In almost all jurisdictions around the world, patentability requirements for the grant of a patent are relatively similar. The claimed invention must be novel, should possess an inventive step, and should also have industrial applicability. However, this three-fold test is preceded by an additional patentability requirement, which is statutorily recognized in India under Section 3 of The Patents Act, 1970. Authorities in India have unanimously reiterated many times that the invention must pass the patentability requirements under Section 3 before we could assess the invention for having novelty, inventive step, and industrial applicability. One such preliminary patentability requirement is provided under Section 3(e) of The Patents Act, 1970 which states 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 an invention. The Indian Patent Office majorly uses Section 3(e) in inventions relating to chemical, pharmaceutical, and biotechnology compositions.
👉 So, when an inventor mixes two components, the resultant substance obtained must not possess the aggregation of properties of these two individual components. In case it results only in the aggregation of properties of the individual components, neither the substance obtained nor the method of producing such a substance will be an invention.
⚡ Now the major question arises – if not the aggregation of properties of the components, then what should be the properties possessed by the substance be obtained? For this, Indian authorities have devised a concept of “synergistic effect” to be shown by the substance obtained when two or more components are mixed together. This concept was first discussed in Sabaf SpA v. MFI Furniture Centres Limited and others (2004) UKHL 45 in which the Court said “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 ‘Manual for Patent Office Practice and Procedure’ further elaborates this requirement as “the relationship between the features or groups of features be one of functional reciprocity or that they show a combinative effect beyond the sum of their individual effects. The synergistic effect should be clearly brought out in the description by Section 3(e) by way of comparison at the time of filing of the application itself.”
📌 Now, how does the Controller or a judicial authority accept that the substance obtained possesses a ‘synergistic effect’? For this, the Indian authorities require experimental data and examples to compare the properties of individual components with the properties of the substance obtained. It is the applicant who has the burden of proving a ‘synergistic effect’ in the properties of the ‘substance obtained’.
📌 Generally, if the ‘useful range’ of components/ingredients used in the composition is substantially proven by data, then the Controller is more inclined to infer that the ingredients are not arbitrarily chosen and helps the applicant to establish the synergistic effect of the substance obtained. In Patent Application No. 779/KOLNP/2012, the Controller allowed the grant of a patent because “evidences were able to show that every ingredient of the inhaler has not been arbitrarily chosen, but is in the useful range for having one component in suspension and another one in solution and exhibiting technical advancement/synergistic effect”.
📌 Along with the objection raised under Section 3(e), the Examiners are cheeky enough to find separate prior arts for each of the individual components of the composition where there is no possible link between the prior arts mentioning the individual components. They cite the prior arts and object that the composition to be ‘obvious to the person skilled in the art’ even though no one on the earth could predict the unexpected properties of the components when the individual components are mixed together in a particular ratio. Most of the known components existing in the world are mentioned in some or the other prior art. If the assertion by the Examiners that ‘it would be obvious to the person skilled in the art to mix the known components mentioned in the prior art’ is considered to be true, then all the compositions made using known components around the world would be ‘obvious’ even though they are showing ‘synergistic effect’. These kinds of finding by the Examiners discourage the inventors from experimenting with the known components, resulting in the loss of unexplored opportunities.
📌 Now, assume that a substance is obtained by mixing two components in which one of the components added was itself novel. Does the applicant still have to show a “synergistic effect” in the substance obtained? For this, thankfully IPAB in Stempeutics Research Pvt. Ltd. vs. Assistant Controller of Patent & Designs 2020 SCC OnLine IPAB 16 has held that “the applicability of Section 3(e) is valid only in scenarios where a claimed product is obtained by combining known or already existing ingredients, and the burden of showcasing synergistic effect for such product is therefore necessary, meaning thereby, a product or composition comprising a novel ingredient cannot fall under the ambit of Section 3(e) of the Act.” So, the question of a substance obtained possessing “synergistic effect” does not arise when one of the components mixed is novel.
📌 Whereas, in case the components mixed together are already known, not only proving the synergistic effect becomes essential, but sometimes the Examiner raises an additional objection under Section 3(d) that the ‘substance obtained’ is a new form of a known substance not resulting in the enhancement of known efficacy.
📍 Section 3(d) of The Patents Act, 1970:
It states 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 or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, the machine or apparatus unless such known process results in a new product or employs at least one new reactant” is not an invention.
⚡ When the Patent Office objects to the patentability of ‘substance obtained’ under both Sections 3(d) and 3(e), applicants often try to overcome both objections in one go as Section 3(d) requires the ‘enhancement of the known efficacy of the known substance’. They intertwine the ‘synergistic effect’ under Section 3(e) with the ‘enhancement of the known efficacy of the known substance’ under Section 3(d).
The applicants typically overcome this Section 3(d) objection by citing the synergistic effect of the composition required under Section 3(e). They argue that, since the composition claimed possesses the ‘synergistic effect’, we can easily infer that the composition also possesses the ‘enhanced efficacy’.
But recently in Best Agrolife Limited vs. Deputy Controller Of Patents And Ors. W.P.(C)-IPD 11/2022 (Decided On 07th July 2022), the IPD bench of the Delhi High Court headed by Honorable Ms. Justice Jyoti Singh has clarified the application of Section 3(d) on composition claims. She held that overcoming Section 3(e) objection is not always sufficient to overcome Section 3(d) objection, even in composition claims.
The bench observed that the applicant has to pass the test under both Section 3(d) and 3(e) separately. That’s why the legislature has enacted two different provisions and the tests for both are different. The bench held that “the applicant would have to pass the test under both Section 3(d) and 3(e), albeit on different aspects by showing enhanced efficacy over known combination of a suspo-emulsion under Section 3(d) and synergistic effect over the mere additive effect of individual components of suspo-emulsion composition”.
This decision also gave clarity on how the ‘form of a known substance’ under Section 3(d) differs from the ‘admixture’ in Section 3(e). The bench observed “This Court also finds prima facie merit in the contention of the Petitioner that synergistic effect can be demonstrated by a combined effect of increase in bio-efficacy and stability of the admixture beyond the sum of their individual effects. However, if bio-efficacy/stability is to be tested in respect of Section 3(d), the test would be bio-efficacy/stability of the form, i.e., suspo-emulsion in this case and not the admixture, over and above the closest prior art brought forth by the opposer, which is the known substance as a comparator.” From the above paragraph of the decision, we can conclude that Section 3(e) does not require the synergistic effect to be shown in the obtained ‘form’ and only requires the synergistic effect to be shown in the ‘combined admixture’.
The decision has definitely increased the standard of patentability requirement under Section 3, particularly for the composition claims. However, the tests required to be passed under both Section 3(d) and 3(e) separately by the applicants will encourage genuine inventions, at the same time will keep a check on the ever-greening of the patents.
After discussing most of the aspects of Section 3(e) of the Patents Act, we can say that there is still a substantial scope left to develop the jurisprudence in interpreting this provision by the Indian Courts. We will definitely observe the development in this regard as the patents having composition claims are being filed and opposed more than ever in recent times.
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