EU push for liberal patents finds favour with PMO
The Financial Express | 2011-01-12
EU push for liberal patents finds favour with PMO
KG Narendranath
New Delhi
Hard lobbying by the European Union (EU), home to many of the world’s
largest pharmaceutical firms like Novartis, Sanofi-Aventis and Roche,
has
struck a chord with the Prime Minister’s Office (PMO), which is now
’putting
pressure’ on a reluctant commerce and industry ministry to include a
contentious IPR chapter in the proposed India-EU trade and investment
pact.
The EU wants India to liberalise its patenting standards exclusively
for the
applicants from the union’s 27 countries. It also clamours for a
string of
associated rewards like a defined period of ’data exclusivity’ and
Supplementary Protection Certificates (SPCs). These additional rights
would
enable the patent-holders to fully exploit the economic value of their
inventions (including incremental ones) by enjoying the exclusive
rights for
longer periods, much more peacefully and to the fullest.
Agreeing to the EU demands could, however, potentially overturn India’s
Patent Act —which was last amended in 2005 and arguably strikes a
balance
between patent rights and the access to medicines—, and hit the
country’s
generic drug industry hard.
Official sources on the condition of anonymity told FE that the PMO has
sought to know from the department of industrial policy and promotion
(DIPP)
as to what it thinks of the EU demands. This is despite the fact that
the
DIPP has been unflinchingly dismissive of these demands citing them as
’TRIPS-plus’ and made its position amply clear to all concerned.
During the India-EU summit in Brussels last month, Prime Minister
Manmohan
Singh and European Commission president JM Barroso declared their
intent to
conclude the trade and investment pact in March, when Singh is slated to
visit Europe again. It is believed that the PMO wants the IPR issue to
be
addressed quickly enough for that plan to materialise.
In a recent note to the department of pharmaceuticals on the PMO
communication it received earlier, the DIPP wrote, "The DIPP does not
support data exclusivity and amendments suggested by the OPPI (an Indian
industry body that consists mostly of foreign MNCs present here) to the
Patents Act..." The department which is the nodal agency for the
policy on
patents, believes that so long as India continues to be a net IPR user
than
an IPR producer (85% of Indian patents go to non-residents), there was
"absolutely no need to tinker (with) /tweak (the Patents Act) in any
manner"
at this juncture. The department asserts that India’s patent laws as
they
exist today are compliant with the WTO’s Trade-Related Intellectual
Property
Rights (TRIPS) agreement, and there is no need for an easing of the
patenting criteria until and unless India’s capabilities on innovation
are
reinforced. Patenting criteria, the department believes, should be
context-dependent and take into account the level of development and
infrastructure of the country concerned.
Data exclusivity denotes protection of the test and other data
(pertaining
to new chemical entities) that is submitted to the drug regulators from
unfair commercial use. This is provided for under Article 39.3 of the
TRIPS
agreement. But the EU wants something more than this: first, it says the
regulator should not rely on the innovator data to approve generic
products
that are bio-equivalent to the originator’s product and secondly, it
wants
the facility to be available for not only NCEs but other pharma
products as
well. Given the time-lines of the patenting and regulatory process, data
exclusivity of this nature could potentially delay the entry of
generics and
scupper government’s ability to invoke compulsory licence, a TRIPS-
complaint
policy tool that is meant to break patents under defined circumstances
like
public health crises. It could also result in an extended period of
market
exclusivity for patented drugs as the innovator can come out with "new
indications" of the drug close to patent expiry and get the
concomitant data
exclusivity.
Although many countries, including China (at the time of its WTO entry),
allow periods of data exclusivity as defined in the EU wish list,
India has
been dithering on this, keeping in mind the interests of the country’s
robust generic industry which is also big hope for under-developed
countries
in Africa wanting to import cheap generic drugs under the Doha
Declaration
on Public Health.
Similarly, the SPC provides for an extension of the patent term for up
to 5
years to compensate for the "regulatory delays"- that is, the time
taken to
obtain the approvals for pre-clinical and clinical (human) trials and
validate the data. Further, the EU wants courts in India to grant
automatic
injunctions as interim relief in patent infringement cases. This, it has
been pointed out, is against the principles of equity. The DIPP says
public
interest should not be dis-served by a permanent injunction. After all,
patent or any other IPR for that matter, is a private right which
should be
enforced by the right owner rather than the state. On patentability
criteria, what the EU wants is a removal/dilution of the Section 3 (d)
in
India’s Patents Act that seeks to prevent patenting of incremental
inventions that don’t bring substantial improvement in efficacy. While
the
government is making up its mind over whether or not to have the
disputatious IPR chapter in the proposed India-EU bilateral pact, the
drug
industry is divided and busy lobbying with the political establishment.
The Indian Pharmaceutical Alliance (IPA) that comprises top-notch
domestic
drug companies, has quoted the World Health Organization to drive home
the
point that the EU demands are unjust : "in bilateral trade
negotiations, it
is important that governments ensure that ministries of health be
properly
represented... (bilateral agreements) should not seek to incorporate
TRIPS-plus protection in ways that may reduce access to medicines in
developing countries." An e-mail sent to OPPI director-general Tapan Ray
elicited an automatic response that he is out of office till Jan 12
and has
no access to e-mail during the period.
The industry body’s president Ranjit Sahani was also travelling and not
available for comment, while its other office-bears said they are not
authorised to speak on behalf of the body to the media.
As a tradeoff, what the EU offers is recognition of a clutch of India’s
geographical indications (a form of IPR linked to the geographical
origin of
a product and the distinct quality it derives from that origin) like
Kanchipuram Silk, Kolhapuri Chappal, Nagpur Orange, Bikaneri Bhujia,
Darjeeling Tea and Agra Petha. However, then economic gain from this
for the
local communities is expected to be meagre, as these reputations are
largely
limited to India.
Although bilateral pacts on IPRs are limited to the countries
concerned, it
could induce other countries to invoke the non-discrimination (most
favoured
nation) clause under the World Trade Organization.
