E-DRUG: Malaysia invokes "Rights of Government" to allow generic ARV use
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dear E-druggers,
Malaysia has invoked section 84 of its patent act to allow the Minister
of Health to authorize a generic drug company to use patents on AZT,
3TC, AZT+3TC and ddI to supply inexpensive generic antiretroviral drugs
to AIDS patients. Under the Malay patent law, there are separate
provisions for compulsory licenses and "Rights of Government," and these
authorizations were made under the "Rights of Government" provision.
The decision by the Ministry of Domestic Trade to authorize the Ministry
of Health to invoke the Rights of Government provisions was made on
October 29, 2003, and announced publically in December by the Minister
of Health at a Conference on AIDS. Reportedly, the patent owners did
not appeal this decision within the time period (40 days) normally
allowed for an appeal.
The royalty for the authorization has not yet been set. Interestingly,
the US recently indicated it wanted to negotiate a Free Trade Agreement
with Malaysia, modeled after the Singapore FTA, which includes
controversial and restrictive language on the setting of compensation
for government use cases.
Not surprisingly, there has been some spirited industry lobbying on
this, including for example efforts on behalf of BMS by Phil Kaplan, a
former US State Department official (who obtained the rank of
Ambassador), now a partner in the Washington DC office of Patton Boggs,
objecting to the authorization to use the ddI patent.
The government notes that the authorization will allow the Department of
Health to obtain less expensive ARV drugs, and increase the number of
persons who receive HAART treatment -- which is necessary for the
patient's survival.
Jamie
--
James Love, Director, Consumer Project on Technology
http://www.cptech.org, mailto:james.love@cptech.org
tel. +1.202.387.8030, mobile +1.202.361.3040
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