[Ip-health] Financial Times on ddI case in Thailand

[Mike Palmedo]

http://www.latimes.com/business/la-ft-aids1mar01,1,3034154.story?coll=3Dla-=
headlines-business

Dose of Optimism in Fighting AIDS
Bristol-Myers drops a patent battle, allowing Thais to make the drug
didanosine more affordable -- and perhaps set a precedent.

By Amy Kazmin
Financial Times

March 1, 2004

BANGKOK =97 With little fanfare, Bristol-Myers Squibb Co. in January
abruptly dropped a long-running patent battle against Thai AIDS patients
over its drug didanosine, one of the medicines that has made treatment
possible in the developed world.

The company said it would surrender its exclusive right to produce
didanosine tablets, which it sells under the brand name Videx, in the
country and would "dedicate the patent to the people of Thailand."

The unexpected move allows the Thai Government Pharmaceutical
Organization to begin its own production of didanosine tablets to sell
at a fraction of the price of the branded drug, which costs about $136 a
month, more than many Thais' monthly earnings.

Pharmaceutical companies have been reducing prices of AIDS drugs in
developing countries =97 and licensing generic versions =97 to counter the
perception that the industry is obstructing access by the world's poor
to lifesaving medicines.

Significantly, activists say, the sudden end to the legal wrangling over
didanosine in Thailand has left standing a court precedent with
potentially broad implications: the recognition of AIDS patients as
injured parties with legal standing to challenge patents.

"This case can be an example for other consumer organizations in other
parts of the world =97 if people cannot access pharmaceutical products,
they can use their rights to basic needs as a consumer," said Saree
Ong-somwang, director of the Foundation for Consumers, which has
campaigned for better access to drugs. "It's a real victory, and people
from other developing countries can learn from this experience."

A Bristol-Myers spokesman said the New York-based firm pulled out of the
legal battle because "the company believed it was to the benefit of all
parties to settle the litigation." He said he did not believe that
patents obstructed access to medicines in poor countries.

In 1999, the Thai Government Pharmaceutical Organization sought
permission from the Department of Intellectual Property for compulsory
licensing of didanosine tablets to make the drug more readily available.
Nearly 700,000 Thais were living with AIDS or HIV in 2001, according to
world health authorities.

But Bangkok's Commerce Ministry rejected the proposal, fearing trade
retaliation from the United States, its biggest single export market.
That left the pharmaceutical agency instead to make a powdered form of
the drug, which has greater side effects.

After the government backed away from the battle, the Thai AIDS Access
Foundation and two people infected with HIV, supported by academics and
activists, filed their own lawsuit against the patent in 2001. Their
complaint focused on the patent's unusually wide scope, in particular
its lack of specific dosage restrictions.

Courts in many countries have ruled that individuals cannot be
considered as parties who have been injured by drug patents, because
they have no intention of producing medicine themselves. In Thailand
too, Bristol-Myers lawyers argued that the AIDS patients had other
medical options and thus no standing to sue over the patent.

But in a groundbreaking legal decision, Thailand's Central Intellectual
Property and International Trade Court judged otherwise.

In October 2002, the court concluded that "medicine is one of the
fundamental factors necessary for human beings," distinct from other
consumer products. The court imposed restrictions on the scope of
Bristol-Myers' patent, saying: "Lack of access to medicines due to high
price prejudices the human rights of patients to proper medical care."

The interests of people in need of medicine are as legitimate as the
interests of drug manufacturers and sellers, the court said.

Encouraged by the initial victory, Thai activists filed a broader
challenge to the didanosine patent on the grounds that the drug,
invented by the U.S. National Institutes of Health, lacked sufficient
innovation to warrant patent protection.

Bristol-Myers appealed the Thai ruling before agreeing in January to end
its fight. Thai activists agreed to drop their broader lawsuit as part
of a deal between the company and the nongovernmental organizations.

That will leave standing a ruling that activists say could provide the
basis for challenging patents on other essential drugs in Thailand.
Likewise, they say, the ruling could inspire activists elsewhere to
undertake similar battles, though such offensives remain expensive and
difficult to mount.