[Ip-health] Hindu Business Line: Indian drug cos worried about patent regime changes

Thiru Balasubramaniam thiru at keionline.org
Mon Feb 9 03:29:31 PST 2015

Indian drug cos worried about patent regime changesPT JYOTHI DATTA

Seek clarification on US trade representative’s testimony that India has
committed to address IP issues that concern America


Has India informally agreed to make changes in its Intellectual Property
Rights regime on the basis of US concerns? A sizeable section of the Indian
pharmaceutical industry and some pro-health groups are worried that it has,
following US Trade Representative Ambassador Michael Froman’s testimony to
the Senate Committee on Finance less than a fortnight ago.

On January 27, Froman, in a written statement, said engagement between the
two countries had helped “secure commitments from India in the 2014 Trade
Policy Forum on a broad range of IP issues of concern to the US and its

*Industry worried*

Commenting on the development, DG Shah of the Indian Pharmaceutical
Alliance, which represents large domestic Indian drug companies, said: “We
are at a loss to understand, and are unaware on what has been committed.
But when Ambassador Froman makes a statement to the Senate committee under
oath, the Indian government needs to clarify what these commitments are.”

The controversy has erupted as India is in the midst of finalising a new
policy on intellectual property rights.

After her meeting with US Commerce Secretary Penny Pritzker, Commerce and
Industry Minister Nirmala Sitharaman had told the media: “We have invited
the Americans to look at the draft policy (on IPR) and give their inputs.
We will then see what we can do with it.” Pritzker was part of President
Obama’s delegation on his India visit.

On the face of it, the Centre’s position that Indian laws are already fully
TRIPS compliant would rule out any major concessions to the US
pharmaceutical lobby, which has been pressuring the American government to
push for TRIPS-plus measures. TRIPS is short for Trade-Related Aspects of
Intellectual Property Rights.

The US lobby is unlikely to make much headway with one of its main concerns
– Section 3 (d) of the Indian Patent Act, which prohibits evergreening —
given that India’s Supreme Court has upheld the constitutional validity of
the provision, which prevents patenting of new forms of known substances
unless they exhibit enhanced efficacy.

Anand Grover, former UN Special Rapporteur on the Right to Health and
Director of Lawyers Collective, is concerned that India may be considering
making concessions relating to data exclusivity and patent linkages. “From
sources, it appears that the Centre is considering bringing these in
through administrative measures. It must make its stand public and not do
anything without parliamentary approval.”

Data exclusivity and patent linkage (see info-box) delay the entry of
inexpensive generic medicines in the market, leaving the market open to
high monopolistic pricing.

*Different views?*

However, a top government official involved with bilateral talks during the
Obama visit and a witness at the CEO forum the dignitaries addressed says
that India has conveyed to the US that they were on different tracks on the
IP issue.

The Prime Minister’s statement on accepting IP suggestions meant that India
was ready to correct or rectify loopholes or loose ends in the
implementation of the law. But India is not changing the law, the official
said, adding emphatically that there was no softening of India’s stand on
data exclusivity or patent linkages.

In fact, the official added, India was taking a cue from China in keeping
the US at bay.

Deepak Parekh, another participant in the CEO forum, had told *BusinessLine* at
the time that only piracy and counterfeiting had been discussed.

*Public health concerns*

But pro-health groups have been cautioning that India is under pressure on
the flexibilities it had been allowed and exercised under the TRIPS

“All these flexibilities (such as opposition procedures, compulsory
licences) are now under attack by the US government at the behest of their
industry,” a Lawyers Collective note alleged, apprehending that India may
adopt a TRIPS-plus IP regime.

Last year, the US’ Special 301 report (on IP) stopped short of further
downgrading India, though it called for “out of cycle” reviews. The year
also saw trade-related investigations by the US International Trade

*With inputs from Amiti Sen and Richa Mishra in New Delhi*
(This article was published on February 8, 2015)

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