A landmark ruling by India’s high court this week struck down a bid by Swiss drugmaker Novartis to extend patent protection for its cancer drug, Glivec.
The decision is seen as a blow to Western pharmaceutical companies seeking to protect their financial interests. Experts say it could embolden pharmaceutical companies in other countries hoping to produce generic versions of name-brand medications. That could mean wider availability of the less expensive drugs throughout the developing world.
India is not the only country manufacturing generic versions of important and popular drugs. Argentina and the Philippines have passed strict laws limiting the patent protections on name-brand drugs developed by U.S. and European pharmaceutical companies, including medications to treat HIV, the virus that causes AIDS.
Patents allow companies that develop a drug to maintain exclusive rights to sell it at a higher price for an extended period of time, in order to recoup their research and development costs. Western pharmaceutical firms say those returns are essential to their ability to develop new and better medicines.
In the India case, which has been wending its way through the country’s judicial system for 7 years, Novartis failed to convince the high court that it had made changes to Glivec, its widely used leukemia drug, significant enough to warrant extending its patent and exclusive marketing rights.
Tahir Amin is a director of the New York-based Initiative for Medicines, Access and Knowledge, a non-profit organization which works on patent cases to increase access to drugs. Amin says the India case is likely to have far-reaching implications.
“Globally, I think a number of countries will look at this and say, “Well India stood its ground,” and will also realize that actually if India is standing its ground, even though it has a stronger geopolitical standing and can actually probably stand up to the U.S. and Europe a little bit more, I think other countries will also take notice of this and say, 'This is in our public interest and health interest to adopt patent laws that are somewhat similar,'” said Amin.
India exports some $10 billion worth of generic drugs every year and, along with China, produces about 80 percent of the ingredients that are used in the manufacture of drugs in the United States. India also produces generic versions of many popular drugs.
Novartis and other drug companies say the Indian court ruling may force them to pull their research dollars out of India.
Mark Grayson is a spokesman for the Pharmaceutical Research and Manufacturers of America, or PhRMA, which represents drug manufacturers.
“We’re disappointed in this ruling because we believe that this just shows a further deteriorating innovation environment in India," said Grayson.
Generic drug versions can be sold at a fraction of the cost of brand-name drugs. For example, Glivec can cost a patient around $70,000 a year, while the Indian generic versions costs around $2,500.
Grayson believes patients who can afford a drug like Glivec should pay full price.
“We believe we need to find ways to get economies that are growing to pay their fair share for the new medicines and the cost that it takes to develop a lot of this medicine," he said.
Grayson says 95 percent of the patients in India who can't afford Glivec can get it for free through a so-called "compassionate care" program run by Novartis.
But Tahir Amin of Initiatives for Medicine says cancer patients have reported that it has been difficult to obtain those free drugs.
“If you are going to be at the whim of philanthropy, then I think most people are not going to get drugs," he said. "And we’ve seen that in other cases as well, where they say we have access programs and so on and so forth. But only a certain percentage of the population or countries get it.”
But with drug development costs sometimes topping $1 billion, PhRMA’s Grayson fears that India’s patent ruling and others that may follow could slow the pace at which critically needed new drugs come to market.