[Ip-health] Firstpost: US report puts India on 'Priority Watch List, ' raises concerns over pharma sector
zack.struver at keionline.org
Fri Apr 29 10:41:40 PDT 2016
US report puts India on 'Priority Watch List,' raises concerns over pharma
Shreerupa Mitra-Jha Apr 29, 2016 20:54 IST
The US’ Special 301 report continues to put India, along with a few other
countries, under its ‘Priority Watch List’ for its intellectual property
rights (IPR) regime and directs its chief trade negotiator to hold foreign
governments 'accountable' for IP-related trade practices that go against
the interests of American innovators and creators.
The special sub-committee that reviewed 73 trading partners of the US
placed India, China, Russia, Ukraine, Venezuela, Argentina, Chile, Algeria,
Indonesia, Kuwait, and Thailand under its ‘Priority Watch List’ (PWL)
category and Canada, Brazil, Switzerland, Pakistan, Egypt among other
countries under its ‘Watch List’ (WL) category. The USTR has listed a total
of 34 trading partners under PWL or WL. India has been under the PWL
category for more than a decade now.
No new country has been added under the Priority Foreign Country (PFC)
The US Trade Representative’s (USTR's) Special 301 report -- a
Congressionally-mandated annual report that has been issued every year
beginning in 1989—identifies trade barriers to US companies and products in
foreign shores due the host country’s intellectual property laws, including
trade marks, patents, copyright, trade secrets etc.
PWL is defined as a trading partner with "serious intellectual property
rights deficiencies" that require increased attention of the USTR while WL
is a trading partner also with "serious intellectual property rights
deficiencies" but which has not yet been placed under PWL.
PFC is the most serious classification under the USTR’s scheme of things
and is applied to a country which is perceived to cause the most egregious
IP rights violations that harm American competitiveness abroad. Placing a
country under PFC may indicate the possibility of the US unleashing
unilateral sanctions on the country. In 2014, influential American
businesses, in particular the pharma and manufacturing sectors had urged
the Obama administration to list India list as a PFC, but that did not
The USTR report complains about an array of issues that include, the
deterioration in IPR protection and enforcement in a number of trading
partners, reported inadequacies in trade secret protection in China, India,
and elsewhere; 'troubling' indigenous innovation policies that may unfairly
disadvantage U.S. right holders in markets abroad, issues around online
The 77-page report expends quite a bit of its attention on India under the
Country Reports section. It states that the manufacture and distribution of
pharmaceutical products and active pharmaceutical ingredients bearing
counterfeit trademarks as problems especially in countries like India,
Brazil, China, Guatemala, Indonesia, Lebanon, Peru, and Russia.
“While it is impossible to determine an exact figure, studies have
suggested that up to 20 percent of drugs sold in the Indian market are
counterfeit and could represent a serious threat to patient health and
safety,” states the report.
The report alleges that 97 percent of all counterfeit pharmaceuticals
seized at the US border in 2015 were shipped from only four economies of
China, Hong Kong, India, and Singapore.
It also complains of unfair market access and states that India maintains
“highest tariffs” on medicines, pharmaceutical inputs, and medical devices
as compared to other WTO members who are mentioned in the report.
The US trade chief argues that India’s National Manufacturing Policy
encourages compulsory licensing of patented technologies to bring about
technology transfer of green technologies. “Such policies, which India has
sought to multilateralise in United Nations (UN) negotiations, will
discourage, rather than promote, investment in and dissemination of green
technology innovation, including those technologies that contribute to
climate change adaptation and mitigation,” states the report.
The report points out to the Indian pharmaceutical industry as a particular
area of concern for the US business set-ups.
It directly attacks section 3 (d) of the Indian patent law. According to
Section 3(d), in order for a new form of a known substance to be
patentable, it must show an enhanced efficacy as against the known efficacy
of the substance concerned. The Trade-Related Aspects of Intellectual
Property Rights (TRIPS) agreement under the WTO has “sufficient
flexibilities” says the US and thus, section 3(d) is over and above
It cites “irregularities” in the application of 3(d) leading to the
rejection of “innovative” pharmaceutical products, and “lack of clarity” on
standards for sections 85 and 92 compulsory licenses and revocation under
section 66. India’s proposed Patent Rule Amendments would “pressure” patent
applicants to localize manufacturing in India and has thereby raised new
areas of concern for the US.
“The United States continues to have concerns that Section 3(d) of India’s
Patents Act, as interpreted, may have the effect of limiting the
patentability of potentially beneficial innovations,” it states. India has
rejected many patents that were accepted in other parts of the world, the
The Supreme Court of India rejected Novartis’s Glivec patent in 2005
because it failed the “therapeutic efficacy” test, among other cases when
India’s highest court had taken steps for enhancing access to medicines to
the public. Similarly, a decision by the Indian Intellectual Property
Appellate Board (IPAB) upholding the grant of the compulsory license over
Sorafenib, a drug to treat primary kidney cancer, had ruffled feathers of
the US administration. Rulings such as these have left the powerful
pharmaceutical lobby fuming.
It also calls the Patents Act’s requirements under Section 8 as “out of
step” and “out of date” with other countries.
India is the world’s most important manufacturer of affordable generic
drugs supplying them to developing countries, including to US-funded
programmes for TB, malaria and HIV drugs.
“It's clear that India will keep facing intense pressure to undermine its
role as 'pharmacy of the developing world',” Nirmala Sitharaman, the Indian
union minister for commerce and industry said in a statement recently.
Sitharaman had called the Special 301 report in the same statement a
“unilateral measure to create pressure on countries to enhance IPR
protection beyond the TRIPS agreement”. She called it an “extra-territorial
application of the domestic law of a country” and said that the government
remains committed to utilize flexibilities under the TRIPS agreement “to
protect domestic pharmaceutical sector from pressure exerted by the foreign
The National Pharmaceutical Pricing Authority implemented pricing
restrictions on 509 drug formulations, effective 1 April, 2015 while
exempting certain medicines manufactured in India and “developed using
indigenous R&D,” to be priced higher. This, the US says, is a competitive
disadvantage to US companies.
“On the one hand, USTR says it is supports "access to medicine for all."
But then USTR sets out a series of complaints about anything that would
make medicines more affordable,” said Jamie Love, Director of Knowledge
Ecology International (KEI), and an American expert in several compulsory
licensing cases and an advocate of delinking R&D costs from drug prices.
“President Obama has never been able to rein in the pharmaceutical or
publisher lobbies, and his administration has been behind the curve or in
opposition to efforts to change business models for drug development, so
that innovation and access would not be in conflict with each other,” he
There is growing concern even within the US on spiraling drug prices that
makes health care steep or out-of-reach for the average citizen. The US
pharmaceutical industries use the report to push governments to open their
IPR regime more to accommodate their interests.
India’s “compulsory licensing” provision under law is problematic to the US
since India uses it as an important tool of industrial policy for green
technologies, “with the potential to be applied more regularly across
The Special 301 report also views “localization” requirements by India that
favour Indian IPR owners or local manufacturers as flouting rules by
“distorting the competitive landscape” and stifling new and innovative
foreign industries. The US had slapped a case on India in 2014 at the WTO
relating to domestic content requirements under the government’s Jawaharlal
Nehru National Solar Mission (NSM) for solar cells and solar modules. India
lost the case at the Dispute Settlement Board but filed an appeal on 21
April this year regarding certain legal interpretations by the panel.
The promotion of local manufacturing by reinstated or increased custom
duties on 45 items in 2016 including for, medical devices, lifesaving
drugs, information and communications technology products, solar energy
equipment etc. go against international patent norms, according to the US.
Since 2010, the US government as part of the Special 301 report has a
‘Notorious Markets List’ “that includes examples of online marketplaces
reportedly engaging in commercial-scale piracy online, including sites
hosted in, operated by, or directed toward parties located in Brazil,
Canada, China, India, Russia, Switzerland, Ukraine, and elsewhere”.
According to the report, the cost of piracy for the creative Indian
industry is massive—losses from piracy of music and movies in India are
approximately $4 billion per year and the commercial value of unlicensed
software approaches $3 billion. Quoting a 2013 study conducted by the
Motion Pictures Distributors Association of India, the USTR says that India
has one of the highest rates of video piracy in the world. The high
incidence of camcording in India indicates the need for effective legal
regulations, the US stated.
KEI reports that ‘trade secrets’ are mentioned 57 times in the report,
“illustrating the increased emphasis on broader definitions to trade
secrets and expansions of corporate secrecy as a trade policy”.
Prime Minister Narendra Modi is scheduled to visit Washington to address a
joint session of the US Congress on June 8. IPR issues are certain to
figure in the discussions between Modi and US president Barack Obama.
The report praises some plurilateral trade deals like the Trans-Pacific
Partnership (TPP) and the proposed Transatlantic Trade and Investment
Partnership (TTIP)—a series of secret trade deals between the US and the EU
--as having “among the highest levels of IPR protection and enforcement in
the world”. Nobel Prize-winning economist Joseph Stiglitz recently
described the TPP as the ‘worst trade deal ever’. The proposed TTIP deal
has also caused much uproar from human rights experts, civil society and
NGOs for its system of establishing private arbitration systems through
which governments could be potentially sued for legislating in public
interest in case such measures go against foreign trade interests, among
The US has promised to work on the issues mentioned in the Special 301
report through the High Level Working Group on Intellectual Property (IP
Working Group), established by Obama and Modi. “The United States is
working with India to foster an environment that will enable India to
achieve its important domestic policy goals of increasing investment and
stimulating innovation through, not at the expense of, IPR protection and
enforcement,” the USTR report states. It recently hosted the Indian
Government for a Copyright Workshop in April 2016 and is holding a Trade
Secrets Workshop in India later this year to have discussions on the Indian
IPR regime and “share new legislative approaches”.
In February 2016, Obama amended the Special 301 statute directing the USTR
to develop action plans for each country that the US identifies as PWL for
more than a year and holding foreign governments “accountable for
intellectual property-related trade practices that disadvantage America’s
creators and innovators”.
“The legality of 301 is questionable. It is a classic case of using
bilateral threat. Developing countries should not be cowed down but rather
should go to multilateral platforms like the WTO and challenge this.
Countries have the absolute right to use flexibilities. This is illegal
under the current WTO framework,” said K.M. Gopakumar of Third World
Network and an expert on patents.
Zack Struver, Communications and Research Associate
Knowledge Ecology International
zack.struver at keionline.org
Twitter: @zstruver <https://twitter.com/zstruver>
Office: +1 (202) 332-2670 Cell: +1 (914) 582-1428
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