Better to Best: Thoughts on Global Health Care Systems

Why I’m even more skeptical about a Novartis exec joining the Gates Foundation

Posted in Health Rights, Human Rights, PharmFree by reshmagar on October 19, 2011

From MSF India – still unclear as to why a executive coming from a company that is trying very hard to deny access to an affordable version of a key life-saving leukemia drug is joining the Gates Foundation, an organization that prides itself in providing inexpensive vaccines and other drugs to developing countries worldwide.

WHAT NOVARTIS SAYS…AND WHY IT’S WRONG

Médecins Sans Frontières briefing note, 4 October 2011

Swiss pharmaceutical company Novartis issued a press statement last week in
response to the growing concerns regarding its latest legal challenge
against the Indian government. Ahead of the next hearing of the case in the
Indian Supreme Court set for 17 October 2011, Médecins Sans Frontières
addresses the issues Novartis raised in its statement.

BACKGROUND: The Supreme Court case is the final act in a legal battle over
the patentability of the salt form of the anti-cancer drug imatinib and
section 3(d) of the Indian patent law that stretches back over five years.
In 2006, the Indian patents office ruled that Novartis did not deserve a
patent for imatinib mesylate, a salt form of a life-saving cancer drug, on
the grounds that the application claimed a new form of a drug too old to be
patentable in India (see notes below). The company then embarked on a series
of lawsuits against the Indian government including the one that is
currently pending before the Supreme Court. In this case Novartis is
challenging a part of India’s patent law – Section 3(d) – which read with
other provisions of the patent law and the Madras High Court decision says
that a new form of a known medicine can only be patented if it is not
obvious and shows significantly improved therapeutic efficacy over the known
substance.

*What Novartis says: “price doesn’t affect access to medicines”.*

In its statement, Novartis writes “Acknowledging innovation by granting a
patent is unrelated to the access to medicines issue. Improving access to
medicines is a matter of making medicines available.”

This is not the entire truth. MSF has found, during its field experience in
working in many developing countries, that granting a patent has had a
direct bearing on access to affordable essential medicines. Granting a
patent on a medicine provides the patent holder with a monopoly on that
medicine, which in turn allows the company to charge a high price in the
absence of any generic competition. In fact, improving access to medicines
is a matter of not simply making the medicine available but also making it
affordable for patients and governments to buy. This is well documented.
When AIDS treatment first became available in the late 1990s, the price of
first line patented AIDS medicines was – even after discounts – US$10,439
per patient per year. Millions died in developing countries, particularly in
Africa, as prices were too high. Generic competition brought prices down
making treatment possible. In MSF’s experience, patents on medicines are a
key barrier to making medicines affordable, as it prevents access to those
who cannot afford it.

*What Novartis says: “this case will in no way impact access to medicines
to poor countries”. *

This is not true. If Novartis succeeds in weakening the interpretation of
section 3(d) for the purpose of obtaining a patent on imatinib mesylate, the
Indian Patent Office would have to apply the same standards of intellectual
property protection as wealthier countries like the US, granting far more
patents than required under international trade rules or envisioned by
India’s lawmakers.

It is not only about this particular medicine. The interpretation of the
clause has a direct bearing on the examination of patent applications
claiming salt forms, pediatric formulations and other improved formulations
of AIDS drugs, the generic versions of which are currently used by MSF in
its medical projects. This case would set a precedent in this regard.

This could lead to generic competition on many essential drugs ending
entirely and prices for these in both India and developing countries
increasing. This would have a devastating impact on not only people MSF
treats, but also on people the world over who rely on affordable medicines
manufactured in India. MSF buys 80% of the ARVs it uses to treat 170,000
people for HIV across the developing world from Indian generic
manufacturers, and donors rely on Indian sources in similar proportions.

It is crucial to preserve the public health safeguards of Indian patent law
– particularly Section 3(d). The future of generic production is largely
dependant upon the outcome this case.

Imatinib mesylate is a crucial anti-cancer drug sold by Novartis in India
for Rs.120,000 (US$ 2,400) per patient per month. Indian generic companies
sell generic versions for Rs. 8 – 10,000 ($160 – 200) per patient per month.

*What Novartis says: “Section 3(d) – as it relates to evergreening – is not
applicable at all to Glivec”. *

Novartis is seeking a patent in India on the salt form of imatinib (Glivec).
Claiming a patent on a salt form of an existing drug is a common and
well-known form of evergreening by pharmaceutical companies to extend the
patent life – and monopoly – of their drugs. And companies do this routinely
to prevent generic competition. An example of this is the AIDS drug
abacavir. Although the abacavir molecule was first developed and patented in
the 1980s, pharmaceutical company GSK applied for a patent in 1997 on
abacavir sulphate (salt form) in developing countries, with the intention of
obtaining a patent monopoly until 2017. Where the patent was granted this
has blocked access to affordable generic forms of abacavir in many
developing countries.

*What Novartis says: “Glivec has been granted a patent in nearly 40
countries and India should also follow suit”*.

This is a mistaken interpretation of international intellectual property
rules. Although the TRIPS Agreement obliges all members of the World Trade
Organization to grant patents on medicines, nothing obliges developing
countries like India to replicate patent systems of wealthy countries. An
important flexibility in this respect is the right of WTO Member States like
India to define the patentability criteria in accordance with their
particular national priorities. This is precisely what India did when it
amended its Patents Act in 2005. At the time of implementing TRIPS, India
felt that many countries were granting a large number of patents on new uses
and new forms of known medicines, which was becoming a key reason for
creating longer patent barriers and high prices in developing countries. So
along with patent protection for new innovative medicines, Indian lawmakers
introduced a specific provision, section 3(d), in its patent law that
excludes from patentability new uses and new forms of known medicines. The
system India has is not perfect, but it does prevent drug companies from
getting unjustified 20 year monopolies every time they come up with a new
use or a new form of a known medicine.
.

*What Novartis says: “medicines can be made available through access
safeguards in international agreements and, in the case of essential and
life-saving medicines, special pricing arrangements in developing
countries”. *

While this is correct – countries have the legal flexibility to issue
compulsory licences to generic producers on patented drugs where it hinders
access to essential medicines – measures like tiered pricing in our
experience are not the most effective way to make medicines affordable.

Novartis also seems to imply that countries can only act once patents are
granted. However, a lesser known key TRIPS flexibility is the right of a
country to take steps before a patent is granted to ensure that patent
applications on routine and obvious improvements of medicines are not
granted so that they do not disrupt supply of affordable generic medicines
to patients. India has chosen to adopt this safeguard with the introduction
of Section 3(d) in its patent law, while allowing patents to be granted on
new medicines from 2005.

*Notes for the editor: *
The basic molecule imatinib was first patented (US 5521184) in 1993. India
signed the WTO TRIPS agreement in 1995 and opened up filing of product
patent applications in India. In 1998, Novartis filed an application
1602/MAS/1998 on the mesylate salt of Imatinib. This case relates to the
1998 application.

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