Compulsory licensing

India lets pharma fight compulsory licenses

Tracy Staton — Mon, 07 Jul 2008 10:14:03 -0400

India's patent office has decided that drugmakers should be able to have their say before the country grants compulsory licenses, which allow domestic generics makers to export copies of patented medicines to countries that don't have the ability to make the drugs needed to combat a public health crisis. Report

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Brazil mulls patent-busting on Tenofovir

Mon, 28 Apr 2008 06:59:55 -0400

The Brazilian government recently deemed the anti-HIV med Tenofovir a "public interest." That's code for, "We're thinking about issuing a compulsory license for this drug." Under WTO rules, countries can circumvent patent protection on drugs it needs to combat a public health crisis. Brazil has some 600,000 people living with HIV.

Currently, Brazil treats 31,300 of those patients with Tenofovir at a cost of $1,387 per person. If the country imported a generic version made in India--at a cost of $170 per patient per year--it could save more than $30 million annually.

Gilead Sciences, which makes Tenofovir, had applied for patent protection for the med in Brazil. The country's health ministry formally dissented. The application remains under review by regulators.

- see the story at Domain B
- get some background in Forbes

ALSO: The U.S. Trade Rep is keeping Thailand on its naughty list for its new habit of issuing compulsory licenses, which allow the government to circumvent patent protection, on various drugs. The pharma industry had been lobbying to have Thailand downgraded. Release | Report

Dems back compulsory licensing

Thu, 10 Apr 2008 06:59:55 -0400

Now Rep. Henry Waxman and 26 of his Congressional counterparts are wading into the compulsory licensing fray. They're questioning U.S. Trade Rep Susan Schwab for her downgrading of Thailand after it issued patent-breaking licenses for three drugs. Though Schwab gave various reasons for putting Thailand on the trade watch list, the reps' letter says the move appears to be a condemnation of compulsory licensing itself. So they're asking Schwab to "reaffirm" the World Trade Organization agreement that allows for those compulsory licenses in public health emergencies at each Member country's discretion.

Can you hear the howling already? As you know, compulsory licensing is controversial in the drug industry; after all, it lets countries bypass the patents on brand-name meds so they can buy cheap copycats. Drugmakers are understandably reluctant. But proponents say that otherwise, patients in poor countries might never get access to the lifesaving meds they need. It's a complex issue, and a contentious one, so you can expect the debate to intensify--especially if Congress decides to get more involved.

- see the House Democrats' letter to the U.S. Trade Rep (.pdf)
- read the item at Eye on FDA
- check out Pharmalot's coverage

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