Black Case No. Tor Por 34/2544
Red Case No. Tor Por 93/2545
Subject: Thai Patent No. 7600 (Improved Oral Dosing Formulations of Dideoxy Purine Nucleosides)
AIDS Access Foundation and 2 HIV infected persons jointly filed a law-suit against Bristol-Myers Squibb Company Limited (“BMS’) and the Thai Department of Intellectual Property (“DIP”) as Defendants with the Central Intellectual Property and International Trade Court (“IPIT Court”).
The background and legal justification of the case.
Currently, there are more than 1 million people with HIV/AIDS in Thailand. In addition, since the start of epidemic in 1984, about 300,000 people with HIV/AIDS have died. This situation is a crisis for healthcare in Thailand because many of those who have died or are currently being ill are the wage earners for their families, and the workforce of the country.
Antiretroviral drugs are the best treatment for HIV/AIDS patients and are standard of care in Western countries. However, these life-saving medicines often cannot be accessed in developing countries because they are extremely expensive. The high price is linked with the monopoly on many of these drugs held by Multi-National Pharmaceutical companies. These monopolies are, in turn, linked with patent protection. Patents are complicated because there is no international patent and so the patent protection status of each drug is different in every country.
Where possible, the Thai Ministry of Public Health provides high quality antiretroviral drugs at reasonable cost - generic versions of antiretroviral that are not patent prtected under Thai law are manufactured by the Thai Government Pharmaceutical Organisation.
The Government Pharmaceutical Organisation (GPO) has researched two generic antiretroviral drugs since 1992: AZT (zidovudine) in capsule form and ddI (didanosine) in both tablet and powder forms. AZT then was marketed in 1995, but ddI tablet has never been produced because a patent for ddI was granted to Bristol-Myers Squibb (BMS) on 22 January 1998.
In recent years, AIDS activists in several countries have looked for ways to overcome barriers to treatment access, including the key barrier of patent protection. On 22 and 23 December 1999, the Thai Network for People Living with HIV/AIDS (TNP+) requested the Minister of Public Health to issue a compulsory license so that GPO could produce generic ddI tablets. However, Thai legislation was amended in 1998 under threat of trade sanctions by the US and the new legislation dose not easily permit compulsory license.
Thai legal and pharmaceutical experts (from The Health and Development Foundation, Drugs Study Group and Social Pharmacy Research Unit of Chulalongkorn University, Faculty of Law of Sukothai Thammathirach University and the Thai Law Society) reviewed the Thai ddI patent, which was for the tablet formulation only: the powder formulation was not patent protected. Therefore the Minister of Public Health was able to avoid issuing a compulsory license but the GPO could still produce generic ddI in a powder form. Thus a legal means of overcoming this patent was found which did not require Thailand to take the difficult step of issuing a compulsory license. This shows that in order to overcome the barrier of a patent it is necessary to know clearly exactly what is patented.
On 7 May 2000, three Thai NGOs - the Thai Network for People Living with HIV/AIDS (TNP+), AIDS ACCESS Foundation and the Centre for AIDS Rights - wrote a letter of request for legal assistance from the Law Society for advice on the rights People Living with HIV/AIDS to access ddI. In order to serve this request from civilians, the chairman of the Law Society then set up a working group of lawyers on 1 June 2000.
Further analysis of the ddI patent granted to Bristol-Mayer Squibb Co., Ltd. (BMS), revealed inconsistencies in the patent application file. When the ddI patent application was first filed, the BMS claim was restricted to a dosing range of 5 to 100 mg. This same claim was also published in the Thai Patent Gazette. However, after the publication period had lapsed more than 3 years, BMS filed with the DIP a request for an amendment of claims. In effect BMS made a broader claim without specifying the range of quantity per dosage of ddI. Moreover this amended claim did not conform to the detailed description of the invention previously disclosed to the DIP
On 22 January 1998, the DIP granted BMS a patent for its ddI formulation, under which BMS’s exclusive rights are broader than its formulation originally filed for the patent.
Issuance of such patent caused BMS to have the exclusive right in producing and selling ddI formulation regardless of the quantity of ddI per dosage. Other pharmaceutical producers cannot produce or sell such ddI formulation of BMS, even though in case of production of the ddI formulation which contains more than 100 mg of ddI. Thus, AIDS Access Formulation and HIV infected person to be the damaged parties such persons were effected by the ddI patent and have to buy anti-viral decease drug produced under the patented formulation of BMS in high price because no one can produces it.
Legal action against BMS on the range of ddI tablet was begun on 9 May 2001 at the Central Intellectual Property and International Trade Court, Bangkok, Thailand. In the suit, the plaintiffs requested the Court to adjudicate that both Defendants had illegally amended BMS’s claims under its patent of ddI Formulation. This amendment gave BMS unlimited exclusive rights under the issued patent.
On 1 October 2002, the IPIT court ruled in its judgment that the Aids Access Foundation and the HIV infected plaintiffs are injured parties, who have the power to sue the Department of Intellectual Property and BMS for the reason that pharmaceuticals are important elements for human survival. In addition, the Court adjudged that the DIP and BMS shall jointly amend the Patent No.7600 with respect to the claims thereunder to the effect that the particulars on the quantity of the contents in the ddI formulation which were previously released be inserted into the claims.
In the said judgment, the Court reasoned that the dispute patent must specify the quantity of the contents. The deletion of the particulars in the claims of BMS in the patent in connection with the quantity of the contents is considered as a material change made to the patent application. This is because such deletion results in the unlimited protection of the dispute patent. Another reason given in the judgment was that the said material change to the patent application was unlawful as such change was effected after the patent application was published in the Patent Gazette without the permission of the Director General of the DIP as required by law.
As a result of the judgment, other pharmaceuticals producer may produce ddI using the formulation with different quantity from that specified in the claims under the patent as amended in compliance with the judgment without any infringement of the patent of BMS.
“ …The deletion (of claims) can be considered as an adding specification of invention. As a consequence, the deletion of ‘from 5 to 100 mg. Per dosage’ from the existing (patent) claims has significantly changed the scope of the patent claims as the patent holder will obtain patent protection from the formulation without any limitation of the quantity per dosage which will be broaden than the range specified in the previous claims. Under this circumstance, the amendment (of the patent claims) has significantly changed the scope of invention to be protected according to new claims will be broaden or beyond the range discussed in the specification of invention which was disclosed at the range of 5 to 150mg per dosage. Therefore, the deletion of ‘from 5 to 100 mg’ per dosage from the patent claims is deemed to be adding addition of substance of invention which is prohibited by law”.
Excerpted from the Central Intellectual Property & International Trade Court Judgement
No. 93/2545 given on 1st October, 2002
Key points to emerge from this case are
• The court ruled that in this case the amendment which removed the dosing range was a significant widening of the rights of BMS (and by implication a narrowing of the rights of the consumer).
• This alteration to the would have gone unchallenged unless civil society took an interest in the issue.
• Thai consumers have utilised their right under Thai law to mount a legal challenge to a Trans-National Pharmaceutical Company.
• Patent applications should be clear and transparent in order to protect the rights of both manufacturer and consumer.
Statement prepared by Medecins Sans Frontieres (Belgium) - Thailand Office, with technical assistance from legal experts, on behalf of the members of the Working Group on the ddI Patent:
• Thai Network for People Living with HIV/AIDS (TNP+)
• Thai NGOs Coalition on AIDS (TNCA)
• AIDS Access Foundation (ACCESS)
• Foundation For Consumer (FFC)
• Center for AIDS Rights ( CAR )
• Medesins Sans Frontieres-Belgium, Thailand (MSF-B)
• The Law Society of Thailand
• Law & Solicitire Limited (LSL) ??
• Drug Study Group (DSG)
• Social Pharmacy Research Unit (SPR) Faculty of Pharmaceutical Sciences Chulalongkorn University
• Health & Development Foundation (H&DF)
• Government Pharmaceutical ??
For information, please contact:
Mr.Paul Cawthorne, Head of Mission
Dr.David Wilson, Medical Coordinator
Ms.Onanong Bunjumnong, Access Campaign Coordinator
Medesins Sans Frontieres-Belgium, Thailand (MSF-B)
Email: msfbthai@ksc.th.com
msfdrugs@asianet.co.th
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