India: Double frontal attack on the 'pharmacy of the developing world'
By Dr Unni Karunakara, International President, Médecins Sans Frontières
Carmen lives with her husband and two children in
But this month, Carmen’s future, and the future of millions of other patients across the developing world, is being played out in the Indian courts. Two multinational drug companies – Swiss Novartis and German Bayer – are each headed to the courts in separate attacks on what
Why should Carmen be so interested in the outcome of legal battles happening on the other side of the world, over drugs to treat a disease she doesn’t even have?
Although she may not know it, she has a vested interest in these cases. If a verdict is handed down in favour of the drug companies, it could slowly choke the lifeline of affordable medicines that
The Novartis dispute stretches back to 2006, when the company was denied a patent in
The spirit of the Indian law is to incentivise research and development on new drugs, but also to stop the drug giants from indulging in ‘evergreening,’ a common practice in the pharmaceutical industry. A single medicine can have several applications for separate patents, each relating to a different aspect of the same medicine.
This is a lucrative game, but a deadly one, too. The high prices of medicines that stem from monopolies can mean the difference between life and death.
Competition among multiple generic manufacturers – which can thrive when patent monopolies don’t stand in the way – is what brings drug prices down. In 2001, it was competition from Indian manufacturers that drove the price of antiretroviral (ARV) drugs to treat HIV down, from over 4.7 lakh Rs (US$10,000) per patient per year to around 8,300 Rs today.
This saves lives. It’s what made it possible for HIV treatment to be scaled up, through treatment providers like MSF. Today, eight million people receive treatment, enabling them to live active, productive lives; Carmen is one of them.
For the past six years, Novartis have sought to use litigation to remove the tougher standards for patentability from
The legal exclusion of patent barriers on medicines enabled
And what of Bayer? While the deadly legal battle between Novartis and
In fact many of the newest HIV drugs are already patented in
Action will have to be taken if access is blocked by high prices or lack of supply. One solution is a legal mechanism in patent laws around the world - a ‘compulsory licence‘ - which authorises price-lowering generic production, in return for royalty payments to the patent owner. In a landmark decision in March, the first Indian compulsory licence was issued, so that a generic company can produce sorafenib tosylate, a liver and kidney cancer drug patented by Bayer.
This mechanism was used because Bayer had failed to make the drug available and affordable at a reasonable price. Bayer’s drug, marketed as Nexavar, costs over 2.8 lakh Rs for one month’s treatment. The new generic version would cost 8,800 Rs per month; a price reduction of 97 per cent.
This decision established a precedent, and shows generic production is still possible in
Bayer, predictably, chose to appeal. They are using litigation to protect their monopoly blindly, rather than addressing the reality that their prices are too high. The appeal was heard earlier this month – we are now waiting for a judgment.
Much hangs on the outcome of both cases. A Novartis win could lower the bar for innovation in India, allowing for more widespread patenting in the short run, making it easier for companies like Novartis to get patents on drugs already in the public domain; and in the future enabling companies to defer the date their products go off-patent in India. A Bayer win would close the door on a potential watershed for affordable generic versions of patented medicines.
Either way, it would mean higher drug prices for people in