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HC backs Novartis, bars Cipla from selling lung drug copy

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By Jagdeep Worah
10 January 2015

In a move which may disappoint those suffering from lung and respiratory diseases, the Delhi High Court on Friday restrained domestic firm Cipla from marketing its affordable generic version of respiratory drug Onbrez, ruling in favour of multinational Novartis.

The court issued an interim injunction directing Cipla to stop the sale of the generic drug, and apply for a compulsory licence on the drug if it feels that sufficient quantities are not available for patients in the country.

Cipla,  India's fourth-largest drugmaker by revenue, will probably file an appeal against the order.

Onbrez, chemically called indicaterol, is used to treat breathing problems associated with chronic obstructive pulmonary disease (COPD). Cipla estimates more than 15 million Indians are afflicted with the disease.

Cipla late last year launched its version of the drug at Rs130 for 10 pills, one-fifth of the price of Novartis' Onbrez, which is sold at Rs677.  it said it had the potential to manufacture adequate quantities of the drug and make it available in the country.

There are an estimated 15 million patients suffering from lung and respiratory diseases in India while Novartis has made the imported drug available to 8,000 patients over the last two years, Cipla pointed out.

Novartis holds the patents for the Indacaterol maleate salt as well as the manufacturing process for the drug, which is sold in India as an inhalation powder and inhaler under the trademark name of 'Onbrez' through Lupin since 2010.

Novartis India vice-chairman and managing director Ranjit Shahani said, "It's a positive outcome to the patent infringement litigation, which has granted an interim injunction preventing the re-launch of Cipla's Indacaterol".

Novartis had moved the high court in December seeking to restrain Cipla from selling its version of Onbrez. This came on after Cipla's plea to the government to revoke five patents held by Novartis on the respiratory drug, after it launched a cheaper copy.

Under the World Trade Organisation TRIPS Agreement, compulsory licences are legally-recognized means to overcome barriers in accessing affordable medicines, where a government allows a company to manufacture a patented drug, without the consent of the innovator company.

In the hearing chaired by Justice Manmohan Singh, the court further directed Cipla to file an application with the government for a compulsory licence within two weeks, and that the decision (on the application) should be taken over a period of six months.

Novartis' Onbrez breezhaler which contains the active ingredient indacaterol is protected by patents till 2020, he added.

Cipla had argued in its plea seeking revocation of Novartis patents that there are 1.5 crore patients suffering from lung and respiratory diseases in India, while Novartis has imported a negligible quantity, making it available to only 8,000 patients over a period of two years   (See: Cipla wants Novartis's patents on respiratory drug revoked ).





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