Novartis says that the original compound, patented before the Indian law, was never made into a drug, and its new form, invented after 1995 (and thus covered by the law) actually makes it into something the body can absorb.
Currently, several Indian generics makers produce variations of Glivec, sold for about 10 per cent of the cost of the brand name, $2550. Novartissays that if Glivec comes back under patent it will make it available to patients who cannot pay through a charitable assistance program.
India has one other option for making drugs available – a compulsory licence. The WTO allows a country to override a patent if it is preventing access to a life-saving medication. Earlier this month, India issued its first-ever such licence, on a cancer drug that is patented by Bayer. The Patent Office said Bayer had failed to make the drug available here at a reasonable cost and licensed a generic firm to produce it, for a cost 97 per cent lower, while mandating that it pay Bayer a royalty.
This is the model that Doctors Without Borders would like to see used on a range of drugs. Ms. Menghaney noted that no one in India legally opposes patents on totally new drugs – a new AIDS therapy, for example, produced under patent by Merck, is being sold here for $2,000 and has not been challenged. But a royalty system would keep the Indian generic industry alive while ensuring the pharmaceutical companies recover their research costs, she said – although it would likely not generate the level of profit to which they are accustomed.
Novartis declined to tell the Globe and Mail how much it has earned from sales of Glivec globally but one figure has been reported as $4.7-billion last year alone.
Now all eyes are on the court, which will begin hearing arguments on Wednesday. India’s Supreme Court has made a series of rulings considered “progressive” on social policy in the past few years, but has also issued a few strongly pro-business decisions of late. Novartis has hired many of the country’s top lawyers for its large legal team; the Indian government has fielded a junior one.
Yusuf Hamied runs India’s largest generic drug company, Cipla; his father was one of those early pioneering biochemists. He sees the case as a watershed for Indian development. “Every country has the right to determine its own laws,” he said. “And India can’t afford monopolies.”