[Ip-health] Open Letter to the Thai DIP, opposing patent applications on TDF+FTC

Jockey jockey.kit at gmail.com
Tue Jul 17 08:34:02 PDT 2012


Dear IP-health group,

As I'm not sure the attachment has been through, I'm sending this email
again with the content of the open letter I copy from the attached letter
(English translation version).

Best regards,
Jockey

*Translation*

*
*

*Open Letter: Opposing the Patent Application of Tenofovir+Emtricitabine
(TDF+FTC)*

*
*

18th July, 2012



Dear  Director General, Department of Intellectual Property,



Thai Network of People Living with HIV/AIDS (TNP+) and non-government
organizations working on AIDS, access to treatment, and public health have
a grave concern when we acknowledge that Gilead Sciences, Inc. has applied
for patents on the fixed-dose combination AVR tenofovir + emtricitabine
(TDF+FTC) in Thailand with claims on dosage/dose, formulation, and
combinations.  These ARV’s patent applications should not be awarded as
they do not meet the patentability criteria, in accordance with the Thai
Patent Act and the pharmaceutical science’s principles.  Due to the
problematic patent database and the mere 90-day pre-grant opposition
period, it is a barrier preventing others to oppose in time.  The country’s
HIV & AIDS treatment will be severely affected and the national goal of the
HIV treatment scale-up is impossible if the Department of Intellectual
Property (DIP) agrees to approve patent applications on TDF+FTC.

In Thailand, the ARVs with the combination of TDF are effective
HIV-treatment regimens and adopted to be alternative first-line regimens to
treat HIV & AIDS and a HIV co-infection disease, Hepatitis B.  The medicine
has been included in the National Essential Drug List (NEDL) and in the
national HIV treatment guideline since 2010, and later on it has also been
in the NEDL for Hepatitis B treatment since March 2012.  Therefore, PLHIVs
who need this ARV - as they cannot tolerate adverse side-effects from the
use of the other ARVs, have HIV co-infection Hepatitis B, or have some
limitations to other ARV regimens, will be able to access effective
treatment and regain their better quality of lives.

But, as we can search for information on the DIP’s online database (as
attached), it is found that there are 3 patent applications related to TDF
- application number 0601002699, 0601002700, and 0401000086.  Two
applications were filed on June 8, 2006 and the other on January 13, 2004,
with 3 types of claims including 1) dosage/dose, 2) formulation, and 3)
combinations.

According to the international patentability standard and the Thai Patent
Act (section 5), there are 3 essential criteria to consider, which are 1)
novelty, 2) inventive step, and 3) capability of industrial application.
By these criteria, the PLHIV network and NGOs consider the fixed-dose
combination TDF+FTC is not entitled to get patents with the 20-year
protection.  This is because TDF is not a newly invented drug and it has
been existed for a long time.  And, its combination requires no high
technology to prove significant inventive steps.  So, the DIP should not
approve all the 3 patent applications filed by Gilead Sciences, Inc.

TNP+ and the NGOs working on AIDS, access to treatment, and public health
had several meetings with relevant government agencies, including DIP, and
repeatedly expressed our concerns on the patent application system,
especially for pharmaceutical products, that it is a problematic system.
As a result, a large number of ever-greening patents have been granted.
Referring to a research on pharmaceutical patents in the last 10 years
(2000 – 2010), which is conducted by a group of Thai pharmacist academia,
it shows that over 90% of those patents are ever-greening patents, as they
are not complied with the 3 essential patentability criteria, in accordance
with the Patent Law, and the pharmaceutical science’s principles.  The
research was presented in the meetings between the DIP and stakeholders, at
least 2 times.  In the final meeting, it was agreed that a manual of
patentability for pharmaceutical products should be developed so that the
DIP’s patent officers will be able to amine patent applications stringently
in order to safeguard people’s health benefits, rather than in favor of the
private sector’s economic benefits.

Nevertheless, it is also found that the search for patent status and patent
applications is problematic; unease to search, not updated information,
incorrect information, and lack of clarity in required information stated
in patent applications, etc.  Such a practice, it becomes a loophole that
the multinational pharmaceutical industry can take advantage and block
and/or delay the local generic-drug industry’s competition, including the
state-enterprise Government Pharmaceutical Organization (GPO).  When it is
difficult to have correct and complete information, the generic-drug
manufacturers cannot be aware of the patent expiry and the patent
applications’ details.  Then, they cannot prepare to produce and market
their generic products to compete at lower prices on a timely basis.

Last but not least, the pre-grant opposition period is limited to 90 days
only - it is consider too short, and it is hard for the public to access
the patent application publication.  Thus, it becomes a barrier for people
or organizations who want to oppose.  In this case, TNP+ and NGOs could not
file opposition in time (information of the application publication dates,
as attached).

Therefore, TNP+ and NGOs working on AIDS, access to treatment, and public
health would like to urge the DIP to take the following actions:

1.      DIP should not approve all the three patent applications.

2.      DIP must accelerate the development of the patent examination
manual for pharmaceutical products by taking civil society’s concerns and
the ever-greening patent research into account and with the recognition of
the public’s interest before the particular business groups’ benefits.

3.      The working group to develop the manual should be comprised of
capable human resources with sound knowledge both in patent and pharmacy
and without any conflict of interest.

4.      DIP must urgently improve its patent database system to be
convenient to search and provide correct, complete and updated information.



Sincerely yours,

Thai Network of People Living with HIV/AIDS

AIDS Access Foundation

Alternative Agriculture Network

Friends of Kidney-failure Patients Club

Cancer Patient Network

Foundation for Consumers

The Rural Pharmacist Foundation

Foundation for AIDS Rights

Thai NGO Coalition on AIDS

Drug Study Group

Biodiversity and Community Right Action Thailand, (Biothai)

Thai Holistic Health Foundation

Ecological Alert and Recovery - Thailand

FTA Watch




On Tue, Jul 17, 2012 at 7:04 PM, Jockey <jockey.kit at gmail.com> wrote:

> Dear IP-health group,
>
> Attached, you can find the translation of Thai CSO's open letter to be
> handed to the Director General of the Department of IP, Thailand on July 18
> at the tomorrow meeting.  This is to oppose Gilead's patent applications on
> TDF+FTC in Thailand.
>
> DIP accepted our request to have an academic forum "Time to have a patent
> examination guideline to prevent ever-greening patent: TDF+FTC" at the
> ministry from 9-12 pm.  It's expected to have 100 participants from PLHIV
> network, chronic-disease patient groups, pharmacist and IP academic,
> government officers from IP and health departments, and NGO workers.  Guest
> speakers from FDA, DIP, GPO, an academic group, and PLHIV network are
> invited to share comments on these patent applications.  Thai patient and
> NGO groups will take opportunity to have dialogue directly to the policy
> makers and give the letter to the Director General at the event.
>
>
> Best regards,
> Jockey
>
>
>



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