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January 29, 2007

Thai Patent Snatch

Thailand has pulled the plug on patent protection for two drugs: Plavix, a blood-thinner, and Kaletra, a "second-line" treatment for HIV/AIDS. The move is not against World Trade Organization rules, called TRIPS, which allow a government to unilaterally declare a public health crisis and peddle patented drugs under compulsory license. Naturally, the drug companies are howling.

TRIPS (Trade-Related Aspects of Intellectual Property Rights) specifies 20-year patent coverage, but the so-called Doha Declaration, signed five years ago in Doha, Qatar, and ratified by 142 countries, including the U.S., allow poor countries to break drug patents and produce much cheaper generic versions under compulsory license, in the event of a public health crisis.

Plavix was originally developed by Paris-based Sanofi-Aventis SA, and is co-marketed in several countries by Bristol-Myers Squibb. The HIV treatment Kaletra is made by Abbott Laboratories.

Thailand had previously decided, last December, to force compulsory licensing for another HIV/AIDS drug, Efavirenz, patented by Merck.

Second-line treatments, such as Kaeltra is for HIV/AIDS, are used when patients develop effective resistance to primary treatment via first-line drugs. Second-line treatments are much more expensive. In Thailand, the Kaeltra second-line regime can cost more than 22,000 baht ($589) per month. Thai health officials estimated savings at 800 million baht ($24 million) a year. Essentially, the compulsory license cuts the cost of the drug by half to two-thirds.

Under the compulsory licensing scheme, the cost of Plavix is expected to drop by more than 90%, to 6 baht (18ยข) per tablet.

Public Health Minister Mongkol Na Songkhla said that, as it was, the government could only afford to provide treatment to one-fifth of the half-million Thais with HIV. Songkhla said the Health Ministry was willing to negotiate with companies about lowering imported drug prices. "We have to do this because we don't have enough money to buy safe and necessary drugs for the people under the government's universal health scheme."

"After the company does 10 years of research, and then suddenly the Thai government would like to impose the compulsory license, taking away their property, their assets -- this is not a good practice," said Dr. Teera Chakajnarodom, president of the Pharmaceutical Research and Manufacturers Association, a Bangkok-based industry group representing large international drug companies. "They claim that the drug is far too expensive for the Thai public to have access. But they never approached the companies before. Everything is negotiable."

Kannikar Kijtiwatchakul, a campaigner in Thailand for Doctors Without Borders, which backs the move, proclaimed that the Thai government made "a brave decision, despite both anticipated pressure from industry and possible threats to withdraw investments. The authorities have engaged in dialogue with companies before, but the discounts have been marginal."

Thawat Suntrajarn, head of the Health Ministry's Disease Control Department, said the generic copycats would initially be imported from India, but that production would then be transitioned to Thailand's state-owned drug maker.

($1=33.40 baht)

Posted by Patent Hawk at January 29, 2007 10:49 PM | International