A specific formulation or dosage form of an active/functional element either alone or with the essential compatible components and carriers for the intended use is usually defined in terms of the combination/composition claims. These claims are important in chemical, pharmaceutical and biotech sectors wherein the invention is usually related to preparing a formulation using a combination of multiple components. Product patents related to food and medicines were not patentable prior to 2005, only the process/method of their preparation was allowed. However, the inclusion of criteria of what is not patentable as suggested under Ayyangar committee report, 1959 under Clause 3(d) “a substance prepared or produced by a chemical process or intended for food or medicine other than a substance prepared or produced by any method or process of manufacture particularly described in the complete specification of the invention or by its obvious chemical equivalent”. The said clause enumerates that mere admixture by aggregation of the known properties of individual components will not be considered as patentable. When the patent statute 1970 came into force the committee’s recommendations were accepted and said clause adopted Section 3(e) of the Indian Patents Act. Generally, claims directed to compositions, combinations, and kits are evaluated under the said provision.
In India, combination/composition claims are allowable subject to satisfy the obligation under Section 3(e) of the Act which precludes patentability of ‘a substance obtained by mere admixture resulting only in the aggregation of the properties of the components thereof or a process for producing such substance. In other words, claims related to compositions obtained by mere admixture resulting in aggregation of the properties of the individual components are not patentable. Thus, the said provision acts as a barrier for ever-greening of the modified compositions and explicitly bars the patentability of pharmaceutical admixtures having no synergistic effect. However, the functional interactions among the components would be considered patentable if the combination/composition results in synergistic effect which is greater than the effects of the individual elements. As an example, the pharmaceutical composition claims cover one or more active pharmaceutical ingredient(s) and functionally acceptable carriers or excipients, such as fillers, binders, diluents, disintegrant, and lubricants, etc. The additional carriers or excipients may or may not have any therapeutic value. It is pertinent to note that mere aggregation of features must be distinguished from a combination invention which essentially requires that the features or groups of features must have the functional reciprocity in order to show a combinative effect beyond the sum of their individual effects or activity. These features should be functionally linked together which is the actual characteristic of a combination invention.
In general, all the substances produced by mixing components or a process of producing such substances should satisfy the requirement of the synergistic effect in order to be patentable under Indian Patents Act. It is also important that synergistic effect should be clearly brought out in the description by way of comparative examples at the time of filing of the specification itself. However, the subsequent submissions regarding synergism are also accepted in a reply to the first examination report or in the written submission of hearing as the case may be. However, such submitted data may need to be incorporated in the specification, subject to the provisions of Section 59 of the Indian Patents Act which restrict the amendment which is beyond the scope of originally filed specification. Further, Section 104-105 of the Act confirmed that the onus lies on the patentee to prove the synergistic effect of the composition/combination. Hence, it is necessary to establish the synergy for the invention directed to composition/combination. It is imperative that in general the inventiveness and requirement of synergy are combined together to evaluate the patentability of an invention. Considering an example of a pharmaceutical drug, wherein the composition includes various components particularly in a definite ratio which exhibits the optimum activity for the designed treatment. In such case the synergistic effect can be evaluated from the parameters such as stability, dissolution and bioavailability which are directly related to the efficacy of the composition. It is also important that preparing a stable composition using the various components and its optimization for intended use which is not disclosed in the prior arts is synergistic as well.
Prevailing jurisprudence on this important issue has largely been interpreted in case of Ram Pratap v Bhaba Atomic Research Centre (1976) IPLR 28, wherein 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. Further, in case of Lallubhai Chakubhai Jarivala v. Shamaldas Sankalchand Shah (1934) 36 BOMLR 881, the Court identified 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 hypothesis 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. Regarding the merit of combination, it was held that “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.”
Based on the settled legal interpretation and analysis of the decisions issued regarding Section 3(e) objection in pharmaceutical cases, it appears that the Indian Patent Office (IPO) usually accepts the synergism data in terms of the efficacy wherein the resulting activity of the chemical composition is greater than what is observed by the mere addition. It is generally understood that an invention must provide unexpected advantages that were previously unrecognized and recognition of such configuration will results in a synergistic mixture. The pharmaceutical dosage forms such as tablets, capsules, injections etc. will be considered as an article wherein 3(e) does not apply. Further, the increased stability and reduced degradation of formulation has been considered by IPO to overcome the said objection. However, for pharmaceutical inventions, not all types of data are considered to satisfy Section 3(e) requirement or meet the synergistic effects such as improved activity and enhanced efficacy in treatment or prophylaxis of any ailment correlated to comply with the requirement of Section 3(d) of the Act. Further, claiming the synergy by means of their intended function (functional aspects) was not allowed by the IPO.
The Patent Office usually accepts the ratio/percentages in the claims which denote that the composition is optimized in terms of the particular strength for the intended function. Further, the functional interactions among components of a composition/combination and its interpretation as an enhanced activity based on the data in the specification are accepted. It is to be noted that the synergistic effect should not be interchangeably used with the efficacy and it is also important to be careful while submitting the synergistic data and its interpretation in the specification.