Novartis, the Swiss drug multinational which fought a six-year battle for retaining its Glivec patent and lost the case in India, seems to have landed in yet another patent controversy now. This time it is about marketing of a respiratory drug, Indacaterol, at a very high price and that too in insufficient quantities. Marketed as Onbrez, the drug is used to treat breathing problems associated with chronic obstructive pulmonary disease and it is estimated that more than 15 million Indians are afflicted with the disease.
Novartis has been granted the patent for the Onbrez in 2008 by Indian patent office but the company never attempted to manufacture the drug in the country and has been importing the same since then. As the import of the drug is not adequate to meet the growing demand of patients, a shortage situation already exists in the country causing distress to several thousands of patients according to Cipla, a leading Indian pharmaceutical company. It is rather surprising that neither the Patent Office in the country nor the Department of Industrial Policy and Promotion took note of the shortage situation after the grant of the patent to Novartis.
Cipla in the meanwhile reported to have launched a cheaper version of the drug in the market on the ground that there is a shortage for the drug in the country and approached DIPP to revoke the patent granted to Novartis. DIPP has not taken a decision on this matter yet. Section 66 of the Indian Patents Act empowers the Central government to revoke a patent in public interest after giving the patent holder an opportunity to explain why it should not be revoked. Cipla’s stand is that there is an urgent and unmet need for the respiratory drug in India and it has to be made available at an affordable price to the patients.
If Cipla’s stand in this matter is factual, then the government needs to act fast on this matter and make the drug available to maximum number of patients in the country. How that should be done in a situation like this has to be decided by the government without any further loss of time. First of all, the government should have monitored the availability of the drug in the market after the grant of patent in 2008 as it is an exclusive marketing right for an essential drug. Cipla’s unilateral decision, at the same time, to launch a generic version of the drug in the market is debatable.
Cipla has asked the DIPP to revoke five patents of Novartis relating to the product citing need for public health access and stated the patent holder Novartis does not manufacture the drug in India.
Last year in April, Novartis had lost a seven-year long legal battle for getting its blood cancer drug Glivec patented in India and to restrain Indian companies from manufacturing generic drugs, with the Supreme Court rejecting the multinational company’s plea.