Drugmakers Struggle with Indian Patents

India's market for international pharmaceuticals was thrown into turmoil in October when the country's patent office revoked Pfizer's local patent for Sutent (sunitinib malate), which is used to treat advanced renal cell carcinoma and gastrointestinal stromal tumors.

In addition, Bayer is currently appealing a patent office decision to let an Indian generics company copy its renal cell carcinoma drug Nexavar (sorafenib), and Novartis has been battling since 2006 to win patent protection for Glivec (imatinib mesylate).

While the Indian government says it is simply protecting customers who otherwise can't afford lifesaving treatment, analysts with GlobalData, a business intelligence provider in London, say that the issue is more complicated.

For the government, “it's a massive balancing act,” says Irfaan Dawood, MBA, an oncology analyst with GlobalData. “They have to make sure that patients can afford the drugs, and that the generic companies continue thriving.”

The government's claim of wanting to keep the drug affordable may be a bit arguable, given the vast economic disparities between rich and poor, points out Ramya Kartikeyan, PhD, a senior analyst at GlobalData. The relatively few Indians at the highest end of the income spectrum can readily manage Glivec's $2,200 monthly price tag, whereas most people cannot afford even the generic price of $170 per month, given an average annual per capita income estimated at below $200.

Many low-income patients already have access to Glivec. Of the 15,690 patients currently treated with Glivec in India, 15,155 have received the drug for free under the Glivec International Patient Assistance Program, Dawood says. Another 370 patients have been given a substantial discount, and only 165 patients have paid the full amount. Many patients who might benefit from Glivec, however, are not treated.

The government is also expected to expand its program of pricing caps for “essential” drugs. Right now, 74 drugs must be sold solely for the cost of manufacture, with no profits. That program is expected to broaden to 348 drugs, including about 30 for treating cancer.

Pharmaceutical companies could get frustrated with the Indian government's actions and pull out of the country. However, Elizabeth DelGiacco, MPH, another GlobalData senior analyst, thinks that's unlikely. Drug suppliers “don't want a domino effect,” she says, with China and other emerging markets following India's lead.