[Ip-health] Alert: USPTO-Pfizer pushing for TRIPS Plus measures in India

[Ratan Singh]

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*Alert: USPTO-Pfizer pushing for TRIPS Plus measures in India*

The United States Patent and Trademark Office, in collaboration with the
Pfizer Limited, is organizing an meeting in India for NGO's and the media
titled =93Intellectual Property and Innovation in the Pharmaceutical Indust=
ry=94
from 2:30-5:30 p.m. at the Taj President Hotel in Mumbai on September 9,
2009.  The meeting is being organized with the assistance of the US Embassy
in India.



On the agenda are controversial TRIPS Plus measures such as Data Exclusivit=
y
and Patent Linkage which are designed to delay the registration of generic
medicines by several years, besides seriously interfering with the
implementation of public health safeguards such as compulsory licensing.
Even if a company is given authority to produce a generic drug under a
compulsory license, it still needs to register the drug with the Indian Dru=
g
regulatory Authority. The DCGI will be reduced to enforcing private
commercial rights and will become in effect the =93patent police=94.**

In addition, Data Exclusivity will undermine one of India=92s most importan=
t
legal safeguards =96 section 3(d) that seeks to prevent the patenting of ne=
w
forms, combination, uses of known medicines. Even when a patent is rejected
on a known medicine, =93data exclusivity=94 will create a new patent-like
monopoly by blocking the registration of generic medicines.



This meeting highlights several issues of concerns =96 among them is the fa=
ct
that a US agency such as USPTO=92s link with the US pharmaceutical companie=
s.
Pfizer has actively lobbied for patent linkage and Data Exclusivity in the
past; going the extent of suing the Philippines FDA officials for starting
the process of registration of a generic version of the medicine =91amlodip=
ine
besylate=92 just before the patent expired.



In addition, Pfizer CEO is the Chairman elect of Pharmaceutical Research an=
d
Manufacturers of America (PhRMA). PhRMA is the business lobby comprised of
US drug manufacturers who have actively pushed for both - Data Exclusivity
and Patent 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.



Not surprising is the continued attack against India=92s position against
evergreening of patents. Therefore on the agenda is a discussion on
incremental innovation and ever greening being led by Mr. Dominic Keating
from the U.S. Embassy. However 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 industrial
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.



The fact is that for incremental innovation by Indian companies the market
and not patents is the driving force. This is borne out by the development
of the three =96in- one AIDS pill =96 one of the most revolutionary innovat=
ions
in AIDS treatment for the developing world. That the individual compounds
were not patented in India made combining them possible.