Scope, Implications Of Section 3(d) Of The Indian Patents Act, 1970 (As Amended)
Under Indian patent law, there are certain inventions which are deemed specifically not patentable.
These are identified in Section 3, and the sub-clause of that section which is relevant with respect to the infamous Novartis case pending before the Chennai High Court and now also IPAB [Intellectual Property Appellate Board] is sub-clause (d) of Section 3.
The relevant Section 3(d) of the amended Indian Patents Act, 1970 as amended by The Patents (Amendment) Act, 2005 is reproduced hereafter:
“3. What are not inventions – the following are not inventions within the meaning of this Act,
Section 3. (d):
The mere discovery of a new form of a known substance which does not result in increased efficacy of that substance
or the mere discovery of any new property or new use for a known substance
or of the mere use of a known process, machine or apparatus unless such process results in a new product
or employs at least one new reactant.
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 efficacy.”
From the manner in which this section is worded, it will be apparent that in order that the underlined portion of Section 3(d) is attracted the following conditions must be satisfied:
1. What is claimed must be a mere discovery;
2. What is claimed must be a new form of a known substance; and
3. Such substance claimed does not result in increased efficacy over known substance.
If any of the above-mentioned three conditions are not met, Section 3(d) cannot and should not be applicable.
A detailed analysis of the claimed subject matter in respect of each of these conditions is set out hereunder:
(1) Mere discovery:
In contradistinction to the expression “invention” (defined in Section 2(1)(j) of amended Indian Patent Act, 1970), the expression “discovery” has not been defined in any section of the Indian Patent Act or any rules thereunder. This is not in any way incongruent with the patent acts of any other jurisdiction throughout the world since in almost invariably none of the national legislation the expression “discovery” has been delineated.
Therefore, one of the logical conclusions to be derived with respect to the usage of the expression “discovery” in the Act is that it has been used in the sense used in common everyday English language.
According to the Webster’s Third International Dictionary of the English Language, the expression “discovery” refers to “the act, process or an instance of gaining knowledge of or ascertaining the existence of something previously unknown or unrecognised.” Therefore, unlike “invention” which refers to a new product or process involving inventive step and capable of industrial application (Section 2(1) (j) of the Patents Act, 1970), “discovery” essentially refers to finding out something which already existed in nature but was unknown or unrecognised.
Accordingly, a claimed invention would have to relate to a something (be it chemical entity, biological sequence etc.) which in some form or other existed in the natural environment to be considered a discovery.
With respect to biological inventions, a chimer protein which is artificially engineered and represents a new product (not normally found together in nature) resulting from a biotechnological process, should be considered as “invention” (patentability is of course subject to fulfilment of other requirements of national law). Therefore, a claimed product, which has been constructed or engineered in a laboratory to meet specific problems faced by existing art in the field through the use of recombinant DNA technology (i.e., involving substantive human intervention), can, by no stretch of imagination, be termed a “mere discovery”.
(2) New form of a known substance:
It will be clear from the combined reading of underlined portion of Section 3(d) and the explanation thereto that an objection under the underlined portion of Section 3(d) can justifiably be raised only with respect to cases where the patentability of a new form of already known chemical substances is in question.
The explanation to Section 3(d) lays down very exhaustively the breadth of the expression “new form” and sets out classes of entities that would be considered to be the “same substance”. Factually, the expression “other derivatives of known substance” appearing in the explanation is, in my opinion, too broad in its ambit to include almost any possible derivatives of the known substance one can think of.
The examples of the new form of known substances which should be considered as same substance stated in this explanation are further qualified by the words “unless they differ significantly in properties with regard to efficacy.”
Pages 138 to 141 of Annexure 1 to the Indian Patent Office’s Manual, 2005 define the forms mentioned in the Explanation to Section 3(d) which is a welcome step since such definition would broadly give an indication to the world as to the exact nature of forms expected in the explanation, despite the fact that the forms stated in the explanation would be evident to a person skilled in the art.
(3) Does not increase efficacy:
The new forms of known substance should therefore be deemed unpatentable only so long as they do not show any “enhanced efficacy” or in other words do not differ significantly in properties with regard to efficacy.
One logical conclusion that can be derived from the wording of the underlined portion of above-stated section is that in case the new form of a known substance results in enhancement of efficacy, then such new form is patentable under Section 3(d) as amended. However, the most pertinent question to be answered is whether an enhancement of efficacy howsoever insignificant would pass muster in respect of the requirement of efficacy under section 3(d). In my humble opinion, the answer to such a question should be in the negative.
This in view of the fact that a reference as to how much enhancement of efficacy is expected is to be found in the underlined portion of the explanation to Section 3(d) which makes it clear that new form of known substances are allowable only when such new forms of the known substances differ significantly in properties with regard to efficacy. So the criterion is not any trivial increment in efficacy but significant improvement in the efficacy of the new over the known substance.
With respect to a pharmaceutical chemical entity, this substantial increased efficacy should form the crux of an invention directed to a new form of known substance and such increased efficacy should clearly be enunciated in the various portions of the description and possibly highlighted in the claims as well. The efficacy can be in the form of enhanced stability or freedom from specific disadvantages or even perhaps increase in bioavailability but it should not be an eye-wash increment in efficacy but a significant increment.