Will compulsory licensing hit Roche, Glaxo?

The World Health Organization's hike in pandemic threat level triggers certain pharma-related events, particularly the release of antivirals from government stockpiles around the world. And with those stockpiles being deployed, naturally FDA et al are coordinating with Roche and GlaxoSmithKline to get replacement stocks of their flu meds Tamiflu and Relenza.

Another less-appetizing prospect, for the two drugmakers anyway, is the fact that with a public health emergency underway, the World Trade Organization allows various countries to buy from low-cost suppliers, a.k.a. generics firms, despite the fact that both meds are still under patent. This "compulsory licensing" process allows poor nations to gain access to meds they can afford, in the event of an epidemic. Intellectual property protections can quickly be trampled by officials aiming to protect their citizenry--and by politicians looking to score some points in the process.

Already India has asked Cipla and Ranbaxy Laboratories for bids on unlicensed Tamiflu copies. (The government also requested a proposal from Roche itself and Hetero Drugs, an Indian firm that has a Roche license.) And Cipla says it's getting inquiries from all over the world. "We have received some inquiries from Mexico, Israel, New Zealand and Latin America, but nothing has been finalized in terms of exports," joint managing director Amar Lulla told Reuters.

Some countries have asked the World Trade Organization for their rights to override patent coverage on various drugs, particularly anti-AIDS meds. Brazil issued a compulsory license on Merck's Efavirenz back in 2007, for example, and Thailand threatened (though didn't follow through) on compulsory licensing of four big-name cancer remedies. Whether compulsory licensing will come into play in this H1N1 outbreak remains to be seen; we'll be watching.

- read the Dow Jones story on India
- get more from India from AFP
- see the Reuters story
- check out the Economic Times article

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