Novartis gets jacked……….

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Image courtesy: HIT consultant

Press Release of Lawyers Collective is below – judgment is available at

*Supreme Court Rejects Novartis’ Appeal; Upholds high standard for
Section 3(d)*

/1 April 2013, New Delhi­/.— 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 law.

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 efficacy.

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 3(d).

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 world”

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.”

*/Lawyers Collective HIV/AIDS Unit and Cancer Patients AID Association/***

*For further information, contact:
Anand Grover:  +91.9899439593 *

*Prathibha S.:  +91.9968050357 *

*Notes for Editors:*

At the root of the case before the Indian Supreme Court is Novartis’
patent application for beta-crystalline form of imatinib mesylate, a
drug used to treat chronic myeloid leukemia (CML), a type of blood
cancer. Novartis’ price for its version of imatinib mesylate sold under
the brand name, Gleevec or Glivec, is INR 120,000/- (USD 2400) per
month, while generic versions are available at a cost of INR 8,000 (USD
160) to INR 12,000/- (USD 240) per month. Cancer Patients Aid
Association procures the generic versions at discounted prices and
provides them to their members at subsidised rates. About twenty five
percent of the generic versions are provided free of cost to Cancer Patient.

In *1998*, Novartis filed a patent application in India for a product
patent on the beta-crystalline form of imatinib mesylate (imatinib
mesylate). The basic molecule, imatinib, had been discovered in the
early 1990s. As such, it was not patentable in India.

In *2005*, the Chennai Patent Office heard patent oppositions filed by
CPAA, represented by Lawyers Collective HIV/AIDS Unit, and other Indian
generic companies.

In *2006*, the Patent Office rejected Novartis’ patent application on
several grounds, including section 3(d). The Patent Office held that the
product claimed by Novartis lacked novelty and inventive step and also
failed to show an increased efficacy over the known substance.

In *2006*, Novartis challenged the constitutional validity of section
3(d) before the Madras High Court in Chennai arguing that the word
“efficacy” in the section was vague. Novartis also filed an appeal
against the rejection of its patent application. However, dismissing the
constitutional challenge, the Madras High Court in *2007* held that the
word “efficacy” used in section 3(d) had a definite meaning in the
pharmaceutical field, i.e. therapeutic efficacy in the context of medicines.

Before the Madras High Court could complete the hearings on Novartis’
appeal against the rejection of its patent application, the Intellectual
Property Appellate Board (IPAB) was notified as the tribunal to hear
patent appeals and Novartis’ appeal was transferred to the IPAB. In
*2009*, the IPAB rejected Novartis’ appeal on the ground that its patent
application did not satisfy section 3(d).

In *2009*, aggrieved by the order of the IPAB, Novartis approached the
Supreme Court. While Novartis did not directly challenge Section 3(d) as
it had before the Madras High Court, it argued for a liberal
interpretation of section 3(d).

*On 1 April 2013, the Hon’ble Supreme Court of India dismissed Novartis’


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