[Ip-health] US industry sends list of complaints to Obama ahead of Modi's visit

Jamie Love james.love at keionline.org
Fri Jun 3 04:31:45 PDT 2016

PhRMA proposes the terms of surrender for India on its IPR and access to
medicine policies.




US industry sends list of complaints to Obama ahead of Modi's visit
 E Kumar Sharma
 June 3, 2016

Prime Minister Narendra Modi

"Real, meaningful progress remains elusive, and recent signals indicate
backsliding in key areas. For instance, India just released its
long-awaited National Intellectual Property Rights Policy, which falls far
short of industry expectations."

Strong words. But it's a sampling of the kind of reservations some of the
leading industry bodies, business groups and trade bodies in the US have
about India. The text above is part of a letter that some 17 industry and
business-related entities in the US have written to US President Barack
Obama ahead of Prime Minister Narendra Modi's visit to the United States,
starting June 6th. They urged the US president "to use this visit to engage
with the Prime Minister to advance both discussions and concrete action to
produce a stronger and more-promising U.S.-India commercial relationship".

Without mincing words, the letter says: "Prime Minister Modi finishes the
second year of his leadership, however, we are concerned that the high
hopes and positive rhetoric that accompanied the beginning of his tenure
have yet to be translated into concrete measures to improve the business
environment for U.S. workers and companies operating in and exporting to
India." The letter has been written on behalf of leading bodies like
Association of Equipment Manufacturers; American Foundry Society (AFS);
Biotechnology Innovation Organization (BIO); Motion Picture Association of
America (MPAA); National Association of Manufacturers (NAM); and the
Pharmaceutical Research and Manufacturers of America (PhRMA) among others.

So, what are the big concerns and what is it that the US pharma industry in
particular, would like India to do? One issue is unhappiness with India's
new IPR policy, which they want Obama to take up with Modi so that India
makes changes in the policy. Very broadly, to the US industry "concrete
measures", as conversations on the subject of Indian IPR have revealed over
the years, translates to measures like scrapping of the section 3(D) of the
Indian Patent Act and clarifying that compulsory licensing will not be used
for affordability argument, which, going by the Indian stand so far, are
non-negotiable. In fact, the new IPR policy, which was out after nearly one
year of deliberations, does not make changes on this.

For many in the US industry, over the years, the key pain points have been
the section 3(d) and Section 84 of the Indian Patents Act, and absence of a
period of exclusive marketing rights when a new drug gets regulatory
approval. Under Section 3(d), new forms of existing medicines cannot be
patented unless they improve therapeutic efficacy. It was under this
provision that India rejected a patent for Glivec. Section 84 allows
issuing a compulsory licence to meet the reasonable requirements of the
public at a reasonably affordable price. A compulsory licence can also be
granted under Section 92 of the Act in case of a national emergency. Natco
Pharma got a compulsory licence, the first ever in India, for generic
Nexavar under Section 84. Many multinational companies feel Section 84
narrows the criteria for patentability and undermines incentives for

India has maintained that Section 84 aims to ensure that a larger section
of its 1.2 billion population gets affordable health care.

In this letter to Obama, dated May 23rd, however the industry has listed
out a range of concerns over India's policies, and says: "Among other
things, it continues to allow sectoral regulations to trump the Copyright
Act. Persistent issues, such as forced localisation policies in the
information technology, energy, and other sectors; excessively high tariffs
in a range of sectors; tariff increases that appear to violate the
Information Technology Agreement; longstanding challenges on intellectual
property; lack of predictability in enforcing the rule of law; barriers to
investment, including proposed bans on further foreign direct investment in
certain sectors and other related barriers to FDI, such as ex ante vertical
integration restrictions in the broadcasting sector; and bureaucratic
action that interferes with private sector contractual arrangements
continue to hinder company operations and ensure that India remains a
challenging place for U.S. companies to do business. Prime Minister Modi's
visit presents an opportunity to discuss and resolve many of these
important commercial matters that are limiting India's own trade engagement
and growth."

On IPR and pharma, where some of the key industry concerns are expressed,
what are the options for Prime Minister Modi and what is it that the Indian
industry is expecting. While this will need to be seen and much depends on
whom the Prime Minister is meeting in the US, broadly the expectation is
that the prime minister may reassure the US industry that compulsory
licenses will not be given to all and sundry and given only in deserving
cases (in a sense, the current policy would continue) . That apart, he may
promise to speed up patent grant referring to the provisions in the new IPR
policy on fast track for patent grant in certain cases as part of efforts
to promote 'Make in India' .

Asked to react on what was expected from the prime minister's visit in the
light of the pressures in the US to make India yield some ground in its IPR
policy, D G Shah, Secretary-General of the Indian Pharmaceutical Alliance
says: "We need to see how the prime minister and the Indian government will
respond to this, though I do not think there will be any change. The pharma
industry, I do not think, is expecting any surprises."

James Love.  Knowledge Ecology International
KEI DC tel: +1.202.332.2670, US Mobile: +1.202.361.3040, Geneva Mobile:
+41.76.413.6584, twitter.com/jamie_love

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