[Ip-health] Thai CL for Kaletra patents (English)

[James Love]

http://www.cptech.org/ip/health/c/thailand/thai-cl-kaletra_en.pdf

DECREE OF DEPARTMENT OF DISEASE CONTROL, MINISTRY OF PUBLIC HEALTH,
REGARDING
EXPLOITATION OF PATENT ON DRUGS & MEDICAL SUPPLIES BY THE GOVERNMENT
ON COMBINATION DRUG BETWEEN LOPINAVIR & RITONAVIR
--------------------------------------------------------

Article 51 of the Thai Patent Act B.E. 2522 (as amended by the Thai Patent
Act no.2 B.E. 2535 and no.3 B.E. 2542)states that, for the public use,
ministry or department may exploit any patent without further negotiation
with the patent holder.  This implication makes clear that, for
non-commercial use, especially in public affairs of the government such as
public health services, government is well within its rights.

The situation of HIV spreading is the key problem of Thai public health.
More than 1 million Thais have been infected with HIV, among this, more
than 500,000 people are still alive.  These infected individuals will
eventually need long-term uses of antiretroviral drugs to maintain their
productive lives..  The Thai Government has launched a policy of universal
access to anti-retrovirals since 1st October 2003, and has a budget
specifically allocated for them. However, it is still difficult to get
accessed to some effective and safer anti-retrovirals.  The high price of
these patented anti-retrovirals have hindered their accessibility under
the universal access policy because of patent protection by law, then
there=92s no competition. The government cannot allocate enough budget.
However, budget for health services in the national health security system
allocated for HIV /AIDS patients in the fiscal year 2007 (B.E. 2550) is
only 3,855.6 million baht for the target group of 108,000 patients. Some
of this group have resistance to the first line ARVs and have to move to
the second line.

Lopinavir + Ritonavir under the tradename Kaletra  is a highly effective
and safe anti-retroviral.   It is also placed in the Thailand=92s National
List of second line Anti-retrovirals.  Because it=92s protected by patent,
no one can produce or import to share the market. So, it=92s price is much
higher than generic products in some other country.  With this higher
price, the budget allocated from the Thai Government can only cover some
patients with it, whereas the rest has to face with fatal opportunistic
infections.  If this ARVs formula could be produced or imported, the lower
price would help more accessible.

Under the Doha Declaration on TRIPs and Public Health , it notifies that
each member state has the right to protect public health in particular to
promote access for medicines for all, by granting compulsory licenses in
cases which constitute a national emergency or other circumstances of
extreme urgency and of public health crisis, including those relating to
HIV/AIDS, tuberculosis, malaria or other epidemics. While Section 51 of
Thailand=92s Patent Act defines the right of "any ministry, or department o=
f
the Government," "by themselves or through others," to exercise the rights
in any patent "for public consumption" , without commercial use as
mentioned above.

By the virtue of provisions of Article 51 of the Thai Patent Act B.E. 2522
(as amended by the Thai Patent Act no.2 B.E. 2535 and no.3 B.E. 2542), the
Department of Disease Control, Ministry of Public Health, thus use the
patent right of a medicine called Kaletra(tm)(or Lopinavir+Ritonavir as a
generic name) and endorse  the Government Pharmaceutical Organization of
Thailand to exercise  the rights contain within Para 1 of Article 36 of
the Thai Patent Act B.E. 2522 (as amended by the Thai Patent Act no.2 B.E.
2535 and no.3 B.E. 2542) under these conditions:-
(1) The use of the above patent rights are effective from today to the 31st
=09January 2012.
(2) The use of the above patent rights will be limited to the provision of
=09Efavirenz to not more than 50,000 patients per year, for those covered
=09under the National Health Security System Act B.E. 2545, Social
=09Security Act B.E. 2533, and the Civil Servants and government
=09employees medical benefits scheme..
(3) A royalty fee of 0.5 percent of the Government Pharmaceutical
=09Organization=92s total sale value of the imported or locally produced
=09Lopinavir+Ritonavir will be paid to the patent holder.

The Department of Disease Control, Ministry of Public Health will notify
the patent owner and the Department of Intellectual Property, Ministry of
Commerce immediately.

This decree is announced to the public.

Issue on 29 th=09January 2007.


(Mr.Thawach Suntrajarn)
Director General of The Department of Disease Control


---------------------------------
James Love, CPTech / www.cptech.org / mailto:james.love@cptech.org / tel.
+1.202.332.2670 / mobile +1.202.361.3040

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