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Thai AIDS activists score victory over pharmaceutical giant

Bangkok, Thailand

A ruling by a Thai court struck down a pharmaceutical giant’s exclusive rights to produce and sell antiretroviral tablets to treat HIV infections, opening the way to greater access to cheaper drugs for HIV/AIDS patients.

Meanwhile, Thai consumer and HIV/AIDS groups filed another lawsuit against the company, Bristol-Myers Squibb, challenging the validity of its patent for the drug. Activists say the court challenges are a case study in how to make lifesaving medicines available and affordable to people in the developing world.

In early October, Thailand’s intellectual property rights court ruled that an amendment to a patent held by Bristol-Myers Squibb for didanosine (ddI) was invalid. The ruling means that Thailand’s Government Pharmaceutical Organization, a state enterprise, can produce a generic formula of didanosine tablets at considerable cost savings to HIV/AIDS patients.

Bristol-Myers Squibb, a multinational $19 billion pharmaceutical and health care products company, has until Nov. 30 to appeal the judgment.

The Government Pharmaceutical Organization, which was a plaintiff in the recent case against Bristol-Myers Squibb, currently makes ddI in a powder form, but the court ruling would allow the state enterprise to begin manufacturing ddI in tablets, which are more convenient, easier for patients to ingest and have fewer side effects.

Eight days after their first court victory, Thai consumers and HIV/AIDS activists filed another suit in the Thai intellectual property rights court alleging that Bristol-Myers Squibb’s patent is invalid because of problems with the patent application and with patent office procedures.

Of the estimated 1 million people with HIV/AIDS in Thailand, 60,000 need antiretroviral medications, said Kamon Uppakaew of the Thai Network of People Living with HIV/AIDS. But only about 10,000 have regular access to the drugs, he said.

“The barrier to that is cost,” Uppakaew said.

Didanosine, sold by Bristol-Myers Squibb under the brand name Videx, costs approximately $2.56 to $4.11 per dosage, in a country with a daily minimum wage of $3.84.

Thailand’s Government Pharmaceutical Organization manufactures affordable drugs for distribution through public hospitals and clinics, which currently includes 13 items under its anti-AIDS program. According to Kanchorn Balangula of the agency, generic versions of these drugs are about 50 percent cheaper.

In 1992, the agency began researching two generic antiretroviral drugs: AZT (zidovudine) in capsule form and ddI in tablet and powder forms. The agency’s AZT entered the market in 1995, but ddI tablets were never produced because of Bristol-Myers Squibb’s patent.

The U.S. government-funded National Institutes of Health developed ddI in 1989. (Ironically, some of the field research was done in Thailand.) The institute licensed the marketing rights for ddI tablets to Bristol-Myers Squibb.

Because stomach acid reduces the action of ddI, the original tablet form of the medication had to be taken with an antacid. Bristol-Myers Squibb developed a formulation that combined an antacid with ddI. Based on this formulation, the company applied for and received patents first in the United States, then in other countries.

Looking for ways to make lifesaving drugs cheaper, a coalition that included the Thai Network of People Living with AIDS/HIV, Doctors Without Borders, the Catholic Camillian Social Center in Rayong and the Thai Foundation for Consumers filed suit -- with representation from the Thai Law Society -- on May 9, 2001, with Thailand’s Court for Intellectual Property Rights and International Trade. On Oct. 1, 2002, the court ruled in favor of the plaintiffs.

While victory in the first case will help put medicine in the hands of people who now cannot afford it, the case filed Oct. 9 could lead to reform of Thailand’s patent system. It raises a number of issues about the patent itself and about how the patent was granted.

The lawsuit challenges the legality of Bristol-Myers Squibb’s patent on the grounds that its formulation of ddI does not show “significant inventive steps or novelty,” a patent requirement. For this reason, Bristol-Myers Squibb’s U.S. patent application for the antacid additive was denied twice before being accepted, according to Paul Cawthorne, country coordinator for Doctors Without Borders in Thailand.

Saree Aongsomwant of the consumer foundation said that the second lawsuit also looks at issues of transparency and procedures in how Thailand grants patents. She said that Bristol-Myers Squibb applied for a product patent in July 1992, but Thailand had no product patent law at that time. Furthermore, Aongsomwant said, the committee that reviews pharmaceutical patent applications has no experts on drugs or chemicals.

Aongsomwant tied Thailand’s court battles to the current round of trade talks of the World Trade Organization, called the Doha Round, which is looking at drug patents as part of its intellectual property rights agenda.

“Doha says that each country has the right to ensure access for its people to medicines,” she said. “Intellectual property rights can have a negative impact on people’s lives. DdI is a case study of that.”

Uppakaew of the Thai Network of People Living with HIV/AIDS said, “We understand that the private company has invested money to produce the drug and it needs to get money back. But the price must be fair. You shouldn’t make a lot of profit out of people’s lives.”

Free-lance writer Dennis Coday lives in Bangkok, Thailand.

National Catholic Reporter, November 29, 2002