[Ip-health] MSF report on Thai NGO victory in ddI patent case
James Love
james.love@cptech.org
Mon, 07 Oct 2002 02:58:59 -0400
This is, of course, a quite impressive victory by the NGOs
in Thailand and also for everyone who assisted in this case.
Here is the MSF summary. Jamie
-
Two People with HIV/AIDS and a Thai NGO mount a legal
challenge against Bristol-Myers Squibb - and win
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
(=93BMS=92) as a Defendant and the Thai Department of Intellectual
Property (=93DIP=94) as a joint-Defendant with the Central
Intellectual Property and International Trade Court (=93IPIT
Court=94).
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 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.
Where possible, the Thai Ministry of Public Health provides
high quality antiretroviral drugs at reasonable cost - generic
versions of antiretroviral that are not patent protected 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.
The GPO could only produce ddI in a powder form to avoid
infringing the patent held by BMS. However, in practice the
powder form has more side effects and is less convenient to
take, so it is more difficult for patients to comply.
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 of
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 applied an amendment of claims to the DIP.
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=92s exclusive rights are broader
than its formulation originally filed for the patent.
Issuance of this amended patent gave BMS the exclusive right
to produce and sell ddI tablet formulation regardless of the
quantity of ddI per dosage. Other pharmaceutical producers
could not produce or sell this ddI formulation of BMS, even if
they produced tablets containing more than 100 mg of ddI.
Therefore, AIDS Access Foundation and HIV infected persons
considered that they were damaged parties: they were effected
by the ddI patent and had to buy an antiretroviral drug
produced under the patented formulation of BMS in high price
because no one else produced 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=92s claims under its patent
of ddI Formulation. This amendment gave BMS unlimited
exclusive rights under the issued patent.
On 1 October 2002, the CIPIT 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.
=93 =85The deletion (of claims) can be considered as an adding
specification of invention. As a consequence, the deletion of
=91from 5 to 100 mg. per dosage=92 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 detailed
description of invention which was disclosed at the range of 5
to 150 mg per dosage. Therefore, the deletion of =91from 5 to
100 mg=92 per dosage from the patent claims is deemed to be
adding addition of substance of invention which is prohibited
by law=94.
Excerpted from the Central Intellectual Property &
International Trade Court Judgement, page 16
Red Case No. 93/2545 given on 1st October, 2002
Key points to emerge from this case are
=B7 Problems in the Thai patent registration processes lead
to the issuing of an invalid patent.
=B7 Thai consumers have utilised their rights under Thai law
to mount a legal challenge to a Trans-National Pharmaceutical
Company.
=B7 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).
=B7 This alteration would have gone unchallenged unless civil
society took an interest in the issue.
=B7 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:
=B7 Thai Network for People Living with HIV/AIDS (TNP+)
=B7 Thai NGOs Coalition on AIDS (TNCA)
=B7 AIDS Access Foundation (ACCESS)
=B7 Foundation For Consumer (FFC)
=B7 Center for AIDS Rights (CAR)
=B7 Medesins Sans Frontieres-Belgium, Thailand (MSF-B)
=B7 The Law Society of Thailand
=B7 Drug Study Group (DSG)
=B7 Social Pharmacy Research Unit (SPR) Faculty of
Pharmaceutical Sciences Chulalongkorn University
=B7 Health & Development Foundation (H&DF)
For information, please contact:
Medecins Sans Frontieres-Belgium, Thailand (MSF-B)
Mr.Paul Cawthorne, Head of Mission
Dr.David Wilson, Medical Coordinator
Email: msfbthai@ksc.th.com
Ms.Onanong Bunjumnong, Access Campaign Coordinator
Phone: +661-8384233
Email: msfdrugs@asianet.co.th
Thai Network for People Living with HIV/AIDS (TNP+)
Mr.Kamon Uppakaew, Chairman
Phone: +662-3760175-6
Email: tnpth@loxinfo.co.th
AIDS Access Foundation
Mr.Nimit Tienudom, Director
Phone: +661-9104884
Email: mit@aidsaccess.com
Center for AIDS Rights (CAR)
Ms.Supatra Nacapew, Director
Phone: +661-7206827
Email: carbkk@loxinfo.co.th
--
------
James Love, Consumer Project on Technology
http://www.cptech.org, mailto:love@cptech.org
voice: 1.202.387.8030; mobile 1.202.361.3040