[Ip-health] A Multi-Prong Strategy to Kill Generic Drugs industry

[Gopa Kumar]

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A multi-pronged strategy to kill generic drugs industry
28 Jul 2009, 0442 hrs IST, KG Narendranath, ET Bureau
  Is the world conspiring against all those sturdy generic drug companies,
many of who are of Indian origin? Such is the fear. If India=92s domestic  =
drug
industry is to be believed, the conspirators are legion and they use a
multitude of means.

All the scheming is at the behest of the big pharma companies in the
developed world who find it increasingly difficult to withstand competition
from manufacturers of generic drugs, given the drying up of new-drug
discoveries.

Foremost on the mind of Indian industry is the US Patents & Trademarks
Office=92s (USPTO) latest proposal to reform the Patent Co-operation Treaty
(PCT) so as to combine international and national processing of patent
applications, a move that would essentially result in =91automatic patent
grants=92 in all PCT member countries. Its proposal has the backing of the
World Intellectual Property Organisation (WIPO).

PCT is now more than anything else a mechanism for reduction of the workloa=
d
of patent offices worldwide through the use of international reports as the
basis for patent grant. The USPTO-WIPO proposal is to reinforce the treaty
by introducing what can be called a system of =91global patenting=92 which
allegedly would make =91developing-country patent laws irrelevant,=92 their
patent offices redundant and patent challenges =91almost impossible.=92

Under the proposed new PCT system, a patent will be deemed to have been
granted elsewhere once the it gets the stamp of the proposed international
system. This pre-empts facility of pre-grant objection which is provided fo=
r
in India=92s Patents Act and even makes post-grant challenge a highly
politically sensitive option.

Then comes a =91perceptible=92 change in WIPO=92s attitude. The multilatera=
l body
aspiring to acquire the status of front-line UN bodies was initially an
ardent supporter of the policy of liberal patenting, but seemed subsequentl=
y
to tread via media (WIPO office-bearers had even openly endorsed Indian
patent law which consists of two controversial provisions to forestall
frivolous and easy patents).

The latest news is that WIPO seems to have gone back to its old ways. For
all practical purposes it has abandoned the core function of
capacity-building of patent offices across countries and is out to =93breac=
h
the ranks of developing-country groups=94 by throwing =91crumbs=92 at some
countries like Brazil.

India=92s position as a leader of developing countries and a meticulous
expositor of the spirit and meaning of the WTO=92s TRIPS agreement has been
deliberately undermined, with WIPO seeking to =93alienate India, discredit =
its
mission at Geneva and =91use=92 Indian bureaucrats at its secretariat.

Adding to these subtle, but highly potent attempts at institutional reforms
are new barriers to generic-drugs trade being arduously built by the wester=
n
Customs authorities and regulators. The EU Customs are trying to restrict
access of India=92s generic drugs exporters to not only the Union countries
but also the consignment in transit to Africa etc., raising the bogey of
counterfeiting.

The recent move to spread Kenya=92s anti-counterfeit Act to the East Africa=
n
Community is also being seen by Indian drug industry as handiwork of the bi=
g
pharma companies based in the US, EU. This has the potential to hamper
exports of legitimate generic drugs from India.

If that is not enough, new norms are being created by the World Customs
Organisation and through Anti-counterfeiting Trade Agreement (which the US,
EU, Japan, Switzerland and Australia are negotiating sub rosa).

The Indian industry also alleges efforts by MNCs to amend India=92s IPR reg=
ime
and backdoor introduction of a TRIPS-plus IPR eco system, in connivance wit=
h
the Patent officers and drug-standards regulator.

To presume all this is being done in concert is fatuous. But there
definitely is a determined attempt to put spokes on the wheel of generic
bandwagon.

As India=92s strength lies in low-cost manufacture of high-quality generics
(no Indian drug company has yet hit the market with a new chemical entity
developed in its own laboratories), the policymakers here have a reason to
aggressively use legitimate tools such as multilateral institutions and law=
s
and domestic policies to foil such skullduggery of the western governments
and corporations. Why be shy of protecting one=92s rightful self-interest?