New Delhi: India's decision to allow Natco Pharma to sell Bayer's patented cancer drug Nexavar has divided the pharmaceutical industry with domestic firms welcoming it while multinationals said 'arbitrarily' using of compulsory licenses will undermine innovation in the sector.
Disappointed with the development, Bayer said it is evaluating options for its next step.
"We are disappointed by the decision of the Patent Controller in India to grant a compulsory license for Nexavar. We will evaluate our options to further defend our intellectual property rights in India," a Bayer Spokesperson said.
While the body of domestic pharma firms, Indian Drug Manufacturers Association (IDMA) said the move will benefit both patients and industry, the group for MNCs, Organisation of Pharmaceutical Producers of India (OPPI) said it would be
detrimental in the long run.
"It is beneficial for patients, industry as well as the whole country. Everyone will be benefited by this order," IDMA Secretary General Daara Patel said.
On Monday, the India Patents Office invoked compulsory licence for the first time in the country, paving way for Natco Pharma to sell its version of Bayer's Nexavar at Rs 8,880 for a month's dose as compared to Rs 2.8 lakh by Bayer.
The multinationals' body decried the step.
"OPPI is disappointed with the decision to issue a compulsory license. We believe compulsory licenses should be used only in exceptional circumstances, such as in times of a national health crisis," OPPI President Ranjit Shahani said.
He further said: "If used arbitrarily, compulsory licenses will serve to undermine the innovative pharmaceutical industry and will be to the long term detriment of the patient."
As per WTO TRIPS agreement, a compulsory license can be invoked by a national government allowing someone else to produce a patented product or process without the consent of the patent owner. It is done for the cause of public health.
As per the order of the India Patents Office, Natco will have to pay a royalty of 6 per cent of the net sales on a quarterly basis to Bayer. It will have to manufacture the drug only at its own plant since it is not allowed to outsource
production.
The Hyderabad-based firm is allowed to sell the drug for treatment of only kidney cancer and liver cancer in India.
The order also makes it obligatory for Natco to supply the drug free of cost to at least 600 needy and deserving patients per year.
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