Info Service on Health Issues (August 07/01)
Indian High Court dismisses Novartis petition
Health activists cheer
the recent Indian High Court decision to uphold Indiaís
Patents Act. This is seen as a major victory for patientís access to
affordable medicines in developing countries.
The article below outlines
the outcome of the courtís decision and is reproduced with the permission
of South-North Development Monitor (SUNS) #6308, 7 August 2007.
Health: Indian High Court
dismisses Novartis petition
By Kanaga Raja,
6 August 2007
The Madras High Court on Monday dismissed a petition filed by the Swiss
pharmaceutical giant Novartis challenging the constitutional validity
of India's Patents
According to media reports from India,
the High Court, in dismissing the petition, held that it was not the
proper forum to decide whether the Act was in compliance or not with
the TRIPS Agreement.
The media reports said that Novartis' petition challenged the constitutional
validity of Section 3 (d) of the Patents Act 2005, under which its patent
application for beta crystalline form of imatinib mesylate, was rejected.
The Act disallows patents for minor modifications to molecules already
invented and that are components in drugs.
In a media release on Monday, Novartis said that the decision will have
long-term negative consequences for research and development into better
medicines for patients in India
The Swiss pharmaceutical giant however said that it will likely not
appeal the ruling.
"We disagree with this ruling, however, we likely will not appeal
to the Supreme Court. We await the full decision to better understand
the Court's position," said Ranjit Shahani, Vice-Chairman and Managing
Director, Novartis India Limited.
Novartis noted that still at issue is why a patent for Glivec - granted
in nearly 40 countries, including Russia,
Taiwan and China - was denied in India in 2006. The Glivec patent appeal
will be decided separately by the newly-operational Intellectual Property
Appellate Board (IPAB).
Meanwhile, in a press release also issued on Monday, the international
medical humanitarian organization Medecins Sans Frontieres (MSF) welcomed
the High Court decision to uphold India's
Patents Act as a major victory for patients' access to affordable medicines
in developing countries.
"This is a huge relief for millions of patients and doctors in
developing countries who depend on affordable medicines from India," said Dr. Tido von Schoen-Angerer,
Director of the MSF Campaign for Access to Essential Medicines.
"The Court's decision now makes Indian patents on the medicines
that we desperately need less likely. We call upon multinational drug
companies and wealthy countries to leave the Indian Patents Act alone
and stop pushing for ever stricter patent regimes in developing countries."
According to MSF, Novartis took the Indian government to court over
its 2005 Patents Act because it wanted a more extensive granting of
patent protection for its products than offered by the law.
Novartis claimed that India's
Patents Act did not meet rules set down by the World Trade Organization
and was in violation of the Indian constitution.
According to MSF, India
only began giving patents on medicines to comply with WTO rules, but
it designed its law with safeguards so that patents can only be granted
for real innovations.
This means that companies seeking a patent for modifications to a molecule
already invented, in order to extend ever further their monopolies on
existing drugs, would be unsuccessful in India. It is this aspect of the law
that Novartis was seeking to have removed, said MSF.
MSF said that a ruling in favour of the company would have drastically
restricted the production of affordable medicines in India that are
crucial for the treatment of diseases throughout the developing world.
Developing country governments and international agencies like UNICEF
and the Clinton Foundation rely heavily on importing affordable drugs
from India, and 84%
of the anti-retrovirals that MSF prescribes to its patients worldwide
come from Indian generic companies.
must be allowed to remain the "pharmacy of the developing world,"
MSF also noted that over 420,000 people worldwide signed a petition
requesting Novartis to drop the case because of the devastating impact
that Novartis' actions could have on access to essential medicines.
Among the signatories to the petition were Indian Health Minister Anbumani
Ramadoss, Archbishop Desmond Tutu, Global Fund Director Michel Kazatchkine,
members from the European Parliament and the US Congress, former Swiss
President Ruth Dreifuss, former UN Special Envoy for AIDS in Africa
Stephen Lewis, German Development Minister Heidemarie Wieczorek-Zeul,
Norwegian Development Minister Erik Solheim, as well as authors John
Le Carre and Naomi Klein.
In another statement, the Indian group, Lawyers' Collective, which is
involved in access to medicines issues and cases in India, gave a background to the case.
It said that in March 2005, the Indian Parliament amended its patent
law and a significant provision (section 3d) was introduced to prevent
ever-greening and granting of frivolous patents.
In May 2006, Novartis filed writ petitions before the Madras High Court,
claiming that the Patent Controller erred in rejecting its patent application,
and further claiming that section 3(d) was, among other things, vague,
ambiguous, and contrary to the requirements of the TRIPS Agreement.
In the challenge to section 3(d), Novartis argued that this provision
is not in compliance with the TRIPS Agreement and that it is in violation
with the government's constitutional duty to harmonise its domestic
laws with its international obligations.
Recognising the fact that the TRIPS agreement is non-self executing
and provides no private right of enforcement, Novartis advanced a somewhat
novel claim that while it is open for the Indian Parliament to repudiate
its international obligations altogether, it is somehow invalid and
unconstitutional for Parliament to otherwise comply with TRIPS except
for one particular provision.
The Government of India and the generic companies argued that neither
could private companies such as Novartis challenge a law as being TRIPS
non-compliant nor could an Indian court decide whether the Indian patent
law is TRIPS compliant or not. The appropriate forum, they argued, is
the WTO Dispute Settlement Body.
Upholding this argument, the Madras High Court held that it was not
the proper forum to decide whether the Indian patent law was TRIPS-compliant
The other ground of challenge raised by Novartis was that the use of
the term "efficacy" in section 3(d) is vague and ambiguous,
and therefore violates the equality provision (Article 14) of the Indian
During the arguments, while conceding that the meaning of the term "efficacy"
is known, Novartis contended that because there was no clarity as to
what constituted "enhancement of efficacy" and "significant
enhancement of efficacy" as required by section 3(d), the law was
vague and lent itself to arbitrary decisions by the Patent Controller.
The Government of India and generic companies argued that section 3(d)
is not in violation of the equality provision of the Indian Constitution
as the concept of efficacy is well-known to persons in the pharmaceutical
industry and it is impossible to lay down a "one size fits all"
standard to determine what constitutes a significant enhancement of
Dismissing the petition, the Madras High Court held that section 3(d)
was not vague or arbitrary and therefore did not violate the Indian
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