In 2007, Thailand was involved in a dispute over the granting of compulsory licenses on medicines, including the patents used for Kaletra, an Abbott drug used in the treatment of AIDS. Kaletra is the brand name for a fixed dose combination of lopinavir and ritonavir (LPV/r) — two drugs invented at Abbott on an NIH grant. In 2007, LPV/r was the preferred combination for protease inhibitor regimes used to treat AIDS. The compulsory licenses were issued in order to ensure that Thailand’s large population of AIDS patients would have sustainable access to LPV/r, when patients developed resistance or low tolerance to first-line treatment options.
In March 2007, Abbott announced a controversial retaliation — it withdrew drug registration applications in Thailand for seven drugs. The following is a cable authored by Ralph L. Boyce, then the U.S. Ambassador to Thailand. The Boyce cable shows that the U.S. government was (1) very aware of the adverse health consequences of the withdrawn drug registrations, and (2) supportive of Abbott’s actions.
The Boyce cable is one of several State Department cables obtained by KEI under a FOIA request that detailed the close surveillance and pressure put on the Thai government by the Bush Administration. Two years later, the Obama Administration placed Thailand on the 2009 Special 301 priority watch list, citing Thailand’s earlier decision to grant compulsory licenses on drug patents.
A PDF of the Boyce cable is available here.
The key passages follow:
R 142323Z MAR 07
FM AMEMBASSSY BANGKOK
TO: SECSTATE WASHDC 5544
ASEAN MEMBER COLLECTIVE
USDOC WASHINGTON DC
DEPT OF HHS WASHINGTON DC
UNCLAS BANGKOK 001524
STATE PASS USTR FOR B. WEISEL, C. WILSON
STATE PASS USPTO
HSS/OHGA FOR AMAR BHAT
USDOC FOR JKELLY
TAGS: ECON, ETRD, KIPR, TH
SUBJECT: ABBOTT LABS HALTS NEW DRUG REGISTRATIONS
1. Abbott Labs, the recent target of a compulsory license on their patented antiretroviral Kaletra, confirmed to Embassy that the company had withdrawn applications for registration of seven new pharmaceutical products in Thailand, and had no plans to introduce new products until its intellectual property was properly respected. The seven drugs include Aluvia, a new heat-stable version of Kaletra. Although the two drugs are identical in effect, the new version is considered ideal for tropical environments such as Thailand. Other drug applications pulled include treatments for hypertension, kidney disease, auto-immune disease and congestive heart failure. . .
4. Comment: Abbott’s actions will certainly be controversial. However, the action may strengthen the hand of Abbott and the rest of industry in future dealings with the RTG. Abbott’s move puts the RTG on notice that there are visible consequences for its actions, rather than solely a vague weakening of the investment environment. Whether this focuses the minds of RTG officials at upcoming negotiations remains to be seen. End comment.