Life and lung issue in Cipla-Novartis battle

Novartis imports 54,000 units a year of a drug to treat lung disease, India needs 180 million, claims Cipla while challenging Novartis' patent

Those with respiratory ailments have a big personal stake in the legal wrangle between drug companies Cipla and Novartis over Onbrez, the drug used to treat the condition.

According to the World Health Organisation, India has an estimated 10.2 million persons suffering from chronic obstructive pulmonary disease (COPD).

Novartis imports only about 54,000 units a year of the Indacetrol-based drug, while India is estimated to need 180 million units, assuming the patient completes a full one-year course, according to documents filed by Cipla with the department of industrial policy & promotion.

"For a month, one patient will need one bottle of 30 capsules of Indacaterol, hereby mentioned as '1 unit'. The number of patients tentatively suffering in India is about 15 million. Current population of India is 1.2 billion. Therefore, approximately 1.23 per cent of the population is suffering from COPD,'' the document said.

The amount of Indacaterol required is 15 million units a month, it adds. ''Assuming the patient takes it for 12 months, India will need 15 million x 12 units per year. The said figure is 180 million units per year. However, the supply through imports by Novartis is approximately 54 000 units per year on an average (as per the Form 27S filed with the patent office)," it says.

If so,the percentage of inadequacy in the requirement per year is close to 99.97 per cent. The market for COPD in India is estimated to be close to Rs 2,000 crore a year.

While the high court here has not given the interim relief sought by Cipla to sell the cheaper generic of Onbrez, the court also made it clear that the relevant tribunal should take a call on whether the firm would be able to sell the cheaper generic under some arrangement (royalty payment, compulsory licence, etc) as Novartis has the patent over five drugs with Indacaterol till 2020.

Under World Trade Organization rules, compulsory licences are recognised as a way to overcome barriers in accessing affordable medicines, where the government allows a company to manufacture a patented drug without consent of the innovator company.