The Indian Patents Law categorizes certain inventions as not
inventions. Among these, the most discussed category is the Section
3(d), which prohibits patenting of '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'. The
"new form" has been further explained to include salts,
esters, ethers, polymorphs, metabolites, pure form, particle size,
isomers, mixtures of isomers, complexes, combinations and other
derivatives of known substance, and such new forms would be
considered as the same known substance unless they differ
significantly in properties with regard to efficacy.
The term efficacy or enhanced efficacy is not defined in the
Act, but the Supreme Court of India has now provided guidance in
deriving the meaning of the term 'enhanced efficacy', in
Novartis Vs. Union of India & Ors (2013) Case No.
2706-2716. The Court clarified that the test of efficacy would
depend upon the function, utility or the purpose of the product
under consideration. Accordingly, for a medicine that claims to
cure a disease, the test of efficacy is to be considered as
"therapeutic efficacy". For a vaccine, the test of
efficacy would be considered as "prophylactic
The Court has distinguished here between the intended or desired
use of the product as compared to the intended or desired use of
the invention. When assessing the novelty and inventive step, the
reference is made to invention. But while assessing the intended
use, the reference is made to the intended use of the product and
not the intended use of the invention. The implication of this
difference is illustrated with the following example.
Consider a compound X which is known. A new form the compound X
is developed, referred as NX. The compound X is for the treatment
of disease Y. The compound X is to be administered only orally in
solid dosage form, say tablets. However, the problem faced by the
industry is that compound X is very hygroscopic and hence, the
tablets are to be formulated in moisture-less conditions.
Maintaining moisture-less conditions throughout the process of
preparing and storing the active pharmaceutical ingredient (API),
and then formulating into tablets until it is packaged in suitable
container, adds substantially to the cost of manufacturing, leading
to high price of the tablet containing the compound X, which is
intended for treating disease Y. Assume that the price per tablet
comes to US$ 4. To solve this problem of formulation industry, the
new form NX was developed, which is sufficiently non-hygroscopic
and hence, a tablet formulation containing the compound NX can be
prepared under regular manufacturing conditions, which results in
reduction of the price of the tablet containing the new form NX,
and this is also intended for treating disease Y. The price per
tablet in this case comes to only US$ 1. We assume here that the
therapeutic efficacy of both the formulations is same or similar,
i.e., the new form NX does not show enhanced therapeutic efficacy
over the known form X.
If we apply the test as laid down by the Supreme Court, the new
form NX fails under Section 3(d), as the intended use of the
product NX is treatment of disease Y, but it does not have enhanced
If we consider the intended use of the invention, it has
significant benefit, i.e., solving the problem of hygroscopicity.
The intended use of the invention is to increase the manufacturing
efficiency, and if the intended use of the invention is to be
considered, enhanced efficacy can be shown in the manufacturing of
tablet formulation. Hence, NX is not patentable under Section
Further aspect of Section 3(d) is that, what is prohibited is
the "mere discovery" of a new form. For discovery of a
form, it would be assumed that such form already exists, but was
not known, and now has been discovered. If it can be shown that the
new form NX never existed, but has been manufactured synthetically,
then would it still be falling foul of Section 3(d), in absence of
enhanced therapeutic efficacy?
In the above-mentioned examination, the new form NX has failed
the test of Section 3(d). I wonder if I can study more so that in
the second attempt, the new form NX passes the test of Section
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This article enunciates the recent, much awaited, and landmark judgment delivered on September 16, 2016 by Hon'ble Delhi High Court throwing light on the important provisions of the Copyright Act, 1962.
Department of Industrial Policy and Promotion recently issued an office memorandum pursuant to receiving representations from various stakeholders for guidance with respect to the applicability of the provisions of Section 31D of the Copyright Act, 1957.
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