[Ip-health] Re: Request for Compulsory License on Fuzeon Patent

[Heesob Nam]

I'd like to make some comments on this action.

Needless to say, the primary aim of the CL request is to make the
medicine to be available to those in needs of it. When a license is
granted to us by the government, not voluntarily by the patentee, we
need to produce and provide the medicine for the patients. Further, we
have to pay a royalty to the patentee. As the patentee did not provide
Fuzeon for about four years, the cost and the profit of the patentee
are both zero. After CL, the cost of the patentee remains zero, while
the patentee can make a profit on the royalty paid by us.

For the CL request, we rely on the statutory grounds that the
compulsory license is particularly necessary in public interest. I do
not think our government is willing to grant a compulsory license.
Main legal issue would be our ability to produce or provide the
medicine under the license. Your solidarity in improving our ability
is quite welcome.

Heesob Nam
IPLeft (Intellectual Property Left)

2009/2/3 KangAra <naengee@hotmail.com>:
> --
> [ Picked text/plain from multipart/alternative ]
>
>
> Signatures in support of Korea compulsory license request for Enfuvirtide=
 (Fuzeon)
>
> On December 23, Korea Patient Groups and NGOs filed requests for compulso=
ry license in AIDS drug Enfuvirtide (Fuzeon) with the Korean government. It=
 comes after the Global Action Week against Roche ((between the 1st and the=
 7th of October) to denounce Roche's infamy. Activists all around the world=
 asked Roche renounce to its patent on Fuzeon since it refuses make it avai=
lable for everyone. However, to date, Roche has not responded to our reques=
t.
>
> Roche, a multi-national pharmaceutical corporation, acquired the license =
to launch Fuzeon in 2004. However, South Korean people with HIV/AIDS have n=
ever seen this drug in the last 4 years. This was due to a strong 'will' of=
 Roche requesting the South Korean Government accept the price of 22 millio=
n KRW (roughly 22,000 USD) per year. The company has been withholding the d=
istribution of the drug for the last 4 years. The exclusive right of patent=
 protection, owned by Roche, guarantees that the company's murderous will i=
s observed in South Korea.
>
> The South Korean Ministry of Health, Welfare, and Family promised the AID=
S patients that they will make use of all formal and informal means to pres=
sure Roche to provide Fuzeon to the South Korean market. The unfortunate tr=
uth is that there is no such means the Government can employ to counter pha=
rmaceutical companies' murders by patents. In the current system where the =
exclusive patent right equals the 'license to kill,' the only tool governme=
nts have is the compulsory licensing of the patent. This is why even the Wo=
rld Trade Organization (WTO) acknowledges the compulsory licensing as a ver=
y important part of the international intellectual property agreement for e=
nsuring patients' access to life-saving medicines.
>
> The TRIPS Agreement, the intellectual property agreement of the WTO, spec=
ifies that member countries can compulsorily license the use of patents to =
protect public health and nutrition and to facilitate the public interest i=
n extremely important areas of socio-economic and technological advancement=
. Articles 106  of the South Korean patent law also specifies that to be us=
ed in a national emergency such as a war and for the non-commercial use of =
the patent for the public interest, the government or the third party can b=
e licensed to use the patent. The article 107 of the South Korean patent la=
w indicates when the use of the patent is particularly necessary for the 'p=
ublic interest,' a compulsory license can be granted.
>
> Despite this, the South Korean Government has kept an extremely passive p=
osition as to the issue of compulsory licenses due to the fear of trade dis=
putes. A well-known example is the rejection of the compulsory license of G=
livec, an anti-leukemic drug, in 2002. However, the Doha Declaration on the=
 TRIPS Agreement and Public Health, adopted in November 2001, clearly indic=
ated that (1) "the TRIPS Agreement does not and should not prevent Members =
from taking measures to protect public health" and that (2) "the Agreement =
can and should be interpreted and implemented in a manner supportive of WTO=
 Members' right to protect public health and, in particular, to promote acc=
ess to medicines for all."
>
> Despite the existence of the international declaration that supports the =
compulsory license, if the South Korean Government does not grant a compuls=
ory license for a clearly non-working life-saving patent, it is only evadin=
g its responsibility for the protection of its citizens' rights to health a=
s well as life.
>
> The compulsory license is not an impudent practice that aims to destroy i=
ntellectual property rights and patent system at once. The institution of p=
atent protection originated not only to protect the private interest of the=
 patent holder but also to promote public interest by technological develop=
ment based on the disclosure of innovations. When the patent right threaten=
s the public welfare against its fundamental objective, it is only natural =
to use compulsory license to regulate it.
>
> Multinational pharmaceutical companies and their astronomical drug prices=
 are harmful not only to individual patients' health and welfare but to fin=
ances of nation-state. For example, the US congressional Budget Office esti=
mates that the medical cost will occupy 25% of GDP in 2025 if it keeps the =
same rate of growth as of now. The Bush administration's secretary of Healt=
h and Human Services said in a speech that if the medical cost keeps rising=
 at the current rate, an enormous national financial crisis, surpassing the=
 subprime mortgage crisis, will eventually develop. The main component of t=
he rising medical cost is tremendous amount of expenses paid to pharmaceuti=
cal companies for new drugs and medical devices. The pharmaceutical cost oc=
cupies 30% of the South Korean medical expenditure. Accordingly the MOH has=
 initiated the Positive List System since 2006.
>
> The basis of the Positive List System  lies at the negotiation between ph=
armaceutical companies and the South Korean Government to determine prices =
of new drugs. However, pharmaceutical companies retain the exclusive capaci=
ty to produce and provide drugs. Therefore, the prices are determined at th=
e rate where pharmaceutical companies would not withhold their drugs. All S=
outh Korean Government can do is to accept the price pharmaceutical compani=
es want, the price that is practically unaffordable to patients. Meanwhile,=
 patients are dying despite the existence of drugs that can save their live=
s. The South Korean Government is simply ignoring this tragedy.
>
> We cannot and should not look away from preventable deaths of patients an=
y more. The patent right cannot supersede the right to lives. Therefore, we=
 Korea Patient Groups and NGOs request a compulsory license of Fuzeon. This=
 is to declare to the world that the right to lives is of utmost importance=
, much more than intellectual property rights. The South Korean Government =
should protect this deserved truth, by granting the compulsory license.
>
> There are 2 things you can do to support our struggle.
>
>
>
>
>
>
> 1. We Korean activist are collecting signatures in support of the compuls=
ory license filing. If you would like to sign on, please send your organiza=
tion's name (or your name if you would like to sign on as an individual), e=
mail address to naengee@hotmail.com
>
> 2. You can fax to Korea Intellectual Property Office to urge them to gran=
t compulsory license. (We attach=C3=A9 one example)
> Fax number is *82-42-472-3464
>
>
> Thank you for your solidarity.
>
>
>
>
> <Example>
>
>
>
>
>
>
> Mr. Jung-Sik Koh
> Commissioner of Korean Intellectual Property Office
> Government Complex =E2=80=93 Daejeon,
> 139 Seonsa-ro, Seo-gu, Daejeon,
> South Korea
> Tel : 82-42-481-5072
> Fax : 82-42-472-9314
>
> Dear Commissioner Jung-Sik Koh
>
> We've heard that Korean civil rights groups and patient groups filed requ=
ests for an open compulsory license on the AIDS drug Enfuvirtide (Roche's F=
uzeon) with the Korean government.
>
> Fuzeon is an essential drug for HIV-positive people who have tried other =
anti-HIV drugs in the past and are unable to keep their viral loads undetec=
table using drugs that are currently available. However, South Korean peopl=
e with HIV/AIDS have never seen this drug in the last 4 years.
>
> To secure the right to access to medicine, WTO suggests one very importan=
t way, compulsory license. The Doha Declaration on the TRIPS Agreement and =
Public Health, adopted in November 2001, clearly indicated that (1) "the TR=
IS Agreement does not and should not prevent Members from taking measures t=
o protect public health" and that (2)the Agreement can and should be interp=
reted and implemented in a manner supportive of WTO Members' right to prote=
ct public health and, in particular, to promote access to medicines for all=
"
>
> Roche's cynicism and systematic abuse of its superior position on people =
living with HIV/AIDS has been raised for a long time. Under this condition,=
 we strongly believe that it is the responsibility for the government to ta=
ke strong measures on unethical behavior of Roche starting with compulsory =
licensing for a clearly non-working life-saving patent so as to protect  ci=
tizen's rights to health as well as life.
>
> The right to life and the right to access to essential medicines are fund=
amental and social constitutional rights. With this letter, therefore, we w=
ould like to express our strong support for compulsory licensing on Fuzeon =
in Korea.
> Thank you for your attention.
>
> Sincerely
>
>
> Ara KangDirector of the Korean Pharmacists for Democratic Society3F, 26-1=
, Ewha-Dong, Chongro-Gu,Seoul, South KoreaWebsite : http://www.pharmacist.o=
r.krE-mail : naengee@hotmail.comTel : 82-11-389-0614Fax : 82-2-766-6025
> _________________________________________________________________
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