Saturday, January 10, 2015

HC stops Cipla's generic drug sales

Dear colleagues,
Here is a temporary setback to a cheaper generic medicine for patients suffering from lung and respiratory diseases. Hope it remains a temporary setback since more than a crore of patients are involved;


Jan 10 2015 : The Times of India (Delhi)
HC stops Cipla's generic drug sales
Rupali Mukherjee
Mumbai:


In a move that may be a damper for patients suffering from lung and respiratory diseases, the Delhi high court has decided in favour of drug MNC Novartis, restraining generic firm Cipla from selling its affordable version of respiratory drug Onbrez in the domestic market.Sources said the court on Friday issued an interim injunction directing Cipla to stop the sale of the generic drug in the market, and apply for a compulsory licence on the drug if it feels that sufficient quantities are not available for patients in the country .
Cipla may file an appeal against the order, sources said. The company had late last year launched its version of the drug at Rs 130 for 10 pills, at one-fifth of the price of the Novartis' Onbrez, which is sold at Rs 677 (for 10 pills). When contacted, Novartis India VC and MD Ranjit Shahani told TOI, “It's a positive outcome to the patent infringement litigation, which has granted an interim injunction preventing the relaunch of Cipla's Indacaterol.“
Novartis had moved the Delhi HC in December last year, seeking to restrain Cipla from selling the generic version of the drug Onbrez.This came on the heels of Cipla's plea to the government to revoke five patents held by Novartis on the respiratory drug after it launched a cheaper copy in the market.In its plea, Cipla had said Novartis has had patents on the medicine since 2008, but instead of producing it in India has imported only a “negligible quantity“, leading to a shortage in the market.
Under the World Trade Organization TRIPS Agreement, compulsory licences are legally-recognized me ans 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, sources told TOI. 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.
Courtesy DR Sugan Bhatia
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