Bristol-Myers catches a break as Indian agency delays Sprycel patent decision

Indian Prime Minister Narendra Modi

Prime Minister Narendra Modi got an earful from both constituents and the U.S. drug industry about India's approach to drug patents during his first visit to the U.S. last month. Three weeks later, there is evidence the government will take a considered approach to the contested issue.

India's Department of Industrial Policy and Promotion, or DIPP, has delayed a decision on whether to grant a compulsory license for Bristol-Myers Squibb's ($BMY) leukemia drug Sprycel, The Economic Times reports. It has sent the ministry a letter, questioning its rationale for saying there was a "national emergency" when chronic myeloid leukemia affects only 0.001% of the population, a source told the newspaper. The letter asked how much the government is spending on the drug, and pointed out that there is no indication of a growing trend in the disease.

Western drugmakers have been very vocal about what they perceive as India's activist approach toward their intellectual property. Pfizer ($PFE) suffered the loss of IP protections on its cancer drug Sutent when Indian patent officials decided last year to revoke its patent. Roche ($RHHBY) fought for years over its patent on Herceptin before letting it go there.

While India has the power to grant compulsory license for medications it thinks are lifesaving but too expensive, so far it has granted only one, for Bayer's cancer drug Nexavar. But reports before the election of Modi said that an Indian committee was reviewing up to a dozen on-patent therapies to see whether additional compulsory licenses could be issued. The ministry of health has repeatedly asked that DIPP grant a compulsory license for Sprycel, the Economic Times points out.

Industry group PhRMA has urged the U.S. to keep pressure on India, which is already on the the U.S. Priority Watch List--a distinction for those countries whose IP-protection practices Washington believes bear close monitoring. This week the Office of the Trade Representative (OTR) started an "out-of-cycle" review of India's progress, while pointing out the two countries have agreed to work more closely on the matter.

At the same time, Modi has heard from plenty of groups urging him not to give into pressure from the U.S. While he was here for meeting, Doctors Without Borders (MSF) publicly called for him to stand strong. In an op-ed piece the charitable medical group said, "Every country has the right to set policies that balance private business interests with public health needs."

- read the Economic Times story
- here's the OTR announcement

Special Report: Top 20 orphan drugs by 2018 - Sprycel

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