[Ip-health] ALERT: SECOND USPTO-PFIZER MEETING IN DELHI ON 9 OCTOBER 2009

[Kajal Bhardwaj]

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[ Picked text/plain from multipart/alternative ]




ALERT: SECOND USPTO-PFIZER MEETING IN DELHI ON 9 OCTOBER 2009



The United States Patent and Trademark Office (USPTO),
in collaboration with multinational pharmaceutical company, Pfizer Limited,=
 is
organizing a series of meetings in India for NGO's and the media
titled =E2=80=9CIntellectual
Property and Innovation in the
Pharmaceutical Industry.=E2=80=9D

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Their second meeting is being
held from 2:30-5:30 p.m. at the Taj Mansingh Hotel in New Delhi on 9 Octobe=
r
2009.=C2=A0 The meeting is being organized with the assistance of the US Em=
bassy in India.
On 9 September 2009, a similar meeting was held in Mumbai.



Pushing TRIPS-plus Measures

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Participants at the USPTO-Pfizer
Mumbai meeting have confirmed that the agenda of the meeting related to con=
troversial
TRIPS Plus measures - Data Exclusivity and Patent
Linkage.

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These measures are designed to
delay the registration of generic medicines by
several years, besides seriously interfering with the implementation of pub=
lic health safeguards such as compulsory licensing. Even if a company is gi=
ven
authority to produce a generic drug under a compulsory license, it still ne=
eds to register the drug
with India=E2=80=99s drug regulator
- the Drug Controller General of India or DCGI.=C2=A0=C2=A0The DCGI
will be reduced to enforcing private commercial rights and will become in
effect the =E2=80=9Cpatent police=E2=80=9D.

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In addition, Data Exclusivity
will undermine one of India=E2=80=99s
most important legal safeguards =E2=80=93 section 3(d) that seeks to preven=
t the
patenting of new forms, combination, uses of known medicines. Even when a p=
atent
is rejected on a known medicine, =E2=80=9Cdata exclusivity=E2=80=9D will cr=
eate a new
patent-like monopoly by blocking the registration of generic medicines.

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The US
government representative reportedly quoted the example of the increase in
foreign direct investment in Jordan
after it introduced data exclusivity. Interestingly, a study conducted by O=
xfam of the impact of TRIPS-plus provisions in Jordan (which was forced to =
implement these
provisions under a free trade agreement with the US) compared drug prices i=
n Jordan as a result of data exclusivity with
those in neighbouring Egypt
that does not enforce these provisions. The study found new
medicines for diabetes and heart disease
between 2 and 6 times more expensive in Jordan. See http://www.oxfam.org.uk=
/resources/policy/health/bp102_trips.html

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It is important to note that the
most recent report of the UN Special Rapportuer on the Right to Health has
highlighted concerns with the adverse impact of
such TRIPS-plus measures on access to treatment and has recommended that
developing countries not adopt these. See

http://daccessdds.un.org/doc/UNDOC/GEN/G09/127/11/PDF/G0912711.pdf?OpenElem=
ent.

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The WHO has also cautioned developing and least
developed countries against such provisions. See http://www.searo.who.int/L=
inkFiles/Global_Trade_and_Health_GTH_No3.pdf

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Attacking Section 3(d)

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The Mumbai meeting also featured an
attack on India=E2=80=99s strict
patentability standards embodied in Section 3(d) of India=E2=80=99s patent =
law. Section 3(d) was
introduced by the Indian Parliament using TRIPS flexibilities to prohibit
evergreening, the practice of pharmaceutical companies to extend their pate=
nt
monopolies by making changes to existing medicines. India
and the US
have very different patentability standards. While US is faced with a
proliferation of patents on new uses, combinations and new forms of known
medicines which is instrumental in keeping generics out of the market and
lowering of patentability standards of novelty, non-obviousness and industr=
ial application; India on the other hand
strictly limits the patenting of known medicines and has rejected a number =
of
such applications related to several antiretrovirals, cancer medications.
=C2=A0

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These meetings highlight several issues of concerns =E2=80=93 among them is=
 the link
between a regulator like the USPTO and US pharmaceutical companies.=C2=A0

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About Pfizer

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Pfizer Ltd. is a US
based multinational pharmaceutical company. Pfizer
has actively lobbied for patent linkage and Data Exclusivity in developing =
and
least developed countries the past; going the extent of suing the Philippin=
es
FDA officials for starting the process of registration of a generic version=
 of
the medicine =E2=80=98amlodipine besylate=E2=80=99 just before the patent e=
xpired.



Pfizer has just been fined a record 2.3 billion dollars
in the US
for unethical drug promotion. See http://www.newsdaily.com/stories/tre5813x=
b-us-pfizer-settlement/

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Pfizer CEO is the Chairman elect of Pharmaceutical
Research and Manufacturers of America (PhRMA). PhRMA is the business
lobby comprised of US drug
manufacturers who have actively pushed for both - Data Exclusivity and Pate=
nt
linkage in developing countries including India. They were
extremely successful in the past. On behalf of PhRMA, the US Government and
United States Trade Representative (USTR) negotiated a number of free trade=
 agreements under which developing countries
(Chile, Jordon) were forced to adopt such TRIPS
Plus measures.