The Delhi High Court has passed an interim order allowing domestic drug firm Cipla to market its version of a lung cancer treatment drug for which Swiss multinational Roche Scientific holds the India patent, pending another hearing scheduled for August 6.
The interim order was passed by the court on Wednesday on a plea filed by Roche Scientific on January 19 this year. The generic name of the drug is Erlotnib, which Roche markets as Tarceva and Cipla as Erlocip.
Ahead of the next hearing, the court has asked Cipla to maintain records of sales of Erlocip.
It has also admitted the counter-claim filed by Cipla that questions the validity of the Roche patent and asked the latter to respond within four weeks from Wednesday.
The case, which is being keenly watched by global and Indian drug firms and consumer interest groups, is the first test case of India's new patent regime.
The new patent law came into effect on January 1, 2005, and offers firms product patent protection against the earlier practice of process patent protection, which effectively allowed firms to make the same drug through a different process.
Days before Roche sought legal redress, Cipla started marketing the drug for Rs 1,600 a tablet, one-third the price Roche charges (Rs 4,800 a tablet). Roche has been selling Erlotinib under the brand name Tarceva in India since 2006.
The crux of Roche's argument is that the product patent right it has for Tarceva prevents competition from manufacturing a copy-cat version of the drug.
In response, Cipla has claimed that the Indian patent is not valid and argued that it was well within its rights to manufacture and market the medicine in the country.
The counsel for Cipla said the high court's order made special mention of the life-threatening nature of cancer and the life-saving properties of this drug.
"Given the price difference, the court did not want patients to be deprived of a low-cost alternative by staying sales of the generic product," the counsel claimed.
Wednesday's decision will ensure uninterrupted supply of a low-cost medicine for treating lung cancer. Nearly 160,000 people in the country are estimated to be suffering from the disease, which has a high fatality rate.
Welcoming the interim verdict, the Cancer Patients Aid Association (CPAI) Chairman Y K Sapru said he was glad to note "the judiciary has given preference to the right of a human being to live over all other rights enshrined under the Constitution of India".
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