Glivec Patent Case in India: FACT vs.

FICTION
It is difficult to look objectively at intellectual property rights and access to medicines. Certain facts,
however, are not debated. We offer these realities to counter some of the most prominent misconceptions
involving Glivec, generics, trade agreements and intellectual property rights.

Glivec: a new drug?

FICTION: Glivec is only a minor tweak of an older compound that already has a patent.

FACT: There is no “new” Glivec. Glivec is one of the medical breakthroughs of the 20th
century and has revolutionized the way certain cancers are treated. It has been granted a patent in
nearly 40 countries, including China, Russia and Taiwan. There is only one Glivec.

The 1993 patent was for synthesizing the molecule of imatinib; this molecule, however, could not
be administered to patients and represented only the first step in the process to develop Glivec.
We developed the mesylate salt of imatinib and then the beta crystal form of imatinib mesylate to
make it suitable for patients to take in pill form. Glivec was launched globally in 2001, and this is
the only form of Glivec we have marketed.

FICTION: Glivec treats HIV/AIDS.

FACT: Glivec primarily treats two rare cancers, chronic myeloid leukemia and
gastrointestinal stromal tumors, not HIV/AIDS. Novartis does not make HIV/AIDS medicines.

FICTION: Novartis raised the price of Glivec 1000% after it received an EMR (Exclusive Marketing
Rights) for the drug in India.

FACT: The price of Glivec has not changed since its introduction in India. The price of Glivec is
almost irrelevant in India as 99% of the patients who need the medicine receive it free from
Novartis through the Glivec International Patient Assistance Program (GIPAP). What is
interesting to note is that while Glivec was the first pharmaceutical product in India to receive
Exclusive Marketing Rights (EMR) during the transition period, it was also one of the first patents
to be rejected after the Patent Act was introduced.

If Novartis wins, do patients lose?

FICTION: If Novartis wins its legal case with Glivec, a cancer drug, access to affordable medicines to
treat life-threatening conditions like HIV/AIDS will be threatened, and people will die.

FACT: Access to HIV/AIDS medications is not threatened by our case. The basis of this
argument is false and very misleading. Consider these facts:

• Independent of the legal outcome in our case, the currently available generic drugs launched
before 2005 – including HIV/AIDS medicines and generic versions of Glivec – will continue to
be available domestically and for export due to the grandfather clause in the Indian patent law.
• All pharmaceutical products, including HIV/AIDS medications, have been patentable in
India since 2005. Many second-line HIV/AIDS treatments are new chemical entities (NCEs)
and therefore patentable under the existing Indian patent law regardless of the outcome of this
case.
• Novartis fully supports flexibilities in the TRIPS agreement that allow governments to make
exceptions to patent rights and import pharmaceuticals produced under compulsory license in
case of a national emergency or a lack of supply from the patent-holder. Our case does not
challenge these provisions.

Glivec Patent Case in India: Fact vs. Fiction Page 1 of 4

 • Novartis actively supports other ways to increase access, such as public-private partnerships,
tiered pricing arrangements and shared contribution models in addition to donation
programs.

The fact is if Section 3(d) is allowed to go unchallenged, patients will lose because effective
patent systems save lives by stimulating innovation leads to the next breakthrough medicines, like
Glivec.

FICTION: Novartis doesn't care about poor people, only about making profits for its shareholders.

FACT: Novartis cares about patients and patient access to medicines, as demonstrated by our
well-regarded record in social responsibility.

In 2006, our access to medicines programs reached nearly 34 million disadvantaged patients
with contributions valued at nearly one billion Swiss francs (USD 755 million). More than 2% of
Novartis Group sales go to our corporate citizenship programs each year. In India, 99% of patients
prescribed Glivec receive it free from Novartis.

Are generics the solution?

FICTION: India is the ‘pharmacy to the poor,’ as one of the major exporters of affordable medicines to
poor countries.

FACT: The reality is that Indian generic companies export to markets where they can sell their
products at a profit; they sell more in wealthy countries than domestically or in poor countries.

For example, groups claim that India is a major supplier of HIV/AIDS medications to the
developing world. India itself actually has the highest HIV/AIDS prevalence in the world (an
estimated 5.7 million people), but only 7% of Indian patients who need antiretroviral therapy
receive it.1

FICTION: Without long-term access to low-cost, generic versions of medicines, poor people in
developing countries will continue to suffer needlessly.

FACT: Generics alone aren’t the solution. Even our critics recognize that generic versions of
Glivec are not accessible for the poor in India. The cost of a year of treatment with generic Glivec
is four to five times the average annual income.

The problem goes far beyond the simple availability of generic drugs; poor people in developing
countries will suffer needlessly until a wide variety of issues such as lack of diagnosis,
infrastructure and distribution are solved. Governments, NGOs and companies need to work
together to find innovative solutions to these issues. A long-term solution for access must include
the research-based pharmaceutical industry because new therapies are needed to better treat
different populations, to counter resistance and to address new and changing diseases.

As a major manufacturer of generics, Novartis understands and recognizes the contribution of

generics once drug patents expire; our concern is with the non-recognition of intellectual
property rights. Without pharmaceutical research and development leading to innovative
medicines, poor people will continue to suffer and die because of treatable diseases like
tuberculosis, malaria and dengue fever. Generic drugs would simply not exist without new,
original medicines.

1 Henry J. Kaiser Family Foundation, HIV/AIDS in India, http://www.kff.org/hivaids/7312.cfm

Glivec Patent Case in India: Fact vs. Fiction Page 2 of 4

International trade agreements
FICTION: Section 3(d) of the Indian patent law is compliant with World Trade Organization (WTO)
provisions, specifically the Doha Declaration, that allow countries to interpret and implement TRIPS “in a
manner supportive of its right to protect public health and, in particular, to promote access to medicines for
all.”

FACT: Our case is seeking clarity on this point. The Doha Declaration continues: “…we
reaffirm the right of WTO members to use, to the full, the provisions in the TRIPS Agreement,
which provide flexibility for this purpose.” The provisions and flexibilities referred to here
include compulsory licensing for medicines in case of a national health crisis, which is completely
unrelated to patent laws and patentability of medicines.

We commend the progress India has made in advancing intellectual property rights, but more
needs to be done to align this increasingly important industrial country with international
standards. Novartis remains concerned about several last-minute amendments to the Indian Patent
Act, and wants to ensure that incentives are in place that stimulate innovation to benefit Indian
patients. As more and more Indian pharmaceutical companies are investing in researching
innovative medicines, good intellectual protection is becoming increasingly critical to domestic
industry objectives.

Patents and access

FICTION: Patents are the barrier to access to medicines.

FACT: Patient access is not about patents – it is about making medicines available. Nearly all
(95%) of the WHO’s ‘essential medicines’ are available at reduced, off-patent prices, but more
than a third of the world’s population still has no access to them.

Access to medicines has political, financial and even logistical barriers. Improving access to
healthcare is about more than affordability; existence of trained healthcare staff and infrastructure,
cultural acceptability of treatment, accessibility of healthcare facilities and quality of care all play
a role in making medicines available.

Innovative medicines will eradicate diseases once thought incurable and prevent illnesses like TB
from spreading through developing countries. Patent save lives by stimulating research, which
leads to these innovations.

FICTION: Patents give companies a monopoly on a product, letting them make money at the expense of
consumers who have no alternatives.

FACT: Patents are short-lived when compared to other forms of intellectual property
protection; they last only 20 years, while copyrights last for the life of an author and trademarks
are valid as long as they are enforced.

In the pharmaceutical industry, companies apply for patents very early in the R&D process for
base compounds, long before they have a marketable product. Because of the development phase
between the original filing for the base compound and the launch of a drug, pharmaceuticals
only receive an average of 8-12 years of protection while they are on the market.

As a major manufacturer of generics, Novartis understands and recognizes the contribution of

generics once drug patents expire; our concern is with the non-recognition of intellectual property
rights that ultimately help sustain and advance pharmaceutical research and development.
Allowing generics manufacturers to take over production of off-patent medications allows
pharmaceutical companies to look ahead and create new, innovative products for the future.

Glivec Patent Case in India: Fact vs. Fiction Page 3 of 4

For more information, please see:

Novartis Glivec patent case information center

http://www.novartis.com/newsroom/india-glivec-patent-case/index.shtml

The Max Foundation

https://www.maxaid.org/

Myths and realities on prices of AIDS drugs

Carol C. Aldeman, Jeremiah Norris, S. Jean Weicher; Hudson Institute
http://www.hudson.org/files/publications/AdelmanARVWhitePaper.pdf

The full cost of HIV/AIDS treatment

Carol C. Aldeman, Jeremiah Norris, S. Jean Weicher; Hudson Institute
http://www.hudson.org/files/publications/Full_Cost_of_HIV-AIDS_Treatment.pdf

Novartis
http://www.novartis.com/

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