Ruling thrills patients and boosts Indian generic drug makers

DELHI -- A recent Indian Supreme Court ruling set tough patent standards on drugs, dropping the price of a cancer medicine that costs $2,600 a month to a $175 monthly charge instead.

The Supreme Court of India in Delhi

DELHI -- In a widely reported judgment at home and abroad, India's top court last month turned down a patent for a cancer drug costing $2,600 a month, in a huge victory for Indian generic drug makers who can now continue to sell it for $175 a month.

While Swiss drug maker Novartis said that the ruling discouraged innovation, it was hailed by legal and health experts as a balanced decision that set tough standards for innovation as well as protected consumers from being charged high prices for newer versions of drugs that did not have greater healing power than the older versions.

Patients suffering from chronic myeloid leukemia, who can't afford the monthly costs for Gleevec, welcomed the decision of the Indian Supreme Court.

“Everybody is very jubilant,” said Y.K. Sapru, head of the Cancer Patients Aid Association (CPAA), the non-profit organization, which fought the Novartis patent case for seven years.

“If we had lost the case then patients would have died,” he said.

The CPAA, which runs on domestic and international donations, provides around 3,000 patients every year with anti-cancer generic drugs for approximately 6,000 rupees a month, or $120. The non-profit subsidizes drug costs further depending on the economic condition of the patient and also gives the medicines for free.

Manish Sarvaiya, 42, who suffers from chronic myeloid leukemia, is thrilled with the judgment because he can now continue to purchase his monthly supply of anti-cancer drugs from CPAA for 1,850 rupees a month or about $20.

“With household expenses, and sending two children to school, there is no way I could afford high-cost medicines of foreign companies,” said Sarvaiya, who sells incense sticks door-to-door in Mumbai.

“I am lucky that I get help to cover costs,” he added. "But the judgment will also benefit so many people who will buy medicines in the market.”

Jyotsana Govil, member of the Indian Cancer Society, which spreads awareness about cancer and provides low-cost screenings, said that almost 85 percent of cancer patients in India bear their own expenditure.

“Very few have the option of medical cost reimbursement by government or an insurance company,” she said. “The rest have to get a generic substitute and if it isn’t available then they go home and die.”

Following the judgment, Novartis said that through its donation programs, it provided Gleevec free of charge to 95 percent of patients prescribed the drug in India, which worked out to $1.7 billion worth of drugs since 2002.

Viji Venkatesh, the country head of The Max Foundation, a U.S.-based non-profit, which runs the Gleevec donation program in India, said that 500 oncologists now send patients to take advantage of the program, which has grown from a few hundred patients in 2002 to over 16,000 today -- a number that does not include chronic myeloid leukemia patients who are on generic drugs or have no access to drugs.

Health experts said that chronic myeloid leukemia is the fastest-growing leukemia among adults in India, with 20,000 to 30,000 patients being added every year.

And these experts are also of the view that essential medicines should be affordable for patients as a matter of policy and not charity, which can be pulled back any time.

To this end, the Supreme Court judgment is welcomed for not only for denying Novartis’ patent plea, but also for raising the patentability criteria for other essential medicines in the future.

And the patentability criteria in India impacts the global supply chain of affordable drugs. Often described as the pharmacy of the world, the country's pharmaceutical industry produces over two-thirds of all of generic medicines used in low- and middle-income countries, including over 80 percent of all HIV and AIDS medicines, according to Oxfam.

In 2001, Indian generic drug manufacturer Cipla’s supply of HIV and AIDS drugs brought the cost of medication down from $30 a day to $1 a day, which, health experts say, saved millions of lives this past decade.

The Indian pharmaceutical industry, valued at $12 billion in 2010, is expected to grow to $74 billion in sales by 2020, according to a study by PricewaterhouseCoopers.

Following the judgment, Novartis, which had applied for the patent in 2006, said that the ruling “discourages innovative drug discovery essential to advancing medical science for patients.”

But the Indian Supreme Court ruled that the compound for which the patent was sought did not qualify as an invention because it wasn’t a significant improvement from an earlier version of the drug on medical grounds.

The judgment hinged on a provision in Indian patent law, which states that “the mere discovery of a new form of a known substance which does not result in enhancement of the know efficacy of that substance is not patentable.”

Sudip Chaudhury, an economic professor at the Indian Institute of Management, Calcutta, wrote in the Economic and Political Weekly that the Supreme Court interpreted efficacy to mean therapeutic efficacy, and decided that the compound under question did not necessarily improve therapeutic effect.

Chaudhury explained that the judgment counters the practice of ever-greening, which involves multinational pharmaceutical companies trying to delay competition by getting secondary patents on minor changes to drugs, and it also protects consumers from paying higher prices just because a drug has new chemicals even if it does not have improved therapeutic value.

In an interview with SmartPlanet, Chaudhuri said that a country still developing its own research capacity is justified in providing affordable medicine by denying patents to foreign companies.

Chaudhuri added that with the exception of the United States, which has always followed a product patent policy, countries like France, Germany, Switzerland and United Kingdom only started patenting drugs after their own companies achieved substantial innovation capabilities.

The implication, Chaudhuri pointed out, is that drug companies in India could be "free-riding" on the innovation of  foreign companies until they developed their own expertise.  "And you can argue that’s it’s a moral question,” he said.

Photos: Thumbnail: ( (Supreme Court of India website)

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