developing countries to follow the Indian model - one that will allow access to critical medicines to be manufactured and distributed by Indian generic drug companies.
It should, however, be noted that the Indian Supreme Court is on the threshold of hearing final arguments in the case of Novartis v. Union of India. This case involves Natco Pharma's Gleevec copycat drug (named Veenat). Gleevec has been patented by the Swiss Pharma company Novartis, but the Indian generic company was allowed to manufactured and sell it at highly discounted rates - which caused Novartis to file the aforesaid lawsuit.
India had stopped granting patents to drugs in 1970, but resumed it in 2005 under pressure from the WTO. However, drugs patented before 1995 did not qualify. Gleevec was patented before 1995, but Novartis claimed that a newer form of the drug was patented after that date. However, the Indian government argued that a newer patent on an older form of the drug would be recognized only if the newer form significantly improves the drug's efficacy. The Madras High Court heard and dismissed the case in August 2007. Novartis appealed to the Indian SC, and we'll know what transpires in a few weeks (or months).
While this case is being carefully observed by the (developed nations') Pharma companies and patent enforcers, today's new development - where the Indian Govt. has summarily authorized Natco to develop and sell Bayer's cancer drug - adds a new and interesting element to the drug patent fight.
I am sure that this will lead to more fights and pressures on India from the developed economies and big pharma which stand to lose big. But does this action mean that the Indian Govt. thinks it is likely to lose the battle with Novartis? We will have to wait and see...
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