On 1 April 2013, The Supreme Court in India dismissed Novartis
AG's appeal for patent protection for its cancer drug
The application sought to protect the beta crystalline form of
Imatinib Mesylate. However, the court ruled that Imatinib
Mesylate was disclosed in a patent application filed previously by
Zimmermann (Imatinib is a derivative of N-phenyl-2-pyrimidine-amine
and Imatinib Mesylate is a methanesulfonic acid addition salt of
this). The court then sought to determine whether the beta
crystalline form of Imatinib Mesylate could be considered to be a
new product and patentable under Indian law.
The main consideration of this point took into account section
3(d) of the Indian Patents Act, which sets out some exclusions to
patentable subject matter in India. In particular relevance
to this case, Section 3 (d) indicates that
"the mere discovery of a new form of a known substance
which does not
result in the enhancement of the known efficacy of that
substance" may not constitute an invention. In the
explanatory notes to this section, it is stated that "For the
purposes of this clause, salts, esters, ethers, polymorphs,
metabolites, pure form, particle size, isomers, mixtures of
isomers, complexes, combinations and other derivatives of known
substance shall be considered to be the same substance, unless they
differ significantly in properties with regard to
In this case, although the beta crystalline form of Imatinib
Mesylate had been shown to possess some advantageous properties
over the known compounds, the court indicated that
therapeutic efficacy needs to be enhanced in order
for an adapted compound to be considered to fall outside of the
Section 3(d) exclusion. Since this was not demonstrated in
the court's opinion, the beta crystalline form of Imatinib
Mesylate was found to be unpatentable.
The section 3(d) requirement discussed above is a feature of
Indian law that is present to prevent "evergreening",
i.e. to prevent a monopoly being created for drugs simply by making
minor changes to compounds in order to achieve further patent
protection. However, this novelty-type exclusion to
patentability seems to be a peculiarity to Indian law, as is
evidenced by the fact that Novartis have achieved patent protection
for their product in nearly 40 other countries worldwide. In
this case, Novartis had not previously enjoyed patent protection
for Glivec in India and it seems that this decision may effect
investment in R&D and innovation in India made by
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guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
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