[Ip-health] Livemint: India’s pharmaceutical patent law may face new hurdle

Thiru Balasubramaniam thiru at keionline.org
Fri Jul 17 01:02:07 PDT 2015



India’s pharmaceutical patent law may face new hurdle

The norm calls for applying non-violation complaints to the World
Trade Organization’s trade-related intellectual property rights

D. Ravi Kanth

Geneva: The patent law for pharmaceutical products in India and other
developing countries, including provisions that define what
constitutes inventions, could face a legal challenge because of a
controversial new norm being pushed by the US and Switzerland.

The norm, which would adversely affect Indian pharmaceutical
companies, calls for applying non-violation complaints (NVCs) to the
World Trade Organization’s (WTO) trade-related intellectual property
rights (TRIPS) agreement.

NVCs enable a WTO member to raise a dispute against another member’s
actions or policies that caused it a loss, even if there is no
violation of a WTO agreement.

So far, NVCs are applied only to the WTO’s provisions governing trade
in goods and trade in services but not to the TRIPS agreement because
of an existing moratorium.
The US and Switzerland, which represent the interests of the largest
pharmaceutical companies like Pfizer Inc., Merck and Co. Inc., Eli
Lilly and Co., Bristol-Meyers Squibb Co., Roche Holding AG and
Novartis AG, among others, want to terminate the moratorium on the
application of NVCs to the TRIPS agreement at the WTO’s 10th
ministerial conference in Nairobi, Kenya, later this year.

Despite raising numerous concerns on the amended Indian patent Act,
particularly the 3(d) provision that prevents pharmaceutical companies
from extending their 20-year product patents by making minor changes
or improvements, the US and Switzerland chose not to bring a dispute
at the WTO.

But NVCs provide a special legal instrument to the US and Switzerland
to take Indian pharmaceutical firms to task at the WTO on the ground
that the Indian patent provisions are causing a material loss even as
they remain consistent with the trade body’s IPR provisions, said IPR
analysts familiar with the issue.

The US and Switzerland could also be pushing the NVC issue on systemic
considerations and not exclusively for their industry interests, a
European TRIPS official said.

But a large majority of countries drawn from Asia, South America,
Africa and even industrialized countries such as Norway and Canada
have consistently opposed the demand from the US and Switzerland to
introduce the application of NVCs to the TRIPS provisions.
Notwithstanding a near-isolation on the NVC issue, the US and
Switzerland have not relented on their stand and continue to remain
inflexible, trade officials argued.

On 9 July, the chair for the WTO’s TRIPS council, Ambassador
Abdolazeez S. Al-Otaibi of Saudi Arabia, convened a closed-door
meeting of select countries to explore whether he can bring about a
compromise between the two sides which remain daggers crossed on the
issue at this juncture.

The chair invited officials from the US, Switzerland, the European
Union, China, India, Brazil, Peru, Argentina, South Africa and Nigeria
on behalf of the African group as well as Russia, Egypt and Taiwan to
discuss the way forward on the NVCs at the 10th ministerial meeting.

Trade officials from Peru, India, Brazil, China, Russia, Egypt,
Nigeria and South Africa told the chair that the NVCs are inapplicable
to the TRIPS agreement on several grounds. Unlike other WTO
agreements, the TRIPS agreement is asui generis agreement that is not
designed to protect market access but rather to establish minimum
standards of intellectual property protection, Peru stated on behalf
of the 17 countries that are calling for inapplicability of NVC to the
TRIPS agreement.
The 17 countries, including India, Brazil, China, Bolivia, Colombia,
Cuba, Ecuador, Egypt, Indonesia, Kenya, Malaysia, Pakistan, Peru,
Russia, Sri Lanka and Venezuela, had earlier called for a permanent
moratorium on NVCs under the TRIPS agreement. “We are going to submit
our proposal to ensure the inapplicability of the NVCs next week,” a
Peruvian official said on condition of anonymity.

India stated that the overwhelming majority of WTO members called for
the “inapplicability” of the NVCs to the TRIPS agreement. The best way
to end the controversy on applying NVCs to the TRIPS agreement is to
make it permanently “inapplicable” and thereby end the cycle of
extensions of moratoriums, the Indian official argued.

The US argued vehemently at the meeting that NVCs be made applicable
to the TRIPS agreement. If there is no consensus on the extension of
the moratorium at the WTO’s 10th ministerial conference beginning on
15 December, the NVCs will automatically apply to the TRIPS agreement,
the US maintained, according to the participant.

Switzerland said it supports the US for applying the NVCs to the TRIPS
The EU maintained that the US and Switzerland have not been able to
convince members why the application of NVC to the TRIPS agreement is
required and under what circumstances it is relevant, a EU official
said, asking not to be named.
The chair said the NVC issue must be resolved once and for all.
Ambassador Al-Otaibi said he will convene another meeting in October
to see if a solution could be found to the NVC issue, which remains
unresolved since 2001.

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