The battle between pharmaceutical giants and AIDS activists is approaching a pivotal point in Thailand, raising the potential for drastic changes in Thailand’s patent system and paving the way for making essential drugs more affordable in impoverished countries.
AIDS activists in Thailand have been pushing the government to strip Bristol-Myers Squibb (BMS) of their patent rights to the antiretroviral drug didanosine (ddI) which is used to treat HIV/AIDS patients. BMS markets ddI under the trade name “Videx”. ddI was first developed in the United States in 1989 by the National Institutes of Health. NIH subsequently licensed the marketing rights of ddI to BMS. NIH’s formulation of ddI required that it be administered with a separate antacid because stomach acid reduces the potency of the drug. BMS improved upon NIH’s formulation creating a single tablet that contained ddI combined with the appropriate amount of antacid.
BMS filed its first patent application for the ddI formulation in 1991. All claims were rejected for obviousness and the application was abandoned. The patent examiner stated that combining ddI with the optimal amount of antacid was already well known and within the ordinary skill level in the art. BMS filed a second application in 1997 and all claims were once again rejected for obviousness. This time the examiner explained that the combination of ddI with an antacid was obvious but failed to deem obvious the optimization of the amount of antacid. BMS argued that the claims were based on their system of optimizing the amount of antacid which itself is unobvious. The examiner finally accepted the claims after requiring an amendment limiting the invention to specific ingredients and proportions. In 1992, BMS filed a patent application for the ddI formulation in Thailand containing the same claims as those rejected in the second U.S. application. The patent was granted however, giving BMS exclusive marketing rights to ddI tablets in Thailand.
Videx costs between $2.56 and $4.11 per dose. While this price may not seem high in the wealthier countries of the world, it is exorbitant in Thailand where the daily minimum wage is $3.84. Affordability of brand name drugs has been an ongoing problem; however, Thailand’s Government Pharmaceutical Organization (GPO) has been able to produce generics at half the price of their brand name equivalents. The GPO began to do its own research on ddI and has been successful in producing a powder form which it sells at a relatively low price. BMS’ patent is blockading the production of ddI in tablet form which are more convenient, easier to ingest and have fewer side effects. So AIDS activists are pushing the Thai government to restrict BMS’ rights and allow the GPO to produce generic ddI tablets.
On May 9, 2001, two Thai AIDS patents and AIDS ACCESS foundation filed suit in Thailand’s Central Intellectual Property and International Trade Court to limit BMS’ exclusive right to produce ddI tablets. On October 1, 2002 the court ordered BMS and the Department of Intellectual Property (DIP) to amend BMS’ patent, limiting BMS’ exclusive rights only to doses of five to one hundred milligrams. In effect, this ruling would allow the GPO to produce generic tablets in doses greater than one hundred milligrams without infringing on BMS’ patent.
Although seen as a landmark case, the effects of the ruling have yet to be realized because there are still more legal battles ahead. In December of 2002, BMS and DIP filed an appeal. In response, the GPO sought temporary court immunity to allow them to produce the tablets and avoid liability while the appeal is pending. DIP and BMS both requested deferral of enforcement of the ruling so they can resume producing tablets at any dosage. AIDS activists have been pressuring government officials to withdraw the deferral request. The court’s decisions on these requests and the appeal will weigh much more heavily in determining BMS’ fate in the ddI market.
Even if BMS is successful on appeal, they still have bigger problems to contend with. On October 9, 2002, shortly after the court’s first ruling, AIDS activists filed another suit seeking to completely invalidate the BMS patent challenging the patent on the grounds of improper patent application and patent office procedures. They claim there were no real product patent laws in place in Thailand at the time the patent was granted and that there are no drug or chemical experts on the committee that reviews pharmaceutical patent applications. Further, they claim that the patent should have never been granted because the ddI formulation lacks “significant inventive steps or novelty”. This argument mirrors the reasons for the rejection of the original claims of the U.S. patent application. If BMS did not really contribute any great innovation, then public policy does not support protection of its patent. After all, the United States government was the original inventor of ddI, so enforcement of the patent seems like a windfall for BMS who did not have to invest much capital in research and development of the drug.
Although the AIDS activists may have public policy and the U.S. patent system supporting their arguments, they have quite a large disadvantage - time. Even if they are successful in limiting or completely eliminating BMS’ exclusive rights to ddI, it could take as long as ten years for the GPO to get permission to start marketing a generic version. Sadly, although the future prospects are promising, those suffering from HIV/AIDS today are left with limited options.
Related Links:
Aphaluck Bhatiasevi, HIV/AIDS- Bid to Quash Property Rights on all
Doses of Antiviral,
Bangkok Post, Oct. 10, 2002.
Thai AIDS Activists Demand Government Drop Support for Bristol-Myers Patent, Agence France-Presse, Jan. 14, 2003.
Information on BMS's ddI Patent:
