Patients Over Patents In a landmark judgment on Monday, the Supreme Court rejected the plea of Swiss pharma giant Novartis to patent Glivec, which is used to treat myeloid leukaemia. Indian manufacturers can now make and sell much cheaper versions of the drug. Priyanka Golikeri looks at the debilitating patents vs patients battle.
a judgment, a glimmer of hope
The Supreme Court has rejected drug maker Novartis AG’s attempt to patent a new version of cancer drug Glivec in a decision that healthcare activists say ensures that poor patients will get access to cheap versions of lifesaving medicines. —AP
K
irti Tiwari is a cancer survivor. But when she was prescribed a breast can cer drug called Herceptin, manufactured by Roche, she and her family had reasons to be feel distraught. She was to take the drug, that cost a whopping Rs 20 lakh for a year. But Tiwari decided to stop it midway through. Today she has reasons to feel relieved, not so much for herself but for other patients for whom Monday's Supreme Court verdict on the issue of a patent for expensive cancer drug Glivec has come across as a fresh lease of life. Tiwari welcomes such judgments since they make life easier for the ill, and the terminally ill. "If generic versions of the same drugs are made cheaper, such acts will help millions." She is right, or course. Millions across the country who were left staring at a wall of despair now see a ray of hope. But is it too early to celebrate as yet? Multinational corporations, for obvious reasons, are already crying hoarse. The managing director of Novartis, the company whose appeal was rejected, Ranjit Shahani believes patents safeguard innovation and discouraging the same can impact drug discovery which is essential for advancing medical science. Although true to a certain extent, experts in India feel patents should never get in the way of any patient seeking care. It is well known that patents imply monopoly up to 20 years in India, and the patent holder is free to charge any amount for the drug. "The issue of affordability of a medicine is more important than patents. Especially, in India where treatments for life-threatening diseases like cancer and AIDS eventually lead to poverty," contends Leena Menghaney of aid organisation Medecins Sans Frontieres (MSF). Novartis is not poor — Glivec has global sales of $4.7 billion. The issue of patents crops up like a leitmotif all the time. Yet, as health economist Sakthivel Selvaraj of the Public Health Foundation of India (PHFI) points out, "As far as a R&D is concerned, India is quite an insignificant market for MNCs as compared to the developed countries." There's a reason here. "Most of their research happens overseas. Often research is part funded by universities abroad and not entirely
by companies themselves," argues Selvaraj. Though firms claim they require $800million-1 billion to introduce an entirely new drug to the market, they can recover that amount within 1-2 years from developed markets. "There, almost everything gets a patent and thus firms can charge any amount and recover their investments quickly," says a patent expert. In some ways it's the poor subsidising the rich. "Why should a poor Indian who cannot afford two square meals a day pay for some future research that will happen somewhere which might not even reach India," asks YK Sapru, chairman of Cancer Patients Aid Association, the group which had locked horns with Novartis over Glivec. Then it becomes a question of rights. "It is unacceptable that patients should die because they cannot afford the medicine. Look at the prices — not even a fraction of the population can afford such drugs. Cancer, HIV/AIDS require life-long treatment," asserts Eldred Tellis, director of NGO Sankalp Rehabilitation Trust, which works with hepatitis C patients and had filed an opposition to a Roche patent on Pegasys. One of the reasons for conflict between patents and patients is that India entered the fray very late. India started granting patents on drugs only from 2005 to comply with rules of the World Trade Organisation (WTO), after signing the trade-related aspects of intellectual property rights agreement (TRIPS agreement) in 1995. Prior to that, India had a process patent act whereby the process used for making the drug would get patented, which meant Indian firms could use another method and produce the same drug. But with the product patent act's entry since 2005, a patent restricts everyone than the patent holder to make and market the drug for up to 20 years. The Patent Act has been designed with safeguards that prevent companies from abusing the system or gaining patents on mere modifications of existing
drugs just to extend monopolies. "Now, instead of abusing the patent system by claiming ever longer patent protection for older medicines, the industry should focus on real innovation," asserts Unni Karunakara, international president of MSF. Indian pharmaceutical firms, nevertheless, are ecstatic. After all, for Novartis' Rs1.2 lakh per month, Indian equivalents cost Rs8,000-10,000 for a month's treatment. "For Indian firms it is a volume game where they look at selling more units of the drug, unlike MNCs for whom it is a value game where due to high costs, the units sold are less," explains pharmaceutical analyst Ranjit Kapadia. YK Hamied, chairman of Cipla, the firm which in 2001 started selling AIDS drugs at $350 per patient per year or one-tenth the price in the US, says he is "pleased with the judgment that prevents use of frivolous patents to deny access to medicines." Experts say while Indian pharma firms are no saints themselves since several have been pulled up by authorities for overcharging, their costs are often lesser than those of MNCs. "Once patent is denied, the field opens to competition which automatically leads to a fall in prices. Competition is key for bringing down prices of medicines or else it leads to monopoly," says Menghaney. So, if market dynamics are going to dictate terms, it might be too early to celebrate, but what is certain is that the Supreme Court judgment has offered millions of cancer patients a reason to cheer about. (with inputs from Deepthi MR)