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MEDIA ADVISORY Monday January 29 2007
AIDS ACTIVISTS
PRESENT "GOLDEN COFFIN" AWARD TO NOVARTIS CEO
Health
GAP • Student Global
AIDS Campaign • Global AIDS Alliance • Stop HIV/AIDS in India
Initiative • American Medical Students Association
(Washington
D.C.) AIDS activists presented a "Golden Coffin" award endorsed by
civil society groups from around the world to representatives of
Novartis, a pharmaceutical company suing the Indian government.
Novartis' lawsuit was triggered by India's decision not to grant a
patent to Novartis on a medicine for life threatening cancer, imatinib
mesylate (trade name Gleevec). Groups from around the world are calling
on Novartis to drop this court case; the most recent hearing of the
case began in India at the Chennai High Court January 29, 2007.
The implications of the case are much broader than one drug or one
condition; India's ability to manufacture low cost generic versions of
newer medicines will be threatened if Novartis prevails in this case,
according to the activists. Generic Indian antiretrovirals are used for
about half of all HIV treatment in poor countries. "People with HIV
around the world depend on India for generic equivalents of
antiretrovirals," said Asia Russell of Health GAP. "Novartis'
wrongheaded court case in India could jeopardize sustainable access for
countless numbers of poor people, particularly in sub Saharan Africa,
where imported generic medicines are saving lives."
India changed its Patents Act in 2005 to meet its obligations as a
member of the World Trade Organization, and began granting patents for
pharmaceuticals. But the government defined the scope of patentability
in India so as to ensure that medicines that were not innovative, were
not granted patents. "Novartis is pressuring India to eliminate a
perfectly legal public health safeguard. If Novartis succeeds, drug
prices will rise, and people will suffer greatly," said Vineeta Gupta
of SHAII (Stop HIV/AIDS in India Initiative). "Novartis should be
ashamed."
"The greed and indifference of [Novartis CEO] Daniel Vasella is
astonishing," said Anuja Singh of the Student Global AIDS Campaign.
"India should be congratulated for prioritizing public health and
access to medicines--not slapped with a court case.
US Activists Try to Deliver Coffin to
Novartis Over Indian Patent Case
WASHINGTON (AFP) - Non-governmental groups tried to deliver a mini
coffin to Swiss pharmaceuticals giant Novartis to protest legal action
aiming to overturn a ban on a drug patent application in India.
The
groups said India's ability to manufacture low cost generic versions of
newer medicines would be threatened if Novartis won the suit.
Novartis's application for a patent for its Glivec cancer drug was
rejected by the Indian patent office in January 2006, but the company is
appealing that decision in the High Court.
A
dozen activists from non-governmental groups attempted Monday to
deliver a golden miniature coffin at a Novartis downtown office in
Washington but were turned away, said David Bryden of Global AIDS
Alliance. "The coffin was meant for Novartis chief executive Daniel
Vasella," he said.
In
front of the Novartis office, the activists slumped to the ground and
shouted, "Patient rights, not patent rights" and "Novartis greed kills
people in need; Drop the case now." The gesture symbolized the "fatal
consequence" of Novartis' action for people dependent on India for
generic medications, Bryden said. "People with HIV around the world
depend on India for generic equivalents of antiretrovirals," the main
treatment for HIV-AIDS, said Asia Russell of Health GAP, a US-based
AIDS and human rights activist group.
Generic
Indian antiretrovirals are reportedly used for about half of all HIV
treatment in poor countries. Novartis said recently it would not give
up the case, disputing the contention by activists that the legal
action would adversely impact access to affordable medicines in the
developing world. The company added that even if Glivec were available
in generic form in
India, it would still be out of reach for most patients, with treatment
costs at 4.5 times annual average income even as a generic. Novartis
said it currently provides Glivec for free to over 6,500 patients in
India, adding that the number was equivalent to more than 99 percent of
those who need it.
AIDS Activists present “Patent-Claim,
Broken-Heart” award to Novartis
Swiss Pharmaceutical Company’s Lawsuit threatens to loosen India’s
Patent Act and threaten future access to lifesaving medicines
Cambridge, MA 2/14/07 –
Forty five AIDS activists presented a "Patent-Claim Broken-Heart" award
to representatives of Novartis, a pharmaceutical company suing the
Indian government, as part of a student demonstration on Valentine’s
Day. Frustrated by India's decision not to grant a patent on its cancer
medicine, Gleevec, Novartis responded by challenging the strict
standards that India has adopted to prevent frivolous patents for minor
changes to existing medicines, arguing that India’s definitions of
patentability do not comply with international standards. Groups from
around the world are calling on Novartis to drop its lawsuit and over
250,000 people have signed a petition to Novartis; the trial of the
case will resume in India at the Chennai High Court on February 15,
2007.
Carolyn Hunt, a student at Northeastern University and member of the
Student Global AIDS Campaign (SGAC) stated, "India should be
congratulated for prioritizing public health and providing expanded
access to medicines--not slapped with a court case."
The implications of the case are much broader than one cancer
drug. India's ability to manufacture low-cost generic versions of
newer, slightly changed medicines for all chronic and infectious
diseases will be threatened if Novartis prevails in this case,
according to the activists. Generic Indian antiretroviral medicines are
used for about half of all HIV treatment in poor countries. "People
living with HIV from Lesotho to Laos depend on India for generic
equivalents of antiretrovirals. Novartis' court case in India could
jeopardize sustainable access to medicines for countless numbers of
poor people throughout the world for every condition from diabetes to
tuberculosis," said Meghan Gallagher, an SGAC member from Clark
University.
India was forced to change its Patent Act in 2005 to meet its
obligations under the World Trade Organization TRIPS Agreement, and
began granting patents for pharmaceutical products for the first
time. But, pursuant to internationally sanctioned flexibilities,
the government took steps to ensure that medicines that were not
truly innovative were not granted 20-year patents. This allowed Indian
manufacturers to continue producing low-cost generic drugs. "Novartis
is pressuring India to eliminate a perfectly legal public health
safeguard. If Novartis succeeds, drug prices will rise dramatically,"
noted Professor Brook K. Baker, a law professor at Northeastern
University and a member of Health GAP. "Novartis’ effort to eviscerate
the heart of India’s strict patent regime is indefensible. It and
other drug companies want to ensure their right to sell high-price,
patent-protected drugs to India’s middle-class even if that means
millions will die, not only in India but worldwide."
INDIA’S
2005 PATENT ACT:
Death by Patent or
Universal Access to Second- and Future-Generation ARVs
By Professor Brook K. Baker, Health GAP
(Global Access Project)
Download Word document
A deconstruction of
Novartis’s defense of its challenge to the India patent regime.
Brook K. Baker, Northeastern U. School of Law, Program on Human Rights
and the Global Economy, Health GAP, February 7, 2007
Given the barrage of negative publicity that Novartis has received as a
result of campaigns contesting its effort to overturn India’s strict
new patent regime, Novartis has issued a three-page
defense of its lawsuit.
This defense contains one truth, numerous half truths, and several flat
out lies:
Truth:
Novartis seeks secure access to middle-income consumers via
patent-based monopoly rights.
“In India, Novartis is faced with a globalization dilemma that
characterizes many emerging economic powers today: two markets within
one country. India has a booming middle class on one hand, and a vast
number of extremely poor people on the other.
[W]e take affluent India seriously as a formidable power with all the
rights and obligations that such status brings with it. As a
consequence, we seek to establish effective protection for
pharmaceutical innovation in
India.”
Half-truths:
Novartis does seek monopoly rights in the India market and it does
compete with Indian companies, but it faces no realistic threat that
patent-free Indian generics would be shipped to its patent-protected
markets in North America, Europe and Japan.
“[I]t is clear that we seek business opportunities in India’s growing
economy. We also compete with Indian companies globally in attractive
markets, and the export of copies of our products into richer countries
is
a major concern to us.”
Rich countries have stringent border controls, drug registration
procedures, and prescription practices that preclude import and sale of
generic versions of patented medicines. If Novartis’s complaint
were true,
the U.S. would be flooded with cheaper generic versions of AIDS
medicines (or even of Glivec, which has been produced and sold at 1/10
the cost in India), but, of course, it is not.
Half-truth: For
Novartis, patents are truly non-negotiable, but it is not true that the
patent system is the best or only way of promoting research and
development.
“Protecting innovation is the
foundation for massive R&D investments made by the pharmaceuticals
industry that are vital to medical progress. Companies can continue to
bring improvements and innovations to patients and societies only with
effective patent laws. For a research-based company such as Novartis,
patents are not negotiable.”
The public sector, especially in the United States, contributes
significant resources to the basic research that is the foundation of
many pharmaceutical innovations. Moreover, under the patent
regime, incentives
for innovation are diverted from true social need towards block-buster
drugs (sales over $1 billion a year) and me-too drugs (minor variations
developed primarily to extent an existing patent monopoly or to gain
market share from a competing block-buster drug). Similarly,
patent-based monopoly rights divert pharmaceutical research away from
preventative innovations, like vaccines, and towards every-day
medicines for chronic diseases that primarily impact rich consumers in
rich markets. As a consequence of this perverse set of
patent-based incentives, there is very little research into the
diseases that primarily affect poor people in the global south.
In addition, there are many viable alternatives to the existing
patent-regime with respect to global public goods like medicines.
Prize funds, research and development treaties, and more robust and
targeted
public investment in research are but a few of the proposals under
discussion that could reduce or eliminate the bloated sales forces and
supra-competitive profits that make drugs so expensive.
Half truth:
Novartis now, belatedly supports one narrow set of TRIPS-compliant
flexibilities for accessing cheaper medicines, but it is concurrently
challenging another perfectly lawful flexibility, namely defining scope
of patentability so as to prioritize public health and to increase
access to medicines.
“Our case does not challenge
provisions that provide for access under international trade
agreements, specifically the TRIPS and the Doha Declaration.
These flexibilities allow production for export under
compulsory licenses
that have been issued for public health reasons. They have been put in
place to allow poor countries to safeguard access to medicines that do
not have sufficient local production capacity. In fact, political
agreement on the Doha flexibilities has been reached in order to
mitigate impact of TRIPS implementation in India. Novartis supports the
TRIPS conditions that promote access for developing
countries.”
Novartis confirms its new-found loyalty to one-narrowly defined TRIPS
flexibility – compulsory licenses issued under the August 30, 2003,
Paragraph 6 Implementation Decision. In this regard it is
important to
note that Novartis previously joined 38 other drug companies and trade
associations in challenging South Africa’s completely lawful Medicines
and Controlled Substance Act that would have permitted parallel
importation. Maybe it now concedes the error of that 1998-2001
challenge to a lawful TRIPS flexibility, but even now it erroneously
implies that compulsory licenses can only granted pursuant to the
August 30 Decision.
But more importantly, Novartis’ lawsuit directly challenges another key
TRIPS-compliant flexibility, namely the right to strictly define
novelty, inventive step, and industrial applicability – the baseline
standards of
patentability – so as to exclude patents for minor variations of
existing chemical entities, for new uses of know chemical entities, and
for mere combinations of existing entities. Novartis and other
drug companies want to impose the same loose standards of patentability
for India and other developing countries that they have gained in the
IP-crazed courts and legislature of the U.S. and Europe. There is
in fact a great deal of
variability of patent standards between countries, and India’s stricter
definition is completely permissible under existing TRIPS standards.
Lie:
The Mashelkar Committee report did not directly address, let alone
hold, that certain provisions of the India Patent Act were
non-compliant with TRIPS.
“Many of the points we have raised
around India’s patent laws have been corroborated by the recent
Mashelkar Committee report on patent issues in India. The
Government-established Mashelkar Committee voiced its views in favor of
incremental innovation and held that certain provisions of the Indian
Patent Act are not compliant with international agreements,
specifically WTO’s TRIPS agreement (Trade-related Aspects of
Intellectual Property Rights).”
The Mashelkar Committee in India was tasked with determining “whether
it would be TRIPS compatible to limit the grant of patent for
pharmaceutical substances to new chemical entity or to new medical
entity involving one or more inventive steps.” This definition
would be even more restrictive than the version of section 3(d) of the
Act that Novartis is challenging. The only thing that the
Mashelkar Committee actually said about the current India’s Patent Act
is that “There is a perception that even the current provisions in the
Patents Act could be held to be TRIPS non-compliant.”
(¶5.11.) A “perception” is not a “holding.”
Lie:
Research-based pharmaceutical companies like Novartis do not make their
investment decisions based on monopoly marketing rights in developing
country markets – which has been produced and sold at 1/10 the cost in
India in rich country markets where their medicines enjoy even higher
standards of intellectual property protection.
“Knowing we can rely on patents in
India benefits government, industry and patients because research-based
organizations will know if investing in the development of better
medicines there is a viable long-term option.”
Many research-based drug companies are exploring and cementing
strategic sub-licensing partnerships with Indian drug companies given
their comparative cost advantages in manufacturing for global sales and
given prospects for lower-cost clinical trials in India. However,
drug companies make 90% of their global sales in the U.S., Canada,
Europe, and Japan. India comprises only 1.3% of the global
market. Does Novartis really want people to believe that its
going to make fundamental investment decisions based on 1.3% of the
global market instead of the 90%? It will set up shop in India in
order to make even more profits in rich country markets not because of
higher patent standards in India.
Donations are not an adequate defense: The best defense that
Novartis mounts is that because poor people can’t afford its drug it
gives much of it away in poor countries like India.
“In 2006, our access-to-medicines
program reached 33.6 million patients. Novartis spent USD 755 million
last year alone. ... The Glivec International Patient Assistance
Program (GIPAP) is one of the most
far-reaching
patient assistance programs every implemented on a global scale.
In India, 99% of patients who receive Glivec receive it free from
Novartis [6,600 people].”
However, corporate donations are not a sustainable solution: (1)
they are frequently hard to access, (2) they are revocable, (3) they
are not offered across the broad spectrum of patented medicines that
poor people need, and (4) they are designed primarily to forestall
generic competition by removing market incentives.
Novartis’s efforts to sanitize its efforts to eviscerate the heart of
India’s stringent patent regime are, in the end, indefensible.
Its defense of its cancer-drug patent today will undermine access to
medicines for
HIV/AIDS, for heart disease, for diabetes, in fact for every new
medicine needed by desperately poor people in developing
countries. Charity does not hide avarice. By protecting its
“fundamentals” – its non-negotiable, patent-right aspirations –
Novartis is revealing the cold and cruel logic of Big Pharma:
profits over people; letting poor people die is less important than
selling to middle-class Indians.
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