[Ip-health] Lawyers Collective - Supreme Court Rejects Novartis’ Appeal; Upholds high standard for Section 3(d)

Ramya Sheshadri ramyasheshadri8 at gmail.com
Mon Apr 1 01:26:49 PDT 2013

In a triumphant victory for patients fighting for access to medicines,
a division bench of the Supreme Court of India comprising Hon’ble
Justice Aftab Alam and hon’ble Justice Ranjana Desai, today dismissed
Swiss MNC Novartis’ appeal for a patent to Novartis for its
anti-cancer medicine, imatinib mesylate (Gleevec). The case is
especially pertinent because it involved the interpretation of section
3(d) of the Patents Act, 1970, a public health safeguard introduced by
Parliament in 2005 to prevent evergreening. Putting an end to the
controversy over the provision, the Supreme Court has recognised the
impact of patents on access to medicines and called for a strict
interpretation of section 3(d).

Rejoicing at the decision, Mr. Y. K. Sapru of Cancer Patients Aid
Association (CPAA), which had opposed Novartis’ patent application,
said, “We are very happy that the Apex Court has recognised the right
of patients to access affordable medicines over profits for big
pharmaceutical companies through patents. Our access to affordable
treatment will not be possible if the medicines are patented. It is a
huge victory for human rights. ”

The Supreme Court’s ruling turned on the interpretation of section
3(d), a key public health safeguard introduced in India’s patent law
by Parliament in recognition of the impact of product patents on
access to medicines. Amongst others, section 3(d) disallows patenting
of new forms of already known molecules, also known as evergreening,
unless the patent applicant shows significant enhancement in efficacy
for its product.

The Supreme Court held that Section 3(d) was introduced in the Patents
Act, 1970 to ensure that patents were not extended on spurious
grounds. The Supreme Court’s judgment that was delivered by Hon’ble
Justice Alam stated that patent applicants also have to meet the
standard of Section 3(d) before they can get patents under the Indian

Novartis also argued that section 3(d) only applies for new forms of
already approved medicines. It also argued that better
physico-chemical qualities, such as shape of the molecule, stability,
hygroscopicity and solubility, would satisfy the test of enhanced

Rejecting Novartis’ argument, the Supreme Court has held that the
physio-chemical properties of the beta crystalline form of imatinib
mesylate i.e. flow properties, decreased hygroscopicity and
thermodynamic stability may be beneficial for patients in some manner
but they do not meet the standard of efficacy required by Section

Welcoming the ruling, Mr Anand Grover, Senior Counsel and Director of
Lawyers Collective HIV/AIDS Unit, who represented CPAA in this matter,
said, “The Supreme Court’s interpretation of section 3(d) keeps it
intact. It is alive and kicking. It gives life to Parliament’s intent
of facilitating access to medicines and of incentivizing only genuine
research. By refusing patent monopolies on minor changes to known
molecules, this judgment will facilitate early entry of generic
medicines into the market for other medicines and diseases too. The
impact will be felt not only in India, but also across the developing

In the past, Section 3(d) has also been used as one of the grounds to
disallow patents for minor modifications of several antiretroviral
(ARV) medicines used to treat people living with HIV.

Loon Gangte of the Delhi Network of Positive People (DNP+) said, “We
are extremely pleased and relieved that the Supreme Court has
recognised the public health importance of section 3(d). We have been
filing several oppositions to patent applications on ARV medicines on
the basis of section 3(d). This is a crucial victory for people living
with HIV and other diseases who can continue to rely on India for
access to affordable treatment.”

The Supreme Court dismissed Novartis’ appeal with costs.

Leena Menghaney for Medecins Sans Frontieres (MSF), which relies on
Indian-made generic drugs to treat AIDS and other diseases in Africa
and many poor countries, said, Although MSF has yet to see the text of
the verdict, this appears to be the best outcome for patients in
developing countries as fewer patents will be granted on existing
medicines. Novartis's attacks on the elements of India's patent law
that protect public health have failed.  The Supreme Court’s decision
prevents companies from abusing the patent system to get secondary
patents on existing medicines, to block price-busting generic
competition on HIV and other essential medicines. This confirms that
all patent offices in India have to use this interpretation and the
law is now clear and must be strictly applied."

The judgment of the copy will soon be made available at
www.lawyerscollective.org website.

Lawyers Collective HIV/AIDS Unit and Cancer Patients AID Association

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