Compulsory licence for Nexavar: A laudable and revolutionary step
Dr Bhagwati Prakash Sharma
The grant of compulsory licence to manufacture and sell the anti-cancer drug Nexavar, to Natco an Indian company, at Rs 8,800 against Rs 2,80,000 of Bayer—a foreign MNC—needs to be hailed.
The first ever compulsory licence granted for the cancer drug Nexavar to the Indian pharma company Natco, which has offered to sell the monthly dose of the medicine at Rs 8,800 vis a vis Rs 2,80,000 being charged by the Bayer AG of Germany due to its monopoly is a welcome move of the Indian patent office. The bold ruling of P H Kurian, the Patent Controller of India is the first ever step of the Indian patent office, ever since the change of law from, process patent to product patent on the drug molecules, invented after January 1, 1995. Indian patent office has paved the way for the future course, for the patent administrators in India and world over, especially in the developing countries.
The multinational companies dubbing the decision ‘as disappointing and another blow to innovation’, should feel ashamed for profiteering more than 3,300 per cent out of human sufferings. The Indian generic company Natco would also invest in the R & D, to develop the process to synthesise that drug at its end, and earn profit even at a price just 3 per cent of what is being charged by the monopoly manufacturer, the Bayer AG of Germany and that too after paying a royalty of 6 per cent to the Bayer AG, as ruled by the patent controller. There are a number of other drugs, which also fall in the category of monopoly drugs, even as per the definition of the Food and Drugs Administration (FDA) of the US. Most of which are patented and exhorbitantly priced. All these need to be contested for compulsory licensing.
Some such examples, out of scores of such monopoly priced drugs, need a mention here. A single 50 ml injection of Roche’s anti-cancer drug Herceptin is sold at Rs 1,35,200, Merck’s Erbitux costs Rs 87,920, Bristol-Myers-Squibb’s Ixempra sells at Rs 66,460, Pfizer’s Macugen is being sold at Rs 45,350 and Sanofi-Aventis’ Fasturtec at a price of Rs 45,000. Most of these are used against cancer, chronic pain management, diabetes, cardio-vascular disorders and other chronic ailments.
There is a point to feel jubilant for the masses, yet, caution is also needed, and public-health-groups should be vigilant to join as intervener, if the Bayer moves to the Supreme Court. Otherwise, if the Bayer would move to the Supreme Court and get an injunction, the issue would hang in air for an indefinite period. One should not forget that when Novartis, which was charging approximate Rs. 11,00,000 for its anti-cancer drug ‘Glivec’, obtained a stay from the Chennai High Court for more than a year, against the economically affordable Indian version of its basic compound, the Imentinib and 24,000 blood cancer patients had to suffer for months during the period of stay, obtained on false pre-text of the molecule being of a date later than January 1, 1995. While the molecule was older one and the court vacated the stay after the hearing was over.
In this case also, a section of commentators are advising the Natco to go for a compromise with Bayer and not to insist to sell Nexavar at such a low price. But, since the Natco would already be paying 6 per cent royalty on its sales, as ruled by the patent office, to the Bayer for its invention, even at this low price. This 6 per cent is a fair reward for Bayer’s invention. So, people should raise strong voice to strengthen the hands of the patent office and the Indian pharma company Natco, with the purpose, that other Indian companies also come forward to apply for compulsory licences to make the costly monopoly medicines available at affordable prices.
This single decision in the history of new post-WTO patents regime has already sent shivers down the spine of the foreign pharma MNCs. Therefore the ‘Roche Holding AG’ a Swiss pharma MNC has within days of this decision, bowed down and has announced to sell cheaper versions of its two costly anti-cancer drugs the Herceptin and Mabthra.
The single injection of Herceptin is available at Rs 1,35,000 and Mabthra at Rs 76,000. But the proposed prices for a cheaper version of the two, would not be as low as is being offered by the Natco by virtue of its compulsory licence. Hence, other Indian pharma companies should come forward to make the costly monopoly priced medicines available at affordable prices, including these two. Moreover, Roche has though announced to sell these two medicines at a lower price, by a different name in India, but that would be too late i.e by the end 2012 or 2013.
Moreover, such a move by the other Indian pharma companies would save costly foreign exchange for the country, help to improve country’s balance of trade, enhance R & D in the pharma sector and facilitate growth of the Indian pharmaceuticals sector. This would also pave the way for the Indian generic sector to improve its outreach worldwide, if the Indian players succeed in getting compulsory licences in other countries as well, as has happened when the Sun Pharma of India had got a compulsory licence from the US for the anti-cancer drug Lipodox, the monopoly drug of Johnson & Johnson.
So, the social organisations, government and all political parties should explicitly support the Natco and Indian patent office in order to pave the way for many more such compulsory licence applications. It is also necessary, to ensure that the Bayer AG do not drag the issue to the Supreme Court to kill time and compel the Natco to agree to compromise with the monopoly firm Bayer. Moreover, pressure of public opinion is also necessary so that issue is not dragged to the Dispute Settlement Body of the WTO, some time later.
The US protest over this issue of compulsory licence to the Natco for this life saving drug issued by the Indian patent office on the ground of public health problem, is altogether unwarranted. The allegation of the visiting US commerce secretary that it would discourage new investments and dilute the international patents regime is not sustainable on any count. The Natco has been asked to pay a royalty of 6 per cent to the Bayer AG is the fair reward for the Bayer AG, the inventor. Profiteering to the extent of 3,300 per cent in the name of promoting research cannot be justified, that too in case of medicine for deadly diseases like kidney and liver cancer. The Minister of Commerce & Industries, Shri Anand Sharma has rightly defended the issuance of the compulsory licence, by the Indian patent office and the Government of India should stay firm on this issue and continue to do so in other such cases too. The patent office has strictly complied with agreement on TRIPS of the WTO. Patent should be used only as a means for fair rewards for the R & D, instead being allowed to be used as a tool for monopoly profiteering.
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