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

[Kajal Bhardwaj]

ALERT: USPTO-PFIZER PUSHING FOR TRIPS-PLUS MEASURES IN INDIA

The United States Patent and Trademark Office, in collaboration with the Pf=
izer Limited, is organizing a meeting in India for NGO's and the media titl=
ed =E2=80=9CIntellectual Property and Innovation in the Pharmaceutical Indu=
stry=E2=80=9D from 2:30-5:30 p.m. at the Taj President Hotel in Mumbai on S=
eptember 9, 2009.=C2=A0 The meeting is being organized with the assistance =
of the US Embassy in India.
=C2=A0
On the agenda are controversial TRIPS Plus measures such as Data Exclusivit=
y and Patent Linkage which are designed to delay the registration of generi=
c medicines by several years, besides seriously interfering with the implem=
entation of public health safeguards such as compulsory licensing. Even if =
a company is given authority to produce a generic drug under a compulsory l=
icense, it still needs to register the drug with India=E2=80=99s drug regul=
ator - the Drug Controller General of India or DCGI.=C2=A0=C2=A0The DCGI wi=
ll be reduced to enforcing private commercial rights and will become in eff=
ect the =E2=80=9Cpatent police=E2=80=9D.

In addition, Data Exclusivity will undermine one of India=E2=80=99s most im=
portant legal safeguards =E2=80=93 section 3(d) that seeks to prevent the p=
atenting of new forms, combination, uses of known medicines. Even when a pa=
tent is rejected on a known medicine, =E2=80=9Cdata exclusivity=E2=80=9D wi=
ll create a new patent-like monopoly by blocking the registration of generi=
c medicines.
=C2=A0
A study conducted by Oxfam of the impact of TRIPS-plus provisions in Jordan=
 (which was forced to implement these provisions under a free trade agreeme=
nt with the US) compared drug prices in Jordan as a result of data exclusiv=
ity with those in neighbouring Egypt that does not enforce these provisions=
. The study found new medicines for diabetes and heart disease between 2 an=
d 6 times more expensive in Jordan. See http://www.oxfam.org.uk/resources/p=
olicy/health/bp102_trips.html
=C2=A0
This meeting highlights several issues of concerns =E2=80=93 among them is =
the fact that a US agency such as USPTO=E2=80=99s link with the US pharmace=
utical companies. Pfizer has actively lobbied for patent linkage and Data E=
xclusivity in the past; going the extent of suing the Philippines FDA offic=
ials for starting the process of registration of a generic version of the m=
edicine =E2=80=98amlodipine besylate=E2=80=99 just before the patent expire=
d.
=C2=A0
Pfizer incidently has just been fined a record 2.3 billion dollars in the U=
S for unethical drug promotion. See http://www.newsdaily.com/stories/tre581=
3xb-us-pfizer-settlement/
=C2=A0
In addition, Pfizer CEO is the Chairman elect of Pharmaceutical Research an=
d Manufacturers of America (PhRMA). PhRMA is the business lobby comprised o=
f US drug manufacturers who have actively pushed for both - Data Exclusivit=
y and Patent linkage in developing countries including India. They were ext=
remely successful in the past. On behalf of PhRMA, the US Government and Un=
ited States Trade Representative (USTR) negotiated a number of free trade a=
greements under which developing countries (Chile, Jordon) were forced to a=
dopt such TRIPS Plus measures.
=C2=A0
It is important to note that the most recent report of the UN Special Rappo=
rtuer on the RIght to Health has highlighted concerns with the adverse impa=
ct of such TRIPS-plus measures on access to treatment and has recommended t=
hat developing countries not adopt these. See http://daccessdds.un.org/doc/=
UNDOC/GEN/G09/127/11/PDF/G0912711.pdf?OpenElement.
=C2=A0
The WHO has also cautioned developing and least developed countries against=
 such provisions. See http://www.searo.who.int/LinkFiles/Global_Trade_and_H=
ealth_GTH_No3.pdf
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Not surprising is the continued attack against India=E2=80=99s position aga=
inst evergreening of patents. Therefore on the agenda is a discussion on in=
cremental innovation and ever greening being led by Mr. Dominic Keating fro=
m the U.S. Embassy. However India and the US have very different patentabil=
ity standards. While US is faced with a proliferation of patents on new use=
s, combinations and new forms of known medicines which is instrumental in k=
eeping generics out of the market and lowering of patentability standards o=
f novelty, non-obviousness and industrial application; India on the other h=
and strictly limits the patenting of known medicines and has rejected a num=
ber of such applications related to several antiretrovirals, cancer medicat=
ions. =C2=A0
=C2=A0
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 =E2=80=93in- one AIDS pill =E2=80=93 one of the most revolutio=
nary innovations in AIDS treatment for the developing world. That the indiv=
idual compounds were not patented in India made combining them possible.