Novartis ($NVS) lost its last bid for an Indian patent on its cancer drug Glivec. As the nation's Supreme Court prepared to rule Big Pharma braced itself for impact. India has blazed a patent-slashing trail over the last couple of years, issuing a compulsory license for Bayer's cancer drug Nexavar, revoking patents on drugs such as Pfizer's ($PFE) Sutent and Roche's ($RHHBY) Pegasys, and basically looking the other way when generics makers launch copies of on-patent meds.
What's happening in India is obviously worrisome for branded drugmakers. The industry's business model depends on intellectual property protections. But what's even more worrisome is the potential spread of Indian-style patent-fighting.
Already, patient advocates are calling on Greece to use compulsory licenses to alleviate drug shortages. Medicins Sans Frontieres recently urged South Africa to loosen up patent protections and consider compulsory licensing, too. The country "lags far behind because it still grants and protects patent monopolies of pharmaceutical companies, at the expense of South Africans' health," MSF South Africa spokeswoman Kate Ribet told Xinhua (as quoted by MedIndia).
Indeed, Ribet suggests that the big emerging markets like Brazil and China can and should save money on drugs by using compulsory licenses. And those countries are precisely where pharma hopes to find its next generation of growth.
Opening a path for cheap generics will get lifesaving treatments to more Indian patients, as MSF points out. It's hard to argue against the fact that more patients will use generics priced at a tiny fraction of the brand's cost--and even harder to argue that the poor shouldn't have access to high-tech drugs.
Naturally, however, drugmakers want to have say-so in these matters. Novartis says it's been providing Glivec for free to 95% of the Indian patients using it, and other Big Pharma companies use various means to get their drugs into the hands of poor patients. Roche is working on cheaper versions of its cancer drugs, to be sold in India under different brand names.
Meanwhile, the Indian saga is far from over. Glenmark Pharmaceuticals today launched its knockoff version of Merck's ($MRK) diabetes treatment Januvia. The Indian generics maker says its version doesn't infringe on Merck's patent, but the branded drugmaker disagrees. Another Indian drugmaker, BDR Pharma, has attracted global attention for targeting the Bristol-Myers Squibb ($BMY) cancer drug Sprycel for a compulsory license--and it's planning to file for four more, including Roche's Herceptin. And if BDR doesn't succeed, another generics maker probably will. The Indian government has said it plans to issue compulsory licenses on Herceptin, Sprycel and Ixempra.
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