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India blacklisted

The Obama Administration has placed India on a priority trade 'watch list' allegedly over lack of intellectual property protection. But the decision contained in the Special 301 report of the United States Trade Representative, announced in May, has not greatly ruffled India's generics industry. “India has been on this list for years,” says Yusuf Hamied, chairman of Mumbai-based Cipla, among the world's largest producers of cheap, generic medicines. “With a population of 1.3 billion and an alarming disease profile, India should not be swayed by outside pressures to alter its chosen course appropriate to its own interests,” he says. India found itself on the blacklist after a string of setbacks to innovator pharma companies—the latest being a court's refusal to extend patent protection to Basel-based Novartis for a new version of its leukemia drug Gleevec (imatinib; Nat. Biotechnol. 31, 371, 2013). The US concern that the court ruling “may limit the patentability of potentially beneficial innovations,” as stated in the special report, is refuted by the Indian Pharmaceutical Alliance. According to a spokesperson, “Indian patent law does not discriminate between domestic and foreign companies but only distinguishes between innovation and discovery of new forms of known substances that do not result in enhancement of efficacy.” The US report urges India to adopt a policy “that strikes a balance between innovation to address important health challenges and a robust generic market.” India insists its patent law does exactly this: it fosters innovation and contains safeguards designed to protect public health. But Darren Smyth, patent attorney at law firm EIP, says that by tinkering with the intellectual property system, India undermines the balance between originators and generics that is essential. “India has elected to become a generics-only jurisdiction, in[to] which originators would probably choose not to enter, and healthcare needs would be met almost entirely by generics companies,” he says.

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Jayaraman, K. India blacklisted. Nat Biotechnol 31, 578 (2013). https://doi.org/10.1038/nbt0713-578a

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