Thai Victory On Aids Drug Patent

[eric1000]

Thai victory on Aids drug patent paves way

Thu Feb 19, 3:45 PM ET

By Amy KazminPossible quote from BMS to come.

With little fanfare, Bristol- Myers Squibb, the US pharmaceutical group, last month abruptly dropped a long-running patent battle against Thai Aids patients over its drug didanosine, one of the medicines that has made Aids a treatable disease in the developed world.

In a comment to reporters, a BMS official said the company would surrender its exclusive right to produce didanosine tablets - which BMS 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 Organisation 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' total monthly earnings.

Pharmaceutical companies have been reducing Aids drugs prices in developing countries - and licensing generic manufacturers - to counter the perception that the industry is obstructing access to lifesaving drugs by the world's poor.

But campaigners for drug access say the sudden end to the legal wrangling over didanosine in Thailand has also left standing a unique 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 organisations in other parts of the world - if people cannot access pharmaceutical products, they can use their rights to basic needs as a consumer," says 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," he said.

A spokesman for BMS said the New York-based group 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 GPO sought permission from the Department of Intellectual Property for compulsory licensing of didanosine tablets to make the drug available to more of the estimated 700,000 Thais living with HIV (news - web sites).

But with deep fears of trade retaliation from the US - its biggest single export market - Bangkok's Commerce Ministry rejected the proposal, leaving the agency instead to make a powdered form of the drug, which has greater side-effects.

After the government backed away from battle, the Thai Aids Access Foundation, and two people infected with HIV, supported by academics and other activists, filed their own lawsuit against the patent in 2001. Their complaint focused on the patent's unusually wide scope, since it had no specific dosage restrictions.

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

But in a ground-breaking 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", saying it was distinct from other consumer products and imposed restrictions on the scope of the company's patent.

The Thai court said: "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, it added.

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

BMS appealed against the Thai ruling but is now dropping its appeal. Thai activists are dropping their broader lawsuit, as part of a deal last month between the company and the non-governmental organisations.

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

"It sets up the precedent in Thailand about the legal rights of the civil society to challenge the validity of the patent," said Jakkrit Kuanpoth, a lawyer and intellectual property rights expert at Sukhothai Thammathirat Open University, who advised the Thai activists.

"The problem is not the didanosine as such - there will be many other essential medicines that poor people in developing countries badly need," he said.

"It depends on the policy of each company, each patent holder, whether they negotiate and compromise with the public.

"If the price [of a key drug] is too high and raises a barrier to access to medicine, civil society will have to fight again."

[Suzy]

Videx is usually prescribed as part of the initial cocktail for treatment of HIV. After 12 months my system aclimatised to this drug and it had little effect necessitating a move to other medication. Needless to say not every item in the second combination is available in Thailand requiring me to return to UK frequently to stock up on medication. What is available in Thailand is excessively priced and the cost of the return fare together with hotel costs is far lower than the cost of treatment purchased here.

With so many HIV cases in Thailand the country is in a desperate situation if the medical authorities can only offer around 12 months basic relief for HIV patients. Thereafter there is little hope of extending let alone saving lives. The Thai government is not totally to blame. The pharmaceutical companies should be able to assist in sponsoring the costs of these medicines in Thailand so that the afflicted Thai nation can enjoy a better standard of living.