Where a patent application is made for a specific formulation or dosage composed of chemicals, the claim(s) is known as a composition claim. The composition claim describes the chemical elements used to generate the material or process.
Chemical Composition Claims in Indian Patent Law
Under Indian Law, two key provisions of the Act govern the patentability of composition claims. In addition to the basic requirement that the invention must be novel, include an inventive step, and have some industrial application,[1] composition claims also need to overcome the hurdle under s 3 of the Act, which defines non-patentable subject matter.
Section 3(e) of the Act 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 an invention.
The merits of a composition claim depend on the result produced by the combination. Where a combination of known components results in 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.” [2] Therefore, to be successful, a composition claim needs to demonstrate that the interaction between the components results in a synergistic[3] effect different from the components’ aggregate effects. In Ram Pratap v Bhaba Atomic Research Centre (1976) IPLR 28, it was held that a mere juxtaposition of features already known before the priority date, which have been arbitrarily chosen from among several different combinations which could be selected, was not a patentable invention.
Synergistic effects in patent claims in India
While the term synergism is not defined in the Act, taking its ordinary meaning, it refers to the interaction of substances or other agents to produce a combined effect greater than the aggregate of their separate effects. The Manual of Patent Office Practice and Procedure (MPOPP) of the Indian Patent Office distinguishes a combination invention from a mere aggregation highlighting that the former “requires that the relationship between the features or groups of features is one of functional reciprocity or that they show a combinative effect beyond the sum of their individual effects”.[4] In IPA No. 10885/DELNP/2015, a composition claim was held to be not patentable under s 3(e) of the Act as the resultant improved effect was only because of how it was administered rather than due to the interaction of the constituent parts of the composition. A synergistic effect can arise from the ratio of known components present in the composition.[5] For example, in IPA No. 201711028226, a claim for a repellent composition was held to be patentable as the specification highlighted the non-obvious and unexpected effect resulting from a 3:2 combination of the components. It is important to note that Section 3(e) is applicable only when a composition includes known components. The applicant does not need to demonstrate synergism when a composition contains a novel component.[6]
Merely claiming a synergistic effect will not automatically overcome the barrier under s 3(e); the burden lies on the applicant to submit evidence relating to the effects of the individual components and their combined results. The MPOPP states that the synergistic effect should be clearly brought out in the description by comparison at the time of filing the Application itself. While submissions regarding synergism can be submitted in response to office action at a later stage, they will be subject to the provisions governing the amendment of claims under s 59 of the Act. In Willowood Chemicals Private Limited v Assistant Controller of Patents & Designs (OA/53/2020/PT/DEL), the Assistant Controller of Patents & Designs rejected a combination claim on the ground that the Application failed to provide data demonstrating the synergistic effect, although the description section of the patent application explicitly disclosed such data. IPAB set aside the Controller’s decision and granted the Appellant a patent on the ground that the complete specification discloses synergistic data. Failure to evidence synergetic data can also lead to the revocation of a patent. A patent titled “injectable preparations of Diclofenac and its pharmaceutically acceptable salts” (IN231479) was revoked under s 3(e) on examination following a post-grant opposition. The opposition board observed: “Explicitly, the composition must noticeably show synergistic effect in respect of ‘reduction of pain’ as the same has claimed to address the said problem. However, there is no data provided in the specification which proves that there is a reduction in pain at the site of injection. In fact, not a single example provided in the composition could prove there is a reduction in pain while injecting.”
While section s 3(e) presents a bar to substances obtained by a mere admixture, s 3(d) bars the patentability 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 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 known process results in a new product or employs at least one new reactant. Explanation. -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.” A literal interpretation of the provision makes it clear that for a new form of a known substance, the new property of a known substance, or the new use of a known substance to be patentable, the applicant must evidence the enhancement of efficacy. Similar to the procedure under s 3(e), to rebut a Section 3(d) objection, an applicant must submit comparative data on the efficacy of the known and new substances/forms/properties.
The above provisions are exclusive to the Indian patent landscape and aim to prevent ever-greening by modified compositions. To overcome the bar under these provisions, it is essential to draft the specification to include sufficient data highlighting synergism/efficacy.
[1] s 2(1)(j), Patents Act 1970
[2] Lallubhai Chakubhai Jarivala v. Shamaldas Sankalchand Shah (1934) 36 BOMLR 881
[3] https://ipindia.gov.in/writereaddata/Portal/Images/pdf/Manual_for_Patent_Office_Practice_and_Procedure_.pdf at pg 91
[4] ibid
[5] Lallubhai Chakubhai Jarivala v. Shamaldas Sankalchand Shah (1934) 36 BOMLR 881
[6] OA/16/2016/PT/KOL
