Claims relating to chemical composition have to always face an objection by the Indian Patent Office (IPO) that claims are statutorily non-patentable under the provision of clause (e) of Section 3 because the subject matter of the claims fall under the provision of section 3(e) of the Patents Act, 1970 (hereinafter the Act) as it relates to a known composition or mere admixture of known components which does not involve any synergistic effects. Therefore claims are not allowed u/s 3(e) of the Act.
To overcome this objection and obtaining patent for invention related to chemical composition in India, it is important to understand, Section 3(e) of the Act, which specifies what not inventions are. Sub-section (e) of Section 3 provides that, a substance obtained by a mere admixture resulting only in the aggregation of the properties of the components thereof or a process for producing such substance is not considered as an invention unless the functional interaction between the features of the components achieves a combined technical effect which is greater than the sum of the technical effects of the individual features.
Hence it is clear that two features of Section 3(e) are important one is mere admixture and second is aggregation of the properties.
To understand the Section 3(e), one has to clear about the term "mere admixture". In this regard the Hon'ble Bombay High Court in the matter of Lallubhai Chakubhai Jarivala v. Shamaldas Sankalchand Shah (1934) 36 BOMLR 881 has held that:
"A new combination may be the subject-matter of a patent although every part of the combination per se is old, for here the new art is not the parts themselves, but the assembling and working them together, which ex hypothesi is new. If the result produced by such a combination is either a new article, or a better article, or a cheaper article than before, such combination is an invention or a manufacture within the statute and may well be the subject-matter of a patent.
The merit of a new combination very much depends on the result produced. When a very slight alteration turns that which was practically useless into what is useful and important, the Courts consider that, though the invention was apparently small, yet the result being the difference between failure and success, it is fit subject-matter.
Where a slight alteration in a combination turns that which was practically useless before into that which is very useful and very important, Judges have considered that, though the invention was small, yet the result was so great as fairly to be the subject of a patent; and, as far as a rough test goes, 1 know of no better.
It seems to me on the evidence to be clear that the particular combination which gave satisfactory commercial results for the first time was only arrived at by the plaintiff after a year of experiments, and that no one else had arrived at a similar process, and further, that there was a demand in the market for whitened almonds-though why there should be such a demand I do not know. But the evidence is that there was a demand for these whitened almonds, and the merchants thought they could get a better price for almonds in that state than for almonds in their natural state; and, in my opinion, on the evidence the plaintiff has proved that he showed a sufficient amount of inventive genius in arriving at this method to justify the grant of letters patent in respect thereof."
From reading the above judgment one can understand that for preparing a mere admixture, its ingredients should be known and also their properties should be known. A mixture would be called as mere admixture, only when someone merely admix the known substances, with an expectation to get an additive effect of both the substances. However, when someone gets more than additive effect, the admixture is not mere admixture and is considered as synergistic composition. When a substance is not known at all, its properties are also not known, and hence, it is not possible to prepare an admixture of such an unknown substance. Hence, for this reason alone, the chemical compositions of the new substance/compound cannot be considered as mere admixture, because neither the compounds of such composition were disclosed in the prior arts, nor their any properties were known.
The Manual of Patent Office Practice and Procedure (MPPP) of the Indian Patent Office (IPO) states that an admixture resulting in synergistic properties is not considered as mere admixture, e.g., a soap, detergent, lubricant and polymer composition etc., and hence may be considered to be patentable.
Aggregation of the Properties:
Further to understand the Section 3(e), one has to clear about the term "Aggregation of the Properties". In Sabaf SpA v. MFI Furniture Centres Limited and others (2004) UKHL 45] case, the term aggregation has been discussed, which is as following:
9.5 Combination vs. juxtaposition or aggregation
"The invention claimed must normally be considered as a whole. When a claim consists of a 'combination of features', it is not correct to argue that the separate features of the combination taken by themselves are known or obvious and that 'therefore' the whole subject-matter claimed is obvious. However, where the claim is merely an 'aggregation or juxtaposition of features' and not a true combination, it is enough to show that the individual features are obvious to prove that the aggregation of features does not involve an inventive step. A set of technical features is regarded as a combination of features if the functional interaction between the features achieves a combined technical effect which is different from, e.g. greater than, the sum of the technical effects of the individual features. In other words, the interactions of the individual features must produce a synergistic effect. If no such synergistic effect exists, there is no more than a mere aggregation of features...
"The Guidelines for Examination of Patent Applications in the Field of Pharmaceuticals" of IPO cites that in Ram Pratap v Bhaba Atomic Research Centre (1976) IPLR 28 at 35, it was held that a mere juxtaposition of features already known before the priority date which have been arbitrarily chosen from among a number of different combinations which could be chosen was not a patentable invention.
The MPPP also advises to patent applicants that synergistic effect should be clearly brought out in the description by way of comparison at the time of filing of the Application itself. The subsequent submissions regarding synergism can be accepted in a reply to the office action as a further support of synergy. However, such submitted data may be incorporated in the Specification, subject to the provisions of Section 59 of the Act.
Requirement of Data to overcome the Section 3(e)
Basically in chemical composition related invention two types of claims are drafted to cover the invention related to admixture:
In composition claim, let say pharmaceutical composition, basically claimed composition having an active ingredient i.e., compound "A" with the pharmaceutically acceptable excipients. In this regard it may be noted that in India composition claim is patentable, if it having synergistic effect, i.e., claimed composition does not fall under Section 3(e). Accordingly to prove synergistic effect of the claimed composition, applicant has to provides therapeutic activity when required amount of compound "A" mixed with required amount of pharmaceutically acceptable excipients. Accordingly, following nature of data is required to overcome the Section 3(e) objection:
(a)Composition of compound "A" in claimed range with pharmaceutically acceptable excipients in claimed range in claimed range provides therapeutic activity.
(b)Composition of compound "A" in outside claimed range with pharmaceutically acceptable excipients in outside claimed range does not provide therapeutic activity.
In combination claim, for example the claimed invention is combination of the first compound "A" with 2nd active agent/ compound "B".
To pass the claimed combination under section 3(e), we need to show that the effect of Compound "A" and Compound "B" combination is not merely the additive effect of individual drugs, but more than that (synergistic effect).
Hence, mere placing side by side of old integers so that each performs its own proper function independently of any of the others is not a patentable combination, but that where the old integers when placed together has some working interrelation producing a new or improved result, then there is patentable subject matter in the idea of the working inter relations brought about by the collocation of the integers.
For example, claims related to a pharmaceutical compositions obtained by mere admixture resulting in aggregation of the properties of the individual components are not patentable under section 3(e) of Act. However, in a chemical composition if the functional interaction between the features achieves a combined technical effect which is greater than the sum of the technical effects of the individual features, it indicates that such a composition is more than a mere aggregation of the features.
Therefore to obtain patent for invention relating to chemical composition in India, role of synergistic data is important.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.