The Delhi High Court, in a recent decision in Alimentary Health Ltd. v. Controller of Patents and Designs, set aside the patent refusal order issued by the Assistant Controller of Patents and Designs (“Controller”) in respect of patent application No. 3989/DELNP/2012 and referred the matter for fresh examination. This post summarises the Court’s stance on the objective analysis of inventive step under Section 2(1)(ja) of the Patents Act, 1970.
Brief Facts
Alimentary Health Ltd. (“Alimentary”) filed a PCT national phase application tilted “PROBIOTIC BIFIDOBACTERIUM STRAIN” in India, disclosing a formulation containing a novel probiotic strain of Bifidobacterium longum, designated as NCIMB 41676 (AH1714), at concentrations exceeding 106 colony-forming units (cfu) per gram, combined with an ingestible carrier.
In the First Examination Report (FER), the Patent Office raised objections citing lack of inventive step under Section 2(1)(ja) and deemed the invention non-patentable under Sections 3(c), 3(d), and 3(i) of the Act. In response, the claims were amended and limited to a set of 13 claims from the original 38. Despite providing detailed responses during a subsequent hearing and further written submissions, the Controller rejected the application stating that the invention lacked inventive step and was not significantly different from existing knowledge. The refusal was based on five prior art documents which, according to the Controller, rendered the isolated strain of Bifidobacterium and its probiotic formulation obvious by applying the teachings, suggestions, and motivations in these documents.
Claims of the Application
The independent claim of the application, as amended, reads as follows:
“A formulation comprising a strain of Bifidobacterium longum NCIMB 41676 (AH1714), wherein the Bifidobacterium longum NCIMB 41676 strain is present in an amount of more than 106 cfu per gram of the formulation; and an ingestible carrier wherein the ingestible carrier
is a pharmaceutically acceptable carrier such as a capsule, tablet or powder or is a food product such as acidified milk, yoghurt, frozen yoghurt, milk powder, milk concentrate, cheese spreads, dressings or beverages.”
Alimentary challenged this refusal, arguing that the Controller overlooked the experimental data demonstrating unique immunomodulatory effects of the novel strain of Bifidobacterium longum and its technical superiority over other strains. The applicant contended that while the Controller acknowledged the novelty of the strain and its formulation, and deemed the formulation patentable under Sections 3(c), (d), and (e), the patent was denied on ground of lack of inventive step. It was also argued that the Controller failed to consider the grant of patents in other jurisdictions, such as Europe and the United States, despite similar prior art citations.
Court’s Analysis
The court observed that the key issue in the matter was whether the characteristics and benefits of the strain represented a substantial improvement in therapeutic efficacy over existing solutions, thereby satisfying the criteria of an inventive step beyond the known properties of other Bifidobacterium strains.
Citing the landmark judgments of Biswanath Prasad Radhey Shyam v. Hindustan Metal Industries Ltd. and Hoffmann-La Roche Ltd & Anr. v Cipla Ltd, the Court emphasized the need for an objective assessment of obviousness and inventive step, anchored in the technical knowledge and capabilities of a person skilled in the art as of the priority date. The court also highlighted the importance of avoiding hindsight bias, and stressing that the inventive step should be assessed solely based on publicly available information before the priority date of the patent application.
The Court asserted that an objective analysis of inventive step is crucial to foster genuine innovation, prevent the monopolisation of trivial enhancements, and avoid the patenting of minor, easily achievable improvements, thereby promoting meaningful technological progress. The Court emphasised that the core principle for evaluating obviousness is to determine whether the invention represents a significant, non-obvious advancement, rather than a simple substitution of known elements or an “obvious to try” scenario.
The Court evaluated the obviousness of the invention considering the cited prior art, technical advancements, and prior judicial decisions. It observed that the formulation demonstrated synergism and enhanced efficacy, concluding that the invention was not obvious to those skilled in the art, thereby meeting the requirements for patentability.
The Court further criticized the order of the Controller for lacking a persuasive and detailed analysis of the prior art documents. It emphasized the Patent Office’s obligation to provide a ‘speaking order’ with a comprehensive comparative analysis of the existing knowledge and the claimed invention. The Court stated that the Controller should have elucidated how a skilled person could logically and predictably progress from existing knowledge to the claimed invention. Absent such analysis, rejecting a patent application for lacking an inventive step is unjustified unless the lack of inventiveness is clearly evident. Therefore, the Court reached the conclusion that refusal on grounds of lacking an inventive step were not sustainable, and the appeal was allowed. The Court also added that the grant of the applicant’s corresponding patent applications in other jurisdictions should have been considered.
Conclusion
The Court ultimately set aside the impugned order and remanded the matter for a limited revaluation of the formulation. The re-evaluation was deemed necessary because the applicant initially claimed the strain itself but later amended the claims to focus on a strain-based formulation, which the Controller had not adequately examined. The Court also directed the Controller to determine if the claimed formulation involves a specific dosage or method of administration for using the strain, potentially contributing to technical advancement, and to assess if the claims pertain to the second medical use of the strain.
Authored by Dr. Neetha Mohan, Patents Team, BananaIP Counsels
Citation: Alimentary Health Limited v. Controller of Patents and Designs, C.A.(COMM.IPD-PAT) 458/2022
Relevant Paragraphs
“12. For our analysis on inventive steps, the decision of the Supreme Court in Biswanath Prasad Radhey Shyam v. Hindustan Metal Industries Ltd.3 and Hoffmann-La Roche Ltd & Anr. v Cipla Ltd.,4 serve as the foundation. These rulings underscore the necessity for an objective assessment of obviousness and inventive step, which should be firmly anchored in the technical knowledge and capabilities of a person skilled in the art as of the priority date.”
“14. In evaluation of the inventive step in patent law, the jurisprudential guidelines established through judicial precedents emphasize the importance of avoiding hindsight bias. This is crucial to ensure that the inventive step is assessed based solely on the information that was available to the public before the priority date of the patent application.”
“15. The objective analysis of inventive step helps to foster genuine innovation and discourage the monopolization of trivial enhancements that do not substantially enrich the technical field. By doing so, it ensures that only those advancements that provide a substantial benefit to the technical field are protected by patents. It also helps prevent the patenting of mere incremental advancements or “workshop improvements” that a skilled craftsman could likely achieve without exerting an inventive effort. (see: Biswanath Prasad Radhey Shyam (supra).”
“20. Therefore, consistent with established jurisprudence on this matter, the mere presence of individual elements of an invention in prior art documents does not, in itself, conclusively establish obviousness. To determine obviousness, there must be a clear coherent thread from the prior art(s) to the invention, and this path should be straightforward. The coherent thread should lead from the prior art to the invention, suggesting a logical and foreseeable progression of technology or methodology. An inventive step requires more than just assembling known elements; it involves a nonobvious conceptual leap that would not be readily deduced by someone with ordinary skills in the field without the benefit of hindsight. The inventive step should not simply be an obvious next step based on prior art but should involve a significant, non-obvious advancement that could not be easily deduced by a skilled practitioner at the time of the invention. It is essential to discern whether the invention represents “a simple substitution of one known element for another to obtain predictable results” or if it constitutes an “obvious to try” scenario—choosing from a finite number of identified, predictable solutions with a reasonable expectation of success. The core principle is thus: whether the invention is actually obvious or merely appears obvious in hindsight due to our current knowledge. If it is the latter, it is hindsight bias and is unacceptable. However, if the coherent thread is evident, the subject patent shall not be denied on account of obviousness.”
“26. This Court has time and again held that the Patent Office must issue a ‘speaking order,’ with detailed comparative analysis of the existing knowledge and the claimed invention while deciding the objection of section 2(1)(ja) of the Act. The decision in Agriboard International (supra) reiterates this requirement, drawing upon the Supreme Court’s ruling in Manohar v. State of Maharashtra & Ors.9 which underlines the necessity of application of mind and recording of reasons as fundamental elements of natural justice, particularly while rejecting patent applications.”
